Thursday, August 09, 2007

Madras High Court ruled against Novartis in Gleevec case

In an article titled Novartis: do Indian patent laws stifle research?, explores the flip side to the arguments made by IT folks about patent reform in the US.

Concerning Novartis' Gleevec, the article states:

The case [for Novartis] failed as Novartis failed to discharge the burden of showing the enhancement of efficacy. Section 3(d) has an in-built guideline for determining the enhancement of efficacy. It states that with ‘known efficacy’ as the benchmark, the person seeking patent has to show the enhancement of efficacy. The explanation to section 3(d) requires such enhancement to be significant. Novartis’ case suffered as they had produced a bioavailability study conducted on rats while the drug was admittedly in the market for many years and was consumed by humans. Then again, it was not shown how the 30 per cent increase was critical in the performance of the drug and how the increase in enhancement of efficacy made a difference when compared to known efficacy.

Aggrieved by the order of the Controller, Novartis approached the Madras High Court with two batches of writ petitions: one challenging the constitutional validity of section 3(d) and the other challenging the order of the Controller with the request for quashing the same as the appeal mechanism (appeal from a Controller’s order to the Intellectual Property Appellate Board — IPAB) under the Patents Act has not come into force by then.

Additionally, on the topic of innovation:

Patents for pharmaceutical substances today fall into two broad categories: Original inventions and incremental innovation.

Incremental innovation is a grey area; what actually amounts to incremental innovation and the extent to which such innovations should be protected is debatable. In any case, the language of section 3(d) permits incremental innovation. But it is for the applicant to demonstrate why a fresh patent should be granted to a known substance. For this the applicant has to demonstrate an increase in efficacy of the substance over the known efficacy. It would be misleading to state that section 3(d) stifles innovation.

Wegner wrote on IPFrontline:

The official “explanation” states that “[f]or purposes of [Section 3(d)], salts, esters, ethers, polymorphs, metabolites, pureform, particle size isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance [for purposes of patentability], unless they differ significantly in properties with regard to efficacy.” Novartis, § 2, p. 8; original emphasis.

[IPBiz: "particle size isomers"???]

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