Novartis, India, MSF and Patent Law

Novartis is a pharmaceutical company based at Basel, Switzerland.

Novartis filed a writ petition in Chennai High Court to declare 3(d) of Patent Acts 2005 non-compliant with WTO's Agreement on TRIPS. TRIPS is trade-related aspects of intellectual property rights.

Trial began in March 2007, and in August the High Court dismissed the case on account that it does not have jurisdiction to test compatibility of a State Act with an international treaty.

3(d) of Patent Acts 2005 prevents from obtaining patents on new form of a known substance without bringing any significant enhancement in the known efficacy of the substance.

Novartis filed the case when its application for a patent on a certain cancer drug was rejected on the ground that this new drug was just a new form of older one without any significant enhancement in its efficacy. Novartis sold drug internationally under brand name Gleevec at 12-13 times the price at which Indian manufacturers were offering generic versions in Indian market.

Gleevec cost USD 32000 per year for a 400 mg/day dose.

Indian patent law allows for any party to oppose a patent before it is granted. In 2005, cancer groups filed the first ever 'pre-grant opposition', against Novartis' patent application for Gleevec.

Commentators from Doctors without Borders (MSF) wrote that patents in violation of 3(d) will deny entry of generic version manufacturers in medicine market. However such comments appear vague: if new forms are not significant enhancement how such patents can prevent generic versions from competing?


84% of AIDS-drugs used by MSF are generic medicines produced in India.


source:
1) http://www.doctorswithoutborders.org/pr/2007/08-06-2007.cfm
2) http://www.epw.org.in/uploads/articles/10944.pdf