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The St. Regis Mohawk Tribe And Restasis Patent
Saint Regis Mohawk Tribe v. Mylan Pharms. Inc., 896 F.3d 1322 (Fed. Cir. 2018) is a United States Patent case, decided by the CAFC, deciding whether or not indigenous tribes' sovereign immunity extended to patent lawsuits. In September 2017, the American pharmaceutical company Allergan agreed to transfer six pharmaceutical patents for the ophthalmic form of the drug Restasis to the St. Regis tribe of the Mohawk people. At the time, the St. Regis tribe viewed this blockbuster deal as a new, viable supply of income outside of their primary source, the gambling industry. Following the deal, Allergan received an onslaught of criticism from outside companies and politicians such as Rep. Trey Gowdy, chairman of the Committee on Oversight and Government Reform, who said that the deal, "'impair competition across the pharmaceutical industry.'" Case details In 2017, Texas intellectual property lawyer Michael Shore claimed that the principle of sovereign immunity applied to Int ...
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Allergan Headquarters
Allergan plc is an American, Irish-domiciled pharmaceutical company that acquires, develops, manufactures and markets brand name drugs and medical devices in the areas of medical aesthetics, eye care, central nervous system, and gastroenterology. The company is the maker of Botox. Allergan plc was formed in March 2015 when Irish–registered Actavis plc acquired U.S.–registered Allergan, Inc., and assumed the Allergan name. In 2016, Allergan sold its generic business, Actavis, to Teva Pharmaceuticals for $40.5 billion. In June 2019, U.S. pharmaceutical company AbbVie announced it had reached an agreement to acquire Allergan for $63 billion. The merged company would be domiciled in the U.S. for tax purposes. History Allergan plc was created from the 2015 merger and Irish corporate tax inversion of two companies, Irish-based Actavis plc and U.S.-based Allergan, Inc. Allergan, Inc. In 1948, pharmacist Gavin S. Herbert founded Allergan Pharmaceuticals, Inc. In 1970, Allerg ...
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Legal Immunity
Legal immunity, or immunity from prosecution, is a legal status wherein an individual or entity cannot be held liable for a violation of the law, in order to facilitate societal aims that outweigh the value of imposing liability in such cases. Such legal immunity may be from criminal prosecution, or from civil liability (being subject of lawsuit), or both. The most notable forms of legal immunity are parliamentary immunity and witness immunity. One author has described legal immunity as "the obverse of a legal power":Dudley Knowles, Political Obligation: A Critical Introduction' (2009), p. 26. Criticism Legal immunities may be subject to criticism because they institute a separate standard of conduct for those who receive them. For example, as one author notes: Types Immunity of government leaders Many forms of immunity are granted to government leaders to rule over the world, continent, nation, province, urban area and rural area without fear of being sued or charged w ...
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Saint Regis Mohawk Tribe
St. Regis Mohawk Reservation is a Mohawk Indian reservation of the federally recognized tribe the St. Regis Mohawk Tribe, located in Franklin County, New York, United States. It is also known by its Mohawk name, Akwesasne. The population was 3,288 at the 2010 census. The reservation is adjacent to the Akwesasne reserve in Ontario and Quebec across the St. Lawrence River. The Mohawk consider the entire community to be one unit and have the right to travel freely across the international border. Location The reservation contains the community of St. Regis and borders the community of Hogansburg in the Town of Bombay. The Mohawk people dispute the Town of Bombay's claim to jurisdiction within the "Bombay Triangle", as these lands are part of the 1796 Treaty with the United States and have never been diminished by the US Congress. Under the terms of the Jay Treaty (1794), the Mohawk people may pass freely across the Canada–United States border. The two parts of the reser ...
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2018 In United States Case Law
Eighteen or 18 may refer to: * 18 (number), the natural number following 17 and preceding 19 * one of the years 18 BC, AD 18, 1918, 2018 Film, television and entertainment * ''18'' (film), a 1993 Taiwanese experimental film based on the short story ''God's Dice'' * ''Eighteen'' (film), a 2005 Canadian dramatic feature film * 18 (British Board of Film Classification), a film rating in the United Kingdom, also used in Ireland by the Irish Film Classification Office * 18 (''Dragon Ball''), a character in the ''Dragon Ball'' franchise * "Eighteen", a 2006 episode of the animated television series ''12 oz. Mouse'' Music Albums * ''18'' (Moby album), 2002 * ''18'' (Nana Kitade album), 2005 * '' 18...'', 2009 debut album by G.E.M. Songs * "18" (5 Seconds of Summer song), from their 2014 eponymous debut album * "18" (One Direction song), from their 2014 studio album ''Four'' * "18", by Anarbor from their 2013 studio album '' Burnout'' * "I'm Eighteen", by Alice Cooper commonly r ...
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United States Patent Case Law
This is a list of notable patent law cases in the United States in chronological order. The cases have been decided notably by the United States Supreme Court, the United States Court of Appeals for the Federal Circuit (CAFC) or the Board of Patent Appeals and Interferences (BPAI). While the Federal Circuit (CAFC) sits below the Supreme Court in the hierarchy of U.S. federal courts, patent cases only have the right of appeal to the Federal Circuit. The U.S. Supreme Court will only review cases on a discretionary basis and rarely decides patent cases. Unless overruled by a Supreme Court case, Federal Circuit decisions can dictate the results of both patent prosecution and litigation as they are universally binding on all United States district courts and the United States Patent and Trademark Office. Early cases (before 1900) *''Tyler v. Tuel'' - Supreme Court, 1810. Held that an assignee of a geographically limited patent right could not bring an action in the assignee's own nam ...
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Collateral Order Doctrine
An interlocutory appeal (or interim appeal), in the law of civil procedure in the United States, occurs when a ruling by a trial court is appealed while other aspects of the case are still proceeding. Interlocutory appeals are allowed only under specific circumstances, which are laid down by the federal and the separate state courts. United States An appeal is described as interlocutory when it is made before all claims are resolved as to all parties. For instance, if a lawsuit contains claims for breach of contract, fraud and interference with contractual advantage, and if there are three defendants in this lawsuit, then until all three claims are resolved as to all three defendants, any appeal by any party will be considered interlocutory. The American courts disfavor such appeals, requiring parties to wait until all the claims as to all parties are resolved before any appeal can be brought to challenge any of the decisions made by the judge during the life of the case. "Althou ...
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Hatch-Waxman 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 ...
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United States Patent And Trademark Office
The United States Patent and Trademark Office (USPTO) is an agency in the U.S. Department of Commerce that serves as the national patent office and trademark registration authority for the United States. The USPTO's headquarters are in Alexandria, