The year 2020 changed the world forever and life as we knew it changed as the Covid-19 pandemic became a global impediment. With a global pandemic going on, its treatment and medication became the center of debate and become the hot topic and still continues to be one. When the first wave of Covid-19 hit the world, in the absence of any vaccination or proper procedure of medication, a lot of drugs such as hydroxychloroquine tablets took the world by storm because of the shortage of these drugs and the absence of proper manufacturing which was limited given the laws and regulation. India overnight became a major exporter of hydroxychloroquine tablets but eventually, restrictions were put in place in order to meet the needs of the domestic markets. While the absence of proper medication or treatment process was creating havoc in the medical industry, the possible treatment through drugs like hydroxychloroquine tablets, anti-viral paracetamol tablets, etc. were the straws that the health care workers were hanging by. The major issue and debate with Intellectual Property Rights laws and patent laws took speed after the arrival of the second wave of Covid-19 which saw the emergence of Covid vaccines and drugs such as Remdevisir which got FDAs approval for Covid treatment. This debate caught the world‟s attention when the issue of patenting came at crossroads with Covid vaccines and the exclusivity of their developers over them. The catastrophic hit of the second wave of COVID-19 led to better 1000 people all over the globe, the situation was more aggravated due to the lack of proper medication or vaccine and amidst this chaos, one of the most important decisions was taken up by India with regards to the patent of Covid-19 vaccines. In order to tackle the issue of shortage of medication, drugs, and diagnostic kits that were of dire need amid this pandemic, a few ways were adopted to deal with it and they were IP waiver proposal, compulsory licensing, and voluntary licensing. The next part of this chapter would be dealing with the IP waiver aspect which is still under consideration before the World Trade Organization Council.
IP Waiver:
India along with South Africa were the first countries that appealed for patent waiver of the Covid-19 vaccines so that this vaccine is readily available to everyone facing this pandemic. Before going into the discussion as to how the patent laws were affected by this is important to understand what is a patent waiver or an open patent. While the patent allows its holder to manufacture sell and market his invention or innovation and also grants him a monopoly over the same so that the innovator can make revenue out of his work thereby monetizing his innovation, patient waiver works in exactly the opposite manner. A patent waiver but an open patent removes these exclusive rights and allows anyone to use the patented information to manufacture, use or market the patented product without the fear of being sued on the grounds of patent infringement. A patent waiver if granted is a huge opportunity for countries that do not hold a patent for the Covid-19 vaccine as it would allow them to manufacture the required amount of vaccine for their own country and help curb the shortage of vaccines that we are facing today. In October 2020, India and South Africa came together to put forward a proposal before the World Trade Organization's Council for trade-related aspects of intellectual property rights requesting for the waiver of certain provisions of the trips agreement in order to tackle COVID-19. In this proposal, it was put forward that given the global pandemic that we are facing where every country in the world is facing some of the other impediments with regards to prevention or treatment of COVID-19, it is important that certain regulations that are provided for under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) must be waived so as to curb this problem of shortage of medication and pharma products. One of the major suggestions that India made in this proposal was with regard to the use of article 31 b which talked about authorizing the use of patent products or technology with the patent holder‟s permission. India contended that the scope of article 31 b should be expanded in order to include medical equipment like ventilators, dialysis machines, diagnostic kits, etc. That is very crucial in this battle against COVID-19, this limitation of allowing only pharmaceutical drugs for production without authorization of patent holder in case of emergency is falling short to tackle the present pandemic.
At first, this proposal faced opposition from the USA, UK, and EU who were against the idea of suspension of patent protection but recently, the USA has changed its direction and is in support of the waiver of the patent. Currently, this waiver proposal is backed by more than 100 countries including Russian and China, along with international organizations including the World Health Organization and the United Nations AIDS charity, UNAIDS. After the unexpected support from the USA government with respect to IP waiver, in one of the recent deliberations between India and the USA representatives, the USA has come forward to showcase that it will also reach out to its allies to gather approval for this IP waiver. However, this waiver still is facing a lot of opposition especially from the pharmaceutical industry, and believe that this IP waiver will only serve as a shortcut for many competitors who will be able to acquire expensive technology without any hassle. Though there are several oppositions to this IP waiver it is important to keep in mind the major reason as to why this waiver is important given the current situation i.e., the majority of vaccine manufacturing companies are limited to high-income countries or middle-income countries and thereby making it difficult for low-income countries to get even their first dose of vaccination as these companies have sold their vaccination to their own governments or high- income governments facilitate their shortage of vaccination. According to an article published by International Monetary Fund (IMF), the total amount of vaccination that will be manufactured by the end of 2021 is six million doses but this will fall short for the global population and thereby creating distress. And given the fact that the maximum of vaccine IP holders and manufacturers are concentrated in the small group of high-income or middle-income countries, it will become very difficult for low-income countries to acquire vaccination and in order to curb this issue, it is important that the patent waiver proposed is taken up and adopted as it would allow these countries to set-up their own manufacturing units for vaccination production. It is important to this core principle that is driving the patent waiver proposal so that this race against covid-19 can be fought efficiently. However, one of the biggest concerns about the knowledge dissemination about vaccines and allowing patent waiver is the fact that the manufacturing of vaccination with perfection. Given the fact that the USA forms one of the major exporters of COVID-19 vaccines two various countries across the globe, their support in the IP waiver proposal was quite unexpected as well as a beam of hope as the concern that only providing the recipe for the vaccine to other companies for manufacturing will also provide the background knowledge, the technique, proper skill, and process for the manufacturing are still pretty prevalent. The fact that the manufacturing process of vaccine does not only require a proper composition and recipe but also requires a lot of quality raw materials, proper infrastructure, and skilled labor and all the above requirements are not always readily available and this might affect manufacturers decided to take up production of the vaccination. Given the fact that the number of raw materials that are available is limited, and if in such scenario these are materials are given to manufacturers without ensuring their expertise in the production of vaccination it will only lead to wastage of raw materials and a much lesser stock of vaccination will be available than that is currently required. So, even though the proposal of patent waiver is a very welcoming and innovative approach that is taken up by countries in order to ensure that the demand for vaccination is met with without any problem whatsoever but if we consider the reality of vaccination production and manufacturing and the expertise that is required to ensure such products we can see that it will take up a lot more than just sharing of the vaccine recipe and hence would not make much difference in the current supply of vaccines.
Compulsory Licensing:
Apart from the approach that has been discussed above i.e., the patent waiver proposal before the World Trade Organization (WTO), there are other ways to ensure that the COVID-19 vaccine demand is met with, and one such way is through compulsory licensing. Under article 31 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) The member states to the agreement are allowed to grant compulsory licenses to third parties with respect to patents. this article allows the member states to enable third-party companies to manufacture patent-protected vaccines in cases of dire situations such as a national emergency. The contents and the objective of this article have been included under the Indian patent legislation which lists down certain situations where compulsory licenses can be granted at the behest of the government. As discussed in previous chapters the concept of compulsory licensing forms part of The Patent Act, 1970 under section 88 of the Act, and under section 92 (3) of the Act it is stated that a compulsory license can be granted by the Government under certain dire circumstances such as:
- National emergency, or
- extreme urgency, or
- Case of public non-commercial usage
