Tomorrow, In Delhi, India: A “Full On The Merits” Glenmark Sitagliptin Phosphate Patent Hearing?

We’ve been waiting for a little over three months for this.

Tomorrow, in Delhi, India, the High Court is scheduled to hear a full argument about whether Glenmark’s phosphate polymorph version of sitagliptin is sufficiently distinct from Merck’s Januvia® (straight sitagliptin), to allow Glenmark to continue to sell its version to the perhaps 35 million diabetics in India. Recall that Merck’s Indian subsidiary abandoned its patent application on that polymorph in India some years ago. [Recall also that, under US patent law, that wouldn’t likely matter — as Merck’s US patent protection would very likely extend to such a polymorph.]

Getting back to the main story here, though — of course, the Glenmark genericized version is already being sold in India — for about one quarter of what Merck’s branded drug fetches there. Thus, a permanent patent loss in India would materially affect the Januvia®/Janumet® franchise, globally.

Having said that, as I noted a few months back, there are signs that should it lose, Merck will partner with Sun Pharmaceuticals (another Indian generic manufacturer) to introduce an “authorized generic” version of Januvia/Janumet — at perhaps one-third the price of the branded (and thus still slightly more expensive than the Glenmark phosphate polymorph).

In short, MSD India — the operating branch of Merck in India — may elect to canibalize its own brand, with Sun Pharma, there — and thus recoup at least some of the margin it is losing to Glenmark, day by day, in country.

We will likely only have delayed reports, on the proceedings, as we have to rely on local Indian MSM reporting here — there is (to my knowledge) no direct, real time, electronic version of full-text court records, and proceedings in India. At least not the sort that may be obtained over the ‘net, from the US, as of yet.

Just the same — here’s a bit of my recent analysis (to which the first graphic, at upper right relates), as a refresher for tomorrow’s head to head:

. . . .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. . . .

And again (slipping into off-topic territory), do say a prayer (or offer a quiet contemplative moment of positive energy, if you prefer) for Trayvon’s travels through the Universe, and for his family and friends — and for all of us, as parents, who know that “but for the grace of the Infinite” — Trayvon’s own fate could easily befall our sons (and daughters, and nieces and nephews and grandchildren) — even in states where concealed carry and stand your ground is not the law.

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