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TMI Blog2013 (4) TMI 235X X X X Extracts X X X X X X X X Extracts X X X X ..... absence of the plaintiff having pleaded so, can interim relief be granted on the basis of such explanation. The answer has to be an emphatic no. - plaintiffs have not made out a case for grant of interim relief. - The application is accordingly dismissed but with a direction to the defendant to diligently maintain accounts of the manufacture/production and sales of the infringing products and to file the same every quarter before this Court with advance copy to the counsel for the plaintiffs. - CS (OS) 586/2013 - - - Dated:- 5-4-2013 - Rajiv Sahai Endlaw,J. Mr. Parag P. Tripathi, Sr. Advocate with Mr. Praveen Anand, Mr. Dhruv Anand, Ms. Udita Mr. D. Sreekumar, Advocate. Mr. A.M. Singhvi, Mr. Rajeev Nayar and Mr. Rajeev Virmani, Sr. Advocates with Ms. Prathiba M. Singh, Ms. Saya Choudhry, Mr. Varun Tikmani, Ms. Anusuya Mehrotra and Mr. Ashutosh Kumar, Advocates. ORDER I.A. No.5167/2013 (of plaintiffs u/O 39 R-1 2 CPC). 1. The plaintiffs in this suit for injunction restraining infringement of patent and for other ancillary reliefs, seek interim relief restraining the defendant from making, use, selling, distributing, advertising, offering for sale and i ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... t of Type-2 diabetes; (vi) that the defendant is a large pharmaceutical company and well aware of the plaintiffs‟ product JANUVIA as well as the patent granted to cover the same and knows of the active ingredient SITAGLIPTIN in JANUVIA. The defendant itself obtained US patent dated 18th December, 2012 for its process for preparation of SITAGLIPTIN and in the said patent has acknowledged the plaintiffs‟ corresponding US patent for SITAGLIPTIN and its proprietary rights by making admissions thereof; (vii) that the product Sitagliptin Phosphate Monohydrate of the defendant infringes the plaintiffs‟ patent aforesaid; (viii) SITAGLIPTIN and any of its salts including its various stereo isomeric forms are covered by the claims of the patent of the plaintiffs and by virtue of Section 48 of the Patents Act, 1970, the plaintiffs have the exclusive right to prevent any third party making, using, offering for sale into India products that fall within the scope of the claims of the plaintiffs; (ix) that the defendant had started distributing SITAGLIPTIN and SITAGLIPTIN PLUS METFORMIN under the brand names ZITA and ZITA-MET in the form of sample packs for the last seve ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... he basis thereof it is argued that infringement is obvious. 6. Attention is next invited to the package-insert of the defendant‟s product ZITA and it is contended that the composition of the defendant‟s product shown therein is the same as the composition of the plaintiffs‟ product as shown in the patent granted to the plaintiff Merck. 7. The senior counsel for the plaintiffs, to allay any influence of the judgment of the Supreme Court in Civil Appeal Nos. 2706 to 2716 of 2013 titled Novartis AG Vs. Union of India pronounced on 1st April, 2013 contended that there is no price difference in the product of the plaintiffs and defendant and thus it cannot be said that the product of the defendant is considerably cheaper than that of the plaintiffs. 8. The senior counsel for the plaintiffs has then invited attention to the documents evidencing the process patent obtained by the defendant in US for preparation of R-Sitagliptin and its pharmaceutically acceptable salts to contend that the defendant therein has admitted the plaintiff No.1 Merck‟s US patent in SITAGLIPTIN. 9. The senior counsel for the plaintiffs has relied on: (a) Hindustan Lever Limited V ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ch were declined and subsequently affirmatively abandoned as aforesaid. From the compilation of documents handed over during the hearing, it is shown that the plaintiffs‟ patent is for Sitagliptin Hydrochloride only and not for Sitagliptin Phosphate; (iii) attention, in the compilation handed over, is invited to the application No. 5948 filed by the plaintiff Merck for the invention PD‟ i.e. Phosphoric Acid Salt of a Dipeptidyl Peptidase-IV Inhibitor and in which the plaintiff had described the same as a novel salt and a new discovery in comparison to its patent Sitagliptin seeking injunction against infringement of which this suit is filed. It is thus argued that the plaintiff in their patent application No.5948 having described the combination of S‟ and PD‟ as a new discovery and not covered by the existing patent S‟ of the plaintiff, cannot now be heard to allege the combination of S‟ PD‟ of the defendant as an infringement of the patent S‟ i.e. SITAGLIPTIN of the plaintiff. Attention is also invited to the download from the website of Controller General of Patens showing the status of the patent application No.5948 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... vited to Section 