Saturday, May 16, 2015

India's Supremes On Januvia® (Sitagliptin) Patents: Still No Written Opinion; Glenmark Still Authorized To Sell Generic Januvia/Janumet

UPDATED: As we've written previously, we might expect a formal opinion on these Januvia®/Janumet® patent disputes in India, by the Fall of 2015, if the parties don't settle prior thereto.

And, as is often true, the embedded message from the very able justices of the Supreme Court, in India, is that the parties ought to settle, and in effect balance the 63 million lives -- almost all of limited means -- against a global juggernaut's "revenue enhancers", in country. From the Times of India then -- a bit -- but do go read it all:

. . . .The bench, which also comprises Justice N V Ramana, said, "In our view, in the present case, the above (balance of equities) would be best served if the existing stock of the two products, viz. Zita and Zita-Met are allowed to be sold in the market which, according to the petitioner itself, can take care of the current demand in the market for five to six months, i.e. September-November, 2015. . . ."

I'll have more -- with links -- at some future point.

~~~~~~~~~~ End, Update ~~~~~~~~~~

As we've been reporting for just under three years now, the burden of diabetes in India is staggering.

There are just so many people in India, and over 62 million people are afflicted, there -- most of them very poor, by Western standards. And so, there is a move afoot to have sitagliptin declared an essential medicine -- and either remove patent protection there, or broadly empower sales of it -- at "access priced" manufacturers, and outlets. To counteract this, Merck is vigorously protecting its patents in country, alleging infringement. [Just search "Glenmark" in the box above for all the dozens of background posts and history, here.]

The latest development this morning, US time, has Glenmark authorized by Indian courts to continue -- past April 28, 2015 -- to sell its generic sitagliptin salt, in country, despite Merck's trial court level win, in a patent infringement suit, there. Here is the Financial Express item, overnight:

. . . .A bench headed by justice Ranjan Gogoi while posting the matter for further hearing on May 12 continued its stay order that in effect allowed the generic pharma major to make and sell its anti-diabetes drugs Zita and Zita-Met, which allegedly amounts to infringing the patent rights of US drug major Merck Sharp and Dohme (MSD), which manufactures sitagliptin under the brand names Januvia and Janumet. . . .

We will report again, after the formal written opinion, should it come to that. Onward!

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