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Continuing Troubles with the Indian Patent Act: Is Novartis On Drugs?

By Dweep Chanana ⋅ August 29, 2007 ⋅  Email this post ⋅  Print This Post ⋅ Post a comment

The Hindu has an exceptional article on the recent Novartis case in India, titled “Do Indian Patent Laws Stifle Research?” that reveals the true story behind Novartis’ failure to secure a patent for its cancer drug, Gleevec. As it turns out, Novartis took a gamble by applying for the patent not in 1993 – when India had only process patents – but in 1998, when India had committed to the TRIPS regime. It did so assuming that the new patent regime would be exactly what it was used to in the US and Europe.That, as it turns out, was not the case, and the article is illuminating on how section 3(d) changes the rules of the patent game. The core of the Novartis case was that this section oversteps the boundaries set by the TRIPS agreement, by requiring that “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” is not patentable. As the article clarifies:

What section 3(d) actually does is to allow genuine improvements and at the same time bar frivolous ‘tweaking’ which are passed under the garb of incremental innovation.

In this regard, section 3(d) is trendsetting provision as it is the first legal provision in the world not to be found in the patent legislation of any country, which provides a check on frivolous patenting.

Incremental enhancements that do not really do anything and have been one of the many banes of intellectual property law. They grant monopoly power without any significant innovation, and thus act as an incentive to drive R&D towards such enhancements rather than truly pathbreaking drugs.

Meanwhile, Kaiser Daily is reporting that a patent application in India for its antiretroviral drug atazanavir was considered “abandoned” by the Indian Patent Office, after Novartis failed to respond to inquiries within the alloted time. Curiously, Novartis India seems to have no clue about the application, which may have been “filed by the company’s international arms.”

Combined with the news that Novartis may be moving significant investment out of India – either out of genuine concern for protecting its intellectual property, or for retribution – this seems to suggest Novartis is now clueless about what to do in India. It clearly is not going to get exactly the patent regime it is used to elsewhere. But considering India is likely to be one of the largest drug markets in the near future, will it it adapt, or die?