Of In-India “Patent-Linkages,” To FDA-Style Approvals: Sound Policy, Or No?

Again, I’ll start with a caveat: I am not trained as a pure patent lawyer, here, or in India. And again, I am relying on India’s papers for the jumping off point(s).

Having said all that, it seems to me at least, an unwise policy to suggest that any FDA style regulator (generally charged with overseeing the safety and, to a lesser extent, the efficacy of medicines and devices) should also have to make a determination about whether a given compound or chemical (or one of its polymorphs!) has been granted appropriate patent or other intellectual property rights, before approving it, from a medical perspective. That seems inefficient — at best.

Moreover, in point of fact, we do essentially the opposite, here in the US. Here in the US, a would-be generic drug competitor filing for FDA approval need only assert that it thinks it has the right, on a good faith basis, to sell a given drug (from an intellectual property perspective), and then that competitor (after a waiting period, to give the innovator time to object) — should it win FDA approval, is free to sell — “at risk” against the branded innovator, in the markets. The vagaries of whether the courts will enjoin an allegedly infringing launch are left to. . . that’s right: the federal courts. [In fairness, I should point out that such “at risk” launches are relatively rare in the US — because part of the paperwork submitted for launch requires that the generic manufacturer admit that as a technical matter, the launch is “willful” — a magic patent law term, that. And then, if the patent courts ultimately find that the generic competitor’s product did infringe upon the branded innovator’s patents, treble damages may lie. That is, it is possible that triple the actual damages will be assessed. Even so, it does occasionally happen here.] So our FDA need make no additional assessment of these patent matters. And that makes sense to me, from a policy perspective.

Apparently, according to several in-India newspapers, Merck is suggesting that there be “patent linkages” at the regulatory approval level, for Glenmark’s sitagliptin phosphate candidate. That is, Merck is suggesting that the Indian version of the FDA shouldn’t approve Glenmarks’s sitagliptin phosphate without proof that it doesn’t violate a Merck patent right.

Here is the Times of India, on the above topic:

. . . .In this case, Merck subsidiary, MSD India, had sought an injunction in the Delhi high court against the sale of generic Januvia launched by Glenmark, saying that it infringed upon intellectual property. The company tried to block the sale of generic on the ground that it has a valid patent, and questioned the marketing approval given to Glenmark’s drug since it had a patent on it.

Industry experts say that “patent linkage” demand by MNCs seems to have been revived after the interim order of Delhi high court in Merck case recently. Glenmark launched the generic version of Januvia nearly 30% cheaper than MSD’s drug in the Indian market. . . .

I’ll keep an eye on this, but at least first blush, that seems an unwise policy, from a societal cost/benefit perspective, in India. Why have a body charged with medical review making intellectual property determinations? That is for the Indian patent office, and the associated courts to sort out — not their FDA.

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