“The principle behind the Bolar exemption is that generic companies should be in a position to take the necessary preparatory measures in order to be able to enter the market without delay once patent protection expires.”

In the life sciences, swift R&D is vital. India’s Section 107A, added by the 2002 Patents Amendment (effective 2005) explicitly carves out a research safe-harbour. It provides that “any act of making, constructing, using, selling or importing a patented invention solely for uses reasonably related to the development and submission of information required under any law in India, or in a country other than India” shall not be infringement. In practice, this means generics or biotech developers can conduct clinical trials, bioequivalence tests or other regulatory studies on a patented drug before patent expiry without liability. (Section 107A(b) likewise permits parallel imports of patented products from an authorized source.  As one recent analysis notes, Section 107A was introduced “to enable patent-protected pharmaceutical products to be brought to Indian markets quicker and in large numbers”, reflecting its public-health purpose.