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Reverse Payment Patent Settlement
Reverse payment patent settlements, also known as "pay-for-delay" agreements, are a type of agreement that has been used to settle pharmaceutical patent infringement litigation (or threatened litigation), in which the company that has brought the suit agrees to pay the company it sued. That is, the patent holder pays the alleged infringer to stop its alleged infringing activity (e.g., to stop selling a generic version of a drug) for some period of time and to stop disputing the validity of the patent. These agreements are distinct from most patent settlements, which usually involve the alleged infringer paying the patent holder. Reverse payment patent settlements result from a peculiarity in US regulatory law arising from the Hatch-Waxman Act passed in 1984. The law encourages patent infringement litigation with incentives outside the patent system. Under the Act, the first generic company to successfully challenge the patents of the innovative company, and that has its Abbreviat ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Patent Infringement
A patent is a type of intellectual property that gives its owner the legal right to exclude others from making, using, or selling an invention for a limited period of time in exchange for publishing an enabling disclosure of the invention."A patent is not the grant of a right to make or use or sell. It does not, directly or indirectly, imply any such right. It grants only the right to exclude others. The supposition that a right to make is created by the patent grant is obviously inconsistent with the established distinctions between generic and specific patents, and with the well-known fact that a very considerable portion of the patents granted are in a field covered by a former relatively generic or basic patent, are tributary to such earlier patent, and cannot be practiced unless by license thereunder." – ''Herman v. Youngstown Car Mfg. Co.'', 191 F. 579, 584–85, 112 CCA 185 (6th Cir. 1911) In most countries, patent rights fall under private law and the patent holder mu ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Drug Price Competition And Patent Term Restoration Act
The Drug Price Competition and Patent Term Restoration Act (Public Law 98-417), informally known as the Hatch-Waxman Act, is a 1984 United States federal law that established the modern system of generic drug regulation in the United States. The Act's two main goals are to facilitate entry of generic drugs into the market and to compensate the original drug developers for regulatory delays by the Food and Drug Administration. It is generally believed that the Act accomplished both goals: encouraging development of new medications and accelerating market entry of generics. Representative Henry Waxman of California and Senator Orrin Hatch of Utah sponsored the act. Background Although the Federal Food, Drug, and Cosmetic Act made it possible for generic companies to get regulatory approval for drugs by filing an Abbreviated New Drug Application (ANDA), in the early 1980s it became clear that very few generics were coming to market. Congress studied the issue and realized t ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Abbreviated New Drug Application
An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug. The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, which provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public. Electronic submissions of ANDAs have grown by 70% since November 2008. The Section IV challenge has been credited with suppressing new drug innovation. A generic drug product is one that is comparable to a patented drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use. All approved products, both innovator and generic, are listed in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Generic drug applications are ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
United States Antitrust Law
In the United States, antitrust law is a collection of mostly federal laws that govern the conduct and organization of businesses in order to promote economic competition and prevent unjustified monopolies. The three main U.S. antitrust statutes are the Sherman Act of 1890, the Clayton Act of 1914, and the Federal Trade Commission Act of 1914. Section 1 of the Sherman Act prohibits price fixing and the operation of cartels, and prohibits other collusive practices that unreasonably restrain trade. Section 2 of the Sherman Act prohibits monopolization. Section 7 of the Clayton Act restricts the mergers and acquisitions of organizations that may substantially lessen competition or tend to create a monopoly. The Robinson–Patman Act, an amendment to the Clayton Act, prohibits price discrimination. Federal antitrust laws provide for both civil and criminal enforcement. Civil antitrust enforcement occurs through lawsuits filed by the Federal Trade Commission (FTC), the Antitrus ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Supreme Court Of The United States
The Supreme Court of the United States (SCOTUS) is the highest court in the federal judiciary of the United States. It has ultimate appellate jurisdiction over all Federal tribunals in the United States, U.S. federal court cases, and over State court (United States), state court cases that turn on questions of Constitution of the United States, U.S. constitutional or Law of the United States, federal law. It also has Original jurisdiction of the Supreme Court of the United States, original jurisdiction over a narrow range of cases, specifically "all Cases affecting Ambassadors, other public Ministers and Consuls, and those in which a State shall be Party." In 1803, the Court asserted itself the power of Judicial review in the United States, judicial review, the ability to invalidate a statute for violating a provision of the Constitution via the landmark case ''Marbury v. Madison''. It is also able to strike down presidential directives for violating either the Constitution or s ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Federal Trade Commission
The Federal Trade Commission (FTC) is an independent agency of the United States government whose principal mission is the enforcement of civil (non-criminal) United States antitrust law, antitrust law and the promotion of consumer protection. It shares jurisdiction over federal civil antitrust law enforcement with the United States Department of Justice Antitrust Division, Department of Justice Antitrust Division. The agency is headquartered in the Federal Trade Commission Building in Washington, DC. The FTC was established in 1914 by the Federal Trade Commission Act of 1914, Federal Trade Commission Act, which was passed in response to the 19th-century monopolistic trust crisis. Since its inception, the FTC has enforced the provisions of the Clayton Antitrust Act of 1914, Clayton Act, a key U.S. antitrust statute, as well as the provisions of the FTC Act, et seq. Over time, the FTC has been delegated with the enforcement of additional business regulation statutes and has promul ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
