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TMI Blog2012 (9) TMI 1129X X X X Extracts X X X X X X X X Extracts X X X X ..... s and diagnostics. It is stated in the plaint that for the purpose of research and development, the said plaintiff engages inter alia into collaborative agreements and alliances with numerous partners and invests approximately 7 billion Swiss Francs in such activities. 2. It is averred in the plaint that the plaintiff No. 2 jointly owns a patent with Pfizer Products Inc. in respect of a small drug molecule medically termed as a Human Epidermal Growth Factor Type-I/Epidermal Growth Factor Receptor (HER/EGFR) inhibitor which is popularly known as 'Erlotinib' (pronounced as err-lot-i-nib). This drug marked a major breakthrough and innovation in the treatment of cancer and is used to destroy some types of cancer cells while causing little harm to the normal human cells. Various tests conducted on this drug have shown a marked increased in the survival benefit in the patients suffering from advanced or metastatic non small cell lung cancer, the metastatic NSLC is most prevalent form of NSLC being the most prevalent form of this cancer. 3. This drug is administered in the form of a tablet. The tablet formulation of Erlotinib is sold by the plaintiffs under the trademark and nam ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... its importance in the cancer treatment. 6. The case of the plaintiffs against the defendant is that the defendant is also engaged in manufacture and marketing of pharmaceutical and health care products in India and the plaintiffs had learnt that the defendant is involved in several actions for violation of intellectual property rights including patent rights as the plaintiffs noticed from various news reports appearing in the print as well as electronic media about the plans of the defendant to launch a generic version of the drug Tarceva (Erlotinib) in India and also for exporting the same to various countries. One of such reports appeared on 11th January, 2008 in an English daily "Mint" published by the Hindustan Times Group and from the aforesaid report, for the first time the plaintiffs came to know about the plans of defendant to infringe and violate legal rights of the plaintiffs with regard to patent. 7. The claim of the plaintiffs is that provision of Section 48 of the Patent Act, 1970 provides for exclusive right of the patentee of a product or a process to prevent any third parties from non-consensual usage of the product or the process. Section 68 provides t ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... icant/ defendant had recently discovered that the suit patent is a mixture of Polymorph A and B and Tarceva is Polymorph B version of the compound namely Erlotinib Hydrochloride. Time was sought by the plaintiffs to file the reply. 10. In the written statement, the following defences are raised by the defendant: a) The plaintiffs have not filed the copy of the specification. b) The patent of the plaintiffs has been granted under suspicious circumstances, c) No documents which vest any right in plaintiff No.1 of ownership or right to sue have been placed on record, d) The patent in question is liable to be revoked, It only sought to improve from the existing prior art as Quinazoline compounds are known to inhibit growth have been used as anti cancer treatment and are available in the market for treatment of various cancers, Thus, it is a derivative of a known compound and hence not patentable under Section 3(d) of the Indian Patent Act. e) The plaintiffs in a subsequent patent filed in the United States Patent Office have admitted the short comings in the patent in issue. The details of the same are mentioned in the counter claim filed by the defendant. f) The plaintiff ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ust, 2008 and on 27th September, 2008 replication to the written statement of the defendant was filed by the plaintiff. 13. The order was reserved in I.A. No. 642/2008 under Order XXXIX, Rule 1 & 2 CPC. The injunction application of the plaintiffs was dismissed vide order dated 19th March, 2008. The operative para-87 of the order reads as under: 87. The result of the above discussion is that the plaintiff is not entitled to claim an ad-interim injunction, in the terms sought. However, this Court is not unmindful of the fact that if no equitable balancing order protecting its interest is made at this stage, there is a likelihood of the plaintiff being prejudiced at the final stage. Therefore, the defendant is hereby directed to: i) Furnish an undertaking to this Court, within two weeks, to pay damages in the event of the suit being decreed. A director or other person, on behalf of the Defendant duly authorized by a specific resolution of its Board of Directors, shall execute the undertaking. The undertaking shall also include a stipulation that it would continue to bind the Defendant, regardless of its change in composition. ii) Towards effectuating direction (i) above, maint ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... rties shall complete their pleadings. The plaintiffs were given four weeks time to file the replication to the written statement in the suit and written statement to the counter claim. The defendant was given two weeks time thereafter to complete its pleadings. 18. In the plaintiffs' application, being I.A. No. 12872/2008, the Court also extended the time to file the documents within eight weeks on behalf of both the parties. The matter was listed before the Joint Registrar on 13th January, 2009 for admission/denial of the documents and before Court on 24th February, 2009. On 13th January, 2009, two documents were admitted by the defendant, being Ex.P-1 and Ex.P-2. The documents of the defendant were admitted by the plaintiffs which were exhibited as Ex.D-1 to Ex.D-14 at the time of admission/denial of the documents. 19. When the matter was listed before this Court on 24th February, 2009, the order was passed in I.A. No. 12762/2008 with the consent of the parties that the evidence be got recorded by a retired Additional District Judge Sh. S.N. Chopra as a Commissioner and the matter was sent to him on 1st April, 2009 for fixing dates for cross-examination of witnesses. Partie ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... itor, Journal of clinical Oneology Vol 19, No.13 (July 1), 2001 PP 3267- 3279 Ex PW1/X2 Pfizer Investigators brochure Ex PW1/X3 Journal of clinical oneology Vol. 25, No.18, June 20, 2007 "Phase II study of Erlotinib in Adv non small cell lung cancer....." Ex PW1/X4 Cancer research 57, 4838 - 4848, Nov 1, 1997 "Induction of Apoptosis & Cell cycle arrest ....tyrosine kinase" Ex PW1/X5 Article - The current situation : Erlotinib.... Cancer, the Oneologist 2005 : 10467 (Ex 2/5 is affidavit) Ex PW1/X6 The new England journal of medicine July 14, 2005. (12/2) of affidavit) (Pw 1/x6) Ex PW1/X7 (2/4 of aff) article - Symptom improvement in lung cancer....Journal of clinical oneology Aug 10, 2005 (PW 1/x8) Ex PW1/X8 (ex 2/10 in aff) article - Erlotinib plus gemcitabine Journal of clinical PW 1/x8 oneology May 20, 2007 (PW 1/x8) Ex PW1/D1 US 5747498 Ex PW1/D2 (Colly) Permission/approval for manufacture of new drug formulation (2 pgs) Ex PW1/Y Agreement between Pfizer and OSI Ex PW2/D1 WO 995/23141 Ex PW2/D2 Gefitinibh phes best supportive care in previously treated ...multicenter study the lancet.com Vol. 366 Oct. 29, 2005 dt. 31.10.09 Ex PW2/DA Dated 18.9.2009 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 0 Page 1-8 Ex. D-1 Getitinib -wiki article Ex. D-2 EP0635507 A1 Ex D-3 EP 0566226 B1 Ex D-4 Article Isosterism & molecular ----- by CW Thornber Ex D-5 Indexes Vol 8, 1979 Radioisotopes in Pharmacy & Medicine. Part 4 Ex D-6 EP 0566226 A1 Ex D-7 EP 0635507 B1 Ex D-8 US 69000221 Ex D-9 EP 0566226 B1 Ex D-10 Tarceva Carton Ex D-11 Pregrant opp by CIPLA against OSI Pharma Ex D-12 CS 537/DEL/96 Ex D-13 Pregrant Opp by b/w OSI Vs CIPLA Ex.D-14 Complete Specification 537/DEL/96 between Pfizer and OSI Pharmaceutical 24. The following are marked documents: Mark PX1 Financial Profile downloaded from cipla.com Mark PX2 Copy of patent 2004/026879 A1 Mark PX3 Copy of patent WO 2004/099119 A1 Mark PX4 Copy of patent WO 2005/21541 A2 Mark PX5 Copy of article from the Business World magazine, Feb 2010 Mark PX6 73rd Annual Report of Cipla (2008-2009) Mark PX7 Copy of article "Cipla eyeing copies of 20 patented drugs" Mark PX8 US CBO Study "Research & Development in the Pharmaceutical Industry" Mark PX9 Copy of article from The Economist Mark PX10 Copy of article "Mukesh, LNM in richest of rich club", Economic Times, 12 March 2010. Mark PX11 Copy of ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... rant opp Mark DW4/16 25.3.2008 letter with written notes of argument on behalf of applicant for compulsory license/petitioner in IP. Documents - Sec.5 TRIPS, Declaration TRIPs - 30.8.2003 decision Page 1-11 Mark DW4/17 Complete Specification Quinzoline Derivatives PFIZER Mark DW 4/18 Patent 196774 Compulsory license action Mark DW4/19 App. for C. License U/S 92/A Patent 196774 Mark DW4/20 App. for C. License field by NATCO PHARMA Mark DW4/21 Assignment in favour of Pfizer Mark DW4/22 International search report Mark DW4/23 Request to Supply copy of reply statement Mark DW4/24 US PTO - Obviousness of Species when prior art teaches genus Mark DW4/25 Natco Pharma Ltd. App. for ERLOTINIB Mark DW4/26 IP filed for App. for ERLOTINIB - Power Point & Written arguments Mark DW4/27 19.10.99 decision Mark DW4/28 Article Isoster ism & Molecular Modification Mark DW4/29 Details of file 537/DEL/96-20.8.2008 Mark DW4/30 Current situation article Mark DW4/31 Written submissions (hearing 1.8.2006) for Patent 592/Del 2000 Mark DW4/32 Decision dated 5.7.2000 Mark DW4/33 16.9.2008. Objections from registry to app. for patent - Natco Pharma Mark DW4/34 PFIZER ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... cly known or publicly used in India before the priority date of the claim or to what was published in India or elsewhere in any of the documents referred to in Section 64 of the Patents Act. d) That the invention so far as claimed in any claim of the compete specification is obvious or does not involve any inventive step, having regard to what was publicly known or publicly used in India or what was published in India or elsewhere before the priority date of the claim. e) That the complete specification does not sufficiently and fairly describe the invention and the method by which it is to be performed, that is to say, that the description of the method or the instructions for the working of the invention as contained in the complete specification are not by themselves sufficient to enable a person in India possessing average skill in, and average knowledge of, the art to which the invention relates, to work the invention, or that it does not disclose the best method of performing it which was known to the patentee for the patent and for which he was entitled to claim protection. f) That the scope of any claim of the complete specification is not sufficiently and clearly def ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... erence of obviousness. 4) It is contended in the counter claim that after knowing the nature of art, the plaintiffs have just replaced the component of alkyl group and by treating the same arrived at the desired result. It is stated that the mere the substitution of Methyl with Ethynyl which are members of same alkyl group can be done by any reasonable person skilled in the art. It is also contended that the said substitution is a mere workshop result. Had it not been so, the plaintiffs would have explained the positive steps towards according the treatment with Ethynyl and difficulties faced by them during experimentation. The complete specification is absolutely silent on the ways of arriving at such substitution. In these circumstances, as per the defendant, it would be safe to infer that the suit patent was obvious to the person skilled in the art. 5) It is contended that Example 51 of the EP'226 is the closest prior art: - From the analysis of the specification it is clear that IN'774 is a patent which relates Quinazoline derivative. It is established in the art and known art that Quinazoline derivative has anti cancer properties. From the perusal of all the releva ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ied and made following the concept of Bio-isosterism. On the basis of the same one of the possible substituent is Ethynyl. 8) The said affidavit of DW 3 deposes after citing the structures of example 51 from EP'226 and alongside the structure of the suit compound that two structures are identical in nature barring the substituents in as much as &dbond;CH3 (methyl) in 3rd Position in EP' 226 is replaced with -C' C (ethynyl) in IN'774. It is deposed in the affidavit of DW 3 that after going through EP 0477700 (Ex.DW3/2), US 4138590 (Ex.DW3/3), US 5427766 (Ex.DW3/4), US 5736534 (Ex.DW3/5), WO 193004047 (Ex.DW3/6), it is evident that there is a clear teaching that methyl and ethynyl may be used interchangeably. It is deposed that there is no fixed pattern can be laid down as to the superiority of one over the other as a matter of rule. In some cases methyl is found to be superior to ethynyl and in some cases vice versa. 9) It is deposed in the said affidavit of DW 3 that that when the said EP' 700 is referred, there are three tables namely Table -1 2 and 3. It is stated in the affidavit that in table 2, the properties of compounds having methyl and ethynyl subst ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... still it was always a reasonable approach on the part of the research scientist to try such alternative which in other applications have proved successful. 12) It is deposed that there could not have been a guarantee to the inventor that the ethynyl substitution would work but due to the successful use of both methyl and ethynyl in an interchangeable manner in several chemical compounds, it was not at all surprising to substitute methyl with ethynyl. 30. By raising the aforementioned grounds supported by the evidence of DW-3 and the contentions afore-recorded, the defendant prays that the suit patent is liable to be revoked on the ground of the lack of inventive step. (There are other affidavits filed of DW-1 and DW-2 which are mainly not relating to aspect of revocation and are discussed later on in another head. 31. Per contra, the plaintiffs have filed the written statement to the counter claim, adduced the evidence of PW-3 and PW-2, Mr. Nick Thatcher and Mr. Robert Griffin, in support of the same thereof and proceeds to answer the grounds of the counter claim by contending the following: a) It is contended by the plaintiffs that the defendant has not discharged the onus c ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... from the above chart, a person skilled in the art will in particular look at Example 2(5) i.e. 6,7-dimethoxy-4-(5-indolylamino)-quinazoline (structure provided below), disclosed in the EP'851 which has the IC50 value of 1nm. (5) Therefore, amongst all tested compounds in prior art, the compound [6,7-dimethoxy-4-(5-indolylamino)quinazoline] as disclosed in EP'851 has the least IC50 value, therefore representing the most potent compound having anti cancer properties. 6,7-dimethoxy-4-(5-indolylamino)quinazoline (6) Therefore it is submitted that the defendant has provided absolutely no evidence to show why EP_226 is the starting prior art as opposed to EP _851. This has been shown by the plaintiffs to contend that when it comes to possibilities, then any one compound can be out of many can be a starting point for further development. (7) In fact, this is conclusively established by DW3, the defendant's own witness who states in paragraph 4(a) of his Evidence Affidavit that was directed to the specific prior art document, EP'226. b) It has been orally argued and countered by the plaintiffs that there is no formal proof on record to show as to how the plaintiff ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... claim 9 and claim 11) of EP'226, however, Example 51 does not feature amongst the five prominent compounds mentioned in EP'226 for which IC50 value have been provided. Therefore, there is no teaching, suggestion or motivation in EP'226, regarding any "useful properties" or "potent and promising activity" to select Example 51 as the lead compound. d) The plaintiffs have further endeavoured to put shadow on the affidavit of Prof Nangia by contending that no motivation or reason exists to select Example 51 of EP'226 is bolstered by the "expert" witness of the Defendant. DW3, Dr. Nangia, has straight-away arrived at Example 51 of EP'226 as the lead compound on instructions of his lawyer, Mr. S. Majumdar. (Para 4 and 6, Evidence Affidavit of DW3; Question nos. 5, 7, 8, 14, 52, 60, 83, 84, PW2,). He has neither provided any reason for selecting Example 51 as the starting point nor has he independently evaluated whether Example 51 was the best starting point as compared to other compounds of EP'226. Thus, the Defendant has completely failed to provide any reason/ motivation for a person skilled in the art to select Example 51 of E ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... Example 51 with ethynyl group in Erlotinib Hydrochloride. • It is pertinent to note that in chemistry, any change may have dramatic and unpredictable effect on the activity of the molecule. This has been conclusively stated by the Plaintiffs' witness, PW2, in his affidavit and cross examination (paragraphs 21 and 26.10, Evidence Affidavit of PW2,; Q, 52, 59, 60, 88, 94, 119, 139-149, PW2,) • More specifically, in the field of pharmaceutical sciences, any change in the structure of a compound can alter its activity and affects the manner in which the compound interacts with the target site, such as EGFR kinase, and thus affecting its biological activity. • Further, the activity of a compound cannot be predicted in advance without performing empirical studies. As an illustration, the core of the enzyme, here being EGFR kinase, is considered a lock and the claimed compound, here being Erlotinib Hydrochloride, which acts on the enzyme, is considered as the key. In pharmaceutical sciences, the researcher in order to make a key for the lock has to perform empirical studies to arrive at a particular conclusion. The researcher cannot make arbitrary choices and do f ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... -position to Ethynyl since as shown hereinabove, the teachings of EP'226 direct a person skilled in the art that 3'-Methyl should be left undisturbed for good biological activity. • The Plaintiffs submit that there is no reason/motivation to modify 3'-position to Ethynyl since as shown hereinabove, the teachings of EP'226 direct a person skilled in the art that 3'-Methyl should be left undisturbed for good biological activity. • Nonetheless, the Defendant, without showing any motivation, has arbitrarily selected Example 51 having 3'-Methyl as the lead compound and applied bio-isosterism principle to arrive at the claimed compound having 3'-Ethynyl group. • The Defendant proceeds to arbitrarily replaces Methyl group at 3'-position with Cyano group. The Defendant has provided absolutely no teaching/suggestion/motivation for a person skilled in the art to change Methyl to Cyano. EP'226 describes that _R2' i.e. 3'-position in Markush structure stands for 45 different substituents. Therefore, EP'226 provides for 43 substituents other than Methyl or Cyano for 3' position. The Defendant has not provided any teaching/ ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... fendant's arguments in the Replication to the Counter Claim are totally artificial and can only be the result of hindsight bias. In other words, the defendant starts the discussion by presuming that the structure of claimed compound, Erlotinib Hydrochloride is known and only then proceeds to discuss the prior art. (Paragraph 8 of the Evidence Affidavit of DW3) • This approach is completely erroneous, since the inventive step must be examined on the priority date of the suit patent i.e. on 30.3.1995. The Plaintiffs submit that on the priority date of the suit patent and without having the knowledge of claimed compound, Erlotinib Hydrochloride, there was no motivation to replace the Methyl group with Ethynyl group. • It is submitted that 5 patent documents (US4138,590; EP0477700A1; WO1993/04047; US5,427,766; US5,736,534) are cited by the Defendant in the Replication. • Of these five patent documents, two patent documents US5,427,766 and US5,736,534 are not valid prior arts under Section 64(1)(f) because they were published subsequent to the priority date of the Suit Patent. • The Plaintiffs submit that out of the 2 cited patent documents, which are not ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ert witness produced by the Plaintiffs, Prof. Roger Griffin in response to a question posed to him during cross examination (Q. 152 and 154) • Dr. Thatcher has further stated that Erlotinib Hydrochloride is the only Quinazoline derivative approved for the treatment of patients who have incurable advanced or metastatic pancreatic cancer. (Paragraphs 34-37 of the Evidence Affidavit of PW3). 