INTRODUCTION
Because of the TRIPS Agreement, the Indian pharmaceutical industry was been confronted with a slew of new obstacles. The institutional elements that had fostered the industry's expansion were altered by a 1970 modification to the Patent Act that introduced product patents. The legislation was expected to have a detrimental impact on India and stifle the growth of the country's pharmaceutical industry because it would no longer be allowed to reverse-engineer or export medications with product patents in place. India amended Patents Act, 1970 from time to time in the years 1995, 1999, 2002, and 2005 to meet its obligations under the TRIPS agreement after signing the TRIPS agreement and becoming a member of the Agreement establishing the World Trade Organization (WTO) for the purpose of reducing distortions and functional constraints to international trade and promotion of effective protection of intellectual property rights. Patents Act of 1970, has also been amended to support India's myriad technical innovations, as well as to catch up with the evolution of international intellectual property legislations. India also amended its intellectual property laws. The amendments aim at making the Act more up-to-date, harmonized, and user-friendly in order to safeguard national and public interests while meeting simultaneously India's international obligations under the TRIPS Agreement. National pharmaceutical industry and non-governmental organisations have been proactive players in India's process of patent reform. Civic activism is the reason why, despite intense external pressure, India was among the most outspoken opponents of the TRIPS Agreement, resisting the introduction of product patents on drugs until the deadline of 01 January 2005. During the TRIPS Agreement negotiations and throughout the 1990s the Indian national pharmaceutical firms, along with non-governmental organizations, collaborated to put pressure on the government as well as to resist changes to the national patent law.
The national pharmaceutical sector perceived the adoption of TRIPS obligations as detrimental to their stake in generic manufacture and biased in favour of foreign enterprises, but NGOs were primarily concerned with the implications for generic medicine access. The Indian Drug Manufacturers Association (IDMA) — an association representing generic firms like CIPLA, and Ranbaxy Laboratories Ltd., a large, national pharmaceutical firm and generic producer that was a member of IDMA in the 1990s— found common cause with public interest NGOs like the National Working Group on Patent Laws (NWGPL), an informal public interest group in lobbying the government to safeguard the generic market and promote the national pharmaceutical industry.
Novartis AG v. UNION OF INDIA, breakthrough judgement which questioned India's agreement with TRIPS Agreement. Here Novartis a company developed a cancer drug called Glivec and wanted to register its patent in India but was denied by the Patent Office, this decline of patent was challenged by the company seeking a declaration that that Section 3(d) of the Patent Act of 1970 as substituted by the Patents (Amendment) Act, 2005 was not in compliance with the TRIPS Agreement and the same was also violative of Article 14 of the Indian Constitution. Here the Hon'ble Supreme Court relied on one of the cases which shed a new light on jurisprudence by Nariman J., State of A.P. vs. Mc Dowell & Co. saying that Indian legislatures are well-aware of the needs of its citizens and cannot challenge the legislature and didn't find its jurisdiction to interfere with the same. The Supreme Court confirmed that there should be some improvement from the previous drug in the new version with reference to its curative property and increased efficacy. Novartis hadn't provided any evidence to support the premise that crystalline form of imatinib had any positive effect on the therapy.
COMPULSORY LICENSE
In simple words, when a government authorises a third party to produce a patented product or
process without the permission of the patent holder or intends to use the patent-protected invention itself, this is known as compulsory licencing. Article 31 of TRIPS Agreement lays down the set of conditions that govern the use of compulsory licensing by WTO members, the most important of which are the following:
- The entity applying for a compulsory license should have been unable to obtain a voluntary license from the right holder on "reasonable" commercial terms;
- If a compulsory license is issued, adequate remuneration must be paid to the patent-holder
- A compulsory license must be granted mainly to supply the domestic market.
After the expiration of three years from the grant of the patent to any person other than the patentee, the controller is authorised under Section 84 of the Patents Act, 1970, to grant compulsory licences by stipulating the terms and conditions of the licence to any person other than the patentee to work the patent on the following grounds –
If the patentee fails to satisfy the reasonable requirements of the public with respect to the patented invention.
If the patented invention is not available to the public at a reasonably affordable price.
If the patented invention is not worked in the territory of India.
This provision is important because it gives prominence to the public interest. Any person, of course, with sufficient interest in it, can apply for a compulsory licence and manufacture the product in accordance with the terms and conditions applied by the Controller while granting the licence if a manufacturer is attempting to exploit the market by charging high prices or by refusing to make it available for production in India.
India's first compulsory license was granted to Natco for Bayer cancer drug which was a landmark judgement reflecting upon the need to look into patents while dealing with medicines with more of a humanistic approach rather than being pro capitalist. This judgement enabled Natco to produce and distribute a cancer drug similar to that of Bayer's Nexavar. The court reasoned that the patent holder, Bayer, had failed to meet the public's reasonable expectation. In India, it had not worked the patent or manufactured it to an acceptable degree. Furthermore, the medicine was not available at a reasonable cost.
The COVID-19 pandemic has devastated industrialised countries in Asia, Europe, and North America in recent years. The disease had spread to underdeveloped nations who had no means of developing vaccine on their own, and they relied on other countries for their vaccine needs. Even in prosperous nations like the United States, many COVID-19 patients have battled with treatment costs, especially those who have suffered from severe COVID-19 and its attendant problems. Patients in developing nations, especially low-income countries with under-resourced health care systems, are more likely to face even greater barriers to receiving and affording medical treatment.
Governments of developing countries should be prepared to issue compulsory licences for any feasible medical treatments in anticipation of the needs of their most at-risk populations. Compulsory licensing, a provision of the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement), enables governments to issue generic versions of patented drugs for use by their domestic population either through local production or importation from other countries. Compulsory licensing, as will be discussed in more detail below, proved to be a potent legislative tool for increasing access to antiretroviral drugs in response to the AIDS epidemic and to Hepatitis C.
REFERENCES
- Jain & Jain Partners, https://www.jainandpartners.com/blog/details/compulsory-licensing-of-patents-in-india/37.
- Civil Appeal No. 2706-2716 of 2013.
- 1996 AIR 1627.
- WRIT PETITION NO.1323 OF 2013.
- FAIR Health. The Projected Economic Impact of the COVID-19 Pandemic on the US Healthcare System. New York: FAIR Health, Inc, 2020.
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