Global Approval of COVID Vaccine Intellectual Property Protection Required by WTO
On May 5, 2021, the Biden administration ad its support for lifting intellectual property protections for COVID-19 vaccines. Naturally, the news made headlines and elicited passionate responses from the medical community and IP holders. But in fact, achieving this waiver will be a complicated process, which depends on many countries and parties other than the United States.
The text of the Administration’s announcement shows that giving up international intellectual property protections will be easier said than done:
The Administration strongly believes in intellectual property protections, but in the service of an end to this pandemic, supports waiving these protections for COVID-19 vaccines. We will actively participate in the text-based negotiations at the World Trade Organization (WTO) necessary to make this happen. These negotiations will take time given the consensual nature of the institution and the complexity of the issues.
In other words, it is the WTO as a whole that must effect an IP waiver. And given that the decisions of the WTO are taken unanimously by its 164 member countries without any formal votes, this process will require much more than the support of the United States, as a country’s dissent on the terms of ‘a derogation would block the initiative. .
To become a member of the WTO, countries must accept the Agreement on Trade-Related Aspects of Intellectual Property Rights (commonly known as the Agreement on Trade-Related Aspects of Intellectual Property Rights). TRIPS Agreement). This agreement contains a minimum set of standards that each country must adhere to regarding patents, trademarks, copyrights, trade secrets and other forms of intellectual property. Thus, in order to forgo intellectual property protection for COVID-19 vaccines, the provisions of the TRIPS Agreement must be replaced. While the TRIPS Agreement provides that “Members may, when formulating or amending their laws and regulations, adopt the measures necessary to protect public health and nutrition”, it adds that this can only be done if “These measures are compatible with the provisions of this Agreement. . “
The attempt to relinquish intellectual property rights began before the US announcement. In October 2020, even before the vaccines were approved, India and South Africa made a proposal to the WTO TRIPS Council for the waiver of intellectual property rights related to the prevention, containment or treatment of COVID-19. More specifically, they requested the waiver of the protections of copyright (Part II, Section 1 of the TRIPS Agreement), industrial designs (Part II, Section 4), patents (Part II, Section 5) and trade secrets (Part II, Section 7), as well as the enforcement mechanisms of Part III. Under the terms of the proposal, member countries would not be obligated to implement, enforce or enforce the above protections with respect to the prevention, containment or treatment of COVID-19. In other words, member countries could choose not to enforce intellectual property rights against vaccine manufacturers who would otherwise violate those rights. The scope of the proposal highlights the myriad of intellectual property rights that could potentially be waived for COVID-19 vaccines to be made by other manufacturers.
While more than 100 countries have expressed support for intellectual property disclaimers in general, they have yet to express their agreement on the scope and duration of such disclaimers. Sixty-two countries, including India and South Africa, submitted a revised proposal on May 21, 2021 which would limit the duration of the waivers to three years, after which the General Council of the WTO “would examine the existence of the exceptional circumstances justifying the waiver”.
Many countries have expressed their opposition to these proposals. Shortly after the announcement of the United States, Germany rejected the waiver proposal, declaring: “The protection of intellectual property is a source of innovation and must remain so in the future. German company BioNTech has partnered with Pfizer for the development of its vaccine and expects $ 11.5 billion vaccine income from supply contracts already signed. European Commission President Ursula von der Leyen said the European Union was open to discussion, but waiving intellectual property “Is not a subject in the short or medium term”. And the G20 countries signed a May 21 »Rome DeclarationClaiming that member countries should take action against COVID-19 while “working consistently under the TRIPS agreement.” Notably, the signatories included US Vice President Kamala Harris.
Even if sufficient exemptions were implemented, this would not ensure rapid production and distribution of vaccines. Production requires many highly technical processes and detailed know-howwhether or not intellectual property restrictions are in place, and manufacturers without intellectual property ownership may not be able to take advantage of a waiver. Moderna can be an example. He promised in October 2020 that it “would not apply our COVID-19-related patents to those who manufacture pandemic vaccines” and that it would license the intellectual property license for COVID-19 vaccines to others for the post-pandemic period. Yet there have been no reports from Moderna that any companies have taken advantage of this opportunity.
Given the above considerations, there will be two important aspects of IP disclaimers to watch out for in the weeks and months to come. The first is negotiation among WTO member countries on the scope of intellectual property waivers and whether these negotiations can proceed quickly enough to have an impact on vaccine availability. The second is whether, in addition to the waivers, IP holders will actively support new manufacturers in vaccine production, and whether this could or would be legislated by the WTO. These are uncharted waters when it comes to international intellectual property rights, not just for COVID-19 vaccines, but potentially for many other life-saving drugs.
© 2021 Proskauer Rose srl. Revue nationale de droit, volume XI, number 201