Novartis Patent Ruling in India a Landmark for Healthcare

Swiss pharmaceutical company Novartis this week lost a seven-year legal battle over a drug patent in India. Given India’s key role in the global supply of affordable medicines, the decision also has world-wide implications, especially considering the current case law decisions in Australian patent law.

In an article published in The Conversation, the case of Novartis' patent of its anti-cancer drug imatinib mesylate, marketed in India as Glivec, is outlined.

Through its legal action, Novartis sought to continue to be able to charge a price for Glivec per patient per year of around A$26,000. Generic versions are presently available at about A$2,000 per year.

What made the patenting of Glivec such a major issue was not only the price of this particular drug in the Indian market, but its significance as a policy precedent for the future. A legal victory for Novartis would have meant a proliferation of patents on a wide range of medicines for a longer period of time in the Indian, but also in the worldwide market.

This seems to be in line with the caselaw coming out of the Australian courts in the recent past including Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd (No 2) [2012] FCAFC 102.

The Advisory Council of Intellectual Property (ACIP), an independent body appointed by the Australian Government to advise the relevant Minister on IP issues, is currently conducting a review into Patentable Subject Matter. This is a topical issue at the moment in the area of biotechnology, for example, as it involves stem cell research and patenting of genetic material, as well as patentable medicines.

In Australia, the test to determine whether an invention constitutes patentable subject matter includes whether the invention is a ‘manner of manufacture’ and which is not ‘generally inconvenient’. In a 2004 review, the Australian Law Reform Commission (ALRC) “recognised the value of a flexible test for patentable subject matter, but found that the manner of manufacture test was ambiguous and obscure” particularly the meaning of the phrase ‘generally inconvenient’. The ALRC concluded their review by recommending that the ‘manner of manufacture’ test be reviewed.

In February 2011, the then Minister for Innovation, Industry, Science and Research requested that ACIP investigate the effectiveness of the innovation patent system in stimulating innovation by Australian small to medium business enterprises and an interim report has been released.

It is yet to be seen what worldwide impact will follow on from the decision in the Novartis case in India, however Australian caselaw seems to suggest a prioritisation on healthcare over profits.

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