Data Exclusivity Patent

CoViD-19 Pandemic Spurs Calls for ‘Openness’ in IP


Corona covid 19The CoViD-19 pandemic may well be humanity’s biggest collective challenge in a post-globalisation era. In the midst of this global emergency, the artificial scarcity produced by international and domestic intellectual property laws and norms is revealing itself to be a scourge to public health systems around the world – from restraining drug research and development to denying access to medical devices. The responses of various stakeholders will certainly have an immediate impact on CoViD-19 related public health responses, but its effects could also mark fundamental changes in the domain of patents and copyright law.

In this post, I cover some of the recent developments towards creating voluntary arrangements for improved access to CoViD-19 related IP.

Patent Pools and Pledges

Several strategies for increasing the availability of healthcare related patents have already been spurred into action in the last few months. The importance of compulsory licensing as a regulatory response to the unavailability of medical devices and pharmaceuticals, in particular, has already been highlighted on this blog by Prashant and Swaraj.

Apart from compulsory licensing and regulatory responses to the availability of patents and copyrights, it is also worth highlighting efforts to improve coordinated responses and voluntary approaches towards countering ‘patent thickets’ and protracted negotiations for the use of patented or copyrighted technologies in the midst of this emergency. Navigating multiple patent rights can potentially hamper the development of responses to CoViD-19, and cooperative mechanisms to facilitate the exchanges of knowledge and IP are crucial to develop at this point. Moreover, compulsory licensing procedures, as crucial as they are, need to meet significant thresholds and standards before being enforced, which thresholds would further pose barriers to public health responses.

Recognising this, a few important mechanisms have been proposed across the world for ensuring the ‘openness’ of IP for tackling CoViD-19.

1. Open Covid Pledge – A group of US scholars and scientists have created a template ‘pledge’ for IP holders to invoke for licensing their intellectual property portfolios. The relevant part of the patent pledge reads as follows:

“The Pledgor grants to every person and entity that wishes to accept it, a non-exclusive, royalty-free, worldwide, fully paid-up license to fully use, practice and exploit all patent, copyright and other intellectual and industrial property rights (other than trademarks and trade secrets) that we have the right to license (the “Licensed IP”), for the sole purpose of ending the “COVID-19 Pandemic” (as defined by the World Health Organization, “WHO”) and minimizing the impact of the disease, including without limitation the diagnosis, prevention, containment, and treatment of the COVID-19 Pandemic.”

The ‘pledge’ is essentially a royalty-free patent license available for any entity to adopt and adapt, in order to increase the availability of protected IP for the purpose of ending or minimising the impact of CoViD-19. The pledge additionally contains a covenant not to sue for ‘regulatory exclusivity’, in a bid to include data exclusivity claims within the pledge. Finally, the pledge also includes a defensive licensing covenant – a pledge which automatically suspends the license if the licensee attempts to assert any intellectual property right against the pledgor.

Importantly, it differs from ‘open’ or (patent/copy)left licenses which would require any IP built from the licensed IP to be licensed on similar terms. Further, the license is time-limited, will revoke from one year after the WHO declares the CoViD-19 pandemic to have ended. This raises the question about the incorporation of licensed IP into products which may be used beyond the license term and what the effects of continued use or sale of such products might be for the licensee.

2. Costa Rica Proposes Emergency Technology Intellectual Property Pool – The Government of Costa Rica has asked the World Health Organisation to establish a glob of IPR and related rights for battling the CoViD-19 pandemic. According to the submission by the President and Minister of Health, such a rights pool “should include existing and future rights in patented inventions and designs, as well rights in regulatory test data, know-how, cell lines, copyrights and blueprints for manufacturing diagnostic tests, devices, drugs, or vaccines. It should provide for free access or licensing on reasonable and affordable terms, in every member country.”

The letter suggests that the WHO should initially reach out to rightsholders and governments to sign a memorandum of intent to pool IP, which can be followed up with negotiations for specific assignment and licencing arrangements. The proposal seems similar to the UN-backed Medicines Patent Pool (MPP), which already covers important retro-viral pharmaceutical developments. One important distinction between the proposed IP Pool and similar ‘patent pools’ includes the breadth of coverage, including copyrights and IP-adjacent rights such as regulatory data. InfoJustice has made a strong case for a similar ‘technology intellectual property pool’ here.

3. Chief Science Advisors ‘Request’ Publishers to Open Scientific Research – The Chief Scientific Advisors of 13 countries, including India, have requested publishers to open up scientific research published by them to PubMed, a US-Government supported repository and archive of medical scholarship and scientific research. It is unclear what effect this call has had on the publishing industry, even though Elsevier has created a CoViD-19 Info Centre. Importantly, the letter emphasises the necessity of machine-readable data formats, highlighting the role that data mining and ‘artificial intelligence’ can play in research around CoViD-19. The plea is also a testament to the continuing failure of substantially publicly funded research to be subject to open access requirements, even as public health and scientific development remains dependent on the whims of large publishing houses.

Voluntary arrangements remain important instruments to consider adopting and advocating for, however, the reliance on such voluntary grants from commercial entities also indicate the dependence of public health systems and scientific research on increasing patent monopolies and the enclosure of public health research by commercial firms. We should not wait for a pandemic to drive home the reality of how skewed and broken the world of medical and scientific research and technology is.

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