August 07, 2007
India Disallows 'Obvious' Patents
India's Supreme Court voided Novartis' application for a patent on a variation of Gleevec, the company's miracle cure for one form of leukemia. The ruling is being hailed by groups like Doctors Without Borders as a major victory for charitable organizations that are trying to get inexpensive medicines to the developing world.
I was struck by the similarities between this case and recent fallout from the KSR v. Teleflex Supreme Court case in the U.S., which involved gas pedals but may have broad implications for many pharmaceutical industry patents. At issue is whether a small change in an existing product qualifies as a new invention, or whether it fails one essential quality of anything considered innovative: it must not be obvious.
What's obvious? When a drug company makes a minor changes in a small molecule drug so it can extend its patent life, that's obvious.
The news coverage this morning of the Novartis case in India left me wondering, though. Is Gleevec off patent? I don't think so. So has Novartis patented this variation as a replacement for later in the drug's life cycle? Is it possible that the Indian company came up with the obvious change in the Gleevec molecule as a way of getting around the original patent, and that variation was already patented by Novartis? And if the Indian company did that, did it also conduct new clinical trials to ensure the new drug works?
This is one case where a barebones story from ten thousand miles away didn't give us the whole picture. Perhaps some of my readers know the answers to these questions.
Posted by gooznews at August 7, 2007 01:54 PMThe coverage of this Indian decision is a mess and reading the Indian press doesn't do a lot to clear things up. I did find some light reading on the subject from Indian sources at the following links:
http://gleevec.legalview.com/news-articles/page/6/
http://www.lawstudent.in/bcgliveccase.htm
http://www.pharmasianews.com/2007/03/intellectual_pr.html
http://www.pharmasianews.com/2007/03/intellectual_pr_1.html
http://www.pharmasianews.com/2007/03/intellectual_pr_2.html
The last three links seems to be the best, as they're reprinted stories from the Pink Sheet. Definitely avoid the Indian daily newpaper stories on the subject, as they're almost incomprehensible.
In any case, from the Pink Sheet articles it looks like Novartis was trying to win a patent on the "beta crystalline" form of imatinib mesylate, which is apparently Glivec. It also appears that a non-crystalline form of the molecule -- referred to in the Pink Sheet as "the original free base form" -- was already patented in India prior to 1995. (Whether Cipla, Ranbaxy and other generics are selling the free-base version or the crystalline form is still a mystery to me.) So the latest decision essentially said that Novartis can't get a patent on the crystalline form because it's an obvious extrapolation of the existing free-base molecule.
At least, that's what I've gleaned between the lines here. Based on this reading, I think you're spot-on with the parallels to the KSR decision.
Posted by: David Hamilton at August 8, 2007 05:23 PMI forgot one additional link here:
http://www.essentialdrugs.org/edrug/archive/200706/msg00044.php
Posted by: David Hamilton at August 8, 2007 05:26 PMThanks David for those links. I suspect we may start seeing challenges to some patents in the U.S. based on the Teleflex decision . . . I mean, is the enantiomer of a racemate mixture really innovative? There's a lot of drug patents out there claiming so.
Posted by: Merrill at August 8, 2007 05:41 PMThe speculation I've read suggests that enantiomer forms will be among the first obvious "innovations" to be disallowed under the ruling.
Posted by: David Hamilton at August 8, 2007 06:20 PMI think that a single enantiomer is a clear inovation if that enantiomer is retested to the satisfaction of the FDA. A single enantiomer should allow a lower dose of drug to achieve the same therapeutic effect.
However, the slight of hand in the creation of the single enantiomer 'Nexium' by AstraZeneca to replace the racemic omeperazole was totally bogus, because both molecules are prodrugs converted in the body to an identical, non-racemic active molecule. Testing was done at the same dose level, or even a little higher to provide only a marginally better therapeutic effect. (See the New Yorker Article by Malcolm Gladwell, October 25,2004