32. In placing this evidence on the Court's record, Dr. Thatcher has relied on several articles including: i. Ex. PW1/X6: "Erlotinib in Previously Treated Non-Small Cell Lung Cancer" ii. Ex. PW1/X7: "Symptom Improvement in Lung Cancer Patients Treated with Erlotinib: Quality of Life Analysis of the National Cancer Institute of Canada Clinical Trials Group Study BR.21" iii. Ex. PW1/X8: "Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a phase III trial of the National Cancer Institute of Canada Clinical Trials Group." iv. Ex. PW2/D2: "Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer: results from a randomised, placebo-con ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... categorizations of the competing stands of the parties rather than putting the positive case on either side. This I have noticed at the outset as the same will also come in to aid while weighing the evidence of the competing parties. 37. As there are number of arguments and grounds raised by the parties in relation to the concept of lack of inventive step, persons skilled in the art and thereafter while making the submissions, the terminologies are transposed with the ones laid down in US judgments and English judgments suitably as per the convenience of the parties by contending that the said person is one who is an 'unimaginary person' or for that matter what "motivated" the inventor to choose any structure as lead compound and various other facets which are laid down as tests in such judgments are being imported in order to satisfy this Court, I think it is necessary to discuss the patent law as governing in India in form of Patents Act 1970 in order to find out the true test on basis of which the obviousness or inventive step in the patent is required to be tested. 38. Indian Patents Act 1970 has been amended in the year 2005 where under the concept of the p ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... on, so far as claimed in any claim of the complete specification, is not useful; (h) that the complete specification does not sufficiently and fairly describe the invention and the method by which it is to be performed, that is to say, that the description of the method or the instructions for the working of the invention, as contained in the complete specification are not by themselves sufficient to enable a person in India possessing average skill in, and average knowledge of, the art to which the invention relates, to work the invention, or that it does not disclose the best method of performing it which was known to the applicant for the patent and for which he was entitled to claim protection; (i) that the scope of any claim of the complete specification is not sufficiently and clearly defined or that any claim of the complete specification is not fairly, based and clearly defined or that any claim of the complete specification is not fairly, based on the matter disclosed in the specification; (j) that the patent was obtained on a false suggestion or representation; (k) that the subject of any claim of the complete specification is not patentable under this Act; (l) ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ives title. (4) Without prejudice to the provisions contained in sub-Section (1), a patent may be revoked by the High Court on the petition of the Central Government, if the High Court is satisfied that the patentee has without reasonable cause failed to comply with the request of the Central Government to make, use or exercise the patented invention for the purposes of government within the meaning of Section 99 upon reasonable terms. (5) A notice of any petition for revocation of a patent under this Section shall be served on all persons appearing from the register to be proprietors of that patent or to have shares or interest therein and it shall not be necessary to serve a notice on any other person. 40. On the bare reading of the aforementioned Sections, it is clear that the definition of "inventive step" nowhere accords any differential treatment to any particular type of invention. Rather, it lays down the general test which is indicative towards technological advancement and the non obviousness of an invention to a person skilled in art. Besides the same, the said definition of inventive step u/s 2(ja) which has been newly inserted in the Patents Act (Amendme ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ringement are decided on the basis of the tests carved out in said case of Biswanath Prasad(supra) till date without any departure. 45. It is further noteworthy that in the said case too, a decision was rendered after trial culminating into the final adjudication. The said case and the observations made therein by Hon'ble Supreme Court of India gains more importance due the said reason also as I am proposing to decide this case finally. In the said case of Biswanath Prasad (supra), Hon'ble Supreme Court has laid down the test as to what constitutes inventive step. In the words of Hon'ble Supreme Court of India it was observed thus:- 24. Whether an alleged invention involves novelty and an 'inventive step', is a mixed question of law and fact, depending largely on the circumstances of the case. Although no absolute test uniformly applicable in all circumstances can be devised, certain broad criteria can be indicated. Whether the "manner of manufacture" patented, was publicly known, used and practised in the country before or at the date of the patent ? If the answer to this questseion is 'yes', it will negative novelty or 'subject matter& ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... vations of Supreme Court, it is manifest that the Hon'ble Supreme Court has laid down the test for the purposes of ascertaining as to what constitutes an inventive step which to be seen from the standpoint of technological advancement as well as obviousness to a person who is skilled in the art. It is to be emphasized that what is required to be seen is that the invention should not be obvious to the person skilled in art. These are exactly the wordings of New Patents Act, 2005 u/s Section 2(ja) as seen above. Therefore, the same cannot be read to mean that there has to exist other qualities in the said person like unimaginary nature of the person or any other kind of person having distinct qualities. 47. Such observations made in the foreign judgments are not the guiding factor in the true sense of term as to what qualities that person skilled in art should possess. The reading of the said qualities would mean qualifying the said statement and the test laid down by the Supreme Court. 48. The said observations relied upon by the parties are judicially created tests depending upon the nature of the case and the subjective satisfaction of the Judge in the given case. As there i ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... with that of the view of Supreme Court while introducing the product and process patents for medicines. All this is indicative of the legislative intent that the legislature was conscious while providing the definition of inventive step that it is according patent protection to medicines, still no such other treatment either in the form of explanation or proviso to the definition of inventive step or anywhere has been provided. 53. On the other hand, wherever it was necessary, such explanations in the form clarifications relating to medicinal patents are provided like explanation appended to Section 3(d) which provides that the Polymorphic version of the drug shall deemed to the same substance unless backed by the efficacy. In absence of any such intent to provide such different tests of obviousness in pharmaceutical patents, it would be legally impermissible to import any such new tests which may somehow seem or appear to be facets of the tests of obviousness as Indian Act nowhere provides such requirement. 54. Therefore, it would be wise to say that there exists a jurisprudential difference between the countries like India where the patent law is still at the nascent stage vis ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... g in the English Courts in UK where the similar debate is prevalent too, the reference is invited to the decision of the Court of appeal in the case of Dr. Reddy's Laboratories (UK) Ltd. vs. Eli Lilly and Co. Ltd.. reported as 2010 RPC Page No. 9 where the Court of appeal has observed that the ordinary approach relating to obviousness should be followed even in cases relating to patents involving chemical compounds rather than what has been followed by other European Courts, patent offices and no special approach is warranted in the law. It is however different matter that in the result, the Court of appeal decided in favour of the patentee but what is important is the observations relating to the tests of obviousness which as per the Court are the same as ordinary approach of obviousness. In the words of Court of Appeal, it was observed thus :- Further, as I have tried to show and as Jacob L.J.'s analysis in paras 44 to 50 demonstrates, the Board's approach in cases such as these is consistent and clear and it is based on its general approach to patent validity on novelty and obviousness. There is nothing in the 1977 Act (any more than there was in the 1949 Act, it i ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... bservations of Court of appeal that the obviousness has to be tested on the basis of technological advancement and what has been known to the person skilled in art and nothing beyond the same. Therefore, the tests which are further modified and are doctrinal in nature are not relevant for the purposes of seeing the obviousness of a patent or for that matter any other patent. 62. Now, the related question arises as to what can be said to be obvious to the persons skilled in art and how to determine the same. It is seen above that the Supreme Court in Bishwanath Prasad observed that the question of obvious to the person skilled in art is a mixed question of fact and law. Therefore, a person setting up a challenge to the patent must aver so and establish the facts material to establish obviousness. The said material facts are bundle of facts which can be said to be chain of events making the invention obvious to the person skilled in the art. The said chain of events in the case of Bishwanath Prasad which were established on record in that case are the 6 points mentioned in the judgments which are established on the record in that case. 63. Therefore, one has to immediately advert t ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... aforementioned observations of the learned author, it is clear that the afore noted chain of events or material facts are to be satisfied at least for the purposes of calling the invention new and non obvious, for the purposes of challenge which has been set up against the patentee, these very chain of events are to be established by the counterclaimant conversely as the onus is upon the defendant to show that the patent is obvious in the revocation proceedings. Therefore, after analyzing the aforenoted events, the following material facts are essentially required to be established by the counterclaimant: a. The selection of the impugned invention is taken from the examples of the known prior art. b. That the selected invention is not far removed from the known range illustrated in the example. Rather, the same is closer to the known range. c. That the selection area is not on the basis of any purpose of the inventor and is merely an arbitrary picking up the compound. The above noted tests are some broad criterion on the basis of which, it can be tested that the whether the onus of the counterclaimant is discharged so far as it relates to revocation of the patent by establis ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... evidence. This is due to the reason that the parties in instant case continue to insist on the anomalies done by each other and also stating the lack of evidence on either side one way or the other. Therefore, it has become necessary to point out that the evidence of the parties are to be tested on the balance of the probabilities. Though, the defendant had raised almost all the grounds available in Section 64 of the Act. However, this Court inclines to discuss only those grounds on which specific pleadings and evidence adduced by the counter claimant. 70. Let me apply the principle of laws enunciated above relating to obviousness and test the present case on the basis of balance of the probabilities in order to see whether the defendant has discharged the burden as to show the obviousness or lack of inventive step in the suit patent. I propose to discuss the same by enumerating the following pointers: 1. The defendant has filed counter claim alleging the ground as to obviousness or lack of inventive step of the suit patent IN'774. In order to support the ground, it is stated and documents to the effect have been filed that the suit patent is anticipated by EP'226. The s ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... er patents cited in the documents someway indicate the use of methyl and ethyl component. • On the basis of the aforementioned two facts, the conclusion was deduced by DW 3 that due to the reason that the inventor Mr. Arnold was common in US 734 and US' 498 which corresponds to IN'774, therefore the said Indian patent was obvious to the person skilled in art. Likewise, Mr. Nick Thatcher PW3 and Mr. Robert Griffin PW2 have filed the affidavits. 6. The defendant has cross examined the plaintiff's witnesses PW3 and PW2 who state that they are the experts. However, the careful reading of the depositions made in the affidavits would reveal that the said experts nowhere inform in the express terms as what was the lead compound for the purposes of arriving at the invention, what steps were taken from to time in order to work upon the said compound from time to time and thereafter as to when eventually the said compound was arrived at. The expert evidence as well as the evidence by way of affidavit is completely silent about the same. 7. The defendant has been able to cross-examine the plaintiffs' witnesses which reveal that the plaintiffs' witnesses inform ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... der to arrive at Ernotilib Hydrochloride. Such depositions if could have been filed and made in the affidavit by the scientist or research and department official of the plaintiff company involved in invention could have brought forward the positive case of the plaintiffs in relation to innovativeness and inventive step which is missing in the present case. 72. Mr. Salve, learned senior counsel and Ms. Pratibha Singh both have submitted that the impugned patent is obvious and is based on EP'226 by making comparison of specification of EP'226 vis-à-vis that of IN'774 and its connected US Patent in the following manner: • It is submitted that the Patent specification (Exhibit PW1/5) consists of the following Sections; 1. Background of the Invention. 2. Summary of Invention. 3. Detailed description of the Invention. 4. Examples 5. Claims The specification was originally titled as "Quinazoline Derivatives" OR "Quinazoline Derivatives Compound and Composition". Thereafter, finally, the title was changed to the present title which is "A novel [6,7-bis(2-methoxyethoxy)quinazolin-4-yl]-(3-ethynylphenyl) amine hydrochloride and ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ounds disclosed in EP'226 which have been picked up and the Methyl with Ethynyl substitution has been made. Methyl and Cyno are shown as substituent in EP'226. By applying the well known principle of Bioisosterism, Methyl and Ethynyl substitution is known in the art. 75. It is also argued by the defendant's counsel that the said substitution is in several of the compounds disclosed in EP'226. The examples disclosed in the suit patent are a mere variation of Methyl and Ethynyl compared to EP'226. From this it is clear that when the patent was filed, it contained no inventive step whatsoever and it was merely a trial and error long sought which was being tried by the Applicants. The fact that more than one example is a copy of compound specifically disclosed in EP'226 further establishes that this is nothing but a combination method without any inventive step. What appears to have happened in the present case is in the compound disclosed in EP'226 or other similar Claim of Quinazoline Derivatives have been altered by substituting Methyl/ Flouro with Ethynyl in order to arrive at the IN'774. If not for this explanation, there could be no other explanat ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ion) • That there is some kind of similarity in the abstracts of specification EP'226 vis-à-vis with that EP566226 (Exhibit D-6) and WO 1995023141 (Exhibit No. PW2/D1 and Exhibit P2/DA and PW 1/5 which has resulted into IN'774. • That there can be a possibility of treatment of ethynyl instead of methyl as they are related to the same kind of group of alkyl which is done in the other patents relied upon by DW3. 79. If one sees the afore-noted three facts emerging from the evidence of the defendants, it is clear that the defendant has been able to show some selection of the compound or range of compounds from the known range as shown and depicted in EP'226, but still it is not shown on record by positive evidence as to how the said selected range is not far removed from the known range and how the selection was arbitrary in nature. The answers to the said two crucial material facts are essential in order to say that the defendant has been able to successful discharge and displace the onus of the proof lying upon him. This could have been done by the defendant by showing clinically that the substitution of the compound containing ethynyl component are ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... fact relating to reason behind the selection is not established. 81. Even if the case of the defendant as per the later submissions made during final arguments is seen to be established, still, the material facts relating to second and third requirements as noticed above still remain to be established are as how the said selected range is not far removed from the earlier range and how the said selection is an arbitrary selection of the compound and why not purposive selection of the same. A submission is canvassed at the bar that there are some similarities in the compounds cited as examples in EP'226 vis-à-vis IN'774. The said example coupled with later denotes the substitution of ehynyl with that of methyl a third position and that is the reason why the said method is arbitrary and based on trial and error. It is also stated that there are similarities in the abstract of the EP'226 with that of IN'774 with the specification initially filed as marked as Ex D6 which reveal that there is cut and copy job done by the inventor. 82. The said submissions are neither present in the written-statement nor in the counter claim nor same are deposed in the affidavit ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... cure the patients properly and consequently was not recommended. Therefore, even if it is shown that the starting point of the invention is EP'226 and there are changes made in the chemical structures cited as example compounds in the said patent by reacting the same with ethynyl later on in relation to selected range, I do not find that such selection can be arbitrary, rather it can be inferred that there may be some further experimentations done in future on the Geftinib compounds which eventually narrowed down the examples cited by the defendant in its submissions, ultimately resulted into the claim No.1 of the patent. All this rather indicates towards purposeful selection rather than arbitrary one. 85. I am inferring this in view of totality of the circumstances, the plaintiffs are engaging into manufacturing of the drugs, their inventors surely are the persons skilled in the field and are aware of quinazoline derivatives and the compounds therein. Of-course, the inventors cannot change the main compound as the said characteristic of curing the cancer emerges from the said very compound which is a quinazoline derivatives. The plaintiff's inventor being a conscious pe ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... e same nowhere indicates that his selection may be random or arbitrary. 88. The defendant has not been able to fully discharge the onus of proof of establishing the obviousness due to non establishment of three material facts. After appreciation of the evidence of the competing parties, I find that the defendant has not been able to show as how the selection of the range of the compound was arbitrary as merely contending vociferously without any deposition will not suffice. On the other hand, plaintiffs though have responded to the defendant's case by pointing out number of mistakes on the part of the defendant. The defendant has not pointed out whether the lead compound was example 51 of EP'226 or not. 89. On balance of probabilities, it can be said that the defendant is not able to discharge the onus lied upon him, though the defendant was able to show that there is a selection of range from the compound which is not far removed at least structurally but has failed to established that the role of the said change in the reaction is bare minimal or the said reactants are known to the person skilled in the art. It is also not established on record clinically to show as to ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... d the evidence of inventor by saying that they have not shown as to what was going through the mind of inventor at the time of working upon the invention and also how many experiments were carried out. Para 48 of the said judgment of Hon'ble Supreme Court recording the trial Court findings is reproduced below:- 48. The learned trial Judge then noted that Purshottam, who was stated to be the inventor, and, as such, was the best person to describe the invention, did not appear in the witness-box, though, as admitted by Sotam Singh (D.W. 3), Purshottam had attended on some dates of hearing. Sotam Sing tried to explain Purshottam's disappearance from the Court without appearing in the witness-box, by saying that he had gone away due to illness. The learned Judge found this explantion unsatisfactory and rejected it-and in our opinion rightly-with the remark that recording of evidence lasted for several days and it was not difficult to secure Purshottam's attendance. Apart from being the best informed person about the matter in issue, Purshottam was not a stranger. He was a partner of the patentee firm and a brother of Sotam Singh (D.W. 3). He was the best informed person w ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... substitution of ethynyl with the methyl was obvious on the date of priority of the US' 498 which 30.3.1995, how the selected range is not far removed from the known compound, also that how the said selection of compound range is not purposeful and merely arbitrary. The plaintiffs evidence in response is equally weak and therefore, the same can be criticized on the same count by not establishing the material facts as to how the substitution of ethynyl with methyl is innovative and steps towards the arriving of the invention by providing who conducted such experiment, and how many and during what period. 97. Accordingly, I reject all the submissions of the defendant on this issue including the argument that the defendant has not shown what motivated the plaintiffs to take example 51 as prior art, all other motivation submissions without prejudice ones, the submission relating to replacement of ethyl from methyl component, secondary consideration as to assuming obviousness. 98. I do not agree with submissions of the defendant that the mere fact that there were commonality in the wordings of the specification of EP'226 with that of US 498, there can be any inference which can ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ossession or power, in support of his defence or claim for set off or counter claim, he shall enter such document in a list, and shall produce it in Court when the written statement is presented by him and shall, at the same time, deliver the document and a copy thereof, to be filed with the written statement. (2) Where any such document is not in possession or power of the defendant, he shall, wherever possible, state in whose possession or power it is. (3) A document which ought to be produced in Court by the defendant under this rule, but, is not so produced shall not, without the leave of the Court, be received in evidence on his behalf at the hearing of the suit.]. (4) Nothing in this rule shall apply to documents- (a) produced for the cross-examination of the plaintiff's witnesses, or (b) handed over to a witness merely to refresh his memory.] Order XIII [1. Original documents to be produced at or before the settlement of issues (1) The parties or their pleader shall produce, on or before the settlement of issues, all the documentary evidence of in original where the copies thereof have been filed along with plaint or written statement. (2) The Court sha ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... der 7 Rule 14 and as also for calling the witness for producing the documents mentioned in the other application. The learned Counsel for the plaintiff referred to the decision of the Supreme Court in the case of Salem Advocate Bar Association, Tamil Nadu v. Union of India. With reference to paragraph 13 thereof, the learned Counsel submitted that the Court may permit leading of such evidence even at a later stage subject to any terms that may be imposed upon by the Court which may be just and proper. 4. I have heard counsel for the parties. The Supreme Court decision in Salem Advocate Bar Association (supra) was in the context of additional evidence. By virtue of the 1976 amendment, Rule 17-A had been introduced in Order 18. The said Rule 17A granted discretion to the Court to permit production of evidence not previously known or which could not be produced despite due diligence. Rule 17A of Order 18 was deleted by the Code of Civil Procedure (Amendment) Act, 1999 which took effect on 1.7.2002. While considering the effect of this deletion the Supreme Court observed: 13. In Salem Advocate Bar Assn. v. Union of India, it has been clarified that on deletion of Order 18 Rule 17A ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ced. In my view, these circumstances clearly show that the conditions necessary before leave of the Court can be granted have not been satisfied. It cannot be said that the plaintiff was not aware of the documents earlier, or that the same could not be produced in spite of due diligence on the part of the plaintiff. All the material now sought to be introduced, was well within the knowledge of the plaintiff at least in the year 2003. As the plaintiff was not diligent enough at that point of time, this Court is left with no alternative but to reject its request. (Emphasis Supplied) 102. I find that the similar situation has arisen in the present case. Till the final arguments were addressed in this matter, the defendant had never made this attempt to bring the said documents on record. No application for seeking a permission of this Court has been preferred which enables the Court to exercise such discretion vested in the Court. The plaintiffs have strongly objected to taking these documents on record and its admissibility at the time of recording of the evidence of DW3 Mr. Nangia and the said objection has been categorically recorded by the learned LC Mr. S.M. Chopra leaving it ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... Quinazoline derivatives invented by Mr. Arnold who is common inventor of the present patent and the said application was filed as PCT application on January 27, 1995 and thereafter the patent which the defendant is relying upon was filed in US in the year 1996. To this, the response of the plaintiffs is that the said application as PCT was published on August 31, 1995 and prior to the same, the same cannot be treated as prior art to the plaintiffs patent US 498, the priority date of which is March 30, 1995, I agree with the submission of the plaintiffs. The prior art in the form of prior patent can be said to be pre published document only when the said patent gets published prior to the priority date of the application filed before the patent office. Therefore, till the time, the PCT version of US 534 was not published on August 31, 1995, the US 498 filed on March 30, 1995 as a priority date cannot be anticipated by way of the said PCT application. • Further, the said invention provides again some references to methyl, ethynyl at 6 and 7 position and the said compound was structure wise is totally different though it has common quinazole core. Accordingly, the mere presenc ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... is to be effected nor does the said patent talks about phenyl quinazolines which is relating to the suit patent, further the position or the place of the reaction is also not made obvious. Therefore, the said depositions made are again based on one premise which is that the reactant methyl and ethylyne interchangeability which per se is inconsequential. • The order of controller of the patents dated 27.6.2007 in respect to pre-grant opposition to IN 77 wherein the said opposition was filed by Natco Pharmaceuticals also analyses on similar count the prior arts containing some relevance pertaining the substitution of methyl with that of ethynyl component. Similar are the prior art documents DW 3/2 to 3/6 relied by the defendant now in order to enable this Court to infer such obviousness. I reject the same in view of finding the concurrence with the findings of the Controller that the said document does not reveal as to how the applicant for the patent learnt about the said reactions, where to react, why not to react with phenyl and at what position. Therefore, the similar prior arts are rejected. So far as the emphasized prior art US 534 is concerned, my answers in specific a ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... s in the present case, thus the same is not applicable to the present case. 106. Various English decisions were referred to by both parties as discussed earlier in detail the jurisprudential difference existing in the tests adopted by the Courts in India with that of Courts in US. Thus, due to operation of the said doctrinal tests like motivation, suggestion and teaching and others existing in US which gives a kind of presumption of validity to the patent but similar position does not happen to the Indian jurisdiction where the patent is always vulnerable to challenge unless displaced by positive evidence. The details of several decisions referred by the plaintiffs in support of the arguments of motivation, suggestion and teaching tests are given as under: a. Technograph v. Mills & Rockley, 1972 RPC 346 at Pg. 355 (35) b. Takeda v. Alphapharm, No. 2006-1329 (Fed. Cir. 2007) at pages 10, 11, 17-18, 21 [reported as 492 F.3d 1350] c. Daiichi v. Mylan, 670 F. Supp.2d 359 at pages 14-15 d. Eli Lilly & Co. v. Zenith Goldline Pharm., Inc., Nos. 2005-1396, -1429, -1430 (Fed. Cir. 2006), at pages 9 [reported as 471 F.3d 1369] e. Star Scientific v. RJ Reynolds, No. 2010-1183 (Fed. ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... secondary consideration to the obviousness and other legal aspects: Case laws on secondary considerations: i. Technograph v. Mills & Rockley, 1972 RPC 346 at Pg 360 (line 30) ii. General Tire & Rubber Company v. Firestone, 1972 RPC 457 at p. 506 (line 26-27). iii. Star Scientific v. RJ Reynolds, 537 F.3d 1357 at p. 18, 20 iv. Eli Lilly v. Zenith, 471 F.3d 1369 at pages 14-15 v. Genetics Instt v. Novartis, 655 F3d 1291 at p. 30 vi. Eisai v. Dr. Reddy's, 533 F.3d 1353 at p. 2 vii. Apotex v. Sanofi, Inventive Step and Obviousness i. FH&B v. Unichem, AIR 1969 Bom 255 at para 13 ii. Takeda v. Alphapharm, No. 2006-1329 (Fed. Cir. 2007)at p. 6 [reported as 492 F.3d 1350] Because a patent is presumed to be valid, 35 U.S.C. 282, the evidentiary burden to show facts supporting a conclusion of invalidity, which rests on the accused infringer, is one of clear and convincing evidence. iii. General Tire & Rubber Company v. Firestone, 1972 RPC 457 at p. 480 (line 15). Line 15: ?It was common ground that when the validity of a patent is attacked under the relevant provisions of Section 32(1) of the 1949 Act, the onus of proof lies, as regards each allegation, on th ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... e is inconsequential without a positive evidence medically and clinically as to how the said reaction is immaterial, then several novel compounds can be declared obvious by such exercise and the same shall affect the research process adversely. The innovation or invention in the sense of chemical compound is not merely to innovate a new set of the compound per se but also making improvements in the existing state of the art by taking the aid of the already existing compound and working upon the same by way of experimentation by way of the reactants. This is the reason why, the Court cannot simply be satisfied by mere reliance of similar structure in the previous art and thereafter assuming that slight substitutions are inconsequential. Therefore, the establishment of the material facts is essential, which is missing in the present case. Resultantly, no ground of obviousness or lack of inventive step under Section 64 (1) (f) of the Patents Act is made out due to the inability of the defendant to discharge the onus casted upon it. Re: Patent violating Section 3(d) of Patents Act 1970 (as amended in 2005) 110. Now, I shall be proceeding to discuss the challenge which has been set up ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... tinib patent which is a selection patent from EP'226 had a priority date 27th April, 1995, it was filed in India on 23rd April, 1996. The Defendant has referred to EP226 as GEFITINIB patent only for the purpose of convenience of arguments in pleadings. • Pre-grant opposition was filed by NATCO and G.M. Pharma Ltd. and the ground of anticipation and obviousness were raised. i.e. Exhibit DW1/7 (NATCO order) is recorded as below; Opponent further argued that the applicant is merely attempting to claim prior art in the quise of selection patent and referred to a cited decision T-0124/87 of European technical board of appeal. In the Gefinitib patent the invention was claimed in the 7 metha positions in the Quinazoline molecule and R2 was shown as 3' 4 diholo substituents. The applicant had also provided reference to various foreign patents