Patent Legislation — Focus turns to India

India’s legislature has a looming deadline. The country is a signatory to the Agreement on Trade Related Aspects of Intellectual Property (TRIPs). Under the Agreement, India must amend its Patents Act by January 1, 2005 to make the Indian patent system TRIPs compliant.

India has taken the full benefit of the transition period provided by TRIPs, and now must complete its TRIPs compliance efforts.

India has made previous amendments aimed at satsfying portions of its TRIPs obligation. But, the most significant amendment has been saved for last. By January 1, 2005, the Indian Patents Act must be amended to extend product patent protection to food, chemicals, and pharmaceuticals.

This legislative issue stands to affect intellectual property interests worldwide. India has a strong interest in providing protection for its emerging research and development industry, but is also mindful of its extensive generic industry. Big pharma is likely to invest capital in India if appropriate protections are available. Socially, the amendment stands to have potentially profound effects on several fronts, including the cost and availability of medicines in India.

The Indian legislature is now in the spotlight of the international intellectual property community. Its standing in this community lost points several years ago in connection with another TRIPs-compliance amendment. Under the TRIPs Agreement, India was required to introduce a facility to receive and hold product patent applications in the fields of pharmaceuticals and agricultural chemicals until January 1, 2005 (the date on which patent protection for inventions in these fields is to be available). The facility was required to be effective on January 1, 1995. The Indian legislature created the facility, termed the “mail box,” but did not do so until 1999 (the “mail box” was made retroactively effective to January 1, 1995).

Similar delays on the current amendments will likely harm India’s reputation and credibility in the international intellectual property community. Also, a delay will create a legal vacuum for the applications currently sitting in the “mail box” (approximately 5000).

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