Under this section, it is made clear that in cases of public emergency where there is a dire need of the medication and it is patented under the Act, then in such cases the Central government is free to grant compulsory licenses to other manufacturers so as to enable the production of the same and meet the needs of the public at large. Given the current situation, ie., the situation of a pandemic where the entire nation is under the grass of COVID-19 and is struggling to find proper treatment and medication for it compulsory licensing of COVID-19 vaccines is one of the major ways to meet the needs of the public and fill up the shortage of vaccines. However, the issue of compulsory licensing off COVID-19 vaccines has been dragged into the debate by pharmaceutical companies and other stakeholders according to whom neither compulsory licensing of the vaccines not waiving off of the patenting rights would be effective in such scenarios as the manufacturing and production of the vaccines need a certain level of technical know-how. According to these companies in order to enable the production of vaccines by other manufacturers there would a necessity to transfer invaluable information, sharing trade secrets as well as some data with regards to clinical trials which are indispensable, and in the absence of proper legislation that talks about the transfer of trade secrets as well as data of clinical trials the transfer of mere recipe of vaccine would not benefit anyone. But given the current situation of pandemics, the government can resort to alternate ways to ensure sharing of such data by providing a mandate to these manufacturers and enabling the production of vaccines through other manufacturers as well. even though the government has enough power to grant licenses to other manufacturers for the production of vaccines yet till today no such steps have been taken at behest of the government, rather the government was criticized when it was found out that the Indian Council of Medical Research (ICMR) would be receiving royalties against every sale of a dose of Covaxin. In the wake of the second wave of the COVID-19, which nearly broke the health industry due to the lack of drugs and equipment that was required for the treatment and led to a large number of deaths in the country, the Supreme Court of India took up suo-moto cognizance to look into the matter with regards to a better distribution of essential supplies and services during the pandemic. In the very first hearing of this matter the Apex Court took up a few of the matters for consideration and one such question upon which the Hon'ble court presided is the Compulsory licensing of Covid medication. While dealing with the aspect of compulsory licensing the affected court took into consideration the Doha declaration 2001, according to its objective member states had the right to promote access to medicine and protect public health, and Agreement on Trade-Related aspects of Intellectual Property Rights (TRIPs). While taking into account the above objective the Court outlined sections 92 and 100 of the Patents Act, 1970 and recommended the government to consider granting of licenses for manufacturing purposes so that the demand of covid medications can be met with, as being a member state to TRIPs agreement is India free to use the flexibilities under Agreement on Trade-Related aspects of Intellectual Property Rights (TRIPs) to the fullest to ensure the objective under Doha declaration is met with. The Court also took into consideration the aspect that both Delhi High Court as well as the Bombay High had similar views with regards to granting of licenses to third parties for generic manufacturing of covid medications. The Apex court took the case of Rakesh Malhotra v. Govt. (NCT of India)into consideration where the Delhi High Court while addressing the issue of insufficiency of drugs and equipment recommended that:
"There are a number of other drugs which are being used for treatment Covid-19 patients, such as Tocilizumab, Favipiravir, Ivermectin, Dexamethasone, Methylprednisolone, Dalteparin, Enoxaparin, HCQ, and Baricitinib. As per news reports, there are shortages of some, if not all, of the aforesaid drugs. Looking to the emergent situation, we direct the Government to immediately reach out to the manufacturers/ patent holders/ licensees so as to forthwith ramp up the production capacities of the above, and all such other medications, as are essential for the treatment of Covid positive patients. We may take note of the fact that the Patents Act provides for Compulsory Licenses under Section 84, and Special Provision for Compulsory Licenses or Notifications by the Central Government, under Section 92. Section 100 provides the power of the Central Government to use inventions for purposes of the Government. Looking to the present-day situation, there can be no doubt that a case is made out for exercise of its power by the Central Government/ Controller under the aforesaid provisions of law."
The Apex Court presided over various issues that revolve around the covid medication and treatment process and one such issue that the court dealt with in the case of In Re: Distribution of Essential Supplies and Services During Pandemic was the "potentiality of compulsory licensing for vaccines and essential drugs" where the court referred to both national and international provisions that covered compulsorily licensing and government licenses. The Court took into note the contentions made by the Union, before the World Trade Organizations (WTO‟s) Council while putting across the IP waiver proposal, that various countries have amended their patent laws in order to expedite the process of issuing compulsory licenses as well as government use licenses and the Court laid down the provisions of Patent Act, 1970 that deals with the same. The Court also outlined section 102 of the Act under which the Government can acquire patents in order to benefit the public at large and places reliance on Canada and Germany, who have relaxed their patent laws in the wake of the pandemic in order to make the process of obtaining compulsory license against patented medication easier. However, these were only recommendations, the Apex Court in the end states that the Central government is free to adopt any such method or approach to tackling the issue of vaccine requirements in an equitable and expedient manner which may involve negotiations with domestic and foreign producers of vaccines.
Voluntary Licensing:
Another approach that can be said to be used in order to deal with the issue of insufficient pharmaceutical products that are required to treat Covid, by the process of granting voluntary licenses to third parties that would allow them to manufacture covid medication that is protected under patent laws. A voluntary license is another form of granting licenses to third parties but in this case, the patentee is at the liberty to fix a rate of a reasonable amount of fee in exchange for the license. As discussed in the previous chapter, the concept of voluntary licensing refers to is the arrangement between the parties where the patent holder and the third party from any of the countries come to an agreement of making affordable medicines in their respective countries. Though after the amendments made to the Patents Act, 1970 in order to comply with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) provisions were added for compulsory licensing, no such specific section is there for voluntary licensing yet this practice is encouraged especially in the current situation of a pandemic even by Courts. In the Rakesh Malhotra case where the court recommended the government to look into the possible granting of compulsory licenses, the court also went ahead to talk about the rights of the patent holder and its importance and stated that:
"..At the same time, the interests of the Patent holders/ licensees should be kept in mind, since it is on account of their investments, inventions, and hard work that such like medicines are made available to the public at large. The best course would be to encourage the existing manufacturers to ramp up their production on a war footing. They should also be encouraged to grant voluntary licenses to other entities to manufacture the requisite drugs.."
The Hon'ble Delhi High Court specifically recommends the importance of voluntary licensing given the situation we are in where both the rights of the patent holder and the public seeking medicine have to be addressed as both hold equal importance. This idea of voluntary licensing was suggested during the IP waiver deliberations, as a solution to the covid crisis, but according to the joint statement made by both the delegations from India as well as South Africa it has proven to be inadequate. They cited the case of Remedisivir where even after receiving a significant amount of funding from the public which amounted to at least 70.5 million U.S. dollars the parent company Gilead signed bilateral licenses with certain generic companies that excluded almost half of the world's population from its license territories. The fact that Moderna issued a waiver of its IP rights from the covid vaccine formulas in October 2020 and yet till today we see no manufacturing company taking on that opportunity to enable vaccine production also showcases that there is bleak hope for voluntary licensing to actually work.
Given the situation that we are in a position where securing an adequate number of Covid vaccines and are there medications that are crucial for its treatment it is important to understand that each and every approach that has been discussed in this chapter has its own set of pros and cons attached with it. While suggestions like IP waiver could be a long-term solution in securing an ample number of vaccinations especially for low-income countries who do not have any vaccine manufacturing companies and are fully dependent on other countries yet the number of resources that would go into setting up of those manufacturing units and starting vaccine production is a long and tedious process and would require a lot more than just revealing of the vaccine recipe. Also, the fact that cutting off incentives, i.e., the monetary fee that vaccine companies get in return for their sale, might work as in detriment. In both situations, where a patent waiver is approved and where it is rejected and nations resort to compulsory licensing, it provides little incentive to manufacturing companies to engage in the transfer of know-how and that is very much essential for vaccine production as without it a simplest mistake can lead to complete wastage of both raw materials and other resources which are very limited.
According to the researcher, there is a different way to help solve this dilemma and work efficiently in curbing the issue of COVID-19 vaccine production i.e., voluntary licensing but with a better framework like vaccine companies entering into a license agreement with the Medicines Patent Pool (MPP), a World Health Organization (WHO) backed public health organization under which the big pharmaceutical companies can negotiate a license with the Medicines Patent Pool (MPP) and get an incentive in exchange of that, and because of the license the generic drug manufacturers are free to develop a new treatment based on that knowledge and also enables them to distribute patented medicines at an affordable cost in low- and middle-income countries.
The Debate of Patent Rights Amid Covid-19
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