Author – ADITYA MEHROTRA, Student from SYMBIOSIS LAW SCHOOL, PUNE
Introduction
IPR laws are becoming increasingly popular in recent years. It gives inventive creators comfort in knowing that their innovation, idea, or discovery will stay theirs. Patent law is the most significant of these. However, when it comes to medication, which is a necessity for everyone, the same patent restrictions function as a roadblock to access to these vital goods[1].
This article discusses the significance of pharmaceutical medications, their patenting in India, and the challenges that have arisen as a result of it in terms of public health access.
A drug’s patent typically lasts 7-12 years after it is granted. It’s because companies file for patents before performing a clinical trial to determine the efficacy of a treatment. Other firms will develop and market the medicine when the patent expires. At this point, the medicine is referred to as a generic drug[2].
How Are Pharmaceutical Patenting Problems Affecting Public Health Access?
Different perspectives exist on the influence on the Indian pharmaceutical sector and access to crucial medications both within and beyond the nation.
With a large number of pharmaceutical businesses, India is rated fourth in terms of manufacturing volume. However, while pharmaceutical medication patents are an important tool in the invention process, the patent system as a whole may be perplexing to those unfamiliar with it[3].
Patent monopolies are frequently abused by drug corporations, as are unnecessarily high pricing for patented drugs. Drug accessibility has been hampered by the establishment of product patents. In India, a high number of generic medications, including vaccines, are copyrighted, making it difficult for the industry to create life-saving pharmaceuticals.
Exorbitant medicine prices prevent regular people from getting medication, which goes against the government’s stated goal of protecting citizens’ health. Especially in a nation like India, where a big proportion of the population lives below the poverty line and healthcare prices are excessive, there is an unmistakable medical-care emergency with inadequacy in terms of healthcare and the affordability, availability, and accessibility of pharmaceuticals[4].
For the Indian government, this is a critical problem. As a result, they have taken a number of steps to protect this situation, including mandatory licensing (in the event of a voluntary license refusal) and parallel trade policies as alternative approaches to assisting developing country governments in making essential medicines more affordable to their citizens. Compulsory licensing lowers consumer costs by introducing competition into the market for patented goods[5].
Right to health
Even though the TRIPS Convention recognizes that member states may exempt innovations that are needed to safeguard public order and morality, such as human, animal, or plant life or health, from patenting in order to avoid serious environmental harm, there is widespread acceptance of the right to health care and reasonable access to health care. In a country like India, which has a diverse socioeconomic landscape, national health systems must be designed with enough flexibility to allow public health authorities to tailor their systems to their specific needs[6].
Patent and The Right to Health
Access to medication is a basic instrument for ensuring health, and it is a basic human right. However, with the current administration, both the right and the means to safeguard it are in serious jeopardy. Pharmaceutical patents play a critical role in ensuring that people have access to medicine in order to stay healthy.
A completely effective patent system, it has been suggested, would result in an inverse connection between the cost of such items and the affordability of access. Some have suggested that the global intellectual property system is experiencing a crisis of public legitimacy, as patents may be preventing regular people from accessing medications and exercising their “right to health.”
CASE LAW – Novartis vs Union of India
Facts – Novartis vs Union of India[7] was the most recent case, which started in 1997 with the petitioner filing a patent application with the Chennai Patent Office for a pharmaceutical called Glivec, which was a slightly modified version of their 1993 patent for an anti-leukaemia treatment. The Assistant Controller of Patent and Design, Chennai Patent Office, denied the application, citing section 3(d) of the Indian Patent Act 1970. As a result, the petitioner resorted to the Madras High Court to contest section 3’s legitimacy (d).
The following are the issues that have been presented in this case:
Section 3(d) is consequently unlawful since it violates the TRIPS agreement.
The word “efficacy” is not defined under Indian patent law, and the Controller has limitless discretion. As a result, it is irrational, arbitrary, and confusing.
Judgement – The World Trade Organization’s Dispute Settlement Procedure offers the sole remedy and a thorough dispute resolution framework for violations of the TRIPS Agreement. When international and local law collide, the High Court finds that municipal law prevails. International agreements are also not directly enforceable in India.
