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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
Patent infringement is the commission of a prohibited act with respect to a patented invention without permission from the patent holder. Permission may typically be granted in the form of a license. The definition of patent infringement may vary by jurisdiction, but it typically includes using or selling the patented invention. In many countries, a use is required to be ''commercial'' (or to have a ''commercial'' purpose) to constitute patent infringement. The scope of the patented invention or the extent of protection is defined in the claims of the granted patent. In other words, the terms of the claims inform the public of what is not allowed without the permission of the patent holder. Patents are territorial, and infringement is only possible in a country where a patent is in force. For example, if a patent is granted in the United States, then anyone in the United States is prohibited from making, using, selling or importing the patented item, while people in other co ... [...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 encourages the manufacture of generic drugs by the pharmaceutical industry and established the modern system of government generic drug regulation in the United States. 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 that under patent and regulatory law, it was easy for innovator companies to make it difficult for generic companies to successfully file ANDAs and that the regulatory pathway to get ANDAs approved was irregular and uncertain. In response, the Hatch-Waxma ... [...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 Food and Drug Administration, 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). ... [...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 regulate the conduct and organization of businesses to promote 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. These acts serve three major functions. First, Section 1 of the Sherman Act prohibits price fixing and the operation of cartels, and prohibits other collusive practices that unreasonably restrain trade. Second, Section 7 of the Clayton Act restricts the mergers and acquisitions of organizations that may substantially lessen competition or tend to create a monopoly. Third, Section 2 of the Sherman Act prohibits monopolization. Federal antitrust laws provide for both civil and criminal enforcement. Civil antitrust enforcement occurs through lawsuits filed by the Federal Trade Commission, the United States Department of Justice Antitrust Division, and private ... [...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 U.S. federal court cases, and over state court cases that involve a point of federal law. It also has 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." The court holds the power of judicial review, the ability to invalidate a statute for violating a provision of the Constitution. It is also able to strike down presidential directives for violating either the Constitution or statutory law. However, it may act only within the context of a case in an area of law over which it has jurisdiction. The court may decide cases having political overtones, but has ruled that it does not have power to decide non-justiciable political questions. Established by Article Three of the United States ... [...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) antitrust law and the promotion of consumer protection. The FTC shares jurisdiction over federal civil antitrust enforcement with the Department of Justice Antitrust Division. The agency is headquartered in the Federal Trade Commission Building in Washington, DC. The FTC was established in 1914 with the passage of the Federal Trade Commission Act, signed in response to the 19th-century monopolistic trust crisis. Since its inception, the FTC has enforced the provisions of the Clayton Act, a key 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 promulgated a number of regulations (codified in Title 16 of the Code of Federal Regulations). The broad statutory authority granted to the FTC provide ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
New York Times
''The New York Times'' (''the Times'', ''NYT'', or the Gray Lady) is a daily newspaper based in New York City with a worldwide readership reported in 2020 to comprise a declining 840,000 paid print subscribers, and a growing 6 million paid digital media, digital subscribers. It also is a producer of popular podcasts such as ''The Daily (podcast), The Daily''. Founded in 1851 by Henry Jarvis Raymond and George Jones (publisher), George Jones, it was initially published by Raymond, Jones & Company. The ''Times'' has won List of Pulitzer Prizes awarded to The New York Times, 132 Pulitzer Prizes, the most of any newspaper, and has long been regarded as a national "newspaper of record". For print it is ranked List of newspapers by circulation, 18th in the world by circulation and List of newspapers in the United States, 3rd in the U.S. The paper is owned by the New York Times Company, which is Public company, publicly traded. It has been governed by the Sulzberger family since 189 ... [...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 Conference, founded by Ernest Solvay, deals with open questions in physics and chemistry * Solvay Indupa, an Argentine petrochemical company formerly owned by Solvay * 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 Public Library, on the National Register of Historic Places * Solvay S.A., an international chemicals and plastics company founded by Ernest Solvay Places * Solvay Castle, La Hulpe, Belgium * Solvay Hut, on the Matterhorn * Hôtel Solvay, a town house in Brussels, Belgium * Solvay, New York, a village * Solvay Mountains, Brabant Island, off the coast of Antarctica People * Ernest Solvay (1838–1922), Belgian chemist, inventor of the Solvay process * Lucien Solvay (1851–1950), Belgian journal ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
AndroGel
Testosterone (T) 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 used as a gel or patch that is applied to the skin, injection into a muscle, tablet that is placed in the cheek, or tablet that is taken by mouth. 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 masculinization. It is recommended that individuals with prostate cancer not use the medication. It can cause harm to the baby if used during pregnancy or breastfeeding. Testosterone is in the androgen family of medications. Testosterone was first isolat ... [...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., 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 PLC 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, Bimatopros ... [...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 with headquarters in Tel Aviv, Israel. It specializes primarily in generic drugs, but other business interests include active pharmaceutical ingredients and, to a lesser extent, proprietary pharmaceuticals. Teva Pharmaceuticals was the largest generic drug manufacturer, when it was surpassed briefly by US-based Pfizer. Teva regained its market leader position once Pfizer spun off its generic drug division in a merger with Mylan, forming the new company Viatris at the end of 2020. Overall, Teva is the 18th largest pharmaceutical company in the world. Teva's facilities are located in Israel, North America, Europe, Australia, and South America. Teva shares are listed on the Tel Aviv Stock Exchange. The company is a member of the Pharmaceutical Research and Manufacturers of America (PhRMA). History Salomon, Levin, and Elstein Teva's earliest predecessor ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Patent Law
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 mus ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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