Author: Srashti Rana, II year of B.A.,LL.B.(Hons.) from National Law University, Sonepat
Co-author: Utkarsh Goel, III year of B.A.,LL.B.(Hons.) from National Law Institute University, Bhopal
On 11 March 2020, the World Health Organization (WHO) designated the Coronavirus as a pandemic. While patent rights are granted to inventors for a limited number of years to safeguard their innovations against unfair competition, this pandemic depicts a scenario in which the rivalry between humans and the virus takes place rather than the competition between corporations. The only way to stop this epidemic is via mass vaccinations of the human population. Other IP rights, apart from patents, impede poor nations which do not have adequate or no productive capability to comply with Article 31bis of TRIPS and lead to a lengthy pharmaceutical importation and export procedure.
Over the last year, the creation of COVID-19 vaccines and therapies has been nothing short of a triumph of ingenuity. It's incredible how quickly researchers and biosciences firms have responded to this obstacle. Advancements in Life science innovation are tough to achieve and loaded with difficulties. Today's treatments are based on a complex ecosystem in which many individuals, government agencies, and private enterprises play critical roles. Large quantities of money must be staked on clinical research, regulatory clearances, and the development of manufacturing and distribution capacities.
As the number of victims started to rise, the world realized the need for accelerated research for vaccine development. As companies worldwide have developed vaccines, it is also asserted that there should be a temporary IP waiver for the same to guarantee equity among nations in terms of vaccine distribution. It is also a view that granting IP rights would prove to be an obstacle for future advancements in the vaccine.
TRIPS AGREEMENT AND COMPULSORY LICENSING
When the World Trade Organization was founded in 1995, countries that signed up as members pledged to adhere to the Agreement on Trade-Related Aspects of Intellectual Property Rights, or TRIPS, in exchange for lower trade barriers. The TRIPS Agreement is not merely a political document. It is a legally binding document that is subject to legal scrutiny and enforceable legal punishment.
The TRIPS Agreement is therefore capable of objective assessment. This agreement pushes for the preservation of intellectual property rights, whether patents or copyright, by knowledge-based economies such as the United States or multinational research-intensive pharmaceutical industries. Before negotiations, patent protection for pharmaceuticals was not recognised by more than 50 nations. Not only lays the basis for future application of the Public Health Declaration and full use of the TRIPS Agreement, but it also gives a legal interpretation of the Public Health Declaration.
The text of a joint proposal by the two nations to the WTO TRIPS Council, seeking a waiver for the prevention, containment, and treatment of COVID-19, was published by the WTO on October 2. It was warmly received by public health campaigners who have been at the forefront of the fight to ensure that people have access to medications. They have always held that patents are the major block to providing inexpensive medicines.
The World Health Organization created the COVID-19 Technology Access Pool in response to the SARS-CoV-2 virus causing devastation around the world (C-TAP). It is a Costa Rican project intended at making vaccines, testing, treatments, and other health technologies available to everyone to combat the pandemic.
It was launched at the end of May and has received support from 30 countries as well as several international partners and organisations. But, beyond the lofty rhetoric, little concrete has resulted.
The decision to submit the joint proposal was made to make COVID's treatments and vaccines "affordable as well as accessible" to underdeveloped and least-developed countries, or LDCs, as they are known in trade jargon. The goal is to ensure that once COVID medications and vaccines are on the market, they are not subjected to unnecessary regulation that delays their availability.
India has requested that Sections 1, 4, 5, and 7 of Part II of the TRIPS Agreement be removed or waived in the joint submission. For medications and vaccines directed at COVID-19, that apply to copyright, industrial designs, patents, and protection of concealed information or trade secrets.
Nearly all types of intellectual property rights (IPR), including patents, are protected and enforced under the TRIPS Agreement, which established worldwide minimum standards.
Before TRIPS, there were no international accords that set minimum standards for patents. Over 40 countries throughout the world did not provide patent protection to pharmaceutical items when the negotiations began. With a few exceptions, the TRIPS Agreement now mandates all WTO members to adjust their laws to the minimal criteria of IPR protection. In addition, the TRIPS Agreement established comprehensive requirements for intellectual property rights enforcement.
The TRIPS Agreement, on other hand, gives countries some freedom in regulating patents for public goods such as pharmaceuticals. The Doha Declaration on the TRIPS Agreement and Public Health, released in November 2001, underlines crucial flexibility granted to nations under TRIPS Article 31 - the authority to award compulsory licences. According to Clause 5(c), “public health crises, including those related to HIV/AIDS, TB, malaria, and other epidemics,” might constitute a “national emergency or other conditions of exceptional urgency.”[i]
There is no sole vaccine manufacturer capable of producing enough vaccinations to cover the whole planet, and demand has far outstripped supply, with high-income countries receiving the largest portion of reserved doses. Proponents of a TRIPS waiver question whether it is appropriate for a global vaccine maker to have exclusive rights that prevent other businesses from stepping up to satisfy the need for vaccinations, particularly in markets not currently serviced by current vaccine manufacturers. They claim that the public has already paid for such innovation once or twice, either upfront through R&D expenditures or purchase guarantees of these items, or both.
