Novartis' Glivec Battle With India - Patentability Of Pharmaceutical Extension Patents

Author:Mr Duncan Bucknell
Profession:Duncan Bucknell
 
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Update and brief strategy analysis

On Monday 6 August Novartis suffered a blow in its battle to obtain Indian patent protection for its beta crystalline form of Glivec (Imatinib mesylate). The case has attracted a lot of attention (a) because of India's unusual section 3(d) which limits patentability and (b) because this is the first patent to be challenged from the famous mail-box procedure. Although Novartis' TRIPS challenge looks like a difficult one to win before the WTO, there may be some room to move.

This article provides the background, an update and some strategic options in the dispute and finishes with a list of online resources for further reading. You can comment on this article at the equivalent post on my blog

IP ThinkTank.

Background

The patent in issue claims a new crystalline form of imatinib mesylate. The original composition of matter patent is not patentable in India as it a drug product patent which was originally filed prior to 1995 when the mail box procedure began.

The Indian Patent Office refused to grant the patent on the ground that it lacked patentability under section 3(d) which states:

'The following are not inventions within the meaning of this Act,

...

'the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.'

A brief consideration of the section quickly reveals a few ambiguities (which I won't discuss here). Section 3(d) was added to the Indian Patent Act as part of the 2005 amendments. The explanation to the amendment states:

'For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.'

Novartis files two High Court challenges

Novartis' response to the refusal was to file two High Court Challenges:

- an appeal from the original decision to the Chennai High Court, arguing that the new crystalline form does in fact have an enhanced efficacy as it has a 30% increased bioavailability;

- a challenge to the enactment of section 3(c) on the ground that it was "unconstitutional as it is vague, arbitrary and violative of Article 14 of the constitution (right to equality)."

(1) The Appeal

Unfortunately, this has not progressed very far. On 2 April 2007, the Indian Government issued a notification...

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