granted for the Gefinitib for the specific molecule claimed in this patent and even the comparative test data was provided. The Controller held as follows: On the basis of the arguments and evidence given by both parties I am of the opinion that the basic skeleton of the prior art compound and the present invention are same. The ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... rior art which in my opinion is the compound 5 of example 34 of EP/0566226, because this compound of the prior art differ from the claimed compound only in the presence of the basic group, which the applicant admitted, play an important role in the activity of the claimed compound. I agree with the opponent's contention that for the demonstration of 'chnical advancement' must be shown to have been achieved by a claimed invention vis-à-vis the prior art by way of demonstrating the presence of an unexpected effect over the closest prior art. Any comparative test data provided against said compound 5 of example 34 could have highlighted the criticality of the 'asic group' in achieving an enhanced activity, which could have formed the basis for the invention. Therefore, I have no doubt that the applicant has failed to provide comparative test data vis-à-vis the structurally closed compound of the prior art. The Controller of Patents thereafter further, holds as follows: Regarding patent ability under Section 3(d), I find that the test data provided by the applicant does not substantiate the applicant's claim or significant enhanced potency re ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... contending the following: a) The defendant has alleged that the Erlotinib compound that has been patented by the Plaintiffs is allegedly a 'ivative' of "uinazoline"which is "known"for its anti-cancer activity and hence, since no new property or enhanced efficacy has been shown by the suit patent over the known substance, the same is not patentable under Section 3(d) of the Indian Patent Act. (paragraphs 16-18 of the Written Statement; paragraph 3.5-3.10 of the Counter Claim). b) In this regard, it is pertinent to note that the Defendant has not led any evidence to prove this averment. However, in any event, the averment of the Defendant is completely fallacious and does not merit any consideration in light of the following: i. It is submitted that "Quinazoline Derivatives" refer to a very wide range/class/family of compounds having a common Quinazoline ring, and the patented Erlotinib compound is just one specific compound of this family. It has further been admitted by the Defendant's expert witness that the Erlotinib compound was not known as a drug or a compound in the year 1995 from which is the date that the patent claims priorit ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... s derivatives of the prior arts compounds. 3. There is an aspect of lack of efficacy which is also mentioned in the paragraph 3.5 to 3.7 of the counter claim in order to contend that provisions of Section 3(d) are attracted. 117. In order to discharge the said onus, the defendant has relied upon the documents showing the compounds in EP'226 patent and also read the observations of the Controller of Patents in this respect while finding that IN'507 is hit by Section 3(d). The DWs.1, 2 & 3, Mr. Gopalakrishnan, Ms. Shashirekha and Mr. Ashwin Nangia do not depose anything specific in their affidavits about the challenge as to Section 3(d) and rather the depositions of Mr. Nangia attempted to show that the plaintiffs' product is Polymorphic B version of the compound which is the subject matter of the suit patent and the same is free from the combination of Polymorph A and B of the suit patent. The said affidavit of Mr. Nangia though deposes as to how the IN'774 would be obvious to the person skilled in the art but does not deposes as to how the IN'774 is the new form of same substance based on EP'226. 118. The defendant, however, has set up the challenge as t ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... nt to show that the suit patent IN'774 is new form of old substance which is EP'226. However, it is not in dispute that EP'226 relates to quinazoline derivatives also contain some compounds, which are structure wise akin to the suit compound excepting the reaction of ethynyl at the third position, would do not axiomatically permit this Court to believe that the suit patent IN'774 is a new form of EP'226 unless shown clinically with some evidence. 120. It is one thing to say that the Patent lacks the inventive step in as much as the same is obvious to the person skilled in art as the same may amount to workshop result which is per se not patentable. However, it is another thing to say the patent is a new form of the old substance which is pre-existing. The line may be blurred between the two but there lies a subtle difference. This is the reason why even the legislature thought it appropriate to insert and define both the concepts separately under Section 2 (j) (a) and Section 3(d). 121. There are some more facts which may be required to be proved which include the complete analysis as to what was actually the old substance, how it can be said to be same as tha ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... al trials and challenge to the same vis-à-vis EP'226 but nothing can be inferred to the contrary while going such cross examination. Accordingly, the plaintiffs have been able to at least justify that the said product Erlotinib is not the same as that of GEFTINIB. This has been done by the plaintiffs by comparing the efficacy. The plaintiffs have not led any positive evidence in the form of deposition before the Court (except comparing the structure as to how they are structurally different), as to how the same shall not be called as new form of the same substance either. However, considering the evidence as to efficacy differences, it can still be inferred that the plaintiffs' patent is not hit by Section 3(d). 123. So far the finding of controller in the opposition proceedings relation IN 507 by way of order dated 15.12.2008 (Ex.DW1/12) is concerned which is on Section 3(d) is concerned, the conclusions deduced by the controller nowhere finds that the said IN'507 is a new form of EP'226 and rather the said order finds that the said IN'507 is Polymorphic form of Erlotinib Hydrochloride which is IN'774 compound. Therefore, the said finding of the con ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... prosecuted, the serial number and date of filing of the application and such other particulars as may be prescribed; and (b) an undertaking that, up to the date of the acceptance of his complete specification filed in India, he would keep the Controller informed in writing, from time to time, of details of the nature referred to in clause (a) in respect of every other application relating to the same or substantially the same invention, if any, filed in any country outside India subsequently to the filing of the statement referred to in the aforesaid clause within the prescribed time. (2) The Controller may also require the applicant to furnish, as far as may be available to the applicant, details relating to the objections, if any, taken to any such application as is referred to in sub- Section (1) on the ground that the invention is lacking in novelty or patentability, the amendments effected in the specifications, the claims allowed in respect thereof and such other particulars as he may require. 129. As the said Section 8 has been raised as a ground of challenge in the revocation, it would be necessary to also reproduce Section 64 relating to revocation where clause sub c ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... e) Undertaking that upto the grant, he shall keep the Controller informed in writing from time to time of the detailed particular as required under clause (a) in respect of every other application relating to the same invention if any filed in any country outside India subsequently to the filing of statement within the prescribed time. 135. If the ingredients of Section 8 are examined closely, it can be discerned that the obligation which is casted upon the applicant for patent relates to any application which he is prosecuting either along or jointly on the date of patent or where the application which is being prosecuted by some person through whom he claims title on the date of application. This is evident from the wordings "...is prosecuting either along or jointly" used in the said Section or "is being prosecuted by someone through whom he claims..." which means that the said Section talks about the applications which are being prosecuted or is prosecuted by the applicant or his predecessors in the foreign countries at the time of preferring the patent applications in India. 136. It is also seen from the reading of said Section that Section 8(1) covers ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... andatorily required and what was not required. 140. It is, however, to be noted that the necessary ingredients noted above must be satisfied in order to attract Section 8 which include foreign application or the application outside India and not the Indian application. Therefore, the expression "any other application" should also be read in the context with the accompanying words which are "relating to the same or substantially the same invention if any filed in country outside India" only in relation to foreign applications which is also clear from the head note as well as from the ingredients of Section, the said provision will attract in relation to Indian application. Therefore, the Court seized of with the revocation u/s 64(1)(m)will examine the question of disclosure or non disclosure as envisaged u/s 8 must confine itself to the enquiry which is permissible u/s 8 and not beyond the same which is relating to information and undertaking regarding foreign application and the aspects relating to the same. 141. Let us see whether in the instant case provisions of Section 8 gets attracted. It has been said by the defendant that the plaintiffs as Patentee has ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... was also re-filed in the opposition proceedings pending between the patentee and the third party. Therefore, the plaintiffs are of the firm belief that the true disclosure has been made. Secondly, it is also stated that Polymorphic version B of the said compound would not come within the meaning of same or substantially the same invention used u/s 8. Thirdly, it is stated that the said Polymorphic version B compound was filed four years after the suit patent IN'774 in the year 1996 in India and the same is different from the suit patent and therefore the same ought not to have been disclosed to the Patent Office on the count of being different in nature. 144. It is also stated that independent of all this, when the derivative compound in Polymorph form B was filed before the Controller of Patents subsequently in India by way of IN'507, There is a complete adjudication done by the Controller in an opposition proceedings on all the aspects including the kind of similarity between the said compound and it is Polymorph form considering the impact of US'221. Therefore, there is no need for this Court to go into the question now as to whether such disclosure is warranted or ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... vis-à-vis the compound containing the combination thereof A & B as both are same in their properties and efficacies. 147. Considering this backdrop, one has to analyze whether such disclosure was warranted. In the light of afore noted discernible facts, it is seen the application which was filed in US'221 was in the year 2000 and the patent was filed in 1996 and patent was granted in the year 2007. The language of Section 8 is very clear where under it is stated that there is a continuous duty of the inventor or the applicant for patent to inform from time to time the Controller about the developments in the patent including filing of subsequent applications in foreign countries relating to same or substantially the same invention. 148. If in the light of the day, which is today when the plaintiffs once faced with the challenge from the defendant as to validity of the suit patent and as to the fact that drug sold in the market corresponds to the suit patent IN'774, is urging that the existence of Polymorph version B and the usage of the same in the market of the said version is immaterial as suit patent IN'774 and its subsequent Polymorphic versions are the sam ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... is IN'774 and the one which is Polymorphic B version of the said compound as it is evident from the specification as Ex.DW1/9 itself. Therefore, the same ought to have been disclosed before the Patent Office in order to comply with the provisions envisaged u/s 8. 151. There are no depositions which are made by the defendants witness DWs.1, 2 and 3 in their affidavit. Likewise, the plaintiffs' witnesses also did not depose the about the justification as to non disclosure. Therefore, the challenge is restricted to what has been stated in the counter claim and the written statement and thereafter the submissions advanced by the parties at the bar. 152. When the defendant has raised this challenge in the counter claim and also filed the documents to that effect that there is an application which was made in US in 2000 as US'221 containing a nexus between the previous compound and the Polymorphic B version of the same and also has read in consonance with the stand which is preferred by the plaintiffs now that both the versions are of the same nature and non grant of one in India is inconsequential, The defendant is able to discharge the onus which lied on him to show that ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... tiffs, still there lies a discretion in the Court not to revoke the patent on the peculiar facts and circumstances of the present case. The said discretion exists by use of the word "may" under Section 64 of the Act. Thus, solely on one ground of non-compliance of Section 8 of the Act by the plaintiffs, the suit patent cannot be revoked. Re: Ground of concealments and false representation under Section 64 (1)(j) 156. The defendant has further raised the ground of concealments by elaborating that the suit patent has been obtained on the basis of the false statements and misrepresentation and therefore the IN'774 is liable to be revoked under Section 64(1) (j) of the Patents Act 1970. Learned counsel for the defendant has pointed out series of the concealments besides Section 8 requirements, the same can be enumerated in the following manner: • Concealment of all agreements and status of title of plaintiffs; • Concealments of patents filed with respect to Erlotinib Hydrochloride abroad and in India; • No witness was produced who had knowledge of the patent filings in India or abroad; • Concealment about the true form of TARCEVA; • TA ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... us relate to the specification or relate to any fact or statement required to be made in connection with the application for a patent. Ordinarily, however, false suggestion or representation is alleged in respect of something contained in the specification. If false suggestion is alleged, it must be established on the basis of the documents in which the alleged false suggestion was made, the onus being of course on the objector. (Emphasis Supplied) 160. From the bare reading of the said observations coupled with the wordings of Section 64(1)(j), it can be said that any other kind of concealment which affect the prosecution of the patent before the office of Controller can certainly be urged as the ground for challenging the patent u/s 64 (1)(j). Therefore, the Court can look into any such concealment if any made before the Controller of Patents affecting materially the prosecution of the patent. Therefore, once the Defendant criticizes the grant of patent on the ground of misrepresentation, then the Court after looking into the facts which are material or non material can draw an inference by analyzing as to which of the concealments would have material bearing while securing ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... the defendant responds that the said principle of feeding the grant by estoppel is applicable to immovable properties and not to moveable properties. Lack of Title/Ownership in respect of plaintiffs 165. During the course of the arguments the learned counsel for the defendant has challenged the ownership of the suit patent as well as title documents. It was argued by the defendant that the entire patent office record shows that there are many discrepancies in order to claim the ownership of the patent in question which also lacks valid title in order to maintain the suit for patent. No doubt, certain averments have also been made in the written statement questioning the rights of the plaintiffs to sue for infringement of patent against the defendant. The defendant has also sought to allege that the plaintiffs have fraudulently obtained the patent which is contrary to Section 64(1)(j). It is a matter of fact that the patent was issued in the names of the plaintiffs. No issue in this regard was framed by the Court. The objection about the title and ownership was not proved by the defendant in its evidence. Since the patent has been granted in favour of the plaintiffs and no issue ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... laintiffs responded the same by stating: • That the Defendant has not discharged the burden which is cast upon him to show that the patent was examined improperly. • That it is not the ground for revocation as envisaged in Section 64 to examine as to whether any improper examination has happened during the time when the patent was examined. • That the counter claimant has not taken any such ground u/s 64 to urge such improper examination. • That there are no pleadings to the effect of improper examination and no allegation of improper examination has been pleaded anywhere and patentee has been taken to surprise. • That the obligations in the examination report have been made by the patentee and the Patent Office has examined the application thrice by two different examiners. • That the amendments to the claims prior to the grant of patent need not be advertised. • That that rule 81(2), Section 57(3) and 57 (6) collectively would reveal the said position. It is also stated that the amendments which were made were already falling within the scope of the patent specification which was originally filed and the said amendment was permissi ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... es of said discussion, following provisions are relevant:- 13. Search for anticipation by previous publication and by prior claim (1) The examiner to whom an application for a patent is referred under Section 12 shall make investigation for the purpose of ascertaining whether the invention so far as claimed in any claim of the complete specification- (a) has been anticipated by publication before the date of filing of the applicant's complete specification in any specification filed in pursuance of an application for a patent made in India and dated on or after the 1st day of January, 1912; (b) is claimed in any claim of any other complete specification published on or after the date of filing of the applicant's complete specification, being a specification filed in pursuance of an application for a patent made in India and dated before or claiming the priority date earlier than that date. (2) The examiner shall, in addition, make an investigation [x x x] for the purpose of ascertaining, whether the invention, so far as claimed in any claim of the complete specification, has been anticipated by publication in India or elsewhere in any document other than those men ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... rejudice to the right of an applicant for a patent to amend his specification or any other document related thereto to comply with the directions of the Controller issued before the grant of a patent.] 