I recently spoke at the Global IP Convention in Bangalore, India. My presentation concerned lifecycle management strategies used by brand-name companies and some recent legal developments that may be helpful for generic companies responding to those strategies.
While at the conference, I sat in on the excellent presentation of Mr. Caleb Gabriel. He discussed various aspects of Indian law, including Section 3(d) of the Indian Patent Act, which is recognized as enacted to prevent "evergreening." Section 3(d) of the Indian Patents Act states:
3. The following are not inventions within the meaning of this Act . . .
(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 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 the same substance, unless they differ significantly in properties with regard to efficacy.
The Indian Supreme Court is currently considering a Novartis challenge to the constitutionality of Section 3(d), but the consensus at the Global IP Convention was that the Supreme Court would uphold the provision. Section 3(d) would likely prevent much of the patenting activity employed by brand-name companies in their strategy to maintain market dominance.
I asked Mr. Caleb if he was aware of a similar provision being adopted in any other countries. He advised that a similar provision has already been adopted in the Philippines and a number of other countries are in the process of adopting such a provision. This is certainly something pharmaceutical companies should monitor in the months ahead.