Explained | The Indian patent regime and its clash with the U.S. norms

What is the News?

The U.S Trade Representative(USTR) has released Special 301 Report 2022. The report has said that India was one of the most challenging major economies as far as IP protection and enforcement is concerned. 

The report retains India on its Priority Watch List along with six other countries- Argentina, Chile, China, Indonesia, Russia and Venezuela.

About India’s 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. Under the act, patents are granted if the invention fulfils the following criteria: 1) It should be novel, 2) It should have inventive step/s or it must be non-obvious, 3) It should be capable of Industrial application and 4) It should not attract the provisions of sections 3 and 4 of the Patents Act 1970.

India and TRIPS

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.

Following this, it amended its internal patent laws to comply with TRIPS, most notably in 2005, when it introduced pharmaceutical product patents into the legislation.

India is also a signatory to several IPR-related conventions, including the Berne convention which governs copyright, the Paris Convention for the Protection of Industrial Property and others.

Note: The original Indian Patents Act did not grant patent protection to pharmaceutical products to ensure that medicines were available to the masses at a low price. This was based on the recommendations of a Rajagopala Ayyangar Commission in 1959.

But patent protection of pharmaceuticals were re-introduced after the 2005 amendment to comply with TRIPS.

What are the issues USTR has with the Indian Patent Regime?

One of the main points of contention between India and the U.S. has been Article 3(d) of the Indian Patent Act. This point is also brought up as an area of concern in both USTR reports mentioned here.  

Section 3 deals with what does not qualify as an invention under the Act. Similarly, Section 3(d) does not allow patents to be granted to inventions involving new forms of a known substance unless it differs significantly in properties with regard to efficacy. Hence, Section 3(d) basically prevents what is known as the “evergreening” of patents.

Validity of Section 3(d) of the Indian Patent Act

The Supreme Court in the case Novartis vs. The Union of India upheld the validity of section 3(d). 

The judgment also says that the section complies with the TRIPS agreement and the Doha Declaration.

What is the Doha Declaration?

The Doha Declaration on the TRIPS Agreement and Public Health was adopted on November 14, 2021 by the WTO member states. 

This declaration recognises the gravity of public health problems affecting developing and least developed nations. It says that the TRIPS agreement does not and should not prevent members from taking measures to protect public health.

These measures include the right to grant compulsory licenses and the grounds for such licenses, the right to determine what constitutes a national emergency or other circumstances of extreme urgency. This includes public health crises and the right to establish its own regime for the exhaustion of intellectual property rights.

Source: The post is based on the article “Explained | The Indian patent regime and its clash with the U.S. norms” published in The Hindu on 10th June 2022.