59. Supplementary provisions as to amendment of application or specification 1[(1) No amendment of an application for a patent or a complete specification or any document relating thereto shall be made except by way of disclaimer, correction or explanation, and no amendment thereof shall be allowed, except for the purpose of incorporation of actual fact, and no amendment of a complete specification shall be allowed, the effect of which would be that the specification as amended would claim or describe matter not in substance disclosed or shown in the specification before the amendment, or that any claim of the specification as amended would not fall wholly within the scope of a claim of the specification before the amendment.] 2[(2) Where after the date of grant of patent any amendment of the specification or any other documents related thereto is allowed by the Controller or by the Appellate Board or the High Court, as the case may be,- (a) the amendment shall for all purpos ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... d indicate that the said Section provides for the process of amendments carried either prior to the grant of patent and/ or after the grant of patent. d) A reading of Section 57(3) would reveal that any application for leave to amend the complete specification made after the grant of the patent and the nature of proposed amendment may be published. e) The said Section 57 though seemingly provides for the process of amendment for both pre grant and post grant proceedings. But, so far as publication is concerned, sub Section 3 only expressly provides for publication in the case where amendments are proposed after the grant which would invite construction of the said provision. f) Section 57(6) provides that the provision of this Section shall be without prejudice to the right of applicant for patent to amend his specification or any document related thereto to comply with the directions issued before the grant of patent. g) The conjoint effect of Section 57(6) and Section 57(3) indicates that the amendments which are filed under Section 57 relates to voluntary amendments and not the amendments which are consequent upon the directions of the Controller as the same remains unaf ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... the bare reading of the provisions existing prior to the amendment vis-à-vis newly inserted provisions after the amendment of 2005, it is amply clear that the amendments are indicative of the legislative intent which is manifest on the face of it. The said legislative intent emerging from the reading of the provisions can be enumerated as under: a) That prior to the amendment of 2005, the said Section 57(3) as well as rule 81(3) provided that any application for amendment of specification after the acceptance shall be advertised and the same holds good both under the Section as well as for rule as they stood prior to the amendment. b) After the amendment, the said aspect of publication has been qualified by addition of words "made after grant" in order to provide the aspect of publication only when the amendments are proposed after grant. c) This is also clear when the said amendment has been carried out restricting the duty to publish with the corresponding discretion which is conferred upon the controller to issue further directions which will remain unaffected. This has been done by insertion of Section 57(6) wherein the controller in any case may give su ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... refore there exists no such duty on the controller to publish each and every amended if the complete specification is amended after acceptance but before the grant. 183. Now, still, the question remains what is the import of the words "examined and investigated" as stated under Section 13(3). This is important for discussion as the defendant is also setting up a challenge to the effect that the patent application has not been examined properly within the meaning of Section 13(3). The said words "examined and investigated" have the same meaning what has been stated in the preceding and subsequent Sections relating to the examination process and investigations carried out during such examination and nothing beyond the same. This can be seen by having closer look at the examination process under the Patents Act. For the purposes of the same Section 12, 13 and 14 are reproduced hereinafter: 12. Examination of application (1) When a request for examination has been made in respect of an application for a patent in the prescribed manner. [under sub-Section (1) or sub-Section (3) of Section 11B, the application and specification and other documents related thereto s ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... and no liability shall be incurred by the Central Government or any officer thereof by reason of, or in connection with, any such examination or investigation or any report or other proceedings consequent thereon. 1[14. Consideration of the report of examiner by Controller Where, in respect of an application for a patent, the report of the examiner received by the Controller is adverse to the applicant or requires any amendment of the application, the specification or other documents to ensure compliance with the provisions of this Act or of the rules made thereunder, the Controller, before proceeding to dispose of the application in accordance with the provisions hereinafter appearing, shall communicate as expeditiously as possible the gist of the objections to the applicant and shall, if so required by the applicant within the prescribed period, give him an opportunity of being heard. 184. Upon the conjoint reading of the aforementioned provisions, the following aspects relating to scheme of the examination and investigation of the patent applications can be discerned: 1. Section 12 provides that upon receipt of the request for examination, the controller shall forward the ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ection (2) of Section 11A shall be made in Form 9. 24B. Examination of application (1)(i) A request for examination under Section 11B shall be made in Form 18 3[within forty-eight months] from the date of priority of the application or from the date of filing of the application, whichever is earlier; 4[(ii) The period within which the request for examination under sub-sec. (3) of sec. 11B to be made shall be forty-eight months from the date of priority, if applicable, or forty-eight months from the date of filing of the application; (iii) The request for examination under sub-Section (4) of Section 11B shall be made within forty-eight months from the date of priority or from the date of filing of the application, or within six months from the date of revocation of the secrecy direction, whichever is later; (iv) The request for examination of application as filed according to the 'Explanation' under sub-Section (3) of Section 16 shall be made within forty-eight months from the date of filing of the application or from the date of priority of the first mentioned application or within six months from the date of filing of the further application, whichever is later;] ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... cative of the view that Section 13(3) only provides a guideline as to the likeness in the manner of examination as a process but does not indicate that the clock relating to prosecution shall be set back and the re-examination in the form examination report can be insisted upon. It is thus still within the discretion of the controller whether to examine and investigate the said patent in the like manner as that of the original specification without issuing a formal examination report or he may proceed to issue the report as per he deems fit. But the same cannot be insisted upon by the third party on the premises that the said examination process should actually result in the examination report when the Rule 24B does not provides for the said purpose a similar examination procedure, though controller may adopt the same approach of examination. Besides, the said reference of the word "first examination report", there is no mandate either under the Act or under the rules to issue the examination report at every stage of the objections. However, it is altogether different matter, that the patent office as a matter of the practice issues the examination reports at the subsequ ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... vestigation under Section 13 of the Act, the right to hearing is also given to that of the applicant. It does not provide the mode as to whether the applicant has to file the response to the said gist necessarily or can simply make a request for hearing or proceed to attend the hearing. The said aspect again indicates that the satisfaction and curing of the objections enlisted in the gist of the objections can be taken care of even in the mode of personal hearing with the examiner. This seems logical in practice even due to the reason that when number of times, there are conversations exchanged between the authorities and the applicant, still there is a room of dissatisfaction or ambiguity in the mind of the examiner, the examiner can inform the gist of the objections and call for hearing and clarify his doubts. There is no irregularity in such cases if the applicant request for hearing to make his submissions rather than to provide a detailed response. 7. The examination and investigation is the matter which is for the satisfaction of the examiner so as to the report to the controller as to whether the said invention submitted in the application satisfies the matters mentioned u ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ner who is seized of the application of the applicant. In the later kind of cases, the examination and investigation are being done by the examiner side by side by calling upon the applicant to make appropriate changes in the application and specification so as to make his application in order for grant. This is seen from Section 14 and 15 read with rules 28, 29, 30 which talks about the procedure as to anticipation and amendments which the controller may ask in order to remove the objection as to anticipation. In those cases, the amendment is consequential to the examination and investigation, the same cannot be said to be re-examined by invoking Section 13(3). 185. The aforementioned discussion relating to process of examination and investigation will enable this Court to consider the challenge as to the improper examination laid by the defendant. Let me now deal with the said objections raised by the defendant. 186. The defendant has raised the challenge relating to examination process by contending the following: A perusal of the entire Patent office record prior to the grant reveals as follows: • The Patent had a total of 27 claims - Not clear whether they were 24 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... d investigation: • On the unclarity of the claims whether they are 24 or 27. I have gone through the complete specification which is Exhibit PW1/5 as well as the one which has been relied by the defendant as Exhibit DW 1/6 to say that there is unclarity with the said claims. The said specifications under the head of claims runs from 1 to 27. The same holds also good for the initial version of the complete specification relied by the defendant to set up such challenge. If the defendant is unclear about the said claims, this Court is equally unclear unless there is a positive evidence to the said effect that how such allegation can be said to be substantiated. I think at the first place, there does not seem to be any infirmities in the claim and secondly, the defendant has not been able to establish as to how the defendant can state that initially there were 24 claims and 3 claims were added later on where there is no document on record to show the same. • The examination report dated 22.2.2006 was issued and replied on 2.6.2006. I think firstly, it is essential in order to adjudge the scope of examination and investigation as to what were the objections raised by the e ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... lating to claim 19 to 24, which was proposed to be cured by the applicant for the patent by omitting certain claims and suitably proposing to amend certain which is permissible. Thus, no infirmity on this count is found in the said examination process. • The connected challenge of the defendant is that the information under Section 8 was called upon by the examiner, which was not fully supplied as the applicant talked only about US' 498 but does not inform about US'221 and US 613. I agree with the defendant and has already arrived at the finding that the applicant has not supplied the complete information relating to foreign application under Section 8 and the same has been dealt with under the separate head of this judgment in detail. • The defendant has stated that the examination report dated 12.7.2006 refers to the specific objection relating to claim 1 to 12 and 20 are not allowable as the efficacy over the known compound is not established. EP'226 has to be cited as known compound. The response to the same dated 27.10.2006 merely replaced 2 new claims and no where satisfied the objection. It is also stated that the applicant could not have relied upo ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... r irregularity in such exercise done either by the applicant or for that matter patent office. • So far as the aspect of clinical trials is concerned, this Court in any case is testing the said trials and its credibility in this suit. The examination process cannot be said to be bad on this count either till the time the process done is fair and reasonable. • The defendant further stated that examination report dated 9.1.2007 raised some objection that the erlotinib Hydrochloride is a well known Polymorph and the said claim 1 is not allowable. The defendant states that no response thereto is sent and straightaway the personal discussion is held and thus the said examination process is bad. To this my response would me on the basis of the elaborate discussion relating to examination and investigation process done above wherein I have stated that the gist of the objections can be either suitably replied or can be cured on the basis of the personal hearing which sounds reasonable in the practice in the absence of any legislative measure or rules containing set pattern. The said practice cannot be said to be unusual or abnormal to ascribe any malice or arbitrary behavior. ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... amendments which are consequential to the process of the examination and investigation cannot be equated with the ones which are voluntary ones. The amendments which are forming the part of the process of the examination are examined simultaneously as done in the present case. Thus, once the letter dated 27.10.2006 proposes 2 new claims, thereafter the letter containing the gist of objections is received on 9.1.2007 containing the objections relating to the erlotinib hydrochloride which is a part of the new claim 1, the said examination done by the examiner is as per Section 13(3) of the Act and is in consonance with the provisions of the Act. Thereafter, during the investigations, the personal hearing is carried out when all such amendments were again considered, it cannot be stated that the patent office was at default in not examining and investigating the new claims. Rather, the examination and investigation of the said claims started right from the 9th January 2007 when the gist of objections relating to the same were handed over to the applicant and thereafter the attempt to satisfy the same by the applicant. Consequently, no infirmity can be found on the said count either. ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ess of examination and investigation is a matter between the examiner and the applicant till the time there is third party opposition is received, therefore, the same has to be adjudged from the same standpoint by ascertaining as to what was passing through the examiner's mind when he or she proceeded to remove the said objections and what was the material placed before him or her. It would be unjust to examine the said examination process from the perspective of third party as the third party would come into the picture at the later stage during pre-grant opposition and no right of the third party would be deprived till the time of conclusion of examination and investigation as per the new scheme of the Act. If the examination and investigation is vitiated by way of contravention of the provisions of the Act and Rules, then certainly illegalities can be ascribed to the said process but if not, then it cannot be said that the examination process is bad on the mere complaint of the third party when the things which went on before the patent office seems to be sequential, just and reasonable. 190. I also do not agree with the defendant's submission that the patent specificat ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... oller so far as it relates to improper examination. 