What is a COVID-19 vaccine intellectual property waiver? | Sunstein srl
While over 48% of the US population is fully vaccinated, only about 15% of the world is. Such disparities have led members of the World Trade Organization (WTO), such as India and South Africa, to request an exemption enforcement of intellectual property relating to diagnostic kits, vaccines, drugs, personal protective equipment and ventilators under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRAVEL).
The United States, home to many of the world’s largest pharmaceutical and biotech companies, has a long history of upholding strong intellectual property protections. However, in a surprising move, the Biden-Harris administration recently announcement its support for the temporary lifting of intellectual property protections under TRIPS for COVID-19 vaccines, while making no mention of diagnostic kits, drugs, personal protective equipment or ventilators.
Supporters of such a waiver argue that it will help speed up vaccinations in poorer countries, while critics argue that it removes the very incentives that have resulted in the fastest vaccine development the world has ever seen. seen. (The previous record holder was the mumps vaccine, which took about four years to develop and deploy in the 1960s.)
TRIPS is an agreement between WTO member countries that establishes minimum standards for the regulation of intellectual property by national governments, as applied to nationals of other WTO member countries. For example, under the TRIPS Agreement, patents must be granted for inventions in all “fields of technology” for at least 20 years (provided they meet certain conditions for patentability). TRIPS also provide standards for the protection of copyright, trademarks and trade secrets.
Without waivers, countries could face trade sanctions for violations of the TRIPS Agreement. The dispute settlement under the TRIPS Agreement does not provide for private action but rather for action between the member countries in dispute. For example, while Moderna would not have standing to prosecute a member country for TRIPS violation, the WTO could impose trade sanctions on that member country if a case was brought to it by the United States. A TRIPS exemption on the COVID-19 vaccine would limit or eliminate the possibility of pursuing such sanctions. However, even in the absence of a waiver, the United States can unilaterally choose not to apply TRIPS. With regard to patents, any waiver is likely to have little practical effect in the short term. While some of the platforms that have been used to develop the currently available COVID-19 vaccines may already be patented, the vaccines themselves have been developed so quickly that patents covering them specifically have yet to be granted in some. member countries, for example., India. A patent that does not exist cannot be applied and it is possible that the pandemic will end before such a patent is granted.
The most immediate impact of a COVID-19 vaccine waiver would likely involve significant unpatented technical know-how related to vaccine production. TRIPS requires member countries to protect trade secrets, as well as information provided during the regulatory approval process. Thus, the identity of specific materials used for vaccine production, formulations, manufacturing methods, and experimental data shared with government regulators are all protected by TRIPS even in the absence of patent protection. India and South Africa proposed that this protection also be lifted. Private companies would not be required to disclose this information if TRIPS trade secret protection were lifted, but a government to which this information was provided could share it without penalty.
Faced with a TRIPS waiver by the WTO, companies do not have much legal recourse to recoup their losses. If the vaccine is made in the United States without a license from the patentee under the direction of the government, the patentee can seek compensation in the Claims Court. However, similar routes are not always available in less developed countries. Moreover, even if an action for reparation is possible, the optics of such an action could be problematic.
Negotiations between WTO member countries on the language of a waiver are ongoing and can take months. European countries have already expressed their opposition to a waiver. Germany argues that capacity and quality assurance, not intellectual property rights, lead to production restrictions, while French President Emmanuel Macron said that increasing the exports and production of vaccines and their ingredients would be the best way to increase global immunization rates. Given that the WTO is a consensus-driven body, it is difficult to predict what the actual text of a waiver would look like, although, given European opposition, it is likely to be less ambitious than the original proposal from India and South Africa. For now, we’ll have to wait and see.