The Evolution of India’s Patent Regime: Implications for Public Health and Pharmaceutical Innovation.
In 2005 Professor Mueller spent time in India studying the changes India to comply with World Trade Organization(WTO) standards, primarily compliance with TRIPS. This was a drastic change as India traditionally did not grant patents on pharmaceuticals. Only about 5 percent of the populace in India had health insurance. During the time of Colonial rule, British-imposed patent statutes caused a scarcity of drugs and increased external control over distribution. After independence, India passed a new patent act that prohibited patents on any medicinal substance. Most recently India has joined the WTO and TRIPS which has prompted India to change its domestic law to allow patents for all inventions including drugs. Generics made before 2005 are not affected by the new patent laws. 80 percent of new drug patents in India are patents from outside entities. The first Indian patent was granted to PEGASYS a swiss drug that fights Hepatits C. 11 million citizens a year in India suffer from Hepatitus C. The cost for the PEGASYS treatment in India is $10,000 a year. 80 percent of the citizens live on $2 a day or less.
India’s Patent act has a unique provision designed to prevent evergreening :
Section 3 (d) “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 or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant. Explanation – For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be same substance, unless they differ significantly in properties with regard to efficacy”
Novartis AG v. Union of India challenged the legality of section 3(d) under TRIPS. The court passed on this issue stating that this was a question for the WTO.
Q: does the patent act encourage Foreign Direct Investment (FDI)?
A:FDI is probably more affected by other factors such as the lower cost of skilled labor. For example a chemist in India is only paid 20% of what she is paid in the US.
Here are the slides from the presentation:
For more information check out her paper on the same topic:
The Tiger Awakens: The Tumultuous Transformation of India’s Patent System and the Rise of Indian Pharmaceutical Innovation, 68 University of Pittsburgh L. Rev. 491 (2008), available at SSRN: http://ssrn.com/abstract