Opinion

Patent pooling, a Covid success story

Balakrishna Pisupati | Updated on June 22, 2020 Published on June 23, 2020

By fostering innovation and collaborative research, patent pooling can speed up efforts to contain the virus   -  Reuters

The Nagoya Protocol on sharing biological resources can be a guiding principle for improved access to Covid care

On October 24, 1856, history was made through the Albany Agreement, resulting in the first patent pool in US history. This was in response to the sewing machine war with nine patents pooled together on manufacture of sewing machines. We have come a long way in using patent pools to deal with many problems such as manufacturing of planes during World War I, for biotechnological applications, manufacturing of mobile phones and, more recently, providing affordable treatment to diseases such as HIV/AIDS.

Essentially, a patent pool supports greater innovation, collaborative research and development, removes bottlenecks in patent regimes and hastens product development.

If there is one time in recent history that international collaboration is peaking in science and technology, it is now. Cautious thanks are due to the current Covid-19 pandemic. Speedy, unprecedented actions have resulted in finding reliable options for testing, controlling, managing and eradicating this unknown virus.

According to GISAID, the global initiative to sharing of all influenza data, as of June 22, 49,781 genome sequences of the Covid virus have been shared, voluntarily, by researchers from around the world. The importance of this sharing, supported by the number of pre-peer review publications of results from research on various aspects of dealing with the pandemic made available for free, online, has enormously speeded up the effort to find medicines and vaccines to stop/contain the spread of this novel virus.

The open sharing of data and information comes on the heels of the recent discussions on patent pooling to manage the pandemic at the World Health Assembly (May 2020), when Costa Rica suggested pooling of rights to deal with the pandemic through free or minimal, affordable licensing to ensure the outcomes of efforts can be used by countries with limited economic resources to deal with the problem. India assumed the chairmanship of the Executive Council.

This proposal received full support, except from the US and the UK. Countries like Canada, Israel, Germany and Chile have taken national measures to tweak their patent regimes to speed up licensing and reduce the burden of patents on collaboration, research and development.

Experience from the past, especially the SARS virus outbreak in 2002 and the H1N1 pandemic in 2009, indicates that governments and the pharmaceutical industry may not favour patent pooling. This concern is more relevant given the economic benefits a drug and or a vaccine for Covid can bring to the industry.

IP issues

The Trade Related Intellectual Property Regime (TRIPS) allows countries to grant compulsory licences to companies to produce a patented product at times of emergencies. In April 2020, the European Commission, the European Medicines Agency and the European medicines regulatory network alluded to options for areas where regulatory flexibility is possible to address some of the constraints that may be faced within the context of Covid developments.

With its initial HIV mandate, the Medicines Patent Pool (an UN-led initiative) mission is to improve health by providing patients in low- and middle-income countries with increased access to quality, safe, efficacious, more appropriate and more affordable health products, through a voluntary patent pool mechanism. The MPP operates as a non-profit voluntary licensing mechanism through partnerships with the pharmaceutical industry that facilitate access and promote innovation, making significant progress in dealing with not only access to medicines but has supported transparency in licence agreements by publishing the same online.

The experience of the MPP in dealing with access to HIV drugs has provided a concrete example of how patent pooling can contribute to addressing some of the innovation and access challenges relating to health technologies more generally. Public health patent pools represent an innovative type of partnership that can be used to manage privately held IP rights in public interest. In March 2020, the MPP expanded its scope to include any health technology that contributes to the global response to Covid.

The forgotten solution

In order to bring fairness and equity to the way countries access and use genetic resources, the Convention on Biological Diversity (CBD) was adopted in 1992 as a legally binding international agreement. Currently, 196 countries are parties to the CBD. The US, predictably, has not yet ratified the convention. Except human genetic resources, all other genetic resources are covered under the CBD.

Article 15 of the convention requires the contracting parties to provide options for benefit sharing when genetic resources are used for commercial purposes. Discussions to implement provisions of this Article resulted in the parties to negotiate and adopt the Nagoya Protocol on access to genetic resources and benefit sharing (ABS) in 2010. Article 2 (e) of the protocol can be interpreted as including the genetic sequence information that forms the basis for all ongoing research and development on Covid treatment and prevention.

A significant missing element in the ongoing discussions on IP issues and Covid is that the Nagoya Protocol and its obligations require sharing of benefits arising from the use of genetic resources. Thus, any commercialisation of Covid-related treatment and/or prevention can be argued to be bound by this protocol and its benefit-sharing provisions.

India is certainly favouring this approach. India’s Biological Diversity Act (2002) mandates that any patent application using the resource obligates signing a formal benefit-sharing agreement with the National Biodiversity Authority, a statutory body established under the Act.

Future options

We need to consider the provisions of the Nagoya Protocol for clarity and certainty in dealing with issues of benefit sharing once the treatment and prevention options for the virus have been found for Covid. It is time all stakeholders considered this legal obligation before attempting to interpret and decide on the IPR issues related to Covid patents so that the patients in need of treatment receive a fair share of the medicines and we can look at the options to contain the pandemic.

The writer is the former Chief of Biodiversity, Land Law and Governance Unit at UNEP, and Chairman, National Biodiversity Authority, Government of India

Published on June 23, 2020
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