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India's apex court is in the witness box facing not-so-subtle protests from the $56.67-billion Swiss drugs giant Novartis that is on the losing side of a far-reaching ruling this week on the crucial area of innovation, research and development in life-saving pharmaceuticals. The carp is that the Supreme Court was unfair in rejecting Novartis's claim on a patent of a beta crystalline form of Imatinib Mesylate (IM), an expensive prescription compound that fights certain forms of cancer.
The company has the right to express disappointment. The patent, after all, has been accepted in 40 countries. But raising fundamental questions about India's pipeline of innovation is an attempt to negate the cold fact that IM flunked the country's sophisticated patent criteria. When the court tested IM against Section 3(d) of the Indian Patents Act, Novartis cut a sorry figure trying to pass it off as an invention. The company was found to be what is called 'ever-greening' of IM -- a process where patent applications are filed with some 'artful drafting' to ensure the protection remains for a longer time.
The following, as per the sub-section, does not amount to invention: 'The mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such process results in a new product or employs at least one new reactant.' Accordingly, the apex court observed: 'This application leaves no room for doubt that Imatinib Mesylate marketed under the name Gleevec, was submitted for drug approval as covered by the Zimmermann patent.'
Jurg Zimmermann's invention of derivatives of the drug N-phenyl-2-pyrimidine-amine, one of which in a freebase -- or one of the forms which many drugs can take -- was called Imatinib and constituted a US patent application (no.5,521,184) granted in May 1996. For the court, an attempt at ever-greening the Zimmermann discovery made 17 years ago, albeit with claims that newer versions are better absorbed by the human body, was, to put it mildly, unfair to patients who have paid an arm and a leg while the case dragged on.
On the access side, Novartis's claims rested on two points. First that it was providing Gleevec free to 95 percent patients under prescription. And also, $1.7 billion worth of medicine has been doled out free under access programmes since 2002. The Supreme Court was rightly unimpressed by both of these. The 95 percent bit is pure mathematical jugglery. It does not reflect the true base of those afflicted by the cancers in question. As for the total outgo in Novartis's access programmes, the assumption clearly is that Gleevec costs Rs.120,000 ($2,200) a month!
Why not deflate the claim to one-fifteenth, since Rs.8,000 ($150) is all that generic folks like Cipla and Natco Pharma charge for the same compound? Beyond Novartis, the judgment is a message for the entire tribe of pharma multinational corporations: That they need to focus their research on genuine innovations than finding artful ways of evergreening what has already found protection for the prescribed period.
Finally, the judgment distills the significance of 'context' in statute. The concerned amendment to the Patents Act, 1970 wanted to respond to the concerns of public health practitioners across the globe over affordability of drugs -- India being the leading global supplier of bulk drugs, formulations and generic anti-retrovirals. We also need to remind ourselves of the nexus between big pharma companies and their governments as brought out by a study 'Changing Patterns of Pharmaceutical Innovation' conducted by the National Institute of Health Care Management.
It bluntly pointed out that between 1989 and 2000, the US Food and Drug Administration approved 1,035 new drug applications. Of that, 65 percent contained active ingredients already in the market (incrementally modified drugs), 11 percent were identical and only 15 percent were considered a 'highly innovative drug'. So, rather than creating a thicket of artful patents, and then crying wolf, the creators of similar predicament will be better off studying what US pharma major Gilead Sciences is doing in India. It is allowing Indian generic licensees to manufacture its cutting-edge medicines and letting them supply these cures to the developing world at much lower prices than the original. Indian judiciary isn't a group of medievalists. The courts in India, more than any one else, respect the golden compound that combines 'access' and 'genuine innovation'.
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