I have yet to see the Intellectual Property Appellate Board’s verdict on the patent application for Novartis’ cancer drug Glivec.
But I did read Shamnad Basheer’s post on spicyip to know that it has rejected Novartis’ claim for a product patent on the drug famously dubbed the “magic bullet” against some cancers by Time magazine in 2001. Shamnad has done a great job of analysing the verdict too.
Apparently, one of the many controversial things that the IPAB has said in its verdict is that any improvement over a known molecule can be patented provided that it not only meets the usual eligibility criteria like non-obviousness, and inventive step but also enhanced “therapeutic” efficacy.
I don’t get that. How is one supposed to demonstrate enhanced efficacy at the time of a patent filing? A patent application is made very early in the research process not when trials have conclusively proven clinical efficacy. And even if such data exists are there experts in the patent office who can analyse it. Isn’t that the job of the drug regulator? And does the patent office expect human trials data as proof of enhanced efficacy or will animal trials do?
I recall that when the Glivec patent dispute was at its peak in 2007 I happened to meet Paul Herrling, head of corporate research at the Basel-based drug maker and also the head of the Novartis Institute for Tropical Diseases at Singapore. This is precisely the point he had raised then. And there still don’t seem to be answers.
The initial reports on the verdict don’t provide any clues. I hope to read the full version and get some. No doubt Novartis does too.
I must say one thing for this case however. When Novartis first dragged the Indian government to court over the denial of a patent to Glivec I thought it was committing harakiri. Its reputation took a big hit and it has not endeared itself to New Delhi. Its own peers were none too happy. But I am now beginning to believe that it was necessary. If this be the only way to seek clarity on an otherwise fairly vague provision in the law, so be it. It’s clear now that Glivec was never going to be an ‘open and shut’ case.