The True Nature of the Danger Behind the IP Waiver Proposal

The problem represents a potential threat in the fight against future pandemics.

Occasioned by the COVID-19 pandemic, the World Trade Organization (WTO) has considered a proposal from South Africa and Brazil to empower member states to impose waiver of intellectual property (IP) rights” related” to vaccines (and probably to antiviral, diagnostic and possibly preventive therapies). The uncertainty about the scope of the waiver is a consequence of the proposed wording, which remains undefined because the agreement is negotiated by WTO member governments, primarily the US, EU, China and South Africa/Brazil.

The details of the production of the COVID vaccine have been exposed in various news sources,1 but these are not disclosed in the detail necessary for commercial production. Much of the “know-how” needed to implement actual vaccine production involves trade secrets, many of which are not limited to COVID vaccines (e.g., production of the lipid nanoparticles in which mRNA vaccines are encapsulated) . Most countries favoring the waiver (except India and South Africa) are unlikely to have the technological infrastructure to produce the vaccine. So, in the short term, the waiver can be expected to do little to solve the real problem of the world’s vaccination.

Recently, the Biotechnology Innovation Organization (BIO) provided a link to the supposed compromise agreement reached to allow WTO member states to waive patent protection for “subject matter required for the production and supply of COVID-19 vaccines without the consent of the right holder in the necessary measure to deal with the COVID-19 pandemic”. The proposed derogation seems patent-centric, but while the derogation states that a Member State may authorize “the use of patented object necessary for the production and supply of vaccines against COVID-19 without the consent of the right holder to the extent necessary to deal with the COVID-19 pandemic”, in a footnote, l term “patented subject matter” is significantly expanded to include “ingredients and processes necessary to manufacture the COVID-19 vaccine.” The rights which the derogation confers on a Member State are expressly not limited to compulsory licensing of patents in the Member’s jurisdiction, but includes “executive orders, emergency orders, and judicial or administrative orders” and undefined “other acts”. These acts or decrees are themselves not limited to internal use within a Member State, but may also include “any proportion of the use permitted to be exported to eligible Members and to feed into joint international or regional initiatives that aim ensuring equitable access members eligible for the COVID-19 vaccine covered by the authorization” (emphasis added; in which the italicized part of the proposal is not defined).

Even if patents involved in the preparation of COVID vaccines are granted, the disclosure necessary to reproduce these vaccines is protected by trade secrets. Under the terms of the proposed waiver, the question will be whether the United States will compel the disclosure of trade secrets held by U.S. companies or that have disclosed them in confidence to the extent that those secrets are part of regulatory filings. The administration’s public stance increases the likelihood of an unprecedented assault on private property in the United States.

Global efforts to develop vaccines, treatments, and better tests and technologies in response to COVID have been impressive. Intellectual property protection has played an important role in these efforts. Past experience and recent developments suggest that intellectual property protection for COVID vaccines, therapies and technologies has had and could continue to have a positive impact and advance the cause of eradication. , or at least the treatment and prevention of this disease. It would be foolish to ignore such contributions by reducing their effectiveness with the proposed waiver, especially when the precise scope (at least as far as trade secret aspects are concerned) is either indefinite or effectively unlimited. The pandemic has created a lot of anxiety about what will happen “the next time” there is a pandemic. This waiver raises the very real possibility that we will be less likely to be able to meet such a future challenge because those with the ability, incentive and economic means to do so will have left the field to pursue other opportunities.

After this article was written and put into production, the World Trade Organization approved an amended version of a COVID-19 vaccine intellectual property waiver.

Kevin E. NoonanPhD, Partner at MBHB Intellectual Property Law Firm and Co-Chair of its Biotechnology and Pharmaceuticals Practice Group

Reference

  1. See, for exampleNeuberg et al., “Exploring the supply chain of Pfizer/BioNTech and Moderna COVID-19 vaccines”; Weiss et al.“A life cycle of a COVID-19 vaccine: from DNA to doses”, USA today, 7 February 2021; King, “Why making a large-scale Covid vaccine is difficult”, world of chemistry, March 23, 2021; Cott et al.“How Pfizer makes its Covid-19 vaccine”, New York TimesApril 28, 2021.

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