As reported by the BBC, Reuters, Bloomberg and others, Novartis have lost their appeal against a refusal of their patent application for Glivec (known as Gleevec in the US).The IPKat previously noted that Indian patent law was against Glivec from the start, given that there was a specific prohibition against patenting of new derivatives of known substances (which Glivec undoubtedly is), barring a significant difference in efficacy. Novartis have been unable to show any significantly increased efficacy for Glivec, and the Chennai court hearing the case was unwilling to rule on India's requirements under TRIPs.
As before, the IPKat is unsure whether this decision is a sensible one, and the rest of the world is out of step, or if India wants to continue taking a free ride on drug developments arriving from outside. In any case, if Glivec is no better than previously available drugs, is patentability really the issue? Could it instead be more to do with a well-marketed trade mark, and the barriers to entry afforded by marketing authorisations?
For a more in-depth analysis of the issues involved, the IPKat recommends his readers to the India-focused Spicy IP blog.
Novartis lose Indian Glivec/Gleevec appeal
Reviewed by David Pearce
on
Monday, August 06, 2007
Rating:
Reviewed by David Pearce
on
Monday, August 06, 2007
Rating:
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Hi David
ReplyDeleteI thought it might be helpful to readers to add a little colour - the question under s 3(d) is whether the imatinib mesylate beta crystalline form patent has an enhanced efficacy as compared to the earlier disclosed free base form.
At the moment, there are two separate actions pending:
(1) the challenge to the validity of s3(d) itself - which Novartis has now said has been deferred to the WTO by the Indian High Court; and
(2) An appeal of the original decision to refuse patentabtility.
Apart from the s3(d) ground (above), the Indian patent office still has the option of denying patentability based on lack of inventive step (in a way which is similar to the comment made by the anonymous commenter onyour earlier post on this dispute).
After all of that, India would still have the option of granting a Compulsory License to a generic company (and presumably they are already lining up for the privilege).
Readers may wish to read a blog post and a detailed article which will publish later today over at my website - duncanbucknell.com
best regards
Duncan