Patented Vaccines: Is Waiving The Way Forward?

Alyshea Low discusses the proposal to suspend patent protection for the COVID-19 vaccine
More than a year has passed since the outbreak of the coronavirus disease (COVID-19) was first reported in Wuhan City, Hubei Province in China. The world, as we know it, has had to adopt and adapt to a “new normal”. Wearing a face mask, sanitising your hands, and keeping social distance are common mantras that we hear from most governments and health organisations.
When word of COVID-19 hit the news in December 2019, drug makers around the world rose to the challenge of finding a vaccine to bring an end to this pandemic. The big boys in the pharmaceutical industry, Pfizer Inc and BioNTech SE announced in December 2020 that the U.S. Food and Drug Administration (FDA) had authorised the emergency use of the mRNA vaccine, BNT162b2, against COVID-19, in individuals 16 years of age or older. In the same month, authorisation for the temporary supply of BNT162b2 was granted in the United Kingdom. Health experts opined that vaccination is the most effective medical intervention to decrease the risk and reduce the spread of COVID-19.  
In October 2020, India and South Africa submitted a joint proposal to the World Trade Organization (WTO) to waive enforcement of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement 1994 (“TRIPS Agreement”) on Trade-Related Aspects of Intellectual Property Rights for all intellectual property related to the prevention, containment and treatment of COVID-19. The proposal, known as the TRIPS waiver, was supported by some countries, but opposed by some high-income nations, such as the United States, the European Union countries, the United Kingdom, Japan and Australia.
In light of the rapid increase of COVID-19 infections in India, and in response to pressure from various activist groups, the Biden Administration is reported to consider a change in its position on the waiver. The United States Trade Representative, Katherine Tai, states:
This is a global health crisis, and the extraordinary circumstances of the Covid-19 pandemic call for extraordinary measures The administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for Covid-19 vaccines The Administration’s aim is to get as many safe and effective vaccines to as many people as fast as possible.
As of May 2021, approximately 4.6% of the world’s population has been fully vaccinated. Although the COVID-19 vaccine has been made available since December 2020, some argue that waiving intellectual property rights for vaccines will speed up global vaccination and in turn, achieve rapid herd immunity. It is therefore not surprising that India has been leading a push at the WTO to do away with patenting COVID-19 vaccines.
On the other hand, some argue that this may not be effective in achieving such milestone.
According to the proponents of the TRIPS waiver, the objectives are to avoid barriers to the timely access to affordable medical products, including vaccines and medicines, and to scale-up the manufacturing and supply of essential medical products. In their view, the waiver proposal represents an open and expedited global solution to allow uninterrupted collaboration in the production and supply of health products and technologies required for an effective COVID-19 response. The waiver would cover obligations in four sections of the TRIPS Agreement – Section 1 on copyright and related rights, Section 4 on industrial designs, Section 5 on patents and Section 7 on the protection of undisclosed information. The waiver would last for a specific number of years, to be agreed by the General Council, and until widespread vaccination is in place globally and the majority of the world's population is immune.
It is reported that negotiations between member countries will take time, given the complexity of the issues involved. However, more challenging is the requirement that all 164 WTO member countries must reach consent on such decisions, as any one member is able to block them.
Patent protection was created as a “win-win” tool for both economic and technological improvement. It provides monopoly rights for a period of 20 years to the patent owner over their inventions. The rationale behind granting monopoly in exchange for disclosure is to encourage innovation, improvements and research. Patent rights also allow the patent owner to reap the benefits of its research and development efforts and expenses by commercialising the invention.
Most, if not all innovations require significant research efforts to create, possibly involving very significant up-front costs. Where research efforts pay off, this can create significant value for the owner, and for society overall. Patent protection therefore provides patent owners with a measure of comfort that up-front investment costs can be recouped over the period prescribed by law, thus increasing the level of research and development activity that patent owners are willing to invest in.
In the context of a vaccine, the patent owner has monopoly over the invention in exchange for the disclosure of the process of developing the vaccine as well as the formula or properties tied to the production of the said vaccine.
It is reported that the mRNA technology would be crucial to rolling out vaccines that are effective against new variants and possibly future pandemics. Experts believe that the mRNA technology could be developed further to treat diseases such as cancer and HIV/Aids. If patent protection is waived, it may stifle such development that could be achieved through the mRNA technology.
