07 April 2011
Patent: Will Section 84 of the Patents Act finally come alive?
In a recent development Indian pharma giant Cipla has been reported to have sought voluntary licensing of the famous anti- HIV drug ‘Isentress’ from its maker Merck stating that the drug is exorbitantly priced in India and that it is not affordable to thousands of needy patients. Cipla, the largest Indian generic drug maker, evidently plans to invoke the compulsory licensing provisions of the Indian Patents Act 1970, should Merck turn down its offer for voluntary licensing.
The simpler the news is, it opens up an opportunity to study and analyse Section 84 of the Indian Patents Act 1970, which has perhaps been the most dormant provision of the statute till date.
Section 84(1) reads “At any time after the expiration of three years from the date of the grant of a patent, any person interested may make an application to the Controller for grant of compulsory license on patent on any of the following grounds, namely:-
a) that the reasonable requirements of the public with respect to the patented invention have not been satisfied, or
b) that the patented invention is not available to the public at a reasonably affordable price, or
c) that the patented invention is not worked in the territory of India.”
‘Reasonableness’ in law is a highly relative concept that depends on numerous factors. No objective rule can be drawn to determine the reasonableness of an act and hence, it requires judicial mind to declare what is reasonable and what is not. One can only draw inferences from the jurisprudence that has evolved on the point through judicial dictum.
Unfortunately in this case, in 40 long years of its existence, Section 84 has barely drawn any attention from the judiciary and has never come up before any competent judicial body in India. Hence the question of ‘reasonableness of price’ for the purposes of compulsory licensing is yet to be determined and settled. Should this case come up before any competent court, we are most likely to witness a new trend being set that may encourage more industries seeking compulsory licensing of products that are currently digging holes in common man’s pocket.The Patent family of the drug in question is provided hereunder for the reference of the readers: