Monday, April 8, 2013

Lost In The "Smoke" Of Gleevec® India "No Patent" Posturing: One Salient Fact -- And My Opinion On It

Many have written -- over the last seven days -- about the potentially debilitating effect the India Supreme Court Gleevec® decision of last Monday may have, on new drug availability, and innovation by non-Indian-domiciled multinationals, when operating inside India, proper.

As ever, some of that concern is well-founded, at least as to other cases now pending in India. But not all of it. Not by a long stretch.

Writing for Forbes this morning, a former R&D guy for a multinational pharmaceutical company I won't name opines that this decision is effectively a "land-grab" by India. His piece also carries a whiff nationalization of property, in its over-the-top rhetorical fourishes.

Of course, almost none of that has anything to do with the actual facts of the Novartis case. The case's facts were fairly unique. It takes about 111 pages to get there, but the Indian opinion, at Section 193., discloses that Novartis was actually seeking to have the Indian courts declare patented a "beta crystalline" form of the drug. The problem is that Novartis had long ago abandoned that claim in India. Novartis, in short, only claimed that "invention" decades later. [Even the usually very careful Derek Lowe glossed right over this important detail, in his definitive piece on it -- last week.]

And so I'll submit this: one other way to look at the India Gleevec decision is to say (unsurprisingly) that one cannot obtain patents on polymorphs for which one submits no timely patent application. That is the holding, narrowly construed. That said, of course, the Indian Supreme Court's dicta goes well beyond that (but dicta doesn't control future cases -- even in India). No, the actual decision turns on the idea that India has set a higher bar for what counts as an "invention" than the US patent system has, in the area of drug compounds.

We may quibble about whether we like where the bar has been set, but for the moment, the case suggests multinational companies must timely file on all polymorphs in India, and attempt to demonstrate both novelty and efficacy advantages in each polymorph (under Indian Section 3(d)). No "overpatenting" will likely be allowed, in India. That is what branded pharma must address itself to -- in order to win, in the future, in India. Here is the decision (a big PDF) -- take a look at around page 110:

. . .193. . . . [I]n the US the drug Gleevec came to the market in 2001. It is beyond doubt that what was marketed then was Imatinib Mesylate and not the subject product, Imatinib Mesylate in beta crystal form. It is also seen above that even while the appellant’s application for grant of patent lay in the “mailbox” awaiting amendments in the law of patent in India, the appellant was granted Exclusive Marketing Rights on November 10, 2003, following which Gleevec was marketed in India as well. On its package1, the drug was described as “Imatinib Mesylate Tablets 100 mg” and it was further stated that “each film coated tablet contains: 100 mg Imatinib (as Mesylate)”. On the package there is no reference at all to Imatinib Mesylate in beta crystalline form.. . .
And so -- while Thomas Friedman may not have it down perfectly in his New York Times opinion piece, last week -- he is not any more wrong than his Forbes-published detractor. But make no mistake, if all the BRIC countries (China, Brazil, Russia and India) follow suit, and India's lead -- in the dicta -- the growth for branded pharma may be severely limited there.

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