Glenmark restrained from manufacturing and selling its anti-diabetes drugs

Delhi High Court: In granting permanent injunction to US drug company Merck Sharp and Dohme (MSD), the Court restrained Indian firm Glenmark Pharmaceuticals from manufacturing and selling its anti-diabetes drugs “Zita” and “Zita-Met”, saying it has infringed patent of the plaintiff. The US drug maker in its plea had sought injunction against Glenmark alleging it of violating its patent rights. The plaintiff sells its anti-diabetic product in India under the brand name “Januvia” and “Janumeta”.

The patent dispute arose in the year 2013 when the plaintiff moved against the defendant, alleging patent infringement. The invention of plaintiffs (MSD), that is, Sitagliptin improves the efficient management of the condition of a patient suffering from type II diabetes by inhibiting the DPP-IV enzyme According to the plaintiff, Sitagliptin phosphate monohydrate, the main component of defendant’s drugs, could not be made without manufacturing the active molecule Sitagliptin, “invented and patented” by the US drug maker.  In reply to this the defendant said, “Sitagliptin  is not the only DPP-IV inhibitor (oral anti-diabetes drug) for treatment of type II diabetes in the market and there are several other DPP-IV inhibitors, including the one manufactured and marketed by the defendant, that is, Teneligliptin”. Further, they argued that Sitagliptin Phosphate Monohydrate as also the combination of Sitagliptin Phosphate Monohydrate and Metformin Hydrochloride are totally different than the Sitagliptin Hydrochloride salt. It was also contended that the process followed by the defendant for production of Zita and Zita-met is completely different than the process of manufacturing followed by the plaintiff.

A K Pathak, J. while permanently injuncting the defendant from making and selling the two drugs said, “it emerges from the comparison of the product inserts of the plaintiffs’ product and that of the defendant that they are the same and contain the same compound, that is, sitagliptin phosphate monohydrate.”  The court remarked that, there was no public interest in the matter as there were other chemical compounds, other than the one invented by the plaintiff, which were used in anti-diabetes drugs.  However, on defendant’s oral plea to allow it to sell its goods already in the market, clarified that it “may sell such of the products which are already in the market i.e in possession of its distributors and retailers”. [Merck Sharp and Dohme Corpn. v. Glenmark Pharmaceuticals Ltd.,2015 SCC OnLine Del 12580, Decided on 7-10-2015]

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