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India - Protection for Pharmaceutical Inventions

Previous Newsletters dated April 1995 (N.S. 186), December 1997 (N.S. 189) and March 1999 (N.S.190) have reported on the difficulties that have been encountered in India in passing permanent legislation to comply with the requirements of TRIPS relating to interim protection for pharmaceutical and agrochemical inventions prior to the time by which India must start granting patents for such inventions. Such a law was finally passed on March 10, 1999, and makes permanent the practice previously implemented by Presidential decree. Under the new law, the filing of patent applications relating to substances for use as a medicine for humans or animals or insecticide, germicide, fungicide, weedicide or otherwise for the protection or preservation of plants is to be permitted but no examination of any such application is to start before December 31, 2004.

As required by TRIPS for the period before full patent rights become available, five-year exclusive marketing rights for substances of these types are provided for as long as certain requirements are met. These are that 1) a patent application for the substance has been filed in India and 2) the applicant has secured both a patent and marketing authorization for the substance in question in some other WTO country or, where the invention was made in India, the applicant has secured an Indian patent on a method for production of the substance and obtained marketing approval in India. Such exclusive rights are, however, specifically stated not to apply to Indian traditional medicines that are already in the public domain. Requests for exclusive marketing rights will apparently be subject to a review to determine whether the corresponding patent application defines something which apart from the prohibitions on the grant of a patent on substances intended for such uses constitutes a patentable invention.


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