Tuesday, April 2, 2013

Emboldened By Gleevec® "No Patent" Ruling (?), Glenmark Conducts An "At Risk" Launch In India: Sitagliptin

The timing of Glenmark Pharma's launch of a generic form of sitagliptin, the active compound in Merck's diabetis medicines branded as Januvia® and Janumet® , seems more than coincidental. As does MSD's suit to enjoin Glenmark's forray.

While Glenmark is not explicitly linking the two events, it seems logical to infer that one led to the other. Note that Glenmark's Indian market introduction came only a day after Novartis lost its Indian patent appeal, on Gleevec.

The most interesting question for my money, here is whether the MSD patents in India predate 1995 -- and thus are outside the new laws, or post-date them. If the Januvia/Janumet sitagliptin patent(s) at issue in India pre-date 1995, then the case looks more than a little like the Novartis' Gleevec case.

In any event, here is a bit of the Reuters story -- do go read it all:

. . . .Although the patent is yet to expire, Mumbai-based Glenmark confirmed it had launched generic versions of the two drugs.

"Glenmark is a responsible company and has launched the products after due diligence and research," it said in an emailed statement.

MSD filed its case with the Delhi High Court on Tuesday, saying it was disappointed with Glenmark's decision to launch products that directly infringed its intellectual property.

There are about 65 million patients in India being treated for type 2 diabetes, MSD said.

"We believe our patents for Januvia and Janumet are valid and enforceable and will vigorously defend them," MSD said in an email to Reuters.

Januvia costs nearly 1,300 rupees ($23.92) for a month's dose while Glenmark has offered the drug at a discount of about 30 percent, an industry source said. . . .

We will keep you posted, as more information becomes available -- but it may turn out to be difficult for Merck to prove its Sitagliptin patents cover a truly novel invention -- given Monday's Supreme Court (of India) ruling, on Gleevec.

That set a very high bar, relatively speaking, on what will be patentable in India, pre-1995, and the new laws.

We shall see.

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