Orange Book Blog

    by Alex Menchaca

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.

RELATED READING:

• The Lancet
• Scienceline