New York Times
''The New York Times'' (''NYT'') is an American daily newspaper based in New York City. ''The New York Times'' covers domestic, national, and international news, and publishes opinion pieces, investigative reports, and reviews. As one of the longest-running newspapers in the United States, the ''Times'' serves as one of the country's Newspaper of record, newspapers of record. , ''The New York Times'' had 9.13 million total and 8.83 million online subscribers, both by significant margins the List of newspapers in the United States, highest numbers for any newspaper in the United States; the total also included 296,330 print subscribers, making the ''Times'' the second-largest newspaper by print circulation in the United States, following ''The Wall Street Journal'', also based in New York City. ''The New York Times'' is published by the New York Times Company; since 1896, the company has been chaired by the Ochs-Sulzberger family, whose current chairman and the paper's publ ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Solvay S
Solvay may refer to: Companies and organizations * Solvay Brussels School of Economics and Management, Brussels, Belgium * Solvay Institute of Sociology, Brussels, Belgium, part of the Université Libre de Bruxelles * Solvay Process Company (1880–1985), a former U.S. company that employed the Solvay process * Solvay S.A., an international chemicals and plastics company founded by Ernest Solvay Places * Solvay, New York, a village in New York, United States * Mount Solvay, part of Belgica Mountains in Queen Maud Land, Antarctica * Solvay Mountains, Brabant Island, off the coast of Antarctica Buildings * Solvay Castle, La Hulpe, Belgium * Hôtel Solvay, a town house in Brussels, Belgium * Solvay Hut, a mountain hut on the Matterhorn, Switzerland People * Ernest Solvay (1838–1922), Belgian chemist, inventor of the Solvay process * Lucien Solvay (1851–1950), Belgian journalist, art historian, and poet * Paolo Solvay, pseudonym of Luigi Batzella (1924–2008), Italia ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
AndroGel
Testosterone is a medication and naturally occurring steroid hormone. It is used to treat male hypogonadism, gender dysphoria, and certain types of breast cancer. It may also be used to increase athletic ability in the form of doping. It is unclear if the use of testosterone for low levels due to aging is beneficial or harmful. Testosterone can be administered through several different routes, including topical gels or patches, nasal sprays, subdermal implants, or tablets dissolved inside the mouth. Testosterone therapy has been associated with improvements in depressive symptoms (especially in hypogonadal men), increased exercise capacity and muscle strength in men with chronic heart failure, and male contraception effectiveness. Common side effects of testosterone include acne, swelling, and breast enlargement in men. Serious side effects may include liver toxicity, heart disease, and behavioral changes. Women and children who are exposed may develop masculiniza ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Actavis
Actavis Generics (formerly known as Watson Pharmaceuticals and Actavis plc, prior to the acquisition of Irish-based Allergan, Inc.) is a global pharmaceutical company focused on acquiring, developing, manufacturing and marketing branded pharmaceuticals, generic drug, generic and over-the-counter medicines, and biologic medical product, biologic products. Actavis has a commercial presence across approximately 100 countries. The company has global headquarters in Dublin, Ireland and administrative headquarters in Parsippany-Troy Hills, New Jersey, United States. Actavis markets brand products through six franchises in key therapeutic categories including: Aesthetics/Dermatology/Plastic Surgery; Neurosciences/CNS; Eye Care; Women's Health and Urology; GI and Cystic Fibrosis; and Cardiovascular Disease and Infectious Disease. The company's products include Botox, Memantine, Namenda, Ciclosporin, Restasis, Linaclotide, Linzess, Nebivolol, Bystolic, Juvederm, Bimatoprost, Latisse, Lo Loe ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Teva Pharmaceutical Industries
Teva Pharmaceutical Industries Ltd. (also known as Teva Pharmaceuticals) is an Israeli multinational pharmaceutical company. Teva specializes primarily in generic drugs, but other business interests include branded-drugs, active pharmaceutical ingredients (APIs) and, to a lesser extent, contract manufacturing services and an out-licensing platform. Teva's primary branded products include Austedo ( deutetrabenazine) which is used for the treatment of chorea associated with Huntington's disease and tardive dyskinesia; and Ajovy ( fremanezumab), used for the preventive treatment of migraine in adults. Additional branded drugs sold by Teva include Copaxone, Bendeka and Treanda, all of which are primarily sold in the United States. Teva is listed on the Tel Aviv Stock Exchange and the New York Stock Exchange. Its manufacturing facilities are located in Israel, North America, Europe, Australia, and South America. The company is a member of the Pharmaceutical Research and Manufact ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Endo International
Endo International plc is an American Irish-domiciled generics and specialty branded pharmaceutical company that generated over 93% of its 2017 sales from the U.S. healthcare system. While Endo's management, operations, and customers are almost exclusively U.S.–based, in 2013 Endo executed a corporate tax inversion to Ireland to avoid U.S. corporate taxes on their U.S. drug sales, and to avail of Ireland's corporate tax system. Predecessors and History In 1920, Intravenous Products of America was incorporated as a privately owned pharmaceutical business operating in New York. By 1935 it had changed its name to Endo Products. The product line focused on medication for the treatment of pain (e.g. Percodan), a focus which continued during its acquisition by DuPont in 1969 (e.g. Percocet). Endo Pharmaceuticals Holdings was created as a result of a $277 million management buyout of the division from DuPont Merck in 1997, led by Carol Ammon. Through the merger with Algos, it c ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
