INTRODUCTION TO PATENTS:
The word “patent” is derived from the Latin word “pater”, meaning “to lay open or to make available in public.” In the modern world, patents are a form of intellectual property where an exclusive right is given by the government to the inventor for their invention. It gives an inventor the right to prevent the unauthorized use of his product, invention, or any process. It also enables the inventor to prevent the manufacture, sale, or offer for sale of his/her product without his/her consent. A patent is a result of an agreement signed between the inventor and the government for a fixed period. The procedure for granting patents and various requirements vary from country to country.
THE EVOLUTION OF PATENT LAWS IN INDIA:
To govern patents in India, the government of India passed the legislation “The Patent Act 1970”, which came into force in 1972. To date, this act has been amended several times. It was amended in 1999, 2002, 2005, and 2006 respectively. [1] Some of the major amendments took place in the year 2005 when the president passed an ordinance to extend patent protection to products in the sectors of drugs, foods, and medicines. [2]Further, this new amendment also allowed the export of pharmaceutical products to countries having insufficient supply or no manufacturing capacity. This amendment also introduces post-grant opposition. Before this amendment, only pre-grant opposition was allowed. After the Patent Amendment Act 2005, the government introduced the “Patents (Amendments) Rules 2021”. The fee for applying for a patent has been reduced to 80% for educational institutions to encourage more filing of patent applications.
RIGHT TO HEALTH IN INDIA:
We all learned that “Health is Wealth” is a state of well-being that means to remain physically fit and mentally and socially well. The right to health does not only mean mere animal existence or survival but also the Right to live with Dignity. Our Indian Constitution does not explicitly recognize the “Right to Health” as a fundamental right under Part III of the Indian Constitution, but the Indian Judiciary has interpreted it as a part of the Right to Life, which is recognized as a fundamental right under Article 21 of the Indian Constitution.
PATENTS AND THE RIGHT TO HEALTH:
As I mentioned earlier, the right to health is a part of the right to life and personal liberty recognized under article 21 of the Indian Constitution, so a violation of the Right to Life is a violation of the Preamble of the Constitution and fundamental rights and the Constitutional spirit. The patent regime could do the same thing as it will violate the right to life by granting patents to the inventor and creating a monopoly in the market. As a result, medicines will be costly and insufficient in supply. This will deny access to medicine to a larger part of the population. This shows that both patents and the right to health have an inverse relationship. [3]
THE INTRODUCTION OF TRIPS AND ITS IMPACT ON PHARMACEUTICAL PATENTS:
The trade-related aspect of the Intellectual Property Rights (TRIPS) Agreement was signed in the year 1994. The objective of TRIPS is to strike a balance by promoting innovation and technological solutions on the one hand and promoting social and economic welfare on the other hand. The TRIPS agreement favoured the developed nations as they produced most of the medicines and drugs, and it became more favourable to them after TRIPS made it compulsory that the patent be granted to both the product and technological process or methods of manufacturing. The developing nations and the least developed nations were not willing to sign the agreement as it would hike the prices and would make essential medicines and drugs inaccessible to their citizens. [4]
If we talk about India, the Indian Patent Act of 1970 was enacted to favour domestic companies and the poor section of society. With the introduction of this act, there was a boost in the production of medicines and generic drugs in India by domestic companies. As a result, prices started to fall and these medicines and drugs became available to middle and poor-class people. But this also resulted in a fall in the share of multinational companies in India. Even though the number of patent applications by foreign companies fell from 4248 in 1968 to 1010 in 1979, India was forced to sign the TRIPS agreement after the US complained to the World Trade Organisation (WTO) that India was neither following proper application filing procedure nor granting exclusive marketing rights. [5] But as mentioned earlier, in the year 2005 some major amendments were introduced. One of them was the introduction of “Compulsory Licensing”. Under Compulsory Licensing, the government can grant the license of production to a third party without the patent holder’s consent. This was implemented to promote balance by providing access to medicines to the poor while also promoting pharmaceutical research and innovation. [6]
SECTION 3(D) OF THE PATENT ACT OF 1970 AND THE NOVARTIS DECISION OF 2013:
India introduced Section 3 in the Patent Act 1970. Under this section, the scope of eligibility for patents was reduced. Section 3(d) of this act talks about preventing “Evergreening”. It means that the patent application should be rejected for the mere discovery of a new form of a known product unless such a product augments the therapeutic efficiency. The same thing was said in the famous [7]Novartis AG vs. Union of India (2013). In this judgment, the Supreme Court of India supported the government legislation and intent to provide a confined interpretation of Section 3. This demonstrates that health and social welfare are priorities for India and that both patent and people’s health can and should be balanced. [8]
CONCLUSION:
The right to Health and Patent Regime are two entities on opposite sides that need to be balanced and both are important, on the one hand, the Right to health which is a fundamental right cannot be violated on the other hand Patent Regime important for protecting the interest of pharmaceutical companies but both should be balanced for the welfare of the public. There is no doubt that India its priority is its people and that’s why India introduced patent laws that favor its people and domestic industry and also various amendments were introduced to favor the poor section of society. But the biggest challenge is how India responds to the challenges of the TRIPS agreement lastly being a member of WTO and TRIPS India should follow its international obligations but at the same time should make or amend its patent laws according to the social and economical needs of its people.
Author(s) Name: Abhed Shrivastava (NRI Group of Institute)
References:
[1]Jaya Vats, ‘Patent and Right to Health care in India’ (IPleader, January 2021)<https://blog.ipleaders.in/patent-right-healthcare-india/#Development_of_patent_law_in_India> accessed on 4 august 2022.
[2]Akshay Anurag, ‘Patent Regime and Right to Health’ (SCC Online, September 3, 2019) <https://www.scconline.com/blog/post/2019/09/03/pharmaceutical-patents-and-healthcare-a-legal-conundrum> accessed on 4 august 2022.
[3]Akshay Anurag, ‘Patent Regime and Right to Health’ (SCC Online, September 3, 2019) <https://www.scconline.com/blog/post/2019/09/03/pharmaceutical-patents-and-healthcare-a-legal-conundrum> accessed on 4 august 2022.
[4]Akshay Anurag,‘Pharmaceuticals Patents and Healthcare: A Legal Conundrum’ (SCC Online, September 3, 2019) <https://www.scconline.com/blog/post/2019/09/03/pharmaceutical-patents-and-healthcare-a-legal-conundrum> accessed on 4 august 2022.
[5]Akshay Anurag, ‘Pharmaceuticals Patents and Healthcare: A Legal Conundrum’ (SCC Online, September 3, 2019) <https://www.scconline.com/blog/post/2019/09/03/pharmaceutical-patents-and-healthcare-a-legal-conundrum> accessed on 4 august 2022.
[6]Akshay Anurag, ‘Pharmaceuticals Patents and Healthcare: A Legal Conundrum’ (SCC Online, September 3, 2019) <https://www.scconline.com/blog/post/2019/09/03/pharmaceutical-patents-and-healthcare-a-legal-conundrum> accessed on 4 august 2022.
[7]Novartis AG vs Union of India 2013, Civil Appeal Nos. 2706-2716 of 2013.
[8]Akshay Anurag, ‘Pharmaceuticals Patents and Healthcare: A Legal Conundrum’ (SCC Online, September 3, 2019) <https://www.scconline.com/blog/post/2019/09/03/pharmaceutical-patents-and-healthcare-a-legal-conundrum> accessed on 4 august 2022.
