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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 ..... ed inter alia to development of medicine for addressing unmet medical needs; (ii) that the molecule having International Non-Proprietary name of "SITAGLIPTIN" was invented by the plaintiff Merck who has patents for the same in 102 countries of the world including India; that the international application for patent was filed on 5th July, 2002 with the priority date of 6th July, 2001 and the application in India was filed on 6th January, 2004 and the patent in India was granted on 6th September, 2007 and is valid for 20 years from 6th July, 2001; (iii) that the aforesaid patent was neither opposed in the pre-grant opposition nor in post-grant opposition by any member of the public or interested party in India despite extensive publicity given to the plaintiffs‟ commercial product sold in India under the brand name "JANUVIA" and "JANUMET"; (iv) SITAGLIPTIN was approved for sale in United States of America (USA) in October, 2006 and in the Indian market on 28th March, 2008 and the plaintiffs since then are selling the product extensively in India. The plaintiff Merck has also granted a license in India to the plaintiff No.2 Sun Pharmaceutical Industries Limited which sells SI ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ant through counsels, being on caveat, appeared. The senior counsels for the plaintiffs and the defendant addressed arguments on the grant of interim relief for about two hours. After the hearing, they were informed that after such a detailed hearing, notwithstanding the written statement/reply being not on record, orders on the application for interim relief will be pronounced and were reserved. I clarify that need is not felt for the written statement/reply of the defendant for final disposal of the application for interim relief, inasmuch as the defendant being on caveats were fully prepared and have during the course of hearing handed over the documents/other materials relied upon by them and which are taken on record and the plaintiffs did not seek any opportunity to meet the same. I may however record that the senior counsel for the defendant has argued that the application for interim relief should not be disposed of and the Court at this stage should consider only the aspect of grant of ex-parte relief, saving the disposal of the application to after the reply thereto has been filed but the said request was declined as the defendant had come well prepared with the case whic ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... e to use his invention without the permission of the former and the former cannot use the improved version without coming to terms with the latter. It is argued that patent is an exclusionary right; (b) M/s. National Research Development Corporation of India, New Delhi Vs. M/s. The Delhi Cloth & General Mills Co. Ltd. AIR 1980 Delhi 132 laying down the principles applicable to the grant of temporary injunction in suits for infringement of patent including, that if a patent is a new one, a mere challenge at the Bar would be quite sufficient for refusal of temporary injunction but if it is sufficiently old and has been worked, the Court for the purpose of temporary injunction, would presume the patent to be a valid one. It is argued that though the said judgment has referred to the age of six years for the patent being an old one but the said rule of six years is not an inflexible one and has in subsequent judgments been reduced; (c) Telemecanique & Controls (I) Limited Vs. Schneider Electric Industries SA 94 (2001) DLT 865 where a Division Bench of this Court held that a monopoly of the patent is the reward for the inventor. 10. Per contra the senior counsel for the defendant h ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... the said persons, also indicating the dates from which they are marketing the same has been handed over and it is argued that since others are also selling the same product which the plaintiffs are seeking to restrain the defendant from selling, the ingredients of irreparable injury and balance of convenience are not in favour of the plaintiffs; (v) attention is invited to paras 139 & 156 of the judgment in Novartis supra to contend that coverage in a patent cannot be permitted to go much beyond the disclosure made by the patentee and that the scope of patent cannot be permitted to be determined by the artful drafting of its claim by skilful lawyers instead of intrinsic worth of the invention; (vi) it is highlighted that had the Sitagliptin Phosphate been not a distinct product from SITAGLIPTIN, the plaintiff Merck would not have obtained separate patent for Phosphate in US and would not have applied for separate patent for Sitagliptin Phosphate in India and which was ultimately abandoned; (vii) attention in this regard is also invited to the recent dicta of this Court in F. Hoffmann-La Roche Ltd. Vs. Cipla Ltd. (2012) 52 PTC 1 (Delhi) particularly to paras 147, 211, 212 to 220, ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... arisen here but was concerned with the concept of „evergreening‟ which is an attempt to keep the patent alive beyond its life/term. Attention in this regard is invited to paras 3, 5, 8 and 9 of Novartis. Attention is also invited to the fifth edition of Philip W. Grubb‟s book on Patents for Chemicals, Pharmaceuticals and Biotechnology carving out a distinction between a basic patent and an improvement patent. 