Doing Patents the Indian Way

Last week’s New England Journal of Medicine features a “perspectives” by Amy Kapcynski of Yale Law School:
http://www.nejm.org/doi/full/10.1056/NEJMp1304400

Prof. Kapcynski reports on a ruling by the Supreme Court of India last April that effectively upholds that nation’s Patent Act, against a challenge to a patent ruling by the drug giant Novartis.

Folks in poorer nations have a strong interest in promoting locally made generic drugs and limiting the ability of international firms to extend the patent life of their expensive brand-name drugs. With these concerns in mind, Section 3(d) of the Indian Patent Act was designed to forbid patents of the sort that lead to the most extreme cases of “evergreening” in the U.S. Pharma world (as described in HOOKED). It forbids a company getting a patent on a new, minor chemical variant of a known drug, such as a salt or isomer, unless it has shown that the new form offers a significant advantage in efficacy.

Novartis tried to extend its patent on the cancer drug Gleevec by claiming a patent on the beta-crystalline form of the drug’s active ingredient. The Supreme Court cried foul.

Prof. Kapcynski says that the Indian law and the Court’s ruling have two virtues. First, they keep prices lower for the developing world. But they also do the opposite of what Novartis immediately claimed when the adverse ruling came down—that the Indian law was stifling innovation by reducing the financial rewards to big companies. Prof. Kapcynski argues that the law rather promotes the right sort of innovation. It turns companies’ attention away from silly me-too drugs and forces them actually to innovate—to discover new drugs that work better than existing drugs.

That’s the business and public health end of the equation. What about the legal end? The basic idea behind patent law, those non-lawyers among us are told when we try to study the issue, is that important criteria for deciding whether to issue a patent are novelty and non-obviousness. Now, patenting a minor chemical tweak in an existing drug sounds like a poster child for “obvious” and “not novel.” So why has the U.S. patent office acted like such a wuss and granted patents to drug companies wholesale for these “new” drugs?

Prof. Kapcynski makes the claim that it’s not merely the case that the Indian patent law should be allowed to stand—but that it would be a great model for other countries to emulate. How about the USA?