Glenmark: It Would Seem That MSD Did Not Patent The Sitagliptin Phosphate Polymorph In India

First the caveats, here: I am relying on local Indian newspapers for this information, not a first hand court document.

That said, apparently Glenmark’s defense to Merck’s sitigliptin patent infringement claim in India centers on the assertion (by Glenmark) that Merck never obtained a patent in India on the “phosphate polymorph” of  sitagliptin (Merck sells sitagliptin around the globe as Januvia® and Janumet®). Merck has apparently patented the phosphate version of sitagliptin in some other geographies around the globe, but apparently abandoned its patent application in India, at some time in the past.

So — if these reports prove accurate, the dispute in India looks a fair bit like the dispute that Novartis recently lost, before the Supreme Court of India — as to a claim on Gleevec®‘s patentability in India. In the hopes of making clear what the differences are between the two sitagliptin forms, I’ve highlighted in orange, at right, the key distinguishing features of each company’s product in India. Let me know if it seems unclear — it is handmade, afterall.

We shall see — and while the appeal of the denial of the temporary relief is to be heard on April 12, 2013, the main patent infringement case won’t be heard until July 2013 at the earliest. So — we wait — but here is a bit of the India Business Standard paper’s report of today (US time):.

. . . .The US firm [Merck] had then said it had invented ‘Sitagliptin’ salt, used in the drugs and has patent over the molecule.

However, the Indian firm [Glenmark] has said it has used ‘Sitagliptin Phosphate’ in its anti-diabetes drugs, Zita and Zita-Met, and the US firm has no patent right over this salt.

Sitagliptin Phosphate has been a distinct product from Sitagliptin and due to this, the US firm had obtained separate patent for Sitagliptin Phosphate in the US, the Indian firm has said.

MSD first applied for separate patent for Sitagliptin Phosphate in India and later abandoned it, it has said. . . .

As ever, we will keep you posted.

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