Once again, India has knocked down Novartis' effort to get patent protection for its blood cancer drug Glivec (a.k.a. Gleevec). The country's last resort patent-and-trademark group--the Intellectual Property Appellate Board--ruled that the drug "lacks innovation." Theoretically at least, this brings a three-year wrangle to a close, but Novartis says it's still "reviewing the decision" and looking "at the various options available."
Here's the deal: The IPAB said that Glivec is eligible for patenting under international law, but Indian law has an additional hurdle that the drug didn't clear. Section 3(d) denies IP protection to drugs that aren't demonstrably more effective than existing meds--and the IPAB said Novartis didn't show any increased efficacy.
One of the strangest aspects to the ruling, however, is something else in quotation marks: The IPAB stated that "Any patent granted to support such a high monopoly price would be against 'public order.'" The board had pointed out Glivec's price tag of 120,000 rupees per month (around $2,500), saying that Indian cancer patients can't afford it. So the IPAB wasn't just looking for increased efficacy. It was looking for cost-effectiveness, too.
Apparently this is the first time that a drug has been denied patent protection because of "unaffordable pricing," the Institute of International Trade notes. The Institute also notes that Novartis could take up a challenge at the World Trade Organization. We'll have to wait and see what the drugmaker decides.