194. There is no evidence lead on the aspect of the misrepresentation and concealments either by the counter claimant or by the plaintiff. The said aspect of improper examination has been raised in the counterclaim and argued purely on the factual aspects without leading any evidence in relation to the same. This is another reason which persuades this Court to observe that the defendant has not discharged its onus of the proof in relation to the aspect of concealments and misrepresentation. 195. To sum up the findings on the concealments and misrepresentation on facts of the present case, it can be observed as under: 1. The defendant has established that the plaintiffs as patentee has not disclosed the information as required by the controller as per Section 8 of the Act which is evident upon from the examination report dated 22.8.2006 and the responses thereto which do not record the subsequent patent in US'221 which ought to have been disclosed. Thus the ground of revocation under Section 64 (1) (m) is made out. 2. The defendant has failed to discharge the onus of the proof on facts that there were concealments made in ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... on 64(1). This appears to follow from the use of the words "a patent may be revoked" (Emphasis Supplied) Therefore, I exercise the discretion in this matter by not to revoke the patent. The reasoning for the same shall follow in answer to the issue no. 5 which is a relief in to revocation. Re: Relief of revocation 196. I have observed in above discussion that the defendant has only made out one ground under Section 64 (1) (m) relating to non disclosure of foreign applications before the controller and the rest of the grounds after evaluation of the evidence and submissions are rejected by me. 197. In the said ground, the objection of the defendant is that the disclosure of US'221 Ex.DW1/8 could have impacted the grant of IN'774 as the said patent relates to substantially the same or the same invention. However, the said position taken by the defendant has to seen by this Court in the light of the stand of the defendant which exists today before this Court. In this Court while resisting the infringement claim, the defendant argued that as the plaintiffs state that both the compounds are different in their Polymorphic forms, therefore the defendant is stating ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... issue no. 1 relating to infringement of the patent. The issue as framed by this Court reads as under: Whether the manufacture, marketing and sale of ERLOCIP by Defendant is infringing the Plaintiffs' Indian Patent 196774? 204. The onus to prove the said issue lies upon the plaintiffs. The plaintiffs claim to be the owner of the IN' 774 titled as Erlotinib Hydrochloride comprising the two claims, however the one relevant to the proceedings is reproduced hereunder: Claim 1 of the suit patent reads as follows: 1. A novel [6,7-bis (2-methoxyethoxy) quinazolin-4-y1]-(3-ethynylphenyl) amine hydrochloride compound of the formula A 205. The case of the plaintiffs is that the defendant has infringed the suit patent wherein the rights are granted in claim No.1. The said suit patent has the same invention and corresponds with US patent No. 5747498 (for short, it would be referred to as US' 498) date of application of the suit patent with priority of 30th March, 1995. The date of US'498 is 28th May, 1996, it was granted on 5th May, 1998. 206. The plaintiffs in the paragraph 11 of the plaint have stated that the defendant had been proposing to launch the generic versio ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... hallenge to the plaintiffs' IN'774 by way of the counter claim. In the counter claim in paragraph 3.8 to 4.3, the defendant explained that the impugned patent is an admixture of the Polymorph A and B and the drug Tarceva which has been manufactured in the market is based on the stable version of derived from Indian Patent which has been a subject matter of Patent in US'221 and in India the same patent application bearing No. IN-507/DEL has been refused. 211. To this, the plaintiffs herein in response in the written statement to the counter claim in paragraph 2 did not deny the factum of rejection of plaintiffs' application of Polymorph B version of the compound but has pointed out certain admission which as per the plaintiffs would proceed to show that the defendant had admitted the aspect of the infringement of the plaintiff's patent. This became relevant as a matter of backdrop of issue relating to infringement so that at the later stage, the arguments and submissions made later on may be evaluated on the pleaded facts of the parties. 212. The plaintiffs have thereafter filed the evidence by way of affidavit of Mr. Shiv Prasad Laud (PW1) who is a constituted ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... version of the said compound. 214. Learned counsel for the plaintiffs has cross examined DW2 Ms. Shashikala at great length. The cross examination of Ms. Shashikala reveals that though in her affidavit she claimed to be inventor of some patented inventions but once she was confronted with the documents relating to structure of the patents she has not been able to make out as to what are the structures of the compounds at several places like Exhibit PX 25 and PX 26 as cited by the learned counsel for the plaintiff. It has also come out well that Ms. Shashikala may know little about the chemical structure and may not be knowing the subject invention well even as it is apparent from her answers which were mainly that she either does not know or does not recall. She however maintained all through her cross examination that her role was confined to analyze the x-ray diffraction and compare it with the trends of what has been appended as Figure 3 in the US _221 patent. No questions were asked by the learned counsel for the plaintiffs on the aspect as to when such x-ray reports were taken, where are the originals of the said x-ray diffractions, about the correctness of the trends and no ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... re put as to factual incorrectness of plaintiffs product being Polymorphic version B of the compound. The questions were asked as to existence of Polymorphs of the compounds in general and that Erlotinib Hydrochloride from Erlotinib base and similarity of the properties, structural formula of the compound with that of the Polymorph. All this indicates that the plaintiffs maintained the position all the time that the said Polymorphic version B may be covered within the suit patent. This at least establishes that the plaintiffs do not seriously dispute that the plaintiffs' drug available in the market is a Polymorph B of the compound which is subject matter of the patent. 218. The plaintiffs have not led any positive evidence to the effect to establish on record that the Polymorphic versions are always the same as that of the underlying compound. It is also not established on record by way of depositions of the plaintiffs that how many Polymorphic versions are available of the suit compound. If there are, then whether all are the same in the nature, characteristics, properties in all respects with the parent compound. It is also not established by the plaintiffs' deposition ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... tment of Non-Small Cell Lung Cancer (NSCLC) in the year 2005 and pancreatic cancer in the year 2006. • It is submitted that Section 48 (a) of the Patents Act, 1970 provides that the patentee can prevent third parties, who do not have his consent, from making, using, offering for sale, selling or importing the said product in India. Therefore, in the present case, the Plaintiffs seek to restrain the Defendant from making, using, offering for sale, selling or importing the claimed compound Erlotinib Hydrochloride. • The plaintiffs have argued that for the purposes of the infringement of patent, the court has to read the claim and then compare it with the product of the defendant. It is argued by stating that the infringement of a patent constitutes the unauthorized act of making or using or offering for sale, selling or importing the claimed invention. Section 48 provides that infringement analysis has to be assessed upon comparison of the Claims of the suit patent with the accused product or process. Therefore, the test to determine infringement is a 2 step process: i. First, the claim needs to be interpreted; ii. Second, the impugned product has to be compared wit ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... diffraction data is used to characterize and identify the Polymorphic form of a compound since an X-ray diffraction graph is unique for a particular Polymorphic form of a compound. 221. The plaintiffs have submitted that they have discharge the onus of proof upon them to show that the defendant product is infringing the patent of the plaintiffs in the compound which is the subject matter of IN'774. As per plaintiffs, the following narration will indicate the discharge of the onus of the proof: a. That the plaintiffs have mentioned in the plaint that the cause of action first arose in January 2008, where, by way of several reports in the media, the Plaintiffs were made aware of the potential infringement of the suit patent by the Defendant. One such report appearing in _The Mint' stated that the Defendant was "to sell copycat version of the Roche drug". This report has not been denied at any point by the Defendant or its representatives. (Q. 121 read with Q. 205, DW1) b. The packaging of the Defendant's product ERLOCIP (Ex. P1,) clearly shows that the Defendant manufactures, offers for sale, and sells Erlotinib Hydrochloride tablets. c. Further, the pack ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... not in Polymorphic form in any manner. i. It is therefore submitted that even prior to January 2008, when the Defendant was "unaware" of the existence of Erlotinib Hydrochloride in Polymorph B form, it had made patent applications, received Government approvals and manufactured Erlotinib Hydrochloride tablets under the trademark ERLOCIP. It is therefore reiterated that the defence taken by the Defendant that it manufactures Erlotinib Hydrochloride in Polymorph B form is an afterthought and a last ditch effort by the Defendant to mislead this Court and deny the claim of infringement by the Plaintiffs. j. It is submitted that there is not even a whisper of this defence either in the pleadings or in Defendant's interim application I.A. No. 1272 of 2008 before this Court. In fact it is submitted that in the Replication to the Counter Claim, the Defendant in fact specifically denies that it is manufacturing Erlotinib Hydrochloride in Polymorph B form. (Paragraphs 3.8, 4-4.5 of the Reply on merits, Replication to the Counter Claim, Part I(B) of the Court Record). k. It is further submitted the Defendant has not placed on record any X Ray Diffraction data to show that ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... rom Erlotinib Hydrochloride bulk (i.e. the Active Pharmaceutical Ingredient which is undisputedly the same Erlotinib Hydrochloride as claimed in Claim 1 of the suit patent IN'774). q. Importantly, even the application for the Erlotinib Hydrochloride in Polymorph B form in the US, US 6900221 (US'221) states that Erlotinib Hydrochloride in Polymorph B form results from re-crystallization of Erlotinib Hydrochloride using different solvents and temperature condition. This has been admitted by DW3 in (Q.82, DW3;), during the course of cross examination. r. Simply explained, different Polymorphic forms of a compound are prepared in pharmaceutical sciences by re-crystallisation of the main compound using different solvents under different temperature regimes (Q.22 & Q.24, DW2,). Further, during preparation of Polymorph of a compound there is no chemical changes taking place on the molecule itself, however, during re-crystallization the molecules are re-arranged/re-oriented in a particular manner and it is this arrangement of molecules which is designated as a particular Polymorphic form of a compound. s. Importantly, there has been no evidence or process stated by Defendant ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... m per se would have been granted, the defendant would have infringed two patents, i.e. the suit patent as well as the Polymorph patent. z. In such an event, it is submitted that the manufacture of the admittedly separate and distinct invention for Erlotinib Hydrochloride in Polymorph B form will still infringe Claim 1 of IN'774. i. This concept has been statutorily recognized under Sections 19 and 91 of the Patents Act, 1970. ii. Section 19 states that where an application for a patent cannot be performed without substantial risk of infringement of any other patent, the Controller may direct that a reference to such other patent be inserted in the applicant's complete specification by way of notice to the public. iii. Following this, if the patent application is granted by the Controller, then the patentees can under Section 91 license each other's related applications so as to enable they can work the invention efficiently or to the best advantage possible. iv. This concept of cross-licensing has been expounded in several leading commentaries including Philip W. Grubb's, PATENTS FOR CHEMICALS, PHARMACEUTICALS AND BIOTECHNOLOGY (at p.4, 1999 edition) stati ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... been narrated by the plaintiffs by contending the following: a. In the pre-grant opposition order dated 15.12.2008 (Annexure to DW1/12), the Controller accepted the Defendant's contention that Polymorph B was non-patentable subject matter under Section 3(d) and rejected the application for Erlotinib Hydrochloride in Polymorph B holding that: i. The mere discovery of Erlotinib Hydrochloride in Polymorph B form was not patentable; ii. The thermodynamic stability of the Polymorph B form did not meet the requirement of "enhanced efficacy" within the meaning of Section 3(d). Controller of Patents in a well reasoned pre-grant opposition order of IN'507 held that Erlotinib Hydrochloride in Polymorph B is the _same pure substance' as suit compound Erlotinib Hydrochloride. iii. The above order has attained finality and the plaintiffs have not appealed the same. b. A rejection under Section 3(d) of the Patents Act deems Erlotinib Hydrochloride in Polymorph B form to be the same as the known substance i.e. the Erlotinib Hydrochloride compound as claimed in Claim 1 of the suit patent, IN '774. Therefore, once Erlotinib Hydrochloride in Polymorph B form is d ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... lead any evidence to show that what exactly Tarceva contains whether a Polymorphic version B or combination of A and B. • The plaintiffs have not asked any questions to the defendant's witness to disprove the fact that the Tarceva actually contained the suit compound. • In view of the above and absence of the evidence by the plaintiffs, it is established that Tarceva contained Polymorphic version B of the compound. • If that is so, then the plaintiffs are estopped by their express admissions and conduct from contending to the contrary today that the plaintiffs' drug Tarceva is covered with in the suit patent compound. As per the defendant, the plaintiffs have made the following admissions: It is the admitted position on record that a separate patent application was filed in USA for Polymorph B i.e. US'221 and other countries. Separate application for product and process being application no.s IN/507/DEL and IN497/DEL were also filed in India for Polymorph B form of Erlotinib Hydrochloride. In the said subsequent patent in USA and patent applications in India clear admissions have been made that the suit patent is related to Polymorph A+B but the ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... lly incorrect. Plaintiffs argue that the product is the same but it is only the packing of the crystals which is different. E.g., of Diamond and Graphite. However, Plaintiffs forget to consider or point out that Diamond and Graphite have completely different properties. One is soft and one is the hardest substance. Their physical properties are miles apart. • It is submitted that The Polymorph B patent application IN'507 of Plaintiffs has been rejected in India. The Plaintiffs cannot be better off after Polymorph B patent is rejected. Firstly Plaintiffs consider Polymorph B as a new invention and a new product and thus file an application for getting a patent. Thereafter, when the said application is rejected by the Controller, the Plaintiffs took a complete somersault and are arguing that the second product is covered by the first patent. If that was the case, why was the application made for the second product at first place? The Plaintiffs cannot have it both ways. • The defendant argued that Section 48 uses the words "that product". The product has to be identified. A product is a commercially saleable product. This is clear from the following decisi ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... er of IN 507. 224. By making the aforementioned submissions, learned senior counsel for the defendant has stated that the defendant has been successfully discharge the onus of proof of non infringement of the patent in the present case. 225. I shall now proceed to evaluate the submissions advanced by the parties alongside the discussion of the pleadings and evidence lead by the parties to the same effect in order to determine the question of infringement of patent. In order to facilitate the evaluation of the case of the either side, it is felt expedient to first consider some legal aspects on the basis of which the infringement of patent is determined. 226. It is also argued by the learned counsel for the defendant that the Clinical Efficacy Studies as mentioned in the literature of the products of the plaintiffs are pertaining to the product of Polymorph B and not pertaining to suit patent. Rule of Construction of Suit Patent Claim 227. The first question for the purposes of the discussion on the aspect of the infringement of patent which arises for the consideration is that how the Court has to test as to whether the impugned product is infringing the patented subject matte ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... lso contain some parts or variants other than the same also. The Courts have in those cases developed a different rule of construction of the patent claim and specification which is a slight departure from what has been stated by the plaintiffs in the present case. 231. The Courts in such cases have evolved the rule of the purposive construction of the patent claim so that in the cases wherever the need be, the claim in the invention is not construed too narrowly which was never the intention of the inventor and not the purpose of the said invention so that the maximum benefit should be given to the inventor by not interpreting the patent claim in a pedantic manner and giving the same an effect which was the real purpose for which the product was invented in furtherance of the practical approach. 