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Authored by - Sanskruti Makwana
INTRODUCTION
In recent years, we have witnessed tremendous growth in the importance of intellectual capital and intangible assets, coupled with an increased tendency for firms and public institutions to privatize their knowledge assets through the use of patents or copyrights. This has been propelled by an understanding that the ownership of such copyrights and patents stands out as significant strategic assets to those who own or control them. The pharmaceutical industry is no exception to the evolution of intellectual property rights, wherein the creation and exploitation of patents for drugs are becoming increasingly common to squeeze out commercial benefits, revenue, and profits.
With an ever-surging number of new and improved drugs being introduced into the market every year private companies involved in the medical industry take a substantial share of gains due to the existence of factors like favorable public policies and decreasing international competition. The apparent relevancy of patents in a world with a booming artificial intelligence era in the healthcare sector, therefore, demands all the more attention; re-examination of old business models and long-term strategies is indispensable.
PATENT PROTECTION
Patent protection is can be said to be the backbone of the very foundational purposes of patents since otherwise they would be deemed inessential in the first place. Governments must hence not only shoulder the responsibility of the formation of strong laws surrounding patents and intellectual property rights, but also bear the burden of enforcing them stringently- they must be protected sufficiently, and those violating them must suffer from a defined set of consequences of punishment.
Nevertheless, not all drugs can be patented; and those who do must conform to the criteria to pass as an invention. Primarily, these are novelty, usefulness, and non-obviousness, i.e., the drug must be new, must serve a purpose, and must not visibly be similar to another drug that is already in existence. This helps not only in giving credibility to the drug patented but also promotes further research.
THE INDIAN PHARMACEUTICAL INDUSTRY
Perhaps the Indian pharmaceutical industry is one of the most majorly affected industries by the growth of patent rights. Earlier, due to the lack of patents, most multinational companies restricted their holding to expired patents and/or several already patented products, which eventually resulted in immense losses in their market shares. The application of reverse engineering of the most advanced medicine by the local producers worsened the situation.
Product patenting by Indian companies is imperative if they are to truly achieve the goal of promoting research in low-cost medicines for Indian diseases. If this is done meticulously, multinational drug companies who had been previously averse to investing in India without product patent protection shall change their stance, and competition in the domestic market would improve.
The TRIPs Agreement (The Agreement on Trade-Related Aspects on Intellectual Property Rights) between all the member nations of the WTO (World Trade Organization) provided for the usage of compulsory licenses and the reasons for which they may be issued, for example, immediate and serious emergency, non-competitive practices, public non-commercial use, etc. The Indian patent law states that the application for a compulsory license can only be made after three years from the date of the awarding of the patent, with the emergency in the country being an exceptional case.
The judgment of Novartis vs Union of India by the Supreme Court must also be mentioned here, as it had a major impact on pharmaceutical patents. It had a far-reaching influence on the public health security of the country. The Patents Act of 1970 refused Novartis a patent because it failed to satisfy the criteria of novelty and usefulness or curative properties to the old form. The court never claimed that a new type of a recognized compound could never be patented, but only affirmed that a new type of a known compound would never be patented. It was neither anti-patent nor anti-invention of science and technology and has the potential to become a precedent for the courts of developed countries across the globe to safeguard public health.
INTERNATIONAL DEVELOPMENTS
The rights of citizens of all member countries to essential medicines at affordable prices and the erosion of the same by the introduction of patents and intellectual property rights in the medical field had been one of the core focus areas of discussion at the 24th session of the United Nations General Assembly Special Session on Social Development (UNGASS).
It was almost unanimously agreed upon that there existed a dire need for the development of strategies that would secure these critical medicines for vulnerable people amidst a surge in patents through increased international cooperation in trading agreements. The negotiations were extensive and difficult, and there has been slow but visible progress in terms of highlighting the efforts made by developing countries to advance the agenda of pharmaceutical firms.
The DOHA Declaration on the TRIPs Agreement and Public Health was adopted by the WTO Ministerial Conference of 2001 in Doha on November 14, 2001. It was a response to the emerging epidemics of HIV/AIDS at the time it was mandated and sought to address the several patent controversies in the health sector in a balanced manner. The declaration too did not prohibit patent rights in the medical healthcare field to arbitrarily promote the security of public health; even as it strived to facilitate access to medicines for everyone. Fundamentally, it reinforced the validity of the directions established in the TRIPs Agreement.
CONCLUSION
With the emergence of intellectual property rights, artificial intelligence, and the advancement in the healthcare industry in India and across the world, the issues of patents and copyrights have been one of the greatest challenges to the governments, that bear the responsibility of forming and protecting the rights of both the producers of the medicines as well as the consumers, i.e., their people who demand the same at affordable prices. International agreements are not conclusively successful in this area due to a series of commercial and non-commercial reasons in developed and developing countries. Constant research to monitor and adhere to the changes collectively is, therefore, a must.
References
Andersen, B. (Ed.). (2006). Intellectual property rights: Innovation, governance and the institutional environment. Edward Elgar Publishing.
Khanna, S. (2016). TRIPS, pharmaceutical patents and health care for the poor in India. ILI Law Review, Summer Issue, 71-95.
Gana, R. L. (1996). Prospects for developing countries under the TRIPS Agreement. Vand. J. Transnat'l L., 29, 735.
World Health Organization. (2002). Implications of the Doha Declaration on the TRIPS Agreement and public health (No. WHO/EDM/PAR/2002.3). World Health Organization.