<img src="https://publish-01.obsidian.md/access/744ac39d33cabbc297b91373bfcac24d/bin/images/USA_map.png" alt="United States of America" class="page-header-sidebar-image"> United States of America has provisions in its legislation relating to the granting of compulsory licences. These can be found in several statutes and legal mechanisms which allow for compulsory licensing under specific circumstances. 1. Government Use (28 U.S.C. § 1498): - Legislation: 28 U.S.C. § 1498 - Grounds: This statute permits the U.S. government or its contractors to use or manufacture any patented invention without the patent owner's consent. The patent owner's remedy is to seek ""reasonable and entire compensation"" through a lawsuit in the U.S. Court of Federal Claims. This provision is often viewed as a form of compulsory licensing, as it allows government use of patents without prior authorization from the patent holder. 2. Bayh-Dole Act (35 U.S.C. § 203) – March-In Rights: - Legislation: 35 U.S.C. § 203 - Grounds: The Bayh-Dole Act allows institutions, such as universities and small businesses, to retain ownership of inventions developed with federal funding. However, the government retains ""march-in rights,"" permitting it to grant licenses to other parties or take ownership of the patent if: - The patent owner has not taken effective steps to achieve practical application of the invention. - The invention is necessary to address health or safety needs that are not reasonably satisfied. - Public use requirements specified by federal regulations are not met. - The patent owner has not substantially manufactured the invention in the U.S. or has granted exclusive rights to another party without ensuring substantial U.S. manufacture. 3. Antitrust Enforcement: - Grounds: In cases where a patent holder engages in anti-competitive practices, U.S. courts may impose compulsory licensing as a remedy. For instance, if a patent is used to unlawfully restrain trade or maintain a monopoly, the court can require the patent holder to license the patent to others on reasonable terms. 4. Specialized Statutes: - Atomic Energy Act (42 U.S.C. § 2183): - Legislation: 42 U.S.C. § 2183 - Grounds: Allows for compulsory licensing of patents related to special nuclear material or atomic energy if the invention is of primary importance and licensing is necessary to effectuate the Act's policies. - Clean Air Act (42 U.S.C. § 7608): - Legislation: 42 U.S.C. § 7608 - Grounds: Permits compulsory licensing of patents for air pollution control devices if: - The invention is necessary to comply with air quality standards. - There are no reasonable alternatives. - The unavailability of the patent may result in a substantial lessening of competition or a tendency to create a monopoly. - Plant Variety Protection Act (7 U.S.C. § 2404): - Legislation: 7 U.S.C. § 2404 - Grounds: Allows for compulsory licensing of protected plant varieties if: - It's necessary to ensure an adequate supply of fiber, food, or feed in the U.S. - The owner is unable to meet public needs at a fair price." ## Compulsory licences United States of America has granted compulsory licence for: - [[Covid-19 vaccine (mRNA based)]] United States of America has been requested to issue a compulsory licence for [[Ciprofloxacine]] by the government. The compulsory licence has not been issued because a price discount was issued. United States of America has been requested to issue a compulsory licence for [[Naloxone]] by the government and civil Society. The compulsory licence has not been issued because the application is still pending. The state of Louisiana, in particular, has been requested to issue a compulsory licences for [[HCV medicines]] by State Health Secretary. The compulsory licence has not been issued because a subscription model for lowering price is being implemented instead.