232. The said rule of purposive construction was used for a long period of time in the Court of appeal in England and time and again the same was approved to accord the benefit wherever possible to the inventor of the patent. However, the Courts have from time to time thereafter also faced a situation where the resort was taken to such construction of the patent claim in order to enlarge ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ractical interest in the subject matter of his invention (i.e. skilled in the art), by which he informs them what he claims to be the essential features of the new product or process for which the letters patent grant him monopoly. It is those novel features only that he claims to be essential that constitute the so called "a pith and marrow" of the claim. A patent specification should be given a purposive construction rather than a purely literal one derived from applying to it the kind of meticulous verbal analysis in which lawyers are too often tempted by their training to indulge. The question in each case is whether persons with the practical knowledge and experienced of the kind of the work in which the invention was intended to be used, would understand that strict compliance with the particular descriptive word or phrase appearing in a claim is intended by the patentee to be essential requirement of the invention so that any variant would fall outside the monopoly claimed, even though it could have no material effect upon the way the invention worked. (Emphasis Supplied) The true question to be asked is thus in summary, whether the strict compliance with the p ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... at giving the benefit to the inventor even in cases where the product impugned does not strictly fall within the ambit of the patent claim. b) That much shall be dependent upon the role of variant attached with the invention which is claimed in the patent in order to arrive at the impugned product. c) There is a compartmentalization of variants, viz major variants and minor variants has been done by Lord Diplock in order to define as to the permissible extent of applicability of rule of purposive construction of the patent claim. d) In cases where the variant attached to the invented work which is in the form of product or process under challenge would have material bearing upon the working of the invention. In such cases, the rule of purposive construction is not applicable as in those cases the variant attached its role thereof would exclude the product in question from the ambit of the patented claim and thereby there will be no infringement of patent. e) The said rule of purposive construction is also not applicable where the invention itself is obvious to the person skilled in art. f) There is thereafter an exception to exception which is laid down by Lord Diplock s ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ing:- The Catnic principle of construction is therefore in my opinion precisely in accordance with the Protocol. It is intended to give the patentee the full extent, but not more than the full extent, of the monopoly which a reasonable person skilled in the art, reading the claims in context, would think he was intending to claim. (Emphasis Supplied) 238. In view of the above observations and the line of authorities emerging from UK, it is clear that the test laid down by Lord Diplock in Catnic (supra) holds the field and is a good law. The said case of Catnic has been followed by the Indian Courts time and again while evaluating the patents in India so far as it relates to obviousness and infringement claims and therefore the approach laid down in Catnic is not alien to the Indian context and consequently can be conveniently relied upon by the courts in India. (See case Bajaj Auto Ltd., State Of vs Tvs Motor Company Ltd, MIPR 2008 (1) 217 where Catnic case has been relied upon by the Madras High Court and same has been confirmed by the Division Bench while deciding the appeal on 18.5.2009, although it is another matter in that the case how the said approach was used depends u ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... and the claims when drafting his patent. So the patentee must be taken to know the framework of form and purpose when he drafts his patent. It is his duty to communicate his invention and his assertion of monopoly to the public in language it will understand. He is warned by the Protocol that his exclusive rights will not necessarily extend to everything which from a reading of the specification it can be seen that he contemplated. Furthermore, the drafting of the specification and claims has to be considered against the background that no one is forced to apply for a patent or to seek as wide protection as possible. The patentee can be taken to be aware of the fact that there is always a balance to be achieved between width of protection and validity. It is up to the patentee to choose the level of risk he wishes to run. 42. Notwithstanding the adaptability of scientific language, the patentee is not expected to be omniscient or to exhibit superhuman thoroughness in drafting. He may not be able to foresee future developments which will be useable with his invention but which make no material difference to the way it works. For example, the invention may relate to a mechanical d ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... nfidence that a particular embodiment was one the patentee wanted to cover involves assessing all the facts of the case. The wording of the claims is the most important one, but is not necessarily determinative. Matters such as the way the inventor describes his inventive contribution and his explanation, if any, of how the invention achieves its claimed results are matters to be taken into account. The factors, and how they interrelate to each other, will vary from case to case. (Emphasis Supplied) 242. From the above observations of Justice Laddie, it is clear that the wordings of the claims and specifications are important but are not necessarily determinative one and if the court has to conduct an enquiry in view of Catnic approach as to whether the benefit which was aimed by Lord Diplock by propounding the rule of purposive is to be given, all the attending facts and circumstances are to be given due respect besides the strict reading of the claims in order to objectively arrive at the conclusion as to what actually the patentee intended to include within the ambit of his patented claim. Justice Laddie thereafter compared /tested the said chemical compound on the basis of i ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... the way the issue of construction was put in Catnic to the way it is explained in Improver. Imagine the case where the notional skilled reader does not understand why the patentee put a limitation in the claim. According to Catnic, in such a case the limitation is effective because it is not "apparent" that the limitations "cannot have been intended by the patentee". The variants will be excluded from the monopoly. By contrast the same facts would be answered differently if Improver question (3) is applied rigidly. Where the reason for introducing the limitation is unclear, the skilled reader could not say that he understood "that the patentee intended to confine his claim". Thus improver question (3) would be answered in the negative and the claim will be construed to include the variants. I think that this difference is more imagined than real. At p.197 of Improver it appears to have been accepted that if the notional skilled addressee would speculate that the patentee had good reason for including the limitation in the claims, the limitation is effective. In other words the Catnic approach was adopted. (Emphasis Supplied) 243. In view of the abov ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... h to demonstrate that the reader of the prior art found the prospects of achieving the desired result sufficiently encouraging to warrant trying it out, even if there are commercial reasons why going down that route is unattractive (see Brugger v Medic-Aid[1996] RPC 635, 661). Where however one is attempting to broaden the patent monopoly to cover variants which are not within the a contextual meaning of the claims, a higher degree of confidence of success must be involved. The reader must have little or no doubt that the variant will, not may, work in the same way to produce the same results. In my view, the distinction between the obviousness test for invalidity and the obviousness required for Improver question (2) is apparent from American Home Products paras [28] and [29]. The claimant gets nowhere near demonstrating the relevant level of confidence in this case. For example, for Professor Scott to say that he would be disappointed if he could not improve the yield and purity were another sulphonic acid to be used instead of MSA does not mean that it is obvious that such improvement would be achieved. 79. In my view it is not proved that the notional skilled reader would hav ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... g the patent specification vis a vis the product or process in question. 247. This persuades me to reject the first submission of learned senior counsel for the plaintiffs that the test is that the Court has to look into the claim and the product and nothing else and no further document can be imported to draw such inference. As I have found during the course of my discussion above as held in the Merck(supra) that the claims are not always decisive, the factors which correlate the role of the variant and reactant with that of the patented claim are also relevant, therefore the Court can see all such documents and draw inference according after analyzing everything. 248. Let me now apply the tests laid down in Catnic (supra) and Merck (supra) to the facts and circumstances of the present case. As seen above, it is already established fact on the evidence that the plaintiffs are making a product which is a Polymorphic version B of the compound Erlotinib Hydrochloride in view of the plaintiffs inability to provide any positive evidence to dislodge the claim of the defendant that the plaintiffs are doing so and time and again maintaining that the Polymorphic version is subsumed in th ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... n is the same which corresponds with that of the plaintiffs patent. The plaintiffs do take the said position but not by way of showing the evidence of the nature stated in this point but rather taking another route of admissions, the impact of which shall be discussed later in this head. 2. If the plaintiffs were unsuccessful in doing above in the instant case, the plaintiffs could have then proceeded to approach the present proposition by establishing that the fact through giving some positive evidence in the form of depositions that how the role of the reactants with which the patented invention is reacted pursuant to the arriving at the product or process in question is bare minimal and the same is sufficiently covered within the ambit of the patented claim. As seen above in the case of Merck (supra) and Catnic (supra), this is essentially a question of fact. The said fact finding is impossible without the aid and assistance of the plaintiffs by showing the positive evidence towards the establishment of such fact. The positive evidence towards establishing the said facts could have been done by deposing on the following facts: • The fact as to what is exactly claimed in ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... of the product of the defendant, the infringement could have been proved on balance of probabilities. The only basis which is emerging for not following the said approach is due to the reason that the plaintiffs are themselves aware that the tablet version of the compound Erlotinib Hydrochloride cannot exist in the form as contained in the claim of the suit patent. This has been clear if one reads the US'221 wherein it is stated that after much reactions are done with several elements at the relevant temperature, the crystalized version and pure form of the Erlotinib Hydrochloride is arrived at which is sold in tablet form. As the plaintiffs were aware that the tablet form could not have contained the exact version of the claimed compound as they have themselves made the tablet in a stable form after obtaining a subsequent patent in US'221, corresponding to IN'507 which has been refused in India on the ground of Section 3(d) of the Patents Act 1970. Having known all this, the plaintiffs have consciously not followed the said approach 1 as enlisted above and rather followed a middle path on the basis of some existing facts by picking and choosing the versions of the par ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... US. What follows from the same is that the plaintiffs by securing the patent successfully in US, are not in the position to contend before this Court that the said role of reactants is minimal. That is the major reason why, the plaintiffs have not also not followed the approach 2 by way establishment of the fact finding as noticed above. 252. What is left by not following the above stated approaches is the case of the plaintiffs before this Court which is that the plaintiffs attempt to discharge this kind of independent onus by pinpointing the facts from here and there from the stands taken by the parties during the progression of the proceedings and calling upon this Court to draw an inferences as to the establishment of the infringement therefrom. 253. The plaintiffs have filed the affidavit of PW3 namely Mr. Nick Thatcher who stated to be a person who has qualified PHD on tumor immunology. The said PW3 states to be familiar with the Erlotinib and other quinazoline compounds in the treatment of the lung cancer. The said PW discusses what contains in the IN'774 by describing a formulation of the said compound. PW3 discusses about the role of the said compound in preventing h ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ve only deposes in relation to infringement of patent on the basis of what is depicted on the drug insert of the defendant's drug and what has been applied before the drug controller. The said affidavit nowhere provides any hint towards what exactly is the plaintiffs product or for that matter defendant so far as it relates to the question of Polymorphic version or otherwise. The said affidavit also does not address the role of the reactants in arriving at the Polymorphic version. The witness was cross examined by the learned counsel for the defendant where Mr. Laud says that he is not technical person etc. The sum total of all this discussion would be that the plaintiffs have not been able to show by way of positive evidence as to what is the exact nature of the plaintiffs and defendant products which are being sold in the market, further, whether the said products corresponds exactly with the claim of the suit patent is also not established. The plaintiffs have not been able to provide any evidence as to whether the Polymorphic version if at all is included with in the same patent claim (except by making legal arguments and arguments on some alleged admission), if so, then w ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... contrasts with the mesylate compounds which exist in three Polymorph states (mesylate Polymorph A B and C). Polymorph B of the hydrochloride was found to be thermodynamically more stable and desirable form and the present invention comprises the Polymorph B compound in the substantially pure Polymorphic B form and pharmaceutical compositions of the substantially pure form of the Polymorph B, particularly in tablet form and a method of selective production of the compound. The Hydrochloride compound disclosed in the US Patent no. 5747498 actually comprised a mixture of the Polymorphs A and B, which because of its partially reduced stability (i.e. from the Polymorph A component) was not more preferred for tablet form than the mesylate salt forms. Specifically, the present invention relates to methods of produced the hydrochloride compounds forms of N-(3-ethynylphenyl)-6-7-bis (2-methoxyethxy)-4-Quinazolinamine and for producing the stable form B in high yield. The mesylate salt of N- (3-ethynylphenyl)-6-7-bis (2-methoxyethxy)-4-Quinazolinamine has been discovered to exist in at least three Polymorphic forms which have been designated A, B and C of increasing stability with diffe ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... absence of the explanation of the said role either as a major or minor reactants coupled with the fact that both in India as well as in US, the plaintiffs have applied for the patent for the said process and product separately than the underlying compound, the purposive construction of the claim and the specification of IN'774 clearly indicates that the said plaintiffs did not intend to include the Polymorphic version B in the suit patent IN'774. It can also be said that this will fall in an exception to the rule of applicability of the purposive construction as no benefit can be given to the plaintiff under the existing patent claim. This inference can be easily drawn in the absence of any positive evidence towards disproving the said fact by indicating that the role of the reactants was minimal and rather inconsequential. Resultantly, the plaintiff has not been able to discharge his burden towards proving an infringement of IN'774 committed by the defendant. 260. The plaintiffs can argue that the IN'507 which corresponds with US'221 which has been relied upon by this Court to infer the role of reactants have been rejected in India on the ground of Section 3( ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... n to show that there is an infringement. The said description of the defendant's product nowhere indicates as to which form of the compound, the defendant is making. The defendant has categorically stated, it making Polymorph B version which corresponds to the Tarceva product, to which the plaintiff has not lead any direct evidence, therefore the mere comparison of trade description, label, drug approvals are insufficient to arrive at the conclusion as to infringement of what is claimed in the suit patent. 