Impact of Covid-19 pandemic on IPR Laws in India
Introduction
The covid-19 pandemic has led to a dramatic loss of human life worldwide and presents an unprecedented challenge to the world of work. It has generated health concerns as well as social and economic crises which induced an acceleration of digitalization practices. It also exposed the existing inequalities of age, income, race, sex and geographical location which led to the inordinate impact of the pandemic on the vulnerable sections of the society.
The Covid-19 pandemic is very different from other forms of crisis as it had an impact on all forms of business, organisations, creative workers and users. The people were unable to feed themselves and their families due to no means of earning income during lockdown. The pandemic has shattered jobs and placed millions of livelihoods at risk.
Intellectual property is a category of property which includes intangible creations of the human intellect. It refers to the creations of the mind, such as invention, literary and artistic works, designs, symbols and many more. Article 2(viii) of the World Intellectual Property Organization defines intellectual property as, “Intellectual property shall include rights relating to literary, artistic, and scientific works, discoveries throughout all areas of human endeavour, scientific advances, industrial design rights, trademarks, service marks, and commercial names and designations, protection against unfair competition.” The World Trade Organization defines intellectual property rights as the rights given to the creators of the creations. These rights give a monopoly to the creator over their ideas for a specific time period and enable them to prevent others from using their creations.
Now, the question arises, what intellectual property has got to do with Covid-19? Well, this article answers this question. In intellectual property, particularly patents are an inherent aspect when we talk about global healthcare or dealing with pandemics. In the context of Covid-19, vaccines, software applications, medical equipment, diagnostics and other innovations have critical intellectual property implications.
TRIPS Agreement
The agreement on Trade-Related Aspects of Intellectual Property Rights is an international legal agreement between all the member nations of the World Trade Organization. It establishes minimum standards for the regulation of different forms of intellectual property.
The TRIPS Agreement requires member countries to make patents available for any inventions, whether products or processes, in all fields of technology without discrimination, subject to the normal tests of novelty, inventiveness and industrial application.
Article 7 of the TRIPS Agreement describes the objectives of the IP system in terms of a balance of rights and obligations.
Article 8 states that members may adopt measures necessary to protect public health and nutrition and to promote public interest in sectors of vital importance to their socio-economic and technological development that are consistent with the provisions of the TRIPS Agreement.
The Doha Declaration on the TRIPS Agreement and Public Health, a landmark declaration adopted at the WTO Ministerial Conference in 2001, reaffirmed the objectives and principles of the Agreement as guidance for the implementation of TRIPS provisions in a manner that is responsive to public health objectives.
The Doha Declaration also clarified certain policy options, or “flexibilities”, within the framework of the TRIPS Agreement. It is thus a well-established principle that the TRIPS Agreement can be interpreted and implemented in line with public health policy objectives and that it provides wide latitude for members to take action to protect public health.
Policy options and flexibilities regarding other IPRs
As mentioned earlier, the role of policy options in other areas of IP rights has also been raised in discussions about intellectual property and Covid-19.
Copyright
Copyright is a type of intellectual property that protects original works of authorship as soon as an author fixes the work in a tangible form of expression.
Copyright provides exceptions and limitations that allow access to those works under certain special cases. Both copyright and exceptions and limitations to copyright have equal importance when considering the question of access to medical technology and innovation.
During the Covid-19 pandemic, some of the copyrights-holders have taken action to make copyright protected content freely available to public access.
Article 13 of the TRIPS Agreement permits limitations and exceptions to copyright if they are confined to exclusive rights to certain special cases which do not conflict with a normal exploitation of the work and do not unreasonably prejudice the legitimate interests of the right holder.
The COVID-19 pandemic has raised many questions about the permissible use of materials and content as campuses have migrated courses that were traditionally taught in-person to a virtual format. Faculty are understandably concerned about how to best use their course materials in this new digital format, including works from third parties that may be protected by copyright.
There are several exceptions to the Copyright Act that may allow faculty to use some copyrighted materials created by third parties in their educational content. This includes the Fair Use exception and the TEACH Act (Technology, Education and Copyright Harmonization Act of 2002), also known as the Distance Learning exception.
Trademarks
Trademark is a type of intellectual property consisting of a recognizable sign, design or expression that identifies products or services from a particular source and distinguishes them from others.
The trademark rules under the TRIPS Agreement also aim to provide for a balance between the rights of trademark-owners and the public interest. Article 17 of the TRIPS Agreement provides for exceptions that members may provide limited exceptions to the rights conferred by a trademark, such as fair use of descriptive terms, provided that such exceptions take account of the legitimate interests of the owner of the trademark and of third parties.
Industrial Designs
An industrial design right is an intellectual property right that protects the visual design of objects that are purely utilitarian. Article 26.2 of the TRIPS Agreement provides for members may provide limited exceptions to the protection of industrial designs, provided that such exceptions do not unreasonably conflict with the normal exploitation of protected industrial designs and do not unreasonably prejudice the legitimate interests of the owner of the protected design, taking account of the legitimate interests of third parties.
