Tuesday, January 21, 2014

India Report: Renewed Intellectual Property "Compulsory License" Processes Afoot -- Januvia® and Isentress® Presently Being "Evaluated"

We have talked at length about this issue before (additional background here). And we are awaiting a written opinion, and a formal decision, from the Indian court system, on the Glenmark v. Merck Januvia® patent fight.

To be fair, the debate centers on whether there are some novel medications that -- under India's view of humane social policy -- are so beneficial to her citizenry (and, generally, so far out of reach, financially -- to the average Indian), that a formal government apparatus may/will be invoked, to make the drug available at nearly 95 per cent off of its Western world retail selling price. That is what is meant by "compulsory licensing," in India. Merck has been recently lobbying Congress about this issue, back here, as well. A loss on both drugs, Isentress® especially, might actually turn out to be material to the financial results of consolidated Merck, world-wide.

Here is a bit -- but do go read it all through a Bloomberg newsfeed, this afternoon:

. . . .Among the therapies the committee is preparing to study or had an early look at are. . . diabetes drugs, [including]. . . Merck’s sitagliptin medication, Januvia. . . [and] Merck’s HIV drug raltegravir, sold under the brand name Isentress. . . according to the people.

The panel is also considering other drugs and it still isn’t clear which ones will be shortlisted, the people said.

Patents provide Merck with the incentive to assume the risks associated with drug discovery, the Whitehouse Station, New Jersey-based company said in an e-mailed response to questions. “We encourage the government of India to reassure investors that India respects and values innovation and the protection of intellectual property. . . .”

To be completely fair, this will affect many multinational pharma concerns, with novel life saving therapies on-market in India.

Even so, last quarter, Merck made it clear that India would no longer be among its top five emerging markets' intiatives, primarily based on the uncertainty around this issue. Now we wait to see what the government-appointed panel in India recommends, as to Isentress (a very expensive, but life-saving, HIV/AIDS med), and Januvia (a very potent diabetes medication -- also priced well beyond the reach of an ordinary Indian wage earner). This is a complex moral and legal question. We will keep you apprised.

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