The proposed WTO agreement on intellectual property and COVID 19 vaccines should not require that authorizations of non-voluntary use of patents list all patents covered.

The recent proposal by the European Union, the United States of America, India and the Republic of South Africa (the QUAD) to resolve the WTO negotiations on intellectual property rights and the COVID 19 pandemic includes a new limited waiver of restrictions on vaccine exports under a compulsory license. There are three conditions attached, a requirement that “authorization shall list all patents covered,” that the WTO be notified of each authorization, and all WTO members take measures to prevent the diversion of vaccines from eligible countries.

The condition that “the authorization shall list all patents covered” is not required in the TRIPS now. This is not a good idea in general, and particularly a bad requirement for vaccines.

It can can be a problem to identify the relevant patent landscape for a vaccine compulsory license.

Originators don’t like to disclose the patent landscape of biologic products and patent landscapes for some vaccines can be quite complex. In the United States, under the Biologics Price Competition and Innovation Act (BPCIA), companies have have to sign an NDA to find out which patents will be asserted against a biosimilar product.

Even if a company wants to cooperate on disclosing patent landscapes, there may be (certainly for mRNA vaccines), all sorts of third parties asserting patent rights. As pointed out by Mario Gaviria and Burcu Kilic in a 2021 article in Nature Biotechnology, and more recently in a WIPO report on COVID-19-related vaccines and therapeutics, “filing activity related to the pandemic has been extraordinarily active.”

There are patents applications that are not filed yet, applications filed but not published, and published applications not approved.

Even if you have granted patents, there are significant controversies and uncertainty over which claims are valid or relevant.

The USA, which agreed to this requirement in the QUAD proposal, is not required to list patents covered in 28 USC 1498(a) cases (use by or for the government), and often litigates patent relevance post non-voluntary use.

A number of countries, such as Iceland, Israel, the UK and the U.S. allow compulsory licenses to be granted on inventions, even if patents are not yet granted. For example, the U.S. Bayh-Dole Act defines an invention as “any invention or discovery which is or may be patentable or otherwise protectable” [35 USC 201(d)]. The UK Patent Act provisions on Crown Use state that :

(6) The authority of a government department in respect of an invention may be given under this section either before or after the patent is granted and either before or after the use in respect of which the authority is given is made

Notification of patents owners in the UK Crown Use act is “as soon as practicable after . . . the use is begun and the patent is granted.”

Several countries that waive prior negotiations on reasonable terms permit rights holders to be notified after the non-voluntary authorization is granted. Kenya, Malaysia, Iceland and many other countries require patent holders to be notified “as soon as reasonably practical” but but not necessary before an authorization.

The Quad proposal states:

In the determination of the relevant patents, an eligible Member may be assisted by WIPO’s patent landscaping work, including on underlying technologies on COVID-19 vaccines, and by other relevant sources.

The WIPO COVID 19 landscape report is, of course, a snapshot in time, that becomes rapidly outdated. Markus Lang offered this assessment.

The Quad propose notes that “An eligible Member may update the authorization to include other patents,” which is an acknowledgement of sorts that identifying relevant patents on vaccines is not a simple requirement, and one that does not address emerging patent claims. But it also raises the question of why have this TRIPS plus requirement at all, particularly on that is inconsistent with the national law in many countries.

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James Love

Director, Knowledge Ecology International, an NGO working on knowledge governance