Indian patent regime vs the U.S. norms

Indian patent regime vs the U.S. norms

Subject: Science and Technology

Section: IPR

Context: The U.S. Trade Representative (USTR) said in a report released last month that India was one of the most challenging major economies as far as IP protection and enforcement is concerned.

Concept:

• It has decided to retain India on its Priority Watch List along with six other countries —Argentina, Chile, China, Indonesia, Russia and Venezuela.
• Among the issues raised in the report are India’s inconsistencies regarding patent protection, including concerns about what can be patented, waiting time for obtaining patents, burdensome reporting requirements, and doubts about data safety.

The Indian patent regime

• A patent is an exclusive set of rights granted for an invention, which may be a product or process that provides a new way of doing something or offers a new technical solution to a problem.
• Indian patents are governed by the Indian Patent Act of 1970.
• India became a party to the Trade ­Related Aspects of Intellectual Property Rights (TRIPS) Agreement following its membership to the World Trade Organization on January 1, 1995.
• India is also a signatory to several IPR related conventions, including the Berne Convention, which governs copyright, the Budapest Treaty, the Paris Convention for the Protection of Industrial Property, and the Patent Cooperation Treaty (PCT), all of which govern various patent related matters.
• An interesting point is that the original Indian Patents Act did not grant patent protection to pharmaceutical products to ensure that medicines were available at a low price.
• Patent protection of pharmaceuticals were re-introduced after the 2005 amendment to comply with TRIPS.

Article 3(d) of the Indian Patent Act

• One of the main points of contention between India and the U.S. has been Article 3(d) of the Indian Patent Act.
• Section 3 deals with what does not qualify as an invention under the Act, and Section 3(d) in particular excludes “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant” from being eligible for protection under patent law.
• This prevents what is known as “evergreening” of patents.

TRIPS and the Doha Declaration

• The Doha Declaration on the TRIPS Agreement and Public Health was adopted on November 14, 2021, by the WTO member states.
• It recognises that “intellectual property protection is important for the development of new medicines,” and acknowledges concerns about its effects on prices.
• It says that the TRIPS agreement “does not and should not prevent members from taking measures to protect public health,” the declaration points out that the agreement “can and should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all.
• Compulsory licenses can be invoked by a state in public interest, allowing companies apart from the patent owner to produce a patented product without consent.
• This ensures the growth of generic drug makers and the public’s access to affordable medicines