Novartis challenges patent rejection in India

Monday, March 26, 2012

The Swiss pharmaceutical company Novartis is about to challenge patent rejection in India before the Supreme Court of India. The court case is to begin on March 28.

Should the complaint be successful millions of people may no longer be able to purchase necessary medication.

Novartis AG headquarters in Basel (2006)
Image: Andrew.

The object of special attention is Imatinib, a medication used to treat certain cancers, which is marketed by Novartis as Gleevec (USA) or Glivec (Europe/Australia/Latin America).

The desired interpretation of patent law would give Novartis a renewal of another twenty years for its patent on the medication.

Over six years Novartis has been struggling over different interpretations of article 3(d) of Indian patent law, which rules the patenting of variants of already approved medicines. On March 28 Novartis will present another interpretation of article 3(d) restricting it to "discoveries", while the patent application would constitute an "invention".

[The case is] about the rewarding of innovation where markets exist, not about impeding access to medicines for poor patients.

—Paul Herrling

Novartis' head of corporate research in Basel, Paul Herrling, told the journal Nature: "[The case is] about the rewarding of innovation where markets exist, not about impeding access to medicines for poor patients. [...] We think that Gleevec is a fundamental breakthrough in medicine. If 3(d) can be used to prevent the patenting of results of innovative biomedical research, it will certainly be a disincentive for both Indian research-based pharmaceutical companies and for foreign companies wanting to be active in India. This would be to the disadvantage of Indian patients."

Brook Baker from the Northeastern University School of Law in Boston, Massachusetts, a professor in the Program on Human Rights and the Global Economy (PHRGE), explained the situation as follows: "Novartis would like the Supreme Court to adopt a low-threshold standard whereby slight improvements will count as significantly enhanced efficacy. [...] If this low-hurdle standard is adopted, companies will be able to evergreen their patents in India much as they do in the United States. [...] India is a major exporter of generic medicines to developing countries, including 80% of the medicine now used to treat over 6.6 million people living with HIV/AIDS. India's status as the pharmacy of the poor and of the developing world is actually under attack."

Médecins Sans Frontières has set up the protest web page "Novartis, Drop the Case!", with information about the court case.