Last year, the world came to a ‘screeching halt’ due to a pandemic that is to this day sweeping the globe. The immediate end of COVID-19 was not on the horizon for many months. However, all that changed with the invention of the COVID-19 vaccines. Although, progress in fighting the virus is relatively slow, the vaccines gave us hope that the pandemic could be tamed soon. This is evident from the example set by Israel, as their vaccine campaign has been quite successful, and people there are already experiencing a sense of ‘normality’ back in their daily lives. From a legal point of view patent law is the legal field aiming at regulating patented inventions such as the COVID-19 vaccines. So, is patent law effective in aiding science during this difficult time?
Starting out with the basics, a patent can be defined as 'an exclusive right granted for an invention which is a product or a process that provides, in general, a new way of doing something or offers a new technical solution to a problem.'[1] Specifically, in the UK according to Section 1 of the Patents Act 1977 'a patent may be granted only for an invention', which 'is new, it involves an inventive step' and 'is capable of industrial application'. It is important to note that if someone wishes to acquire a patent 'technical information about the invention must be disclosed to the public in a patent application.'[2] Patent law grants the owner of the invention with an 'exclusive right to prevent or stop others from commercially exploiting the patented invention.'[3] Thus, the invention 'cannot be commercially made, used, distributed, imported or sold by others without the patent owner's consent'.[4]
In a way a patent owner is granted with a 'monopoly'. At times this monopoly has caused controversy, especially in situations where there has been a major health crisis, similar to the one, we are now facing. For example, patent law was heavily criticized during the outbreak of the AIDS/HIV health crisis in the 1980s and 1990s. An important realisation, this situation brought, was the fact that patent laws can be utilized 'to oppose policies adopted by democratically elected governments to balance patent rights' and provide medicines in accessible prices to the countries in need.[5] Therefore, the notion that patent laws must be applied with 'a willingness to occasionally set aside financial considerations in favour of ethical or moral concerns' should be highlighted when looking at the current situation we are now dealing with.[6]
At this point it must be noted that the TRIPS Agreement, which is one of the most influential intellectual property conventions, and the Doha Declaration (2001) provided a significant tool for public health emergencies like these with the introduction of 'compulsory licenses.' The importance of the protection of public health is highlighted in paragraph 4 of the Doha Declaration. There it is stated that 'the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health.' Furthermore, countries agreed that: 'while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO Members' right to protect public health and, in particular, to promote access to medicines for all.'
But as COVID-19 is in full swing now, where does patent law stand? Legal scholars are of the opinion that patent law should aid innovation and encourage scientists to innovate more, so society can reap the benefits of the world's innovative minds. If we apply this notion to the current situation one could argue that 'the global IP system provides an incentive framework in which urgently needed innovation in relation to COVID-19 can be encouraged.'[7] A statement that has turned out to be true. Anyone who follows closely the news regarding the pandemic will have noticed the effective development of a variety of vaccines and treatments from scientists from different parts of the world. Thus, one of the main justifications behind the patent law system seems to have been confirmed. On top of that, as mentioned above, in order for the inventor to be granted a patent there must be disclosure of certain information to the public. Consequently, in the fight against the ongoing pandemic 'the disclosure requirement and dissemination of patent information' can 'ensure access to technical information, which can support research and development (R&D) needs'.[8]
So, one could suggest that patent law has proven to be in a way effective so far. A critical issue that has emerged is the proposal of certain countries regarding the introduction of a 'TRIPS COVID-19 waiver' in relation to COVID-19 technologies, such as vaccines. A 'TRIPS COVID-19 waiver', which was suggested by South Africa and India would hypothetically 'temporarily waive patent rights over these products to facilitate increased production volume and more widespread manufacturing worldwide'.[9] This would aid countries with less financial power such as the developing or less developed ones to acquire the COVID-19 vaccines more easily. Although, developed countries whose companies are producing the COVID-19 vaccines seem to be hesitant, it should be stated that it could prove to be beneficial for them as well. This argument could be justified, since it is evident that 'the financial costs to all countries during the pandemic goes far beyond paying for the research and development, treatments and vaccines to manage COVID-19 cases.'[10] Thus, the long-term global financial impact of the pandemic outweighs their current concerns regarding the introduction of a 'TRIPS COVID-19 waiver'.
It should be highlighted that it is especially challenging for the few companies that have produced effective COVID-19 vaccines to reach their goals in relation to the quantity of vaccines needed to serve the public. Already, rifts have emerged between companies that manufacture vaccines and the countries that have signed contracts with them, such as the recent disagreement between the European Union (EU) and AstraZeneca concerning the distribution of their vaccine. It is evident, that in order to produce the desired quantity of vaccines there should be efficient 'licensing and transferring technology to more manufacturers'.[11] The counter argument of the states, that do not wish to introduce a 'TRIPS COVID-19 waiver' is based on the notion that the TRIPS Agreement is 'already flexible in its allowance of compulsory licensing to facilitate generic manufacture of patented vaccines'.[12] Although, one can point out that in practice the usage of compulsory licenses is no easy task.
In conclusion, humanity is facing a major challenge. New challenges call for new measures, new ideas and new approaches. It is important for countries to learn from their past mistakes and adapt to the existing landscape in order to tackle and overcome the ominous virus that is negatively impacting our daily lives and our future. Patent law plays an important role in this ongoing crisis and has led to the invention of the highly desired COVID-19 vaccines. It has helped us see the light in this grim situation. Now, the question is whether states and companies will think progressively and find ways to overcome the present obstacles, to manufacture enough vaccines as quickly as possible to protect public health. Arguably, a 'TRIPS COVID-19 waiver' does seem like a viable step towards the resolution of this issue. So, one cannot help but wonder, whose position should prevail in this debate?
Endnotes
[1] World Intellectual Property Organization, 'Patents'. [2] World Intellectual Property Organization, 'Patents'. [3] ibid. [4] ibid. [5] Enrico Bonadio, Andrea Baldini , 'COVID-19, Patents and the Never-Ending Tension between Proprietary Rights and the Protection of Public Health' (2020) 11(2) European Journal of Risk Regulation, 394.
[6] ibid. [7] WTO, WIPO, WHO, 'Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade', 3. [8] WTO, WIPO, WHO (n7). [9] Open Access Government, 'How will everyone benefit if WTO members sign the TRIPS COVID-19 waiver' (15 February 2021). [10] Open Access Government (n9). [11] Open Access Government (n9). [12] ibid.