COVID-19 And Medicinal Availability and Patents

Introduction

During the COVID-19 pandemic, there have been discussions about intellectual property and access to COVID-19 treatments, vaccines, and diagnostics. Some countries and organizations had called for the relaxation or waiving of certain patent rights to ensure global access to these critical products. The World Trade Organization (WTO) had been considering a proposal to temporarily waive intellectual property rights related to COVID-19 vaccines and treatments.

Patents are a form of intellectual property rights granted to inventors or assignees of an invention. Patents provide exclusive rights to the patent holder for a limited period, typically 20 years, during which others are prohibited from making, using, selling, or importing the patented invention without the patent holder’s permission.

Pharmaceutical companies often seek patents for their drugs to recoup the costs of research, development, and clinical trials, as well as to gain a competitive advantage. Patents allow them to maintain exclusivity and charge higher prices for their products.

India is sometimes referred to as the “pharmacy of the developing world” since it has been a significant provider of generic medications, which are low-cost pharmaceutical commodities, for many years. Patent rights may be revoked in extraordinary situations to maintain a delicate balance between a patentee’s monopoly rights and the government’s duty to provide accessible and cheap public healthcare in India.

The high cost of patented drugs can create barriers to access, particularly in low- and middle-income countries. These countries may struggle to afford patented medications, limiting the availability of life-saving treatments. This issue has been a topic of debate and concern for public health advocates. To address public health emergencies or ensure access to essential medicines, some countries have provisions for compulsory licensing. This allows a government or a third party to manufacture a patented drug without the patent holder’s consent. Compulsory licensing can help make medicines more affordable and accessible during emergencies.^[1]

The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, administered by the WTO, sets the minimum standards for intellectual property protection, including patents, on a global scale. The TRIPS Agreement allows countries to implement safeguards to protect public health and promote access to medicines, including compulsory licensing, in certain situations.

Vaccines and Covid

A key weapon in the fight against the COVID-19 pandemic is vaccination. They function by triggering the immune system to identify and combat the bacteria and viruses that are attacking the body. Once immunised, the body is able to fend off disease-causing germs when exposed to them, preventing sickness. Patents are the most well-known IP right applicable to vaccines and vaccine-related innovations. By granting its owners exclusive rights, patents enable pharmaceutical businesses to take control of and protect the outcomes of their research and development. The owner of a patent has the authority to forbid others from making use of their innovation, and as a result, they have control over how these things are made, sold, and priced. 

Patent Act and Covid Medicines

Under normal circumstances, patent law grants exclusive rights to the patent holder, preventing others from producing or using the patented invention without permission. The Patent Act generally covers pharmaceutical products, including vaccines and treatments, meaning that the companies holding patents for COVID-19 vaccines, such as J&J and Pfizer, had legal protection to prevent others from manufacturing their patented vaccines.

The decision by companies like J&J and Pfizer not to share their vaccine formulas during a global pandemic raised ethical concerns. Critics argue that in a public health crisis where global access to vaccines is crucial, protecting intellectual property rights can impede the availability of life-saving medicines. The ethical debate revolves around balancing profit motives and public health interests. Some argue that prioritizing access to medicines and sharing knowledge and resources would have been a more ethical response.

According to the compulsory licence regulations, a third party that is an interested party may request for a compulsory licence. Before a forced licence may be given, several requirements must be met, such as the requirement that the party must have the aptitude and capacity to work on the patented innovation and must first make an effort to get a voluntary licence.

Although this clause has been in effect for a while, Sorafenib has only ever received one obligatory licence. There were other cases as well, but they were unsuccessful on the basis that they did not satisfy the essential requirements for submitting an application for a compulsory licence.

The central government may make the patent available for a compulsory licence in situations of national emergency, such as COVID-19, and anybody interested may submit an application for a compulsory licence.

What Is Compulsory License?

Compulsory licensing is when a government allows a third party to produce a patented product or process without the consent of the patent owner or plans to use the patent-protected invention itself.

The Patents Act, 1970 was amended three times in 1999, 2002, 2005 to include the concept of ‘compulsory license’. These are given in the sections 84-92 of the Indian Patents Act, 1970.

The Indian Patents Act, 1970 and the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement at the international level both contain provisions relating to compulsory licenses.

Compulsory licencing is a subject that is hotly debated. Due to the scarcity and high cost of medicines, many developing nations place a high value on compulsory licencing and are awarding an increasing number of these licences each year. The industrialised nations of Europe and the United States disagree with this viewpoint since it would make it harder for pharmaceutical corporations to innovate.

Trips Agreement

Through the TRIPS agreement, the WTO developed the current system of international intellectual property rights. The WTO-governed international trading system now has regulations governing intellectual property, negotiated between 1986 and 1994. Generally speaking, the TRIPS agreement establishes baseline levels of protection that each WTO member state must uphold inside its territory with regard to the intellectual property of other WTO members, providing market incentives to promote research and development (R&D). By giving medical innovators like pharmaceutical companies, government research organisations, and public-private partnerships exclusive rights (for instance, through patents) to commercially exploit their innovations, the TRIPS agreement, which focuses specifically on medical innovations, offers sufficient market incentives for R&D in relation to the majority of medical conditions.^[2]

Bayer Corporation vs Natco Pharma Ltd (2013)

The country’s first compulsory licence has been granted by the Indian Patent Office to Hyderabad-based drug-maker Natco. Natco requested authorization to make a kidney cancer drug Nexavar (sorafenib tosylate) from Bayer in the first and only successful action against the patent holder. Natco’s application for a compulsory licence for Nexavar was filed before the Controller General of Patents in 2011 in accordance with Section 84(1) of the Indian Patents Act, 1970.

The Controller came to the conclusion that the patentee did not satisfy public criteria and approved the application for a compulsory licence.

Therefore, The controller of patents’ ultimate decision was to issue Natco Pharma a mandatory licence for the medicine “Nexavar”. Bayer was unable to comply with any of the section’s criteria, thus the controller made his ruling under Section 84 of the Patents Act of 1970.

Conclusion

The experience with the COVID-19 pandemic has prompted discussions about potential exceptions in patent law for future public health emergencies. Calls have been made to establish mechanisms that allow for the rapid sharing of vaccine formulas and technology to increase global production capacity during a pandemic. This could involve temporary waivers of intellectual property rights or the use of compulsory licensing to ensure broader access to essential medicines.

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^[1]https://www.ipstars.com/NewsAndAnalysis/Patents-in-India-and-access-to-medicines-during-COVID-times/Index/7842

^[2] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7928919/#fn5