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.

• It has decided to retain India on its Priority Watch List along with six other countries —Argentina, Chile, China, Indonesia, Russia and Venezuela.

Background

• Right granted for an invention- 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.
• Patent protection of pharmaceuticals -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 re­introduced after the 2005 amendment to comply with TRIPS
• Recent situation- The USTR report highlighted a range of issues in domains ranging from copyright and piracy to trademark counterfeiting and trade secrets, saying that India “remained one of the world’s most challenging major economies with respect to protection and enforcement of IP.”

Analysis

What is a patent?

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 solutions to a problems.

What is India’s Patent regime?

India’s Patent regime is governed by India’s Patent Act 1970, with the provision:

• It should be novel
• It should have inventive steps or it must be non-obvious
• It should be capable of Industrial application
• It should not attract the provisions of sections 3 and 4 of the Patents Act of 1970

What does the Section 3 of Indian patent act deal with?

• Section 3 deals with non-compliance as established under the Act.
• Section 3 (d) does not exclude “the discovery of a new type of known object that is not effective in developing the known success of that object.
• or the mere discovery of any new space or new use of a known object
• or just the use of a known process, machine or resources unless that known process results in a new product
• or uses at least one new reactant ”to qualify for protection under copyright law.
• Section 3 (d) prohibits what is known as "ever-greening" of patents.
• It is a business, legal, business, and technical strategy to extend / extend the patent granted to an expired site, in order to save profits for them, by taking new patents.
• According to the Committee report, Section 3 (d) allows generic competition by authorizing only novels and real inventions.
• A minor decision in the Novartis vs. case. Union of India (2013), proposed the validity of section 3 (d).

Judicial Intervention (Novartis v/s Union of India):

• In this case, pharmaceutical company Novartis filed a patent for the latter type of cancer drug Gleevec, which was challenged in the Supreme Court.
• The Supreme Court concluded that Gleevec was a beta crystalline type of known drug, i.e., imatinibmesylate, and did not differ significantly in properties in terms of efficacy. Therefore, it would not be patented in India.
• The decision also states that Article 3 is in line with the TRIPS agreement and the Doha Declaration.
• The Doha Declaration on the TRIPS and Public Health Accord was adopted in November 2021, by WTO member states.
• The declaration recognizes the “complexity of public health problems affecting developing and developing countries” and emphasizes the need for TRIPS to be part of a broader national and international initiative to address these issues.
• The declaration states that the agreement "can be interpreted and should be interpreted and implemented in a way that supports the right of WTO members to protect public health and, in particular, to promote universal access to medicines."
• These conditions include the right to issue compulsory licenses and the reasons for such licenses,
• the right to decide what “includes the national emergency or other emergency, including public health problems”
• and the right to establish its own state of intellectual property rights.
• Compulsory licenses may be requested by the state in the public interest, which allows companies without a patent to produce a patented product without permission.

What are the major issues related to the Indian patent act?

• Copyright issues have continued to be "a major concern in India," highlighting the threat of copyright withdrawal, lack of speculative copyright and narrow licensing process as "issues affecting companies in various sectors".
• The issue of narrow licensing procedures was also raised in terms of Section 3 (d) of the Copyright Act of India, with the report that in the field of pharmaceutical industry, the United States “continued to monitor the limited patent title in the Category. 3 (d) of the Copyright Act of India and its implications.

Issues addressed by Parliamentary committee on Patents:

• The threat of copyright infringement, lack of consideration of patent infringement and narrow patent conditions as problems "companies with various sectors were largely addressed by the Parliamentary Standing Committee which took over 'the intellectual property rights review in India.
• The Parliamentary Standing Committee noted that section 3 (d) “acts as a protection against the irrational establishment in line with the flexibility provided for in the TRIPS agreement.
• According to the Committee report, Section 3 (d) allows for "generic competition by authorizing only novels and real inventions."

Issues with TRIPS agreement: The process of policy development and production has a few steps, and involves a complex approach to intellectual property. Different types of IP rights apply to different processes and no single type of IP can unlock the policy generating policy. Performance technologies may be protected as a trade secret, and data from clinical trials evaluating the safety and effectiveness of the policy may be protected by copyright. Manufacturing vaccines will require designing a vaccine production process, obtaining the necessary equipment, building production facilities, and conducting clinical trials to obtain regulated approvals. The production process itself has different steps, some of which may be incorporated into other organizations. Thus, copyright withdrawal alone does not give producers the ability to start producing a product immediately.

Way Forward:

• Common issues related to IPR were largely addressed by the Parliamentary Standing Committee which began ‘reviewing intellectual property rights in India.
• Voluntary Licensing: The state of compulsory licensing is compulsory and may have the advantage of forcing a number of pharmaceutical companies to grant licenses voluntarily.
• India has historically played a leading role in stabilizing TRIPS flexibility as a compulsory license to the WTO. In this global and national health emergency, the government must enforce compulsory licenses in a mysterious way.
• The government's efforts to strengthen National IPR policy, IP court of appeals, electronic governance and commitment to compliance with the WIP TRIPS agreement by letter and air will help advance India's global vision.
• An effective and equitable system of inventory can help all countries recognize the potential of intellectual property as a catalyst for economic development and social and cultural well-being.
• It is important to ensure effective, affordable, and equitable access to all anti-epidemic tools, and therefore, the need to create a framework for their distribution.
• The report also highlights the positive steps India has taken in the past, such as joining the World Intellectual Property Organization (WIPO) Performances and Phonograms Treaty and the WIPO Copyright Treaty, jointly known as the WIPO Internet Treaties, 2018 and Nice . Agreement for 2019.