12. The senior counsel for the defendant has in sur-rejoinder contended that the plaintiff Merck having in its own application which was abandoned claimed Sitagliptin Phosphate to be a new invention and having suppressed abandonment from the plaint/application in this suit, cannot be heard to orally argue that it was merely an improvement patent. It is also contended that there is no concept of a basic patent in India. Attention is invited to Section 54 of the Act which permits addition to patents and it is contended that the plaintiffs have not come to the Court with a case of Sitagliptin Phosphate being an improvement patent within the meaning of Section 3(d) and as per the documents suppressed by it was making out the same to be a case under Section 54 o ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... with a case simpliciter of product of the defendant infringing the patent SITAGLIPTIN of the plaintiff Merck and the senior counsel for the plaintiff also confined the opening argument to pharmaceutical description of the two products being identical but the real controversy for adjudication in the present suit is and the controversy veers around to, whether the combination by the defendant in its product, of SITAGLIPTIN in which the plaintiff Merck undoubtedly has a patent, with phosphate, have a material effect upon the way SITAGLIPTIN works. If the answer to the said question is to be in the affirmative, the product of the defendant would be outside the patent and if not, in infringement of the patent. 16. It is for this reason only that the senior counsel for the plaintiff, arguing in rejoinder, brought in the argument of „basic‟ and „improvement‟ patent to contend that the combination in the product of the defendant of SITAGLIPTIN with Phosphate is merely an improvement falling within the meaning of Section 3(d) and is not an invention in which patent can be granted and notwithstanding such improvement, there would be infringement. 17. There indeed i ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... aintiff. Thus, similarity of pharmaceutical composition of the products cannot be a ground for infringement. 25. Strangely, the plaintiff, neither in the plaint nor in the opening arguments has pleaded/made out a case on which ultimately interim relief is claimed, i.e., of Sitagliptin Phosphate being made by the defendant being made with the same object as the patent of the plaintiff and the addition of Phosphate to the patented SITAGLIPTIN not embodying any inventive advancement and the treatment of Type-II diabetes by Sitagliptin Phosphate being no different from treatment by SITAGLIPTIN. 26. The plaintiff in a suit restraining infringement of patent ought to have known the defence which the defendant has put forth and ought to have met the same in the plaint, as has been done in the arguments in rejoinder by arguing on „basic‟ and „improvement‟ patents. There is not an iota of pleading on the said aspect. The plaintiff, to show that the defendants product, inspite of combining Phosphate with patented SITAGLIPTIN, medically remained equivalent to SITAGLIPTIN, was expected to plead in detail on the aspects of efficacy of SITAGLIPTIN, reason for itself com ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... h injunction was claimed constituted a reason enough for denial of interim relief. I find the final judgment of the Single Judge in the said proceeding also, in para 297 holding that mere rejection of the second patent applied for by the plaintiff cannot lead to a straight conclusion of the patented article and the product subject matter of the 2nd application (which is rejected) being the same substance and that it has to be proved so by the plaintiff. In fact in the said case final relief also was denied to the plaintiff for the reason of an unsuccessful application for patent having been filed by the plaintiff in that case also. 31. No only so, the only response of the plaintiff to the plea of the defendant of at least 9 to 10 other persons also marketing Sitagliptin Phosphate, duly supported by documents handed over, was that instructions on that aspect will have to be taken. However, the said plea also belies the existence in favour of the plaintiffs of the ingredients of irreparable injury and balance of convenience. Though, ordinarily infringement by others does not constitute a ground for denial of the relief of injunction against an infringer but it can be a consideration ..... X X X X Extracts X X X X X X X X Extracts X X X X
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