Special 301 Report: Section 3(D) of the Indian Patent Act opposed by the US

The US has taken exception to India’s level of protection provided to Intellectual Property as it brought the “Special 301 Report” for the year 2014 which classifies India as a “Priority watch list country”. The reports mentions US concerns based on the information provided by the US industry on their perception of the level of protection provided by India to Intellectual Property.

Key issues in the report include:

  • Concerns over the provision of Section 3(d) of the Patent Act which relates to non-patentability of inventions involving chemical forms that do not show increased efficacy
  • Issue of Compulsory License by the Controller General of Patent, Designs and Trademarks under section 84 of the Patents Act

Inclusion of a statement relating to Compulsory License for green technologies in India’s National Manufacturing Policy and challenges relating to enforcement of IP Rights.

Section 3(d) of the Indian Patent Act 1970 (as amended in 2005) prohibits grant of patent to inventions involving new forms of a known substance unless it differs significantly in properties with regard to efficacy. Thus preventing ever-greening of patents. The US pharma companies are opposed to this Act.

The “Special 301” process is a unilateral step taken by the US under their Trade Act, 1974 to put pressure on countries to enhance Intellectual Property Rights (IPR) protection beyond the TRIPS pact. It is an extra territorial application of the domestic law of a country and is not reasonable under the overall WTO regime.

India has a sound legislative, administrative and judicial framework to protect IPRs which meets its obligations under the Trade Related Intellectual Property Rights (TRIPS) Agreement while making use of the flexibilities provided in the international regime to address its developmental concerns.

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