Efficacy is defined as the capacity to accomplish a desired or anticipated impact. The court dismissed the second contention that this clause gives the patent controller unguided power since the phrase “efficacy” was not defined. In other words, the effectiveness test in section 3(d) would alter depending on the expected or intended result of the product under consideration.
As a result, efficacy would be defined by the function, utility, or intended application of the product. The primary measure for efficacy when it comes to medications that claim cures is “therapeutic efficacy.”
Novartis’ patent application for the beta-crystalline version of Imatinib Mesylate failed to pass Section 3 due to the lack of improved therapeutic effectiveness (d). The petitioner’s patent application was denied by the Supreme Court, which supported the decisions of the High Court and the Indian Patent Office.
Solutions To The Problem Of Public Healthcare Access
India is one of the most prominent members of the TRIPS Agreement, which went into effect in India in 2005. Drug product patents were not issued in India prior to the TRIPS system. Despite the tight patent laws in industrialized nations, the generic medication sector prospered in India at that time. This system has its own advantages, such as the fact that medications are readily available in India. Furthermore, the cost of pharmaceuticals was quite low, even for treatments that were extremely expensive in other nations.
One of the most essential requirements of developing countries is the availability of pharmaceuticals at a reasonable cost. As a result, compulsory licensing should be implemented in such a way that neither the laws nor the regulations are overly restrictive, causing problems with drug regulation, nor are they too liberal, allowing individuals to abuse the system[8].
Conclusion
The Indian patent law is an excellent example of patent legislation that seeks to balance the interests of both ordinary people and innovators. A wide range of pharmaceutical items can now be patented in India thanks to the implementation of the product patent regime. Before filing for a patent, researchers should carefully analyze the patentability criteria, and the guidance of a patent specialist is highly recommended in this regard. Patent rights can be assigned or licensed to other people or corporations once they have been obtained. As a result, the country must strike a meaningful balance between using patent law to allow pharmaceutical companies to develop new treatments for diseases that are currently incurable, and the interests of patients to benefit from such medicines without bankrupting themselves or state and federal budgets
[1] Mondaq.com. 2019. Patents And The Indian Pharmaceutical Industry – Intellectual Property – India. [online] Available at: https://www.mondaq.com/india/patent/865888/patents-and-the-indian-pharmaceutical-industry [Accessed 15 February 2022].
[2] Indialawjournal.org. [online] Available at: https://www.indialawjournal.org/archives/volume5/issue_1/article3.html [Accessed 15 February 2022].
[3] Lexlife India. 2021. Patenting of pharmaceuticals in India- a threat to the country’s public health. [online] Available at: https://lexlife.in/2021/10/02/patenting-of-pharmaceuticals-in-india-a-threat-to-the-countrys-public-health/ [Accessed 15 February 2022].
[4] Ijlmh.com. 2018. [online] Available at: https://www.ijlmh.com/wp-content/uploads/2019/04/PATENT-IN-RESPECT-OF-MEDICINE-DRUG.pdf [Accessed 15 February 2022].
[5] Lawcutor. 2022. PHARMACEUTICAL PATENTING IN INDIA- PROBLEM OF PUBLIC ACCESS TO HEALTH. [online] Available at: https://lawcutor.com/intellectual-property-laws/pharmaceutical-patenting-in-india-problem-of-public-access-to-health/ [Accessed 15 February 2022].
[6] Sharma, D., 2019. Pharmaceutical Patents And Healthcare: A Legal Conundrum | SCC Blog. [online] SCC Blog. Available at: https://www.scconline.com/blog/post/2019/09/03/pharmaceutical-patents-and-healthcare-a-legal-conundrum/ [Accessed 15 February 2022].
[7] Novartis vs Union of India, (2013) 6 SCC 1.
[8] Iprlawindia.org. 2021. [online] Available at: https://iprlawindia.org/wp-content/uploads/2021/04/Madhurima-Mohajon.pdf [Accessed 15 February 2022].