In the context of the COVID-19 pandemic, countries may review their internal legislation on compulsory licensing of patents for medical products so that it can be granted smoothly and speedily, in case it does become a necessity.
As the world eagerly awaits any and all developments in therapeutics and vaccines to treat and prevent COVID-19, it is important for each country to consider whether its legal framework has the adequate tools to ensure that the patent protection of medical products will not encumber the affordability and availability of an upcoming panacea.
Although several world leaders (such as Angela Merkel, Emmanuel Macron, and the WHO’s Tedros Adhanom Ghebreyesus) have called for a future COVID-19 vaccine to be declared a global public good – and, thus, unmoored by monopoly rights – such language is nowhere to be found in the Seventy-Third World Health Assembly’s Resolution, titled ‘Covid Response’, which was meant to provide a unified worldwide response to the pandemic. Instead, a cryptic reference can be found in that document to the use of “the flexibilities as confirmed by the Doha Declaration on the TRIPS Agreement and Public Health”.
Those “flexibilities” are a reference to the possibility, afforded by the aforementioned Doha Declaration on the TRIPS Agreement and Public Health, for countries to grant compulsory licenses of patents under (among others) grounds of national emergency.
Since it is highly likely that forthcoming COVID-19 vaccines and therapeutics shall be protected by patents, it is of the utmost importance to ensure that the monopoly rights which may be granted to private parties will not prevent a universal distribution of those medical products. Patent rights granted to private parties may make medical products prohibitively expensive, or simply unavailable in the necessary quantities to allow for universal treatment and prevention.
This has led some countries to take measures, within the limits established by the TRIPS agreement, which show that they are ready to resort to compulsory licensing, if the current situation deems it necessary.
For instance, on March 19, 2020, Israel effectively granted a compulsory license for the importing of a generic version of antiviral medicine lopinavir/ritonavir, which had (at the time) shown promise in the treatment of COVID-19. Interestingly, on the very next day, AbbVie, the company which owns the patents for lopinavir/ritonavir, announced that they would no longer enforce their patents against generic medications.
The Chamber of Deputies of Chile and the National Assembly of Ecuador have both adopted resolutions allowing for the use of compulsory licenses for patents over technologies apt for treating COVID-19. The Canadian House of Commons has gone further, and actually changed domestic laws regulating compulsory licensing, in order to make the proceeding of granting compulsory licenses independent from the requisite of a prior attempt at negotiation with the patent owner.
There have been reports that Germany and France are also taking steps to make compulsory licensing easier to grant in the near future. It is, perhaps, a good occasion for countries to take a step back and take a look at their legislation on compulsory licensing of patents. This mechanism, which is rarely used in developed countries (having never been deployed in either Portugal or Spain, for example), may very well become of pivotal importance in the not-too-distant future.
As such, at a time when time is of the essence, and thousands of lives may depend on whether adequate measures are taken in one week or delayed to the next, it may do well for countries to review their internal legislation on compulsory licensing before the need to resort to it actually arrives; so that, in case it does become a necessity, compulsory licensing of patents for medical products may be granted smoothly and speedily.
Garrigues Intellectual Property Department