In a 22-page decision (available here) delivered on April 5, 2013, a Single Judge of the Delhi High Court denied interim injunction to Merck in its suit for patent infringement against Glenmark Pharmaceuticals. Merck’s patent IN209816 claimed the drug sitagliptin sold under the name “Januvia/Janumet” which is used to treat non-insulin dependent diabetes (Type 2), and restraint was sought against Glenmark’s “Zita/Zita-met”.
The suit was heard just 3 days ago, on the 2nd of April. Glenmark, which was on caveat, was represented in the Court by Dr.Abhishek Manu Singhvi, while Merck was being led Mr.Parag Tripathi. Despite Glenmark’s request that it was only contesting the grant of an ex parte relief, and not with respect to the interim injunction itself, the learned Single Judge took the view that Glenmark was prepared to argue the interim injunction itself, and proceeded to hear the application. Here’s the relevant portion:
“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 which it was required to meet and has chosen to make lengthy arguments in opposition and the Court cannot repeatedly grant opportunities to the parties.”
On merits, Glenmark alleged that Merck had 3 different patents in the US covering 3 products, namely Sitagliptin, Sitagliptin Phosphate and another derivate of Sitagliptin respectively. However in India, there is only one patent claiming Sitagliptin Hydrochloride, and the applications for the other two derivates stand abandoned By Merck. Consequently, according to Glenmark, the other two derivatives could not now be claimed as part of the sole subsisting Indian patent. Para 156 of the Novartis judgment on coverage and disclosure was cited to support this argument.
Merck, on the other hand argued, that the phosphate salt must be deemed to be included as part of the patent on Sitagliptin in light of Section 3(d). Further, Merck drew attention to Glenmark’s patent application in the US wherein it was stated that Sitagliptin Phosphate is a pharmaceutically acceptable salt of Sitagliptin.
The Court narrowed down the issue to the following question- “Does the phosphate salt materially alter the working of the Sitagliptin? If no, then isn’t the addition of the salt an immaterial variant?”
When the above question was posed to Glenmark, the judgment says no satisfactory response was forthcoming. Here’s the relevant portion:
“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.
These observations could lead any reader to conclude that the Court was convinced that there was a prima facie case of infringement, however, the following paras reflect the subsequent turn of the tide:
“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 product of the defendant as of the plaintiff.
24. However the defendant pointed out that the patent of the plaintiff Merck was not in the pharmaceutical composition as described on plaintiff’s product but only in a part thereof and which fact was not denied by the plaintiff. 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.”
True, product to product comparison is not the basis for infringement. That said, if the Court can form a view on whether the phosphate salt is an immaterial variant of Sitagliptin, wouldn’t the issue be answered? But again, Merck’s own treatment of the products and existence of separate US patent did not help its case. This coupled with the absence of a claim to product comparison to establishment infringement, dissuaded the judge from granting an interim injunction. Here are the relevant paras:
“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 being a new invention worthy of patent.”
But what surprises me is the following observation of the Court:
“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...”
How can a party be expected to anticipate the arguments of the other side? I am not sure...