3(d) of the Act particularly to the explanation thereof to contend that there can be no patent in a derivative of a known substance. It is argued that SITAGLIPTIN is the invention and in which the plaintiff No.1 Merck has a patent and Sitagliptin Phosphate is merely a derivative thereof and in which under Section 3(d), no patent could have been granted. It is contended that the application filed by the plaintiff Merck for grant of patent in Sitagliptin Phosphate was misconceived and had been rightly rejected and for this reason only the plaintiff Merck abandoned the same. It is further contended that no weightage ought to be given to the contents of the said application to the effect that Sitagliptin Phosphate was a new discovery inasmuch as it was essential to write so while applying for a patent, though under Section 3(d) no patent could have been granted therein. It is explained that the need for applying for a separate patent for Sitagliptin Phosphate in USA arose since under the laws of USA, there is no equivalent of Section 3(d) of the Indian Act. Attention is invited to the defendant‟s application for process patent in USA to re-emphasize that the defe ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... itagliptin Phosphate is being exported to a large number of countries of the world much prior to February, 2013. Reliance is also placed on M/s. Bishwanath Prasad Radhey Shyam Vs. Hindustan Metal Industries (1979) 2 SCC 511 in support of the argument that grant of patent does not guarantee the validity of the patent. It is again highlighted that the defendant is challenging the validity of the patent of the plaintiffs and till the said validity is decided in this suit, the question of grant of any interim relief to the plaintiff, does not arise. It is further argued that the rights under Section 48 of the Act are qua the product in which the patent is granted and not in a different product. 13. The senior counsel for the plaintiffs though in further arguments sought to urge that the defendant has not denied to having commenced marketing its product in the last seven days only, was informed that the arguments cannot take the place of pleadings and when the counsel for the plaintiffs has chosen to argue in detail on the very first date of hearing, in the absence of pleadings of the defendant, he cannot be permitted to take advantage of a plea in the plaint having not been denied in ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... sulin by Pancreas. 19. The package-insert of the defendant‟s product also describes the same as a combination product which inhibits Dipeptidyl Peptidase-IV. 20. I had for this reason asked the senior counsel for the defendant to explain as to how the combination by the defendant in its product of Phosphate with SITAGLIPTIN amounted to a different treatment of Type-II Diabetes than treatment by SITAGLIPTIN. 21. No satisfactory response was forthcoming. 22. To my mind, if the infringing product are made with the same object in view which is attained by the patented article, then a minor variation does not mean that there is no infringement. Trifling and unessential variations are to be ignored. Conversely, a miniscule advancement could be recognized as an invention. 23. Interestingly in the present case, the plaintiff Merck as patentee of SITAGLIPTIN is also not marketing SITAGLIPTIN alone as a product and is marketing Sitagliptin in combination with Phosphate just as the defendant is doing. The senior counsel for the plaintiff in his opening argument, on being asked to demonstrate infringement, had done so on the basis of identical pharmaceutical composition of the ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... USA, India and Europe having claimed it to be a new invention and a different product than SITAGLIPTIN. 28. The position which thus prevails today is that we have the argument of the defendant of Sitagliptin Phosphate being a different product than patented SITAGLIPTIN together with the plaintiff Merck‟s admission to the same effect in its patent applications aforesaid for Sitagliptin Phosphate. Though the plaintiff when faced therewith has urged such patent applications to be a mis-adventure, under wrong advise at least in India, but the plaintiff in the plaint has not pleaded so. 29. I have wondered whether in the absence of the plaintiff having pleaded so, can interim relief be granted on the basis of such explanation. The answer has to be an emphatic no. It was for the plaintiff to plead the circumstances in which its application for a separate patent in Sitagliptin Phosphate was made and to explain away the admission made therein. The plaintiff has not done so. Though it may be open for the plaintiff to at the trial explain so, but the plaintiff certainly cannot be granted interim relief on a case not pleaded and in the face of its admission of Sitagliptin Phosphate ..... X X X X Extracts X X X X X X X X Extracts X X X X
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