In 2020, we saw more than 2 million deaths due to the pandemic caused by the novel coronavirus. As vaccination drives have begun around the world, our hope for a normal life has been restored.. Till then, it is certain that until we develop herd immunity or the virus mutates into an innocuous strain or we have a mechanism to vaccinate all, the death rate will decline but not stop.
In a country like India, the idea of a patent pool of medical technology related to COVID-19 to increase access to drugs in middle- & low-income groups, should be a welcome move. Given that India is generic drug manufacturing hub and has such a vast population to vaccinate. Such a patent pool will not only escalate production & availability but also provide an impetus to the economy.
A Patent Pool is a group of two or more organizations authorizing each other or any third party to license their patents. The need for a patent pool arises when there are complications in the development of a technology and the only way forward is by collaborating with other patent holders to accomplish the goal. Typically, patent pools have been used by entities that are in need of technologies patented by others.
WIPO 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”. According to USPTO, “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”.
Previously, a patent pool was proposed in a 2005 WHO bulletin for developing a treatment for SARS. It suggested pooling the patent rights of several universities and research centres to allow wider access to treatment after the SARS outbreak. Unfortunately, the idea was never put into action. This example left many lessons to be learned, especially now when few vaccines have been developed but the availability and accessibility of it to middle- and low-income groups is unclear.
Patent pools guarantee that sub-licensees of licensed drugs have access not only to these medicines, but also licenses to produce, market, and distribute generic copies of these medicines. It is an effective method to bring emerging technology together, to be used at a fair price and to be subject to developer fees. Typically, they are regulated by a central agency and the licenses, know-how, etc. of the drug are exchanged and made available to the central agency for licensing. The central agency determines the rate payable for such licenses and can approach the pool and work with interested entities. In the case of a vaccine, there are multiple components involved that are produced by different firms, unlike a generic prescription product, so patent pooling allows some drug producing companies to combine separate products into single/fixed doses in order to manufacture result yielding drugs.
The establishment of Medicine Patent Pooling, an international public health organisation backed by United Nations in 2010, has led to creation of pools to focus on increasing access to medicines in low- and middle-income countries. The MPP has license agreements with several product developers, allowing manufacturers to develop and sell generic versions of the medicines in poorer countries. The MPP’s mandate includes drugs and health technologies for treating HIV, Tuberculosis, Hepatitis C etc.
The Covid-19 Technology Access Pool or C-TAP, initiated with the sponsorship of MPP, is an effort to make drugs, vaccines, examinations, and other health-related innovations available to all, in order to provide respite from COVID-19.
One of the major facets of C-TAP is licensing. In November 2020, with the aim to combat COVID-19, a group of 18 companies representing a substantial portion of the world’s generic pharmaceutical manufacturers, vowed to work together through the Medicines Patent Pool to speed up production and access of the vaccine. The number of participating companies has grown to 21.
However, the initiative by the WHO to form a “voluntary” patent pool is still suffering from a lack of widespread involvement. Unless it is solely a voluntary pool, MPP would be more successful. Only developed and developing countries may, either by compulsory licensing or through other means, force MNCs to enter the pool. Generic drug manufacturing countries, such as India, are more involved in voluntary licensing than in compulsory licensing which comes in the way of making a patent pool successful.
A big advantage of a patent pool is that enables several worldwide suppliers to obtain licenses instantly, leading to accelerated release of COVID-19 drugs. This will also ensure adequate research and development, while having no legal hassles. In the case of the Covid-19 vaccine, a multinational pool would fast-track the distribution process globally and no manufacturer would have to obtain licenses from patent holders to manufacture the drug. They may also skip on mandatory requirements like compulsory licenses or state purchases.
The Medicines Patent Pool and the Joint Research Centre of the European Commission joined hands recently, in January 2021, after signing a Memorandum of Understanding (MoU) that focuses on laying down the foundation for cooperation between the organisations, with regards to intellectual property in the health sector that is aimed towards combatting COVID-19, through research and innovation.
The two organisations shall work together to “identify mechanisms and incentives to encourage the beneficiaries of EU funding to make available their IP through MPP, (ii) find synergies on common public health initiatives such as the ACT accelerator, and (iii)collaborate beyond COVID-19 on access to essential medicines, among other aims”.
The COVID-19 Technology Access Pool can foster creativity, speed up development and streamline diagnostic requirements for the care of patients if adequate steps are taken to provide important and applicable patents, as well as proper license negotiations that resolve public health issues and include equitable compensation to IP owners at the same time.
Authored by
Ritabrata Roy
PhD. Scholar University of Sussex Law School, UK
&
Siddharth Mathur
Designated Partner, Lex Protector LLP
Patents and Patients 