Since the COVID 19 Pandemic began, there has been a spirited debate over patent rights, including a highly publicized 20 month debate over a proposed WTO waiver on intellectual property rights. During that time a handful of countries have taken action to relax patent monopolies. In some cases, such as for Germany or Canada, statutes were amended to provide for new exceptions, and in a small number of other cases, compulsory licenses on patents were actually granted. There are also a number of pending compulsory licensing cases relating to COVID 19. (Medicines Law and Policy maintains a database of such actions here: http://tripsflexibilities.medicineslawandpolicy.org/)
KEI has concluded an initial review of COVID 19 related R&D or procurement contracts by the United States government. Many of these documents were obtained from FOIA requests and litigation with the U.S. Army and other federal agencies. We were able to identify relevant provisions in 62 contracts. Of these, 54 included the broadest authorization for non-voluntary use of patented inventions, and five included a more limited authorization. For people working in the topic of compulsory licensing of patents, this is an eye opening finding, and one that illustrates the degree to which the U.S. government is far more willing to waive exclusive rights in patents than any other country, despite frequent rhetoric to the contrary.
This document is best read from the PDF file found here:
KEI Briefing Note 2022:1, Selected U.S. Government COVID Contracts with Authorization and Consent to Non-Voluntary Use Of Third Party Patents, July 19, 2022
These are some quotes from the introduction to the briefing note:
A KEI review of contracts between the United States government and private companies to provide countermeasures for COVID 19 illustrates the simplicity of the legal mechanism used by the federal government to eliminate exclusive rights to use patented inventions for federal programs, and the surprising frequency that this was done for COVID 19 countermeasures.
Using the U.S. Freedom of Information Act, KEI obtained a number of research and development and procurement contracts related to COIVD 19, Many of the contracts contained significant redactions. For 62 contracts, KEI was able to identify language relating to the government authorization to use patented inventions without the permission of patent holders. Among the 62 contracts, 54 provide a broad authorization to use any U.S. patented invention. Five contracts authorize the use of any inventions that were not “commercially available to the public by the Recipient.” Another 3 contracts contained a clause stating that there was no consent, express or implied, for such authorization.
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The beneficiaries of the government use authorizations involving well known companies like Corning, Eli Lilly, Merck, Moderna, Novavax, Philips, Qiagen, Sanofi or Siemens, as well as many small companies and a few universities. The contracts were for COVID 19 countermeasures, including vaccines, drugs, diagnostic tests and other technologies.
In each of these cases, the authorization is broad, done without naming specific patents for which the non-voluntary use is authorized, applies to patents that may be granted at a later date, and does not require prior negotiation with patent holders. The U.S. government assumes responsibility for compensating patent owners, if any, who can demonstrate their inventors were used by the contractor.
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