INTRODUCTION “I only feel angry when I see waste. When I see people throwing away…
Efforts around the world to fight the Covid-19 pandemic have led to an unprecedented amount of collaborative research work. Platforms like GISAID and preprint servers are thriving with research work and new information on the novel Coronavirus. The data and know-hows made available by these open access resources have taken the pursuit of better diagnosis and treatment of the disease ahead. In the wake of the pandemic, an idea of a patent pool of Covid-19 related health technologies to increase access to drugs in middle and low-income countries poses as a welcome move. Such a patent pool can facilitate a mechanism to increase production of live-saving drugs and also increase its availability. For a generic drug manufacturing hub like India, such a move can turn out to have a twofold advantage: firstly, to battle the pandemic; and secondly, to give an impetus to the economy. However, the initiative by the WHO to form a “voluntary” patent pool is suffering from the lack of widespread involvement. Furthermore, the pharmaceutical industry is apprehensive about the “voluntary” scheme of things and has out rightly dismissed the notion.
What are Patent Pools?
A patent pool is referred to an agreement between two or more patent holders to license their products to each other or to any other third party. In other words, a patent pool is an aggregation of patent rights which can be made available collectively to the parties or any third party. Generally, the patents are made available in exchange of a fees (for a non-party to the pool) or in proportion of a party’s contribution to the pool (for a party to the pool). Traditionally, patent pools have been used by entities that are in need of the technologies patented by others and vice versa. The USPTO defines patent pool as “an agreement between two or more patent owners to license one or more of their patents to one another or third parties. A patent pool allows interested parties to gather all the necessary tools to practice a certain technology in one place, e.g., “one-stop shopping,” rather than obtaining licenses from each patent owner individually.”
Patent pools have several benefits. Patent pools speed up the production process due to better access to information and technological know-hows. This gives an impetus to innovation and efficiency also gets increased. Furthermore, members of patent pools don not have to go through the hassle of seeking permissions, licenses etc over and over which helps in saving time and money. Therefore one can say that patent pools can increase innovation and efficiency, and reduce transaction costs at the same time.
Patent Pools in the Field of Medicines
Although patent pools have not been very active in the field of medicines as compared to other fields, there have been instances where patent pools have been used to reduce the cost of life saving drugs in poor countries. The Medicines Patent Pool (MPP) which is a UN backed public health organization has been involved in creating pools to increase access to medicines in low and middle income countries. The MPP has license agreements with several product developers, allowing generic manufacturers to develop and sell generic versions of the medicines in poor countries. The MPP’s mandate includes drugs and health technologies for treating HIV, Tuberculosis, Hepatitis C etc. The MPP is now looking to expand its mandate to bring under its ambit the medical and technical know hows for treating Covid-19. The MPP has already updated its database to include “Remdesivir” which it claims as a product for the treatment of the novel virus related infections. The MPP has also signed license agreements with other developers with drugs that are undergoing clinical trials in Canada for treatment of Covid-19. These steps taken by the MPP comes after its announcement to support WHO’s “Voluntary Patent Pool” initiative.
WHO’s Voluntary Patent Pool
The WHO has launched a voluntary pool for patent rights, test data and other vital information with respect to the treatment of Covid-19. The pool aims at a collaborative effort from countries, industries, research centers and other organizations to increase access of Covid-19 medication and treatment to poorer countries. The pool was initially suggested by the Costa Rican government and now the WHO is working with Costa Rica and MPP to create and expand a license pool for Covid 19 related treatments. Initially, the idea of the voluntary pool emerged as an alternative to compulsory licensing of costly drugs. In the wake of the pandemic, several countries took the initiative to issue compulsory licenses. Many drug makers also signed voluntary licenses with generic manufacturers to sell generic versions in other countries. The proponents of the voluntary pool claim that it would be more effective in increasing the access to drugs than what is facilitated by frequent licensing. The pool seeks to collaborate technology and know-how from a number of entities and for a number of products rather than on a developer-to-developer or a product-to-product basis.
Nonetheless, the initiative of the voluntary pool has failed to receive much support from countries and drug developers alike. Only a few dozen countries have signed the pool initiative. Major economies and drug manufacturing countries like US, UK, China, India etc. are yet to sign the agreement. WHO’s deteriorating relations with the Trump administration does not pose as a good sign for getting support from the US and other major economies. The lack of participation by major economies in the voluntary pool makes it unlikely to increase access and availability of treatments and medicines widely enough to fight the pandemic.
Moreover, the pool has failed to get any support from the pharmaceutical industry. Pfizer’s CEO, Albert Bourla went to the extent of calling the pool “nonsense”. The stand taken by the pharmaceutical industry regarding this issue is quite understandable. It all boils down to the protection of Intellectual Property. After all, the foremost concern of these pharmaceutical companies is to protect their IPs and maximize their profits. Historically, these companies have always been against compulsory licensing as it deprives them of their patent rights. However, many developers in the past have issued voluntary licenses to soften the harsh criticisms they faced regarding their policies. There have been such instances in the past with HIV and Hepatitis medications. More recently Gilead Sciences has done the same with its Covid-19 product- Remidesivir.
Past Lessons, Challenges and the Way Forward
In a 2005 bulletin of the WHO, a patent pool for developing a treatment of SARS was proposed. It suggested pooling patent rights from several universities and research centers to allow wider access to treatment following the SARS outbreak. The idea never took off as it faced numerous challenges. This instance, nevertheless, left many lessons to be learnt especially in the present times of the Covid-19 outbreak.
Keeping aside the issue of lack of incentive for the pharmaceutical industry in sharing their IP, there are far and wide benefits that the voluntary pool can fetch. However, there are accompanying challenges as well. Patent pools are not very common and celebrated in the pharmaceutical industry. Historically, patent pools have failed to kick start, for example, during the SARS outbreak and the HINI pandemic. These raise a lot of doubts and apprehensions over the feasibility and success of such agreements. Furthermore, the high costs of research, development and production, and the long time periods consumed in clinical trials, holds back the pharmaceutical companies from collaborating due to their quest for market exclusivity. On the other hand, the countries fear losing control over compulsory licensing as a mechanism to ensure availability of life saving drugs. Thus, major economies also fail to find any incentive to be a party to the pool. The voluntary pool as launched by the WHO can go a long way in increasing accessibility of regulatory testing, treatments and life-saving drugs. If proper measures are taken to include essential and relevant patents as well as proper licensing negotiations are facilitated which addresses public health concerns and provides reasonable compensation to IP owners at the same time, the Covid-19 patent pool can encourage innovation, accelerate production and streamline the diagnostic standards for treating the patients.
Author: Aparthiba Debray, a 4th year student of Institute of Law, Nirma University, and intern at Khurana & Khurana, Advocates and IP Attorneys. In case of any queries please contact/write back to us at [email protected].