The World Health Organization (WHO) issued a directive that classified the Coronavirus disease (hereinafter ‘COVID-19’) outbreak as a global pandemic, subsequent to this many questions have emerged regarding the patent rights around the medicines, vaccines, technology that are used in laboratory tests for COVID-19. This raises the question, what is the importance of patent rights in the health sector and how does it affect the interest of the public during a pandemic? The patent system was introduced to promote and encourage innovation in the respective field by assuring the developers’ exclusive rights over their innovation. In the context of the health sector, development of new drugs and technology requires long term research, expensive clinical trials, and other regulatory procedures and by ensuring exclusive rights over their innovation it serves as an incentive to make the initial investments.
The challenge that arises with such exclusivity is to find an optimal balance between the rights of the patent owners and public welfare. In a recent article, co-authored by the Nobel Laureate in economics, Joseph E Stiglitz stated that “With the arrival of COVID-19, it is now painfully obvious that such monopolization comes at the cost of human lives. Monopoly control over the technology used in testing for the virus has hampered the rapid roll-out of more testing kits, just as 3M’s 441 patents mentioning “respirator” or “N95” have made it more difficult for new producers to manufacture medical-grade face masks at scale. Worse, multiple patents are in force in most of the world for three of the most promising treatments for COVID-19 — remdesivir, favipiravir, and lopinavir/ritonavir. Already, these patents are preventing competition and threatening both the affordability and the supply of new drugs.” This captures the detrimental effect of patent rights and monopolization in the health sector on the greater public good.
For the longest time in the history of patent rights, there has been an on-going debate between public health advocates and pro- IP practitioners about the implications of patent rights and monopolization of the health sector. Though patent protection drives innovations and research, it simultaneously culls competitions and democratization of new drugs and technologies. For years, pharmaceutical companies have commercialized the health sector and hoarded knowledge through countless patents over life-saving drugs. Such actions are often ignored in our day to day life, however, when the world comes to a standstill by a pandemic, we are forced to revisit these protections and privileges that may further deny us the technologies we need at this hour.
The need to democratize health sector in the face of a pandemic
It is unfortunate to note with the arrival of COVID- 19, that monopolization comes at the cost of human lives wherein many of the drugs that were meant to cater to the needs of the public are kept beyond their reach and affordability. However, over the past months, we have witnessed several strategies being spurred to action in order to ensure the increased availability of patented drugs. Costa Rica’s government recently called on the WHO to establish a voluntary pool of IP rights for COVID-19 treatments, which would allow multiple manufacturers to supply new drugs and diagnostics at more affordable prices to the public. Such patent pools, prize funds, and other similar alternatives fall within the broader program of increasing the accessibility of life-saving drugs at crucial hours such as the pandemic we are currently battling. Many countries, including Germany and Israel, are seen to be acting on their feet by suspending patent rights over the drugs that are required to battle this pandemic. It is imperative for the governments to formulate policies and measures to ensure that patent protections do not hinder access to medicines, technologies, and other necessities. Further, governments can permit compulsory licensing or government use of products that are protected by patents in the face of such unprecedented times. All these initiatives will help further the goal to replace a monopoly-driven system with one based on cooperation and shared knowledge which will inevitably preserve the rights and wellbeing of the public.
The cost of such openness?
Though openness may be called on for at such uncertain times, protecting the rights of the developers to ensure they reap the benefits of their efforts may be the only way forward to ensure ground-breaking innovations in the health sector. In the past we have witnessed governments intervening to remove such barriers to safeguard the public interest; in 2001, US Congress and the Administration were reported to have considered intervening Bayer’s patent on Cipro in order to hoard the drug against a potential anthrax attack. In the Cipro case, the Government used the threat of breaking the patent to negotiate a long-term contract with Bayer at an unusually low price. This approach might be termed ‘bending’ the patent. Admittedly, the governments more often than not are tempted to break patents covering important drugs or treatments that may help assuage a crisis. Furthermore, in light of the recent pandemic, Israel issued a compulsory license over AbbVie’s Kaletra which has resulted in AbbVie dropping its patent rights over the medicine worldwide. It is highly likely that we will soon see a surge in the use of compulsory licenses issued by governments to tackle experimental treatments of COVID-19, especially if the companies are not willing to disclose their research. However, will the efforts by the governments and policymakers result in an unintended consequence of discouraging efforts to innovate during crisis situations? Further, will it disincentivize innovators from developing crisis specific treatments? It is understandable that lawmakers are concerned about the greater good of the public and to keep them at bay but will these measures counter the very object of its implementation? These empirical question ought to be etched at the back of the government while issuing such directives because it would be unfortunate to see that the directions intended to protect the wellbeing and the health of the public has been the very reason for its demise.
Though the proactive measures and efforts by the governments are laudable and noteworthy, we need to determine whether they are a step forward in the right direction or two steps backward. The predicament that the policymakers have found themselves in this crisis is a murky and unclear one, where a step to assuage the crisis has the potential to substantially and detrimentally affect the domain of patent and copyright laws. At this juncture, it is necessary to not compromise the welfare of the public nor squander the spirit of innovation, but create a delicate balance of the two to navigate through this crisis. Though compulsory licensing may appear to be the apt solution at this fork on the road, what will its impact be on the innovators once we come out of this crisis? Or will the most valuable drugs and technologies not be catered for crisis situations such as these? Successfully navigating through this labyrinth of hurdles and uncertainty will lead to a more sophisticated and efficient regime for patent protection in the health sector for the future.