Patents
A patent is a type of intellectual property that gives its owner the legal right to exclude others from making, using or selling an invention for a limited period of time. The patent law forms an important part of a country’s national innovation system as it encourages technological progress and innovation.
Article 28 of the TRIPS Agreement grants exclusive rights to a patent holder to prevent others from producing, using or selling the patented product without their consent.
The TRIPS Agreement contains certain adaptability provisions which provide for exceptions where the World Trade Organization members can permit the use of patents without the authorization of the patent holder.
Article 30 of the TRIPS Agreement provides exceptions to rights conferred. It states that members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with the normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties.
Another key exception to patent rights, confirmed in TRIPS dispute settlement practice is the Bolar exception. It allows potential competitors to use a patented invention during the patent term without the consent of the patent owner for the purpose of obtaining marketing approval for a prospective generic product. In the context of COVID-19, this may be important in cases where the term of patent protection of possible treatments is approaching expiry.
Waiving patent rights for Covid-19 vaccine
The proposal for waiving IP and patent rights for Covid-19 vaccines was first introduced in October 2020, by South Africa and India at the World Trade Organization. This proposal was opposed by the UK and European Union, among other countries.
In June 2022, the World Trade Organization announced a compromise text that gained consensus among its members including the UK and European Union.
For five years, developing countries will be allowed to authorise the use of patented materials and ingredients for the manufacture of Covid-19 vaccines without the consent of the rights holder to produce vaccines, for domestic and eligible markets. Rights holders will be compensated.
Compulsory licences
Compulsory licence is an authorization granted by the Government to someone else i.e., a third party to produce a patented product without the consent of the patent owner who has been taking undue advantage of exclusive rights granted by patent.
According to Indian Patent Act, compulsory licence can be granted after the expiration of a period of three years from the date on which the patent has been granted.
Article 31 of the TRIPS Agreement allows compulsory licensing and government use of a patent without the authorization of its owner under a number of conditions aimed at protecting the legitimate interests of the patent-holder. The patent holders are entitled for remuneration. All members may grant such licences for health technologies, such as medicines, vaccines and diagnostics, as well as any other product or technology needed to combat COVID-19.
Compulsory licensing may serve as a useful policy tool to increase access to eventual treatments or vaccines for COVID-19, in particular in situations in which from a member’s perspective access to affordable health technologies in sufficient quantities cannot be otherwise secured.
Regarding the basis for a compulsory or government use licence, the TRIPS Agreement does not specifically list the reasons that might be used to justify compulsory licensing and thus leaves members the freedom to define the grounds for issuing a compulsory licence. Many laws include national emergency as one of the grounds for issuing a compulsory licence. A number of members have declared a national emergency in the context of the COVID-19 pandemic.
India’s first case of granting compulsory licence was to an Indian company called Natco Pharma for the generic production of Bayer Corporation’s Nexavar.
This medicine called Aspirin drug was used for treating Liver and Kidney Cancer, and one month’s worth of dosage costs around Rs 2.8 Lakh. Natco Pharma offered to sell it for around Rs 9000 making this potentially life saving drug easily accessible to all parts of the society and not just the rich people. The Government took this decision for the general public benefit. However, it was heavily criticised by the Pharmaceutical Companies as they felt the licence should not have been given.
However, Natco Pharma is paying the royalties to Bayer at a rate of 6% of all sales on a quarterly basis in accordance with the guidelines set by the United Nations Development Programme (UNDP).
Conclusion
The impact of covid-19 pandemic on India has been largely disruptive in terms of economic activity as well as a loss of human lives. Almost all the sectors have been adversely affected as domestic demand and exports sharply plummeted with some notable exceptions where high growth was observed.
Thus, when it comes to the impact of Covid-19 on the essential medicine laws under the Patents Act, the Indian Patent laws are self-sufficient and protect the interests of the general public.
When it comes to India’s role on a global platform, the argument for a global IP waiver in times of pandemics is an important argument that has been raised by India. Even though Indian laws may be self-sufficient, it may not be the case for all countries and thus it is necessary that companies and nations place the interests of the general public before their individual interests of obtaining patents and royalties arising from the use of such patents.
Works Cited
Introduction to TRIPs Agreement, https://www.jpo.go.jp/e/news/kokusai/developing/training/textbook/document/index/TRIPs_Agreement.pdf. Accessed 2 July 2023.
“15 October 2020 Page: 1/13 Original: English 1 THE TRIPS AGREEMENT AND COVID-19 INFORMATION NOTE1 Key points • A full response.” World Trade Organization, 15 October 2020, https://www.wto.org/english/tratop_e/covid19_e/trips_report_e.pdf. Accessed 2 July 2023.
Sehgal, Diganth Raj. “Intellectual property and COVID-19 : lessons for the future.” iPleaders, 18 November 2021, https://blog.ipleaders.in/intellectual-property-and-covid-19-lessons-for-the-future/. Accessed 2 July 2023.
“WTO | intellectual property – overview of TRIPS Agreement.” World Trade Organization, https://www.wto.org/english/tratop_e/trips_e/intel2_e.htm. Accessed 2 July 2023.
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Written by- Meghana D