263. If at all there is a material on record which suggests that the defendant is making generic version of Tarceva product, even then the same by itself nowhere establishes infringement. This is due to the reason that the defendant has been able to show by x-ray diffraction as to what contained in Tarceva is the Polymorphic version B of the compound. Thus, again the plaintiffs' argument on this count fails and cannot enable this Court to assume infringement in the manner stated by the plaintiffs due to the reason that in the prayer, the plaintiffs sought injunction against the defendant in any manner infringing the legal rights in the drug Tarceva. In para-11 of the pla ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... he alleged admissions. The answer of mine to this contention would be again that the plaintiffs have to first establish infringement on the basis of what is contained in the defendant's product and not what the defendant claims to be doing. The defendant might have been inspired by ongoing drug of the plaintiffs in the market which in fact the defendant is doing as the defendant stand before press and media is clear that the defendant is intending to launch the generic version of Tarceva Drug. In case, the plaintiffs were able to prove before Court that the defendant's products are not Polymorph B version but under the patented product of suit patent, the position would have been different.. However, until the plaintiff explains who is a patentee and is under duty to explain what exactly is contained in the drug and how the patent is being infringed in the said product by taking from what is contained in the drug, the defendant cannot be imposed the responsibility of remaining in non- denial mode. The question of admission and non denial would come when the plaintiffs explain everything as to constituents of the plaintiffs' drug and whether the same corresponds with the ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... asked that the question in cross-examination from defendant's witness that diamond and graphite are two Polymorphic versions of the carbon in the cross examination. If the answer is in affirmative, then even if the plaintiffs have obtained the patent of the carbon and thereafter attempted to obtain the patent diamond separately by showing the working upon the carbon, the infringement has to be measured from by comparing the rights under the diamond patent vis-à-vis the product of the defendant and not by simply placing relying on the fact that the plaintiffs have obtained carbon patent and as the diamond contains carbon, therefore it will infringe carbon patent. This is due to the reason that the diamond is different in form, composition and its features than the mere carbon. Therefore, unless the plaintiffs explain from the purposive construction of the claim that the inventor intended at the time of framing of the patent to include such substance be it diamond in an example or Polymorphic B form of the suit patent in the suit patent, the said onus of the plaintiffs is not discharged. In the present case, the plaintiffs have not adduced any positive evidence to show the ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... to approach the patent office again to secure the patent from US and also an attempt of similar kind was made in India. Further, the said role of reactants stated in the specification would show that the reactants and steps mentioned in US'221 leads to more stability and change in dosage etc which means that the said role affects the working of the invention. In such a case, the plaintiffs' argument cannot be acceded to. 271. The argument of dependency of working of one invention over the other has been raised by the plaintiffs by contending the defendant is surely infringing the suit patent as the Polymorphic version is a working upon the suit patent. I think the said argument would have been believed only when the plaintiffs would have shown that the role of such solvents and temperature conditions are inconsequential. But, the US'221 suggest that not merely the said solvents and steps mentioned therein are material but also affects the working, characteristics of the invention which takes it to another level. Then in such a case, the Polymorphic version B of the compound falls outside the scope of the patented compound as it was never intended by the plaintiffs to b ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... o public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment;] (c) the mere discovery of a scientific principle or the formulation of an abstract theory 2[or discovery of any living thing or non-living substance occurring in nature;] 3[(d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant. Explanation : For the purposes of this clause, salts, esters, ethers, Polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy;] Upon the mere reading of the provision Section 3(d) of the Act as well as the explanation appended thereto, it cannot be said that the provisions use the words "deeming" or "deemed ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... tiffs. I think the controller of patent had arrived at the finding in the pre-grant opposition order as he was not convinced with the evidence on record as available with him as to how the Polymorphic version B significantly differs from the efficacy and proceed to treat the same as same substance by not treating the plaintiff's case within the later part of the explanation which is an exception to the rule. At that point of time, the onus was on the plaintiffs herein and the applicant therein to discharge the said onus to the satisfaction of the controller to treat the case of the plaintiffs as the one which may fall in the later part of the provision. The plaintiffs were unsuccessful in discharging the said onus and consequently the finding of Section 3(d) was arrived at by the controller. Turning back to the present case, here the onus of the plaintiffs is completely reversed, which is to establish the role of reactants are inconsequential which means that in the present case, the plaintiffs have to establish that the role of the reactants are such which is so immaterial or minor so as to show that the product in question is subsumed within the claims of the patent. The sa ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... no relevance to the efficacy of the product. It is also stated as under:The conclusions from the questions posed to PW-3 on this issue have been summarized for the convenience of this Court below: a. Polymorphism has never been raised as an issue in terms of patient benefits. (Q.115, PW3,) b. Polymorphism has never been raised as a problem in terms of the clinical benefits of Erlotinib Hydrochloride. Therefore, from the patient activity point of view, the issue of the stability of the compound in the suit patent (invented in 1995) in the tablet form is irrelevant. (Q. 168, PW3) c. If there was a clinical patient benefit difference based on Polymorphism of the Erlotinib Hydrochloride, it would have been known prior to commercial availability of the drug to expert and experienced clinicians such as PW3. (Q. 169, PW3) d. Even assuming, the compound was less stable than Polymorph B, if there was a reasonable expectation of anti-tumor activity the differences in stability may not be a big issue during clinical trials. In fact, there are some anti-cancer drugs, which on account of being unstable have to be protected from light during patient administration. (Q. 155-156, PW3) e ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... e that the suit patent may mention as example the mode of the administration in solid form, but that by itself may not establish that what contained in the plaintiffs' product is the same compound as claimed in the suit patent and not the Polymorphic version B. The establishment of the fact tablet was known in the year 1997 again nowhere indicates what is the current position in the market. I think that may be indicative of the only fact which is that somewhere down the line, the plaintiffs' suit patent contemplated an administering of the compound in solid form or tablet form, but thereafter this discussion ought to have been furthered by the plaintiffs by showing positive evidence as to what happens till date is the Polymorphic version B, the role of the steps mentioned in US'221 is inconsequential and no where affects the working of the invention, by not doing so, the onus of the plaintiffs even by placing reliance on the aforementioned facts still remains un-discharged. 277. In US'221 specification it is clearly revealed that the said patent IN'774 corresponding to US Patent No. US'498 is a mixture of Polymorph A&B. Therefore, the plaintiffs had knowled ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... does not discharge the burden of the plaintiffs which is independent and upon the plaintiffs. The admissions which the plaintiffs are again and again emphasizing are all ambiguous and disputed by the defendant here and there, the fiction argument I have already dealt with, the claim interpretation also does not reveal that the product in question falls within the ambit of the patent as the rules are different when the product contains certain variants which is apparent from the discussion done above. The sum and the substance of the entire discussion is that the plaintiffs have not indulged into the clinically examining the defendant product by pointing out as to what exactly the defendant is manufacturing a Polymorphic version B or the combination of A and B, on the other hand, the defendant has been able to provide the x-ray diffraction by the evidence of DW1 Ms. Shashikala which gives a hint towards the fact that the trends taken in x-ray are the same which are mentioned in US'221 which is relating to Polymorphic version B and there is no cross examination on this aspect by the plaintiffs' counsel and no attempt has also been made to dislodge the same. 279. The plaintif ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... the plaintiffs have not proved in evidence that they are marketing their product Tarceva other than Polymorph B version. Similarly, no evidence has been adduced by the plaintiffs in order to prove that the defendant's product namely ERLOCIP is other than Polymorph B version. The only explanation given by the plaintiffs at the time of arguments in this regard is that the suit patent was not restricted to any particular polymorphic form and the defendant could not have arrived at Polymorph B of Molecule without crossing the stage of preparation of combination of Polymorph A & B. 282. The defendant many times at the time of arguments has not denied the fact that the defendant is marketing its products under Polymorph B version which is similar to US'221. The justification given by the defendant is that since the patent application of the plaintiffs bearing No. IN'507/DEL which corresponds to 221 has been rejected by the Controller of Patents in India, the defendant is entitled to manufacture and market its product under Polymorph B version. Not only that the statement was also made by the learned counsel for the defendant that any injunction passed on such patent will no ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... • The plaintiffs' non-denial of the fact that the Tarceva is based on the Polymorphic B version and non traversal to the defendant's position that the defendant product is not actually Polymorphic B version but is the one corresponding the suit patent. • The plaintiffs maintaining the position that the Polymorphic version B was intended to be covered within the purview of the claim of the suit patent without establishing and defining the role of the reactants as major and minor. • The plaintiffs' inability to justify as to whether the Polymorphic version of the said compound affects the working of the invention materially or not. • The existence of the attending circumstances like specification of US'221 which clearly provides that there are reactions done to the suit patent compound subsequently which makes the product under the Polymorphic version B more stable which lead to the conclusion that not merely the role of such reactants are major but innovative enough to call it as a patent in itself. The said US'221 also reveals that the working of the product like dosages and form like tablet one also changes than the earlier one. &bu ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... t to restrain the defendant from manufacturing the generic version of drug Tarceva and violating the legal rights in the drug Tarceva. It has been established on record on balance of the probabilities in view of the answer of issue No. 1 which is in negative that the defendant is not infringing the IN'774 as the tablet Tarceva consists of Polymorphic B version of the compound namely N-(3-ethynylphenyl)-6-7-bis (2-methoxyethxy)-4-Quinazolinamine. Accordingly, no protection in the form of permanent injunction can be granted. Issue No. 5 287. The issue No. 5 relates to relief which may include damages or rendition of the accounts. The plaintiffs have sought the exemplary damages on the basis of the violation of its Patent rights in IN'774. I have already come to the finding that the plaintiffs have failed to discharge the onus of the proof as to show the infringement of the IN'774. Accordingly, the discussion as to the aspect of calculation of damages and prayer for damages is not warranted. The prayer of damages to the plaintiffs is accordingly rejected. Issue No.4 288. Now I shall proceed to answer issue no. 4. The said issue no. 4 reads as under : Whether defendan ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... of positive evidence that clinically the said Polymorphic version needs to be separated or converted in strict sense of term in the present case, unless the plaintiffs could have shown at the first place that the said Polymorphic version B is covered within the suit patent, which the plaintiffs are incapable in the instant case. Hence, I find that the existing depositions and the statements made by the plaintiffs in US'221 are sufficient evidence in this case at least to displace such onus especially in the light of the negative answer coming in relation to issue no. 3 relating to infringement. 295. Now I shall deal with the submission of the learned counsel for the plaintiffs in relation to the present issue which are as under: • Firstly, the learned counsel for the plaintiffs relied upon the rules of construction of the specification as done above for infringement to urge that the Court has to the see the specification and not to rely on other documents to draw the inference. I have already answered the said submission under the head of the infringement that the tests vary from case to case basis and where there is a product containing variants, the tests laid down in ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... was found to _comprise of' Polymorphs A and B which can be distinguished from _consists of'. I think one cannot read the words used in the specification like that of the statute. The argument that comprise may be construed to mean that the said patent may contain other forms other than combination of A and B is untenable. If that is so, then the next question arises that where was the occasion for the defendant to take a separate patent US'221 calling the process and product arrived at consequent upon reactions as Polymorphic version B as novel compound. Therefore, this kind of interpretation cannot aid the case of the plaintiffs. • Learned counsel pointed out weaknesses in the defendant's evidence by arguing that the defendant has not carried out any independent study, the defendant witnesses stated that they are not conversant with the patent law, the conduct of the defendant is bad etc. I have already addressed on the weakness of evidence by observing that the in the light of the emerging position in the present case, the said evidence though weak is sufficient to discharge the onus. • Learned counsel for the plaintiffs argued that the subsequent s ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... bt especially when the plaintiffs have failed to discharge any such onus as to show the infringement. • It is also stated that the defendant ought to have conducted the surveys to show that the efficacy wise, the suit patent and its Polymorphic version are different rather than merely relying upon specification. I think this could have been valid criticism from the plaintiffs' side when the plaintiffs themselves could have been discharge the onus that both the Polymorphic version and the patented compound are same. As the plaintiffs have not done so at the first place by clinically and medically examining the product, I think it does not lie in the mouth of the plaintiffs to criticize the defendant's evidence on this count. • It is argued by the learned counsel for the plaintiffs that the stability which has been mentioned in US'221 relates to the stability in storage. It has been canvassed that the statements contain the specification of US'221 are misread and misinterpreted. The plaintiffs have sought to give their own interpretation to the specification during the argument. I still find that the overall reading of the specification of US'221 ind ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... be proved by the plaintiffs in accordance with law and that is the reason why the plaintiffs are not able to make out a case for infringement of patent. Thus, the said order also does not rescue the plaintiffs automatically to dislodge the evidence lead by the defendant. 297. I have addressed almost all the submissions advanced by the learned counsel for the plaintiffs. I think there are some submissions which are quite repetitive and are common to this issue as well as the infringement issue. Therefore, the cross-reference can also be made between the two issues in order to find out the answers of the same as the necessity of deciding this issue rests on the strength of the evidence which the plaintiffs have lead in order to establish the infringement of the patent. 298. In view of the abovementioned discussion, I hold that the defendant has proved that the plaintiffs' subsequent US'221 patent contains the admission on the part of the plaintiffs that claim No.1 of the suit patent is a mixture of two Polymorph A&B and US'229 patent has an effect on the suit patent of the plaintiffs. The issue is accordingly decided in favour of the defendant and against the plaintiffs ..... X X X X Extracts X X X X X X X X Extracts X X X X
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