The TRIPS convention was signed in 1994 with the creation of the world trade organization (WTO) and intended to establish a worldwide system of intellectual property rights that would unify law standards across WTO member states. To maintain low medication pricing before the TRIPS agreement, several nations exempted pharmaceutical items from patentability. All TRIPS agreement signatories are expected to arrange for compulsory licencing.
A patent grants the owner a monopoly to make and market a patented product as they see fit and to prevent others from doing the same. Compulsory licencing laws provide the government with the authority to award such rights to parties other than the patentee without the patentee's permission. The right to a priority scheme was one of the stipulations of the Paris convention dealing with patent protection, the freedom of patents in several countries, the inventor's appointment as a patentee, the patentability of inventions in the context of sales limitations. In the case of fee payment, mandatory authorizations for non-workable time are required, the restitution of patents or cases of non-committal. The Paris convention, on the other hand, contains no substantive provisions relating to patent protection, covering the patentable subject matter, patent rights' effects, and patent protection's duration. It was challenging because the mandatory license provisions in cases of failure to work were ambiguous. Accordingly, the TRIPS agreement establishes patentable subject matter, the repercussions of patent rights, the tenure of patent protection and other special patent protection measures. There are also detailed and explicit laws regarding compulsory licensing.
Each type of usage will be evaluated on its own merits. It will be limited to the rationale for the application's approval and will only be used for non-profit public purposes or to rectify an anti-competitive activity discovered through the judicial or administrative process in semiconductor technology. Moreover, this usage can only be permitted if the prospective user has made reasonable efforts. In the present situation, the COVID pandemic is a global phenomenon and requires immediate attention. Also, there is a quite huge difference between the supply and demand of COVID vaccines, especially in smaller world countries.
The COVAX Facility's main goal is to increase the number of individuals in participating nations who can acquire COVID-19 vaccinations as promptly, fairly, and safely as feasible. Participating nations and economies will have access to the world's biggest and most diversified portfolio of COVID-19 vaccines, as well as an actively managed portfolio, by joining the Facility.[ii] The Facility keeps a close eye on the COVID-19 vaccine landscape to identify the best candidates based on scientific merit and scalability and works with manufacturers to incentivize them to expand their production capacity before vaccines are approved by the FDA.
Normally, manufacturers are hesitant to make the large expenditures required to develop or scale up vaccine manufacturing facilities until a vaccine has been approved. However, given the context of the present epidemic, which is costing the world economy US$ 375 billion a month, this would undoubtedly lead to enormous delays and, at first, vaccine shortages. To avoid this, the Facility is collaborating with manufacturers to offer investments and incentives so that manufacturers are prepared to provide the doses we require as soon as a vaccine is licenced.
The Facility will also make use of the collective purchasing power that comes with having so many nations involved to negotiate very competitive rates from manufacturers, which will be passed on to members. Vaccine doses sufficient to vaccinate between 10 and 50 percent of a country's population can be requested by self-financing nations and economies participating in the Facility. The amount they pay into the Facility will be proportional to the number of doses they want. The Facility acts as a key insurance policy for these nations, increasing their chances of obtaining vaccinations even if their bilateral agreements fail.
IP waiver would enable the manufacturers of the vaccine, build production facilities and produce enough vaccinations to transmit this cure to a broader population in the shortest possible period possible. The main difficulty is that in a small number of nations with high and moderate incomes, manufacturing, research and development vaccines are excessively concentrated. The bulk of accessible vaccines have been sold by companies in these countries, which also are the principal IP owners, to their governments and other high-income governments.
With the existing flexibility of TRIPS, nations may, without a patent holder's consent, already grant compulsory licences for the production of vaccines. Voluntary authorization and technology transfer from the originators' companies could contribute to increased productive production capacity, especially if linked to public investment; and, while this is particularly important in the context of widespread vaccine hesitation, the creators also have an interest in enforcing safety and quality control standards.
Generic manufacturing in large numbers without any patent obligations would aid in removing supply limitations in the availability of cheap medications, treatments, and vaccinations during periods of high caseload and mortality toll owing to COVID-19.
[i]Art. 31, The Agreement on Trade-Related Aspects of Intellectual Property Rights,1 January 1995
[ii] COVAX Explained by Dr Seth Berkeley