On the other hand, a strong argument in support of waiving includes expediting the inoculation of the global population to eradicate this highly contagious and fast-mutating virus. This would mean generic or otherwise non-licensed manufacturers could begin production in the countries that have capacity for production.
As most patent legislation have some form of compulsory licensing mechanism, one must consider whether it is even necessary to resort to seeking a waiver under the TRIPS Agreement. In the context of Malaysian law, the provisions of the Malaysian Patents Act 1983 relating to compulsory licensing and public interest deserve consideration. 
At the time of this article, it is unclear as to the status of registration for the relevant patents for the COVID-19 vaccine in Malaysia. As the compulsory licensing and public interest provisions under the Malaysian Patents Act 1983 apply to patents that have been granted, recourse to these provisions is only possible after the relevant patents have been granted. 
Article 31 of the TRIPS Agreement sets out the conditions where use without authorisation of the patent owner is allowed. In addition to the conditions as set out in Article 31, the compulsory licensing provision may only be invoked when the third party has made efforts to obtain authorisation from the patent owner on reasonable commercial terms and conditions and that such efforts have been unsuccessful within a reasonable period of time. However, such a requirement may be waived by a Member in the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use. In such instances, the right holder must, nevertheless, be notified as soon as reasonably practicable. Article 31(h) further provides that the right holder shall be paid adequate remuneration in the circumstances of each case, taking into account the economic value of the authorisation.
It is reported that Chile adopted a resolution declaring that the global outbreak of COVID-19 justifies the use of compulsory licensing provisions for any treatment device or vaccine that helps to prevent, diagnose or to treat the virus. It is also reported that the National Assembly in Ecuador approved a resolution that requested the Minister of Health to issue compulsory licences for patents related to COVID-19 technologies.
In Malaysia, provisions for compulsory licensing are contained in Part X of the Malaysian Patents Act 1983. Section 48 defines a “compulsory licence” as “the authorisation to perform in Malaysia without the agreement of the owner of the patent in respect of the patented invention any of the acts referred to in paragraph 1(a), and subsection 36(3)”. Under section 49, any person may apply for the grant of a compulsory licence after the expiration of three years from the grant of a patent, or four years from the filing date of the patent application, whichever is the later, under any of the following circumstances:
  1. where there is no production of the patented product or application of the patented process in Malaysia without any legitimate reason;
  1. where there is no product produced in Malaysia under the patent for sale in any domestic market, or there are some but they are sold at unreasonably high prices or do not meet public demand without any legitimate reason.
In light of the requirement to wait at least three or four years before applying for a compulsory licence, this provision may not be practicable as the requirement for the COVID-19 vaccine is highly time sensitive. Be that as it may, the Malaysian Patents Act 1983 provides for a situation where the Malaysian Government may exploit a patented invention without the agreement of the patent owner where it is of public interest.
In Malaysia, section 84(1) of the Malaysian Patents Act 1983 provides for the Government to allow the exploitation of a patented invention by a government agency or a third party in certain circumstances, predominantly for domestic market supply, without the consent of the patent owner but with adequate remuneration to it. Section 84(1) provides that where:
  1. there is a national emergency or where the public interest, in particular, national security, nutrition, health or the development of other vital sectors of the national economy as determined by the Government, so requires; or
  1. where a judicial or relevant authority has determined that the manner of exploitation by the owner of the patent or his licensee is anti-competitive,
the Malaysian Government may decide, even without the agreement of the owner of the patent, that a Government agency or a third party may exploit a patented invention.
In light of the current global pandemic and the urgency to achieve herd immunity in the fastest possible manner, this section appears to be the most effective provision under Malaysian Patent law for the Government to rely on once the patent is registered as it does not require any fixed time frame before it can be invoked.
In early 2021, following the amendment of its patent legislation, Canada implemented measures to make patented inventions accessible to the government without authorisation from the patent owner in the event of a national emergency, with compensation to be decided by the Commissioner of Patents. In the United Kingdom, compensation may be payable to a patent owner when this provision is used.
Deciding whether to enforce a waiver of intellectual property rights in the COVID-19 vaccine is not a straightforward decision nor process. There is the challenge of balancing between providing incentive for development and innovation of vaccines, and the inoculation of the worldwide population, coupled with the ability of manufacturers to keep up with demand. In any event, a decision to implement or not implement such a measure will receive criticism either way. This goes to show how valuable one’s intellectual property can be, particularly in times like the ones we are facing.
Article written by Alyshea Low (Senior Associate) of the Intellectual Property Practice of Skrine.