Saturday, June 9, 2012

Bolar Exemption under Section 107A(a): What is Exempt from Infringement?

It is commonly assumed that use of a patented invention for the purposes of research is exempt from infringement under Section 107A(a) of the Patents Act, which is commonly referred to as the Bolar exemption. (which has its genesis in the decision of the US Court of Appeals for Federal Circuit in Roche Products v. Bolar Pharmaceuticals)

Contrary to popular perception, Section 107A(a) does not provide a blanket safe harbor for use of the patented invention for “research”. As reflected by the wording of Section 107A(a), it permits any act of making, constructing, using, selling or importing the patented invention “solely for uses reasonably related to the development and submission of information required under any law for the time being in force, in India, or in a country other than India that regulates the manufacture, construction, use, sale or import of any product”.
In light of such restricted wording, I don’t see how is it possible to conclude that any use of a patented invention for any research enjoys exemption from infringement under Section 107A(a). We are entitled to have any opinion on what the law ought to be, but what the law is must be understood from the Act. In short, the opinion must be an "informed one".

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