HCV medicines is manufactured by several companies and is used to treat HCV. ## Compulsory licenses A compulsory licence application is currently pending for HCV medicines in Chile. The application was submitted by civil society. A compulsory licence application is currently pending for HCV medicines in Romania. The application was submitted by civil society. Compulsory licenses have been issued for HCV medicines in the following instance: ### Chile issued on March 01, 2018 [[Chile]]'s provisions on compulsory licences can be in Law No. 19.039 on Industrial Property. Under Article 51, licenses may be granted where: - Anti-competitive behavior Patent holder found by the Competition Tribunal to violate free competition in connection with patent use. - Public health, national security, public use, emergencies When justified by these grounds and declared by the competent authority. - Dependent patents A later patent that cannot be worked without infringing an earlier one—only granted with special conditions. More information can be found [here](https://www.wipo.int/wipolex/en/legislation/details/21453). ### Romania issued on March 01, 2015 [[Romania]]'s provisions on compulsory licences can be in Arts. 43 to 47 of the Romanian Law No. 64/1991 on patents. According to Art. 43(1) PL, at the request of any interested person, the Bucharest Tribunal may grant a compulsory licence upon the expiry of a period of four years from the filing date of the patent application or a period of three years after the grant of the patent, whichever term expires later. More information can be found [here](https://e-courses.epo.org/wbts_int/CompulsoryLicensing/CL_RO.pdf). ### United States of America (Louisiana) issued on May 01, 2018 [[United States of America (Louisiana)]]'s provisions on compulsory licences can be in across 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. However, a compulsory license has not been executed for HCV medicines in this case because: a subscription model for lowering price is being implemented instead. ## Other products issued by the same manufacturer [[ARVs]] [[HCV medicines]] [[All medicines]] [[ARVs +]] [[Generics]] [[DDI, IDV, LPV/r]] [[IDV, LPV/r, NVP, TDF]] [[3TC, D4T, AZT, NVP, EFV, TDF, DDI, LPV/r, SQV, RTV, NFV, ABC]] [[3TC, 3TC/AZT, 3TC/AZT/NVP, 3TC/D4T, 3TC/D4T/NVP, DDI, EFV, IDV]] [[ABC, DDI, EFV, EFV/FTC/TDF, LPV/r, TDF, FTC/TDF]] [[DAAs]] ## Other products for the same disease [[Sofosbuvir]] [[DAAs]]