The intellectual property exemption proposed by the WTO: what can it be used for? — An analysis | McDonnell Boehnen Hulbert & Berghoff LLP
As job On Monday, BIO (the Biotechnology Innovation Organization) provided a link to the supposed compromise agreement reached recently 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 address the COVID-19 pandemic.” The effects of such a waiver are being debated by those who oppose it (primarily members of industry with vaccine-related intellectual property protection and vaccine manufacturing industries) and for (NGOs, such as Doctors Without Borders) and, of course, governments seeking to benefit, starting with waiver sponsors India and South Africa.
The proposed disclaimer seems patent-centric, but the devil, as usual, is in the details (to see “If the devil of waiving WTO intellectual property is in the details, what are the details?“). For example, 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” (emphasis added). The rights which the derogation confers on a Member State are expressly do not limited to compulsory licensing of patents in the member’s jurisdiction, but includes “executive orders, emergency orders, and judicial or administrative orders” as well as “other acts” undefined. These acts or decrees are themselves do 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 COVID-19 vaccine-eligible Members covered by the authorization” (emphasis added; in which the italicized part of the proposal is not defined).
But as these considerations suggest, while a dramatic development (after all, the proposal was to be voted on last fall), disclaimers of patent rights are not the entirety of the patent rights provisions. intellectual property in the proposal nor those that are necessary if the sponsors actually intend to remove real barriers to wider distribution of vaccines, especially in low- and middle-income countries. Details of the production of the COVID vaccine have been exposed in various news sources (to see Neuberg et al.,”Exploring the Pfizer/BioNTech and Moderna COVID-19 Vaccine Supply Chain“; Weiss et al.,”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) and in the scientific literature (to see Low,”Vaccine Manufacturing Myths“, Scientific Translational Medicine, February 2021). But these are certainly not disclosed in the detail necessary for commercial production, and the intricacies of production are illustrated in the graphics of the Times article, in which DNA is prepared in Chesterfield, MO and shipped to Andover, MA for mRNA production; then the mRNA sent back to Chesterfield or Kalamazoo, MI to be packaged into the vaccine nanoparticles; then sent back to Andover for testing before release. While some of this complexity may be company-specific, it also represents the different technological requirements to prepare an effective vaccine.
It is obvious that, in the relative lack of patents involved in the preparation of COVID vaccines to date, the disclosures necessary to reproduce these vaccines (as difficult as this may be in practice) are not protected by patents (a few notable exceptions that have raised the specter of patent infringement litigation against major U.S. vaccine makers). Much of the “know-how” needed to implement actual vaccine production involves trade secrets, many of which are not limited to COVID-19 vaccines (for example, the production of the lipid nanoparticles in which Pfizer mRNA vaccines and Moderna are encapsulated). 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. Either action would constitute a “taking” under the Fifth Amendment (“Nor shall private property be taken for public use, without just compensation”); to see Epstein et al.,”The Fifth Amendment Levy Clause“, Interactive constitution: common interpretation. Seemingly simple and straightforward, nearly every word of the clause is subject to interpretation, none perhaps so much as determining what “fair compensation” entails. It is likely that, if the government were to act peremptorily with respect to trade secret seizures justified by a WTO waiver clause, the effect on trade secrets rather than patent waivers would result in the greatest consequences and will generate the most controversy. Indeed, the resulting outlook is probably among the biggest hurdles to enforcing any waivers in a way that might have a chance of achieving the stated goal of facilitating COVID vaccine production.
These barriers typically relate to global inequalities in access to medicines, including vaccines. The negative consequences of inequalities between the developed world and all others on global public health and the intellectual property regime are not only appreciated today (to see, for example.,”A modest proposal for drug pricing in developing countries“; “The Law of Unintended Consequences Appears in the Application of the TRIPS Agreement to the Protection of Patented Medicines in Developing Countries“; “Africa (still) depends on the kindness of foreigners in the pricing of AIDS drugs“; and “Global drug pricing scheme in chaos“) but like many issues, the COVID-19 pandemic has raised the temperature of the debate. And the fact is that most countries in favor of the waiver (with the possible exception of India and South Africa) have the technological infrastructure to So, in the short term, the waiver can be expected to do little to solve the real world vaccination problem (or at least the part that is not convinced that the vaccine is useless, harmful or an infringement on their freedoms) Some small steps have been taken to solve the distribution problem; for example, Pfizer and BioNTech have agreed to work with the Biovac Institute in South Africa to locally produce their mRNA vaccine (see “Is this the end of the WTO waiver game? Pfizer and BioNTech agree vaccine technology transfer with South Africa’s Biovac InstituteThere have been efforts to export doses from ‘have’ countries to ‘have-not’ countries (see for exampleEvent et al., 2021, “The COVID-19 Vaccine Production Club: Will Value Chains Temper Nationalism?”, World Bank Policy Research Working Paper 9565, 2021). But perhaps more productive pathways to these solutions would better focus on 1) open and resilient global supply chains; 2) further cooperation between industry players to speed up production; 3) strengthening vaccine financing and sharing for middle- and low-income countries; and 4) regulatory approval of new vaccines. The motivations for such efforts should not (and do not rely) exclusively on altruism. As has become apparent, the virus has the ability to mutate so that variants can emerge with unknown resistance to current vaccines. Vaccines, especially mRNA-based vaccines, may not be effective against these variants and therefore it is in everyone’s interest to expand vaccination globally (regardless of the size of this challenge) in order to reduce the probability of occurrence of such variants.
Global efforts to develop vaccines, treatments, and better tests and technologies in response to COVID-19 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-19 vaccines, therapies and technologies has had and could continue to have a positive impact and advance the cause of COVID-19. eradication, or at least 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.