On 17th June, in a patent infringement suit initiated by Merck, the Delhi High Court passed an ex parte injunction order, preventing Aprica pharmaceuticals from launching generic versions of Januvia and Janumet. The high court order can be accessed here.
Merck’s counsel argued that the drug (sitagliptin) has been patented in over 102 countries. Merck’s counsels also contended that the invention entailed huge investment and the sales of the medicine in India alone exceeded several crores and in case the defendants (Aprica) are able to launch their product, irreparable loss and injury would be caused to them.
Justice Sanjeev Sachdeva opined “The plaintiff has established a prima facie case on merits and I am of the view that in case ex parte injunction is not granted to the plaintiff and defendant is able to launch the product, irreparable loss and injury would be caused to the plaintiff, which cannot be compensated in terms of money. Balance of convenience is in favour of the plaintiff.”
The order employs standard language and does not seem to address the general principles issued by Supreme Court in such cases. (Not that I am complaining about the outcome itself!). Prashant, in his previous posts has discussed the general principles laid down by the Supreme Court precedents.Although not explicitly stated in the order, the fact that the patent had been granted in other major jurisdictions worldwide seemed to have worked in Merck’s favour.
The order does not discuss the patent claims and there was no finding of infringement of any specific product. The order restrains the defendant from dealing with any product that infringes subject matter of the patent (talk about vague!).Also what’s more, there is no reference to the previous order where the court refused to grant interim relief to Merck, for the very same drug. Readers may recall that we had covered the previous order denying interim relief to Merck over here.
What was different in the previous order? Well, Glenmark argued that their product comprises three components (sitagliptin, a dihydrogenphosphate and a crystalline form). Glenmark also argued that Merck had filed separate patents for sitagliptin, a dihydrogenphosphate salt form considering the salt form to be a new invention worthy of a separate patent. The patent to the dihydrogenphosphate salt form was abandoned. Merck failed to satisfactorily plead the circumstances for obtaining a separate patent application and the court denied interim relief to Merck.
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Mad rush for sitagliptin?
As Prashant points out, The Form 27 working statement filed by Merck for the year 2012, reveals that the sales of Januvia and Janumet put together exceeds 180 crore (whopping amount)! The sales of its closest rivals Novartis’s (Vildagliptin) i.e. Galvus and Galvus-met is around 165 crores for the year 2012!!
Also,the health ministry in India recently banned pioglitazone belonging to the thiazolidinedione class of anti-diabetic drugs because of reports of increased risk of bladder cancer associated with its use. Another anti-diabetic drug Rosiglitazone belonging to the thiazolidinedione class was banned a few years ago following reports of the drug causing cardiac problems. So apart from metformin and sulphonylureas, the only alternative left for Type-II diabetics amongst oral hypoglycemic drugs are gliptin class of molecules. No wonder everybody seems to want to have a piece of the sitagliptin pie!