Novartis' Glivec battle: is India a weak link for patent protection?

Jason Rutt examines the potential impact on innovator pharmaceutical companies and generics manufacturers, published by LexisNexis.

IP & IT analysis: What implications could the Indian Supreme Court’s refusal of Novartis’ appeal against the refusal of a patent protection of Glivec (also known as Gleevec)? Jason Rutt, head of patents at Rouse, examines the potential impact on innovator pharmaceutical companies and generics manufacturers.

Original news

India: Supreme Court rejects Novartis’ plea to preserve patent, LNB News 02/04/2013 31

What was the outcome of this case?

This case saw final refusal of a patent application covering the commercial form of the Novartis cancer treatment Glivec in India. When the patent was refused by the Indian patent office, Novartis appealed the decision through the Indian Court system. The decision by the Indian Supreme Court is the final word on this subject, and means that Glivec is generic in India and may be manufactured and sold freely there.

Was the case about making medicine affordable or was it simply a case where the product did not constitute an invention?

Novartis chose to use the Glivec patent refusal as a public test case on the Indian patent system. To crudely paraphrase their position: ‘every other country has granted and upheld this patent—why won’t India?’.

When the original Imatinib compound was discovered in the 1990s, a patent application covering the compound was filed, although not in India. At that time, compound patents were not available in India, although later in the development process, when the beta crystal form of Imatinib was discovered to be the most advantageous form for administration the drug, a patent application for this moiety was filed in numerous countries, including India, as compounds were now patentable. Indian Patent Act, s 3(d) makes it extremely difficult to get patent protection to new forms of a known compound. As such, this is the rigid application of Indian patent law rather than a comment on the cost of Glivec.

In not granting patent protection for these types of inventions, India is certainly making life easier for its home-grown generics industries. The generics companies, not having the research and development (R&D) costs that innovator pharmaceutical companies have, can make the medicine much more cheaply.

What will this case mean for the innovator pharmaceutical companies and generics manufacturers in the future?

This case is one of a number of recent judgments that have favoured the generics industry over pharmaceutical companies engaged in R&D. In 2012, we saw Indian courts grant a compulsory licence to generics manufacturer Natco Pharma, allowing it to make a generic version of Bayer’s cancer drug Nexavar, and generics companies succeeding in a revocation action in relation to Pfizer’s patent for Sutent. This seems to confirm a trend that India is not keen to pay for new medicines.

It's good news for generics companies, although they still make the bulk of their money in wealthy regions such as the US and Europe.

India is a huge potential market for innovator pharmaceutical companies. Without revenues from the Indian market, they will struggle to fund future R&D to the same extent. As such, I doubt they will be prepared to accept the status quo. However it will require international pressure to persuade India to change tack. A debate on price must also be likely.

What does it mean for the applicability of Trade-Related Aspects of Intellectual Property Rights (TRIPs) and the Doha declaration?

Pharmaceuticals is a global market. By not granting the IP that other countries do, Indian medicines are available at a much cheaper price than in other countries, meaning that Indian law is skewing this market. Pharmaceutical companies need to recoup R&D investment and they do that by charging for the drugs they sell. If some countries such as the US are paying full price for patented drugs and India is not, then I think we can expect the US and others to start lobbying India to take its obligations under TRIPs more seriously.