When Compulsory Licenses Apparently Just Won’t Do: The US Backs Waiver of Rights to IP Relating to COVID-19

USPTO Establishes COVID-19 Prioritized Appeal Pilot Program

On Tuesday, May 5th, 2021, US Trade Representative Katherine Tai released an unprecedented statement in support of a “Covid-19 TRIPS Waiver”. In particular, Ambassador Tai stated: “[t]The government is a firm believer in the protection of intellectual property but supports the waiver of this protection for COVID-19 vaccines in the service of ending this pandemic. We will actively participate in the text-based negotiations at the World Trade Organization (WTO) that are necessary to achieve this. “

The stock market was unimpressed.

To quote the speaking heads: “And you may be wondering how did I get here?”

The agreement on trade-related aspects of intellectual property rights (TRIPS) today sets the minimum standards for the protection of intellectual property worldwide. TRIPS allows WTO member states to apply compulsory licensing as part of the overall effort of the agreement to strike a balance between promoting access to existing drugs and promoting incentives for intellectual property.

The term “compulsory licensing” does not appear in TRIPS. Rather, Article 31 of the TRIPS allows a member state to “permit[] for any other use of the subject matter of a patent without the permission of the copyright holder ”, provided“ the following provisions [are] respected. “

Two provisions are particularly relevant here.

Article 31 (b) generally requires that “such use is permitted only if the proposed user has made efforts to obtain authorization from the rights holder prior to such use.”can be dispensed with by a member in the event of a national emergency or other urgent matter or in cases of public non-commercial use. “

Second, Article 31 (h) provides that “the right holder regardless receive an appropriate remuneration under the given circumstances, taking into account the economic value of the permit. “

However, TRIPS does not pretend to have a unified approach to intellectual property, which was clarified in the 2001 Doha Declaration. In that statement, the WTO stated:

  1. “Each member has the right to issue compulsory licenses and to determine the reasons for which such licenses are issued.”
  2. “Each member has the right to determine what constitutes a national emergency or other situation of extreme urgency. It is understood that public health crises, including those related to HIV / AIDS, tuberculosis, malaria and other epidemics, may constitute a national emergency or other circumstance of extreme urgency. “

Still, in October 2020, South Africa and India pushed the WTO for more, calling for the Council to essentially ban COVID-19 patents. Despite widespread support, this request has stalled. Probably not much longer. The question of a waiver – despite the mandatory licensing provisions of TRIPS – will certainly be the focus of discussion at the meeting of the TRIPS Council from June 8th to 9th. With the support and support of the US for India / South Africa to “waive” TRIPS regulations in relation to COVID-19, this could just happen.