Ciprofloxacine is manufactured by Bayer and is used to treat anthrax. ## Compulsory licenses Compulsory licenses have been issued for Ciprofloxacine in the following instance: ### United States of America issued on October 01, 2001 [[United States of America]]'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 Ciprofloxacine in this case because: a price discount was issued. ### Canada issued on October 01, 2001 [[Canada]]'s provisions on compulsory licences can be in the Patent Act. There are several grounds for issuing a compulsory licence. Government Use (Section 19): - The Commissioner of Patents may authorize the Government of Canada or a provincial government to use a patented invention without the patentee's consent. This can occur when the government applies for such authorization, and the use is subject to terms considered expedient by the Commissioner. The patentee is entitled to remuneration deemed adequate by the Commissioner, considering the economic value of the authorization.   Abuse of Patent Rights (Section 65): - If the exclusive rights under a patent are deemed to be abused, an interested person can apply to the Commissioner for a compulsory license. Abuse may include situations where the demand for the patented article in Canada is not being met to an adequate extent and on reasonable terms, or if the trade or industry in Canada is being unfairly prejudiced. National Emergency or Extreme Urgency (Section 19.1(2)): - In cases of national emergency or extreme urgency, the requirement to seek authorization from the patentee on reasonable commercial terms may be waived. This allows the government to use the patented invention promptly to address the emergency. Public Non-Commercial Use (Section 19.1(2)): - The government may authorize the use of a patented invention for public non-commercial purposes without the patentee's prior consent. This includes uses that primarily benefit the public and are not of a commercial nature.   International Humanitarian Purposes (Sections 21.01 to 21.2): - Canada's Access to Medicines Regime (CAMR) allows for the issuance of compulsory licenses to manufacture and export patented pharmaceutical products to countries with public health problems, especially those lacking sufficient manufacturing capacity. This is in line with the World Trade Organization's decision on the implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health. More information can be found [here](https://laws-lois.justice.gc.ca/eng/acts/p-4/ ). However, a compulsory license has not been executed for Ciprofloxacine in this case because: a price discount was issued. ## Other products issued by the same manufacturer [[Ciprofloxacine]] [[Sorafenib Tosylate]] ## Other products for the same disease