Enforcing Phamaceutical Patents in India: A Case Study of the Sitagliptin Litigation
05 May 2014
This April marks the first anniversary of the judgment of the Indian Supreme Court in the Novartis case, wherein the decision of the Indian Patent Office refusing grant of a patent to Novartis for its famous anti-cancer drug Gleevec (sometimes known as Glivec) was upheld. This judgment had caused a furore in the media with the big pharmaceutical companies criticizing the judgment as “a stunning defeat for intellectual property rights” (as in an April 2013 Time magazine story) and public-health activists hailing the decision as “a win for patients seeking cheaper treatment” in the same story.
However, is the future of pharmaceutical patent law in India as bleak as it was painted to be? It appears not. The Courts in India, specifically the Delhi High Court, have recently given forward-looking decisions in patentrelated matters. These range from decisions whereby a committee was appointed for achieving time bound disposal of pending and fresh patent applications at the Indian Patent Office, such as December 16, 2013, Orders of the Delhi High Court in Nitto Denko Corp v. Union of India, to various decisions granting interim injunctions in patent infringement suits.
A convincing case-study for the latter kind of decisions consists of the orders of the Delhi High Court in recent patent infringement suits filed by Merck Sharp & Dohme Corp (MSD) in connection with its patent for oral antihyperglycemic drug Sitagliptin and its pharmaceutically-acceptable salts. Interestingly, April also marks the first anniversary of the Sitagliptin litigation initiated by MSD against third parties.
In April 2013, MSD and its Indian licensee Sun Pharmaceutical Industries (Sun) had filed a patent infringement suit against Glenmark Pharmaceuticals upon learning about the commercial launch of its generic Sitagliptin products. At the first hearing, the court, in view of the voluminous documents handed over in court by Glenmark, declined to grant an interim injunction. This order was challenged in an appeal, in which orders were reserved in August 2013.
MSD and Sun filed a patent infringement suit against a second company, Aprica Pharmaceuticals, which was about to commercially launch a Sitagliptin product. On June 17, 2013, the court granted an ex parte interim injunction against the said entity. The injunction is continuing to this date.
Thereafter, MSD and SUN filed another patent infringement suit against Shilpex Pharmysis to stop an impending launch of its infringing products. The court, upon being convinced, granted an ex parte injunction in the plaintiffs’ favour on July 30, 2013. On November 1, 2013, this matter was decreed in favour of the plaintiffs, as per the settlement entered into between the parties, which included the payment of token damages to the plaintiffs.
MSD and Sun filed a fourth patent infringement suit against NMC Biopharm, which was about to launch a Sitagliptin product. On September 2, 2013, an ex-parte injunction was granted. This suit was decreed in favour of the plaintiffs on December 18, 2013, after considering ex-parte evidence.
A fifth patent infringement suit was filed against WinBioz Remedies, which was also about to commercially launch a Sitagliptin product. In the said suit, once again an ex-parte injunction was granted in favour of the plaintiffs, this time on December 20, 2013. The said injunction is subsisting.
Subsequently, on February 7, 2014, JohnLee Pharmaceuticals was stopped from launching an infringing product by way of a patent infringement suit filed against it. This suit was the sixth suit filed by MSD and Sun for the same patent. On February 28, 2014, this suit was decreed in favour of the plaintiffs as per the settlement entered into between the parties.
A seventh patent infringement suit for the same patent was filed against Oscar Remedies. In this suit also, an ex-parte injunction was granted against the party on February 19, 2014. This suit has also now been decreed in favour of the Plaintiffs as per the settlement entered into between the parties on March 27, 2014.
Thus, after the initial refusal of injunction, there have been six patent infringement suits filed for the same patent, wherein injunctions have been granted in favour of MSD and Sun, including one by the judge who initially declined it.
Four of these lawsuits now stand decreed in favour of the Plaintiffs.
The above decisions of protecting the Sitagliptin patent highlight the progressive trend of the Indian Courts of enforcing granted patents. Defending and enforcing a pharmaceutical patent in India, like in the other countries, may be an uphill task. However, slowly and steadily, India is developing a patent regime which suitably and equitably balances the interests of both the innovators and the public.
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