The Prime Minister's Office (PMO) has sought the opinion of various stakeholder departments on the need for further amendments to the patent law to introduce some of the controversial provisions that were kept out during the previous amendment to the Indian Patent Act five years ago.
The move, which comes ahead of the India visit of US President Barack Obama, is significant as many of these issues have been raised by multinational pharmaceutical companies.
The PMO suggestion is based on a submission made by the Organisation of Pharmaceutical Producers of India (OPPI), the association representing the global pharmaceutical industry in the country. OPPI has sought a more stringent intellectual property regime than what is compulsory under the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement of the World Trade Organization.
The proposed changes, if enacted, can have a significant impact on the way patents are granted in the country.
The industry lobby group has sought a review of the scope of a specific section of the Indian Patent Act that disallows patenting of incremental innovations without significant advantages.
Data exclusivity, patent linkage and allowing patents to incremental innovations by amending the section 3 (d) of the Patent Act have been the most important demands of the global pharmaceutical companies.
The United States Trade Representative, in its annual "Special 301" Report, also highlights the need for a strengthened intellectual property regime as one of the requirements before India can be removed from its "watch list".
This report relates to the agency's views on the adequacy and effectiveness of US trading partners' protection of intellectual property rights.
In a note to the departments of health, industrial policy and promotion, legal affairs and pharmaceuticals, PMO wanted the issues raised by OPPI on the need for regulatory data protection and amendment to the Patent Act be examined by each department and submit their views. The Department of Pharmaceuticals has been asked to coordinate the matter.
