India’s intellectual property rights related issues and the country’s Patent Act have been in news recently owing to a report released by U.S. Trade Representative (USTR) called ‘Special Report 301’. This annual report focuses on evaluating intellectual property protection and market access practices globally. India is highlighted as one of the most challenging major economies when it comes to the protection and enforcement of IP.
The report brings attention to various problems ranging from copyright and piracy to trademark counterfeiting and trade secret theft. Consequently, India continues to remain on the U.S.’s Priority Watch List along with Argentina, Chile, China, Indonesia, Russia, and Venezuela. The list comprises trading partners that pose significant concerns regarding IP rights.
An Overview of the Indian Patent Regime
The Indian patent regime is governed by the Indian Patent Act of 1970 which provides exclusive rights for an invention, whether it is a new product or a process. The patents under the act are granted if the invention is novel, non-obvious, capable of industrial application, and doesn’t violate provisions of sections 3 and 4 of the Patents Act 1970.
Post its entry into the World Trade Organization in 1995, India amended its internal patent laws in accordance with the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. The notable amendment occurred in 2005 with the introduction of pharmaceutical product patents into the legislation.
Indian IPR-related Conventions
India is a signatory to several Intellectual Property Rights related conventions including the Berne Convention, Budapest Treaty, Paris Convention for the Protection of Industrial Property, and the Patent Cooperation Treaty (PCT).
The original Indian Patents Act did not protect pharmaceutical products’ patent to keep medicines available to the masses at affordable rates. Pharmaceutical patents were reintegrated post-2005 amendment in compliance with the TRIPS agreement.
Key Indian Concerns Raised by USTR
The USTR report marked that patent matters, such as the threat of patent revocations, lack of patent validity presumption, and narrow patentability criteria, are of specific concern in India. The issue of narrow patentability criteria was raised again in context to Section 3(d) of the Indian Patent Act that limits patent-eligible subject matter in Indian pharmaceutical sector.
Understanding Sections 3 and 3(d) of the Indian Patent Act
Section 3 of the Indian Patent Act defines what doesn’t qualify as an invention. Particularly, Section 3(d) states that mere discovery of a new form of known substance with no enhancement in its efficacy will not be eligible for patent protection. This section also prevents “evergreening” of patents, which is a strategy for extending the term of a granted patent about to expire.
In the context of generic competition, it allows the patenting of only novel and genuine inventions. The Novartis vs. Union of India case in 2013 upheld the validity of section 3(d).
Nuances of the Novartis vs. Union of India Case
Pharmaceutical company Novartis filed a patent for the final form of cancer drug Gleevec in this case. The Supreme Court held that Gleevec was simply a beta crystalline form of a known drug, thus not considerably different in properties with regard to efficacy. As a result, it could not be patented in India. The judgment affirmed that section 3 complies with the TRIPS agreement and the Doha Declaration.
The Doha Declaration on the TRIPS Agreement and Public Health stresses the need to address severe public health problems impacting developing and least-developed nations. It asserts that the agreement should be implemented to support members’ right to protect public health and promote access to medicines for all.
Way Forward for India
India must uphold the patentability criteria under Section 3(d) considering it has the sovereignty to stipulate limitations on patent grants consistent with its socio-economic conditions. This ensures the growth of generic drug makers and public’s access to affordable medicines.
To resolve differences with the U.S. regarding disqualification of incremental inventions, bilateral dialogue is essential. WTO’s member countries must optimally utilize TRIPS agreement by adopting rigorous definitions of invention and patentability to curtail ‘evergreening’ and award patents based on genuine innovation. Through Section 3(d), India aims to balance international patent obligations with its commitment to safeguard socio-economic welfare and public health.
