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10. By the order dated 02.04.2013/05.04.2013, learned Single Judge in paragraph 22 was of the opinion that a minor variation in the combination in Glenmark‟s product (phosphate with Sitagliptin) could not mean that there was no infringement; trifling variations had to be ignored. However, he went on to notice that MSD, as patentee of Sitagliptin was not marketing Sitagliptin alone as a product and was marketing Sitagliptin in combination with phosphate, just like Glenmark. Nevertheless, he noticed that interim relief and the pleadings did not suggest that Sitagliptin Phosphate made by Glenmark was with the same object as MSD‟s patent; equally he noted that there was no pleading that the mere addition of phosphate to Sitagliptin did FAO (OS) 190/2013 Page 8 not embody an inventive advancement. The impugned judgment, therefore, concluded that the plaintiff did not prove the case it ought to have i.e. how Sitagliptin Phosphate is merely a new form of Sitagliptin that was medically equivalent to Sitagliptin, thus rendering the interim injunction unwarranted. The impugned order relied upon a Division Bench ruling in Hoffman La Roche Ltd. v. CIPLA 2012 (52) PTC 1 (Del) to the effect that if a related patent claim in India is rejected and that information is not forthcoming at the time of the subject patent claim, no injunction can be granted.

13. Mr. Andhyarujina, the learned Senior Counsel for MSD next argued that the basic question to be addressed was whether MSD‟s grievance that Glenmark had infringed its suit patent was borne out prima facie from the records. He contended that it was; to demonstrate that, he placed reliance on Glenmark‟s US Process Patent No. US8334385 dated 18.12.2012. This patent is for "Process for the preparation of R. Sitagliptin and its pharmaceutical salts". This patent, argues counsel, clearly admits that FAO (OS) 190/2013 Page 10 Sitagliptin is developed for the treatment of T2DM and is the active free base7. It also gives the full description of the process for preparing Sitagliptin freebase in the patent specification which is Scheme „6‟ in Merck‟s patent; reliance is placed on MSD‟s US patent for Sitagliptin in support. The claim of Glenmark‟s patent is for a crystalline salt of Sitagliptin. It is stated that suitable "pharmaceutically acceptable" acids include phosphoric acid. Glenmark however, did not disclose this patent in its reply. It totally disproves the allegation that Sitagliptin was not disclosed in the suit patent and was not capable of industrial application. Consequently, submitted MSD, on Glenmark‟s admission, Sitagliptin and its pharmaceutically acceptable salt is incorporated within the MSD's patent, and Glenmark cannot be heard to state to the contrary. Mr. Andhyarujina relies on the World Health Organization (WHO) assigning Sitagliptin an "INN" name. For this reason, Glenmark in their US patent refer to the chemical compound as Sitagliptin and not by its chemical name. The submission was that anyone using the INN Sitagliptin is unquestionably referring to the same chemical name and structure as given in MSD‟s patent specification and claims.

28. In support of the plea that the patent salt is liable to be revoked, Glenmark argues that Sitagliptin Free Base is not disclosed either as a raw material or as an intermediate product in the patent application and that MSD‟s admission in the SPM patent application disclose its awareness of, and unequivocal acceptance of Sitagliptin Free Base‟s unpatentability due to lack of industrial application. Here, the statement that the "form of sitagliptin is relatively unstable and not suitable for pharmaceutical development" and further that "...the amorphous hydrochloride salt of sitagliptin was tested but rejected for pharmaceutical development due to inter alia its hygroscopic and morphological properties" by MSD in its patent application is relied on. MSD‟s clear understanding that Sitagliptin is unformed, not isolated, industrially unusable and therefore not patentable is highlighted. It is urged that what was put to clinical trial was SPM, and not Sitagliptin Free Base, or even Sitagliptin Hcl. All these, states Glenmark, exemplify MSD‟s disregard and violation of the statutory mandate contained in Section 10 (4) with respect to complete disclosure of the specification. It is further argued that textually Section 48 presupposes rights in respect of the patented article alone- an interpretation supported by the definition of "invention"; reliance is placed on the judgments reported as Bhor Industries v. Collector Central Excise, 1989 (1) SCC 602 and Delhi Cloth and General Mills Co. Ltd v. R.R. Gupta, 1976 (3) SCC 444. It is argued that the failure to fulfil the disclosure mandate of the Patent Act renders the suit patents liable to revocation. When the suit patent was examined, a claim for SPM FAO (OS) 190/2013 Page 22 was made and MSD knew that neither Sitagliptin Free Base nor Sitagliptin Hydrochloride had any industrial application. Therefore, for it to now contend that the suit patent subsumed those compounds or substances was impermissible. It was lastly argued that the patent was liable to be revoked as MSD‟s applications, as well as pleadings before the Court, when it alleged infringement by Glenmark, were replete with half truths and suppression of material facts.

"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, in spite 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 combining the same with Phosphate and the role of Phosphate being inconsequential in the disease which SITAGLIPTIN cures. It was for the plaintiffs to have made a case of Sitagliptin Phosphate being merely a new form of SITAGLIPTIN which does not result in the enhancement of the efficacy of SITAGLIPTIN or being a mere combination of other derivatives of SITAGLIPTIN. I am unable to find any pleading of the plaintiffs to the said effect. Rather, the plaint proceeds on the premise that Sitagliptin Phosphate is the same as SITAGLIPTIN but which is not found to be the case of the plaintiffs in its own FAO (OS) 190/2013 Page 70 application for grant of Sitagliptin Phosphate and which was abandoned.