Indian approach
Article 3 (d), Indian Patents Act
Article 3 (d) of the Indian Patents Act states: "The following are not inventions within the meaning of this
Act, [...] 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 the same substance, unless they
differ significantly in properties with regard to efficacy."
Article 3 (d) of India's Patents Act aims at excluding any pharmaceutical product that does not rise to the level of "new chemical entities" or a "new medical entity". New chemical/medical entities in this sense are only those substances that, compared to the original substance, show significant improvements in medical efficacy. In other words, product derivatives can be considered mere discoveries if they fail to add the requisite degree of efficacy.
The Novartis case
Article 3 (d), Patents Act was, however, challenged by the foreign pharmaceutical company Novartis as inconsistent with the TRIPS Agreement and the Indian constitution.
Novartis had applied to the Indian Patent Office
for a patent on its drug Glivec, which was rejected on the basis of
Article 3 (d), Indian Patents Act. Therefore, Novartis challenged Article 3 (d) of India's Patents Act
at the Madras High Court who rejected
the Novartis claim in August 2007. The High Court confirmed the
constitutionality
of
the Indian provision. On TRIPS, it said it had no jurisdiction to
adjudicate
the matter and referred to the WTO Dispute Settlement Understanding. So
far, no case has been brought before the Dispute Settlement Body.
However, this decision did not deal with the rejection of Novartis' patent application for Glivec by the Indian Patent Office. The question whether Article 3 (d), Indian Patents Act was applied correctly in the particular case is to be decided by India's IP Appellate Board. This body may still come to the conclusion that the Patent Office did not correctly apply Article 3 (d) of the Patents Act and that Novartis should be granted a patent for Glivec.
An interesting interview by Prof. Janice Mueller of the University of Pittsburgh School of Law explains the Novartis case pointing out the different positions of Novartis and the Indian Government. To listen to an excerpt of the interview, please click on the player below. (.mp3, 1.4 MB).
Her article "Taking TRIPS to India - Novartis, Patent Law, and Access to Medicines" (.pdf, 334 kB) gives you a good overview of other safeguards/flexibilities implemented in the Indian patent law to ensure sufficient public access to essential inventions.