Wednesday, March 25, 2015

UPDATE: At Least Until April 28, 2015, Glenmark May Continue To Manufacture And Sell Generic Sitagliptin In India -- Supreme Court Of India


In an update to our coverage of last week, the Indian news-wires are reporting this morning that the Supreme Court of India has granted Glenmark a stay on the injunction -- through April 28, 2015 -- when their Supremes will hear the Glenmark appeal. That means Glenmark is free to keep selling its "at risk" generic sitagliptin in India (a right the High Court allowed, in any event, to sell off Glenmark's existing inventory).

I am uncertain about this, but it would surprise me if Glenmark didn't already have enough inventory on hand to keep shipping through April 28, 2015. In the event that it does not, it is now free to manufacture enough to reach that date. Glenmark may still have to pay Merck a royalty on all these sales, but the people of India may still source cheaper generics from Glenmark. Here's a bit, locally:

. . . .Supreme Court today stayed util April 28 the order of Delhi High Court barring Indian pharma major Glenmark Pharamceuticals from making, marketing or selling its anti-diabetes medicines in which US drug major Merck Sharp and Dohme (MSD) has claimed patent right.

"Up to April 28, there will be an interim stay on the order of the High Court," a bench comprising Justices Ranjan Gogoi and N V Ramana said. . . .


So, even if the Indian Supreme Court decides that the High Court's injunction will stand -- Glenmark will likely only ever owe Merck a running royalty on sales -- through the date of that decision. I do think the Supremes will ultimately enjoin Glenmark, and effectively force it to buy a license from Kenilworth, but I expect that generic sitagliptin therapies, from either "authorized generic" sources -- or Glenmark and Aprica -- i.e., non-authorized sources. . . are here to stay, in India. Merck has tacitly acknowledged this fact, by reducing its own pricing in country, since 2014.

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