Friday, March 20, 2015

Januvia® Patent Litigation In India Continues -- Over "At Risk Launched" Generic Sitagliptin (-Phosphate) -- But Merck Wins A Round

We've been waiting for a little over 21 months for clarity on this request for an injunction by MSD India, the local Merck & Co. affiliate there.

This very morning, as various and sundry Indian news outlets are reporting -- the Delhi High Court three-judge panel has granted Merck an injunction, keeping any new inventory of the Glenmark generic form of sitagliptin off market there. However, Glenmark will be allowed to sell out its existing inventory of Zita and Zita-met, the knockoffs of Januvia®, and Janumet®.

As we first reported in June of 2013, MSD India was granted a similar order, barring another generic maker -- Aprica -- from selling a generic form of sitiagliptin phosphate in India.

. . . .The Delhi high court on Friday restrained Indian firm Glenmark Pharmaceuticals from manufacturing, marketing or selling its anti-diabetes drugs Zita and Zita-Met, saying it has “prima facie” infringed the patent of US drug major Merck Sharp and Dohme (MSD). . . .

The court also set aside its single-judge’s 5 April 2013 order refusing to restrain Indian company from manufacturing and selling its medicines meant for treatment of Type-2 diabetes. . . .

The bench, however, on Glenmark’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”. . . .

I still think there will be a global settlement here, with all the generic makers -- since diabetes represents such a high-burden disease in the relatively limited means populations of India. But we will keep you apprised.

For now, Merck has been able to take another extremely low price alternative off-market in India. Even so, Merck sells its own branded sitagliptin (Januvia) at a big discount in India, compared to what it charges in the US, and EU. On a global basis, the company's sitagliptin sales growth (in dollars) has slowed for Kenilworth, since mid to late 2014, in part due to these factors we have been steadily covering. Now you know. [NB: Weekend outage alert -- traveling and out of pocket.]

No comments: