The threat of COVID-19 has been real and the whole world has been experiencing it and the present situation in India has already shook the healthcare system and has been causing too much panic.
However, as pharmaceuticals issues go, Intellectual Property issues follow and as at present there is only one forward looking solution which is vaccine as even the treatment through Plasma therapy has not been advised by the Indian Medical Association lately. The virus has unintentionally brought to the forefront, the public-health and private-profits tension. At this point of time, around ten different pharmaceutical companies worldwide have developed a safe and effective vaccine while many more companies are in line to develop effective vaccines. Some Pharma companies used the traditional vaccine methods which included testing previously developed vaccines for other viruses, while others have been using new technology to address the outbreak. Now, coming on to the basics of the patent, these monopolistic privileges are granted by the government so that the private companies are encouraged to innovate faster than they would in the absence of such privileges. The ongoing process is with the basic presumption that innovation leads to the progress of society. However, speaking historically, the progress has been underwhelming when compared with the pace of the developing world. Severe inadequacies of the Pharma patent system still exists, and there have been many calls for delinking Research & Development costs from drug prices, as well as looking for new pharmaceutical innovation models but unfortunately, they have had very little impact. The Epidemic Diseases Act, 1897 and National Disaster Management Act, 2005 grant the Government of India a great deal of autonomy and control in declaring an infectious disease as a pandemic and in suspending citizen’s rights. Three distinct but related legal issues regarding the government’s handling of intellectual property rights under the Trade Related Aspects of Intellectual Property Rights Agreement (the “TRIPS Agreement”) of the World Trade Organization (the “WTO”), consumer rights, and product liability for the COVID-19 vaccines are discussed, as the raging pandemic has created uncertainties in the implementation of these laws.
Patents waver on Vaccine
It is well known by now that existing COVID-19 vaccines including the ones that represent the application of a new type of vaccine technology, mRNA vaccines are covered by multiple layers of patent rights. Proponents of a patent waiver for COVID-19 vaccine emphasize the problems created by the exclusivity created by intellectual property rights, and they are correct in their diagnosis.
Having adopted a legal regime that grants patent rights to any inventions meeting the substantive criteria set forth in international and national patent laws (a threshold that many of the current patent applications on COVID-19 will, in all likelihood, clear), we now face the logical consequences of such a regime: absent some kind of intervention, vaccine patent holders have the ability to refuse licensing their technology to others, even against a backdrop of vaccine scarcity.
A waiver is thus portrayed as a mechanism to overcome this exclusionary ability that traditionally inheres to a patent: in light of the tragic proportions of our shared public health problem, let us do away with the exclusionary right for a certain period of time and other companies will be able to 1) replicate existing vaccines and 2) manufacture at a large scale so that considerably more doses of vaccine will start flowing. In order to understand the practical limitations of a waiver of intellectual property rights when a vaccine is involved, it may be useful to think of patents as informational mechanisms akin to the information and tools needed to turn a recipe into an edible product. One or more patents will provide a recipe for a process or a component needed to produce a vaccine. But, just as with a culinary recipe, the informational power of a patent does not cover any tips or instructions that have not been memorialized in writing, nor does it provide any access to the raw materials needed to put a vaccine together. Waivers, therefore, temporarily remove exclusionary rights, but do not address two fundamental sources of the current vaccine scarcity problem. In relation to the patents on the vaccines themselves, most of the concerns that the vaccine manufacturers express are around the protection of their vaccine platforms for the purposes of making future or non-COVID-19 vaccines. Moderna shared information about its patents in summer 2020. The manufacturers, as evidenced by the number of licenses to manufacture granted to date, are eager to find partners with the capabilities to expand production. It is not to their benefit to produce an inadequate supply of a highly sought-after vaccine. However, even willingness to transfer patented vaccine technology has faced numerous practical hurdles to date: 1) infrastructural limitations; 2) scarcity of raw materials; 3) concerns about licensees having the ability to actually manufacture effective vaccines in light of the infrastructural and product scarcity, even in situations in which there might be no informational gaps.
Basically, the proposed waiver is intended to ramp up the production and export of vaccines and medicines to stem the pandemic’s surge in the developing world. It would let countries obtain know-how and forge compulsory licenses without facing blowback in the form of trade complaints and sanctions from other nations. Still, some vaccine producers from the United States, like Moderna Inc., Johnson&Johnson and Pfizer Inc., might sue the U.S. to recoup some of their losses, If the manufacture of the vaccine is done in the U.S., under the government’s authorization, there are avenues for compensation in American courts. In India though, the production of vaccine is coped up by Bharat Biotech which is a government subsidiary.
Is waiver of a Patent a possible solution for the matter?
Contrastingly, waiving off the vaccine patents for COVID-19 would be a wrong legal and policy tool because it would not address the lack of knowledge sharing nor the shortage of raw materials and manufacturing capacity. Furthermore, the use of a waiver is politically fraught as was the use of compulsory licenses in the context of HIV/AIDS. We submit that battles of the political economy are best fought when prevailing on the use of a legal tool that actually solves the underlying practical problems. For the reasons stated above, that is not the case with waivers.
It can be appealing to see a patent waiver as an attractive short-term solution. Yet, even the short-term needs are too intense and the challenges too complex for waivers to fully address the infrastructural and knowledge gaps, as well as the additional problem of inequitable distribution of existing vaccines.
Another question lies here, it is a reality that more than the intellectual property problem, we Have the issue of Contractual and Infrastructure Problems.
It might be accurate to say that we have the problem related to IP if talking about the patent system inclined in fundamental level as the main legal regime designed to encourage investment in biopharmaceutical R&D. Most vaccines needed for the prevention or response to epidemics and pandemic fare poorly under predominantly market-driven R&D funding models. Specifically in this sense, the question related to excessive reliance on current legal regimes designed to spur innovation, which subject vaccine R&D to the same utilitarian principles that apply to vastly different types of goods.
It is imperative that in a more immediate sense and in the context of the COVID-19 pandemic the real problems are infrastructural and contractual. While we address the current limitations on vaccine production capacity ahead of future pandemics a problem that several countries have already turned to by investing or planning to invest in the construction of infrastructure for vaccine manufacturing.
It is also crucial at this point, that, against the current situation of scarcity of vaccine, the allocation problems which the world is experiencing also needs to be addressed which has further resulted in most available doses being given to populations elsewhere. This can be probably regarded as a contractual problem: currently, there is no legal mechanism which would prevent two parties — a country and a vaccine manufacturer — from subjecting negotiations involving pandemic vaccines to the same bargaining and contractual dynamics that govern the production and allocation of most other commodifiable goods.
Setting aside cases of voluntarism, there are no enforceable legal requirements compelling higher-income countries able to appropriate large amounts of vaccine doses to share them with other countries. This is a problem worth deep discussion ahead of the next pandemic.
But it also the area in which immediate policy efforts are presently best deployed. Instead of advocating for a waiver, countries, international organizations, activists, commentators and other interested parties should concentrate their efforts on mitigating the unbridled effects of existing contractual frameworks by nudging governments to adopt more equitable approaches to the global sharing of vaccine doses.
Indian Patent Act and Challenges
The present condition under which we are subsisting is a national public health emergency. In this scenario the government, through compulsory licensing can allow pharmaceutical manufacturers to produce generic versions of the patented medicines for the public in general. Now, under The Patents Act, 1970 (the “Act”), two provisions are important in this matter. These two provisions are Section 92 and Section 100 respectively.
Section 92 (1) of the Act states that “If the Central Government is satisfied, in respect of any patent in force in circumstances of national emergency or in circumstances of extreme urgency or in case of public non-commercial use, that it is necessary that compulsory licenses should be granted at any time after the sealing thereof to work the invention, it may make a declaration to that effect, by notification in the Official Gazette, and thereupon the following provisions shall have effect, that is to say- (i)the Controller shall on application made at any time after the notification by any person interested grant to the applicant a licence under the patent on such terms and conditions as he thinks fit; (ii) in settling the terms and conditions of a licence granted under this section, the Controller shall endeavour to secure that the articles manufactured under the patent shall be available to the public at the lowest prices consistent with the patentees deriving a reasonable advantage from their patent rights”.
As per the reading of this provision, a special provision is envisaged enabling the central government to issue compulsory licences for the manufacture of patented drugs in a public health emergency.
Also, under section 100 (1) of the Act, “Power of Central Government to use inventions for purposes of Government. -Notwithstanding anything contained in this Act, at any time after an application for a patent has been filed at the patent office or a patent has been granted, the Central Government and any person authorised in writing by it, may use the invention for the purposes of Government in accordance with the provisions of this Chapter”.
Thus, as per this provision it is clear that Section 100 enables it to use patented inventions for government purposes.
Although, as per many patent experts, it is believed that the government should have engaged with the pharmaceutical industry and could have worked out feasible options with them on ramping up production of vaccines and drugs.
The Act thus gives power to the government to take over the patent temporarily. It is possible that some manufacturing units may not have the production capacity. But that is where the government can step in to provide aids to the companies so that the essentials required to combat Covid-19 can be made readily available.
A patent waiver for the Covid-19 vaccine is welcome news when the world is searching for some form of respite from the harshness of the pandemic, but the practical reality and hard truth is that it isn't going to make that much of a difference to the current epidemic. Even if other manufacturers choose to make use of the waiver to ramp up vaccine production, precautions need to be put in place to ensure safety remains the highest priority. We need to ensure that in our hurry to protect ourselves we don't harm ourselves further.
Coronavirus Resource Center by Harvard Health Publishing; See https://www.health.harvard.edu/diseases-and-conditions/coronavirus-resource-center
Damian Garde, A detailed guide to the coronavirus drugs and vaccines in development. See https://www.statnews.com/2020/03/02/coronavirus-drugs-and-vaccines-in-development/
Nicoletta Lanese, First coronavirus vaccine trial in the US is recruiting volunteers. See https://www.livescience.com/us-coronavirus-vaccine-trial-recruiting.html
4th-year student, BA.LLB (Hons.) course