Indian Court Halts Glenmark From Manufacturing Merck Diabetes Drugs
India’s Supreme Court has temporarily barred Glenmark Pharmaceuticals from making new copies of Merck’s diabetes drugs Januvia and Janumet, but the Mumbai-based company may continue to sell its existing stock.
In an order released last week, Glenmark may exhaust its inventory of Zita and Zitamet, which should last roughly five or six months, but can’t process any unfinished formulations, at least for the next several weeks.
The ruling — which continues a stay on an interim injunction against Glenmark until the next scheduled hearing on July 22 — follows other recent signs that India’s hardline stance against protections for brandname drugs is mellowing.
Vince Suneja, CEO of TwoFour Insight Group, called it a partial victory for Merck.
The lawsuit originated in 2013 when Merck sued Glenmark for patent infringement of sitagliptin, the active ingredient in both Januvia and Janumet. The case is pending in the Delhi High Court. The Supreme Court has requested an expedited schedule for the case and ordered that all evidence be recorded by June 30. Arguments will be heard starting July 6.
The Supreme Court’s decision in favor of Merck contrasts with a ruling in April 2013 that denied Novartis its patent for cancer drug Glivec (imatinib mesylate). At the time, Novartis raised concerns regarding India’s nonrecognition of intellectual property rights.
Last year, the U.S. Trade Representative’s Special 301 Report placed India on a priority watch list for violating IP protections.
And in September, the U.S. and India established an intellectual property working group that would meet annually as part of the countries’ bilateral trade policy forum. PhRMA welcomed the working group as a positive step in resolving IP issues on the subcontinent.
In January, the U.S. and India agreed to collaborate on IP reforms, after India’s government refused to grant patent protection for Gilead’s expensive hepatitis C drug Sovaldi (sofosbuvir).
Neither Merck nor Glenmark responded to requests for comment by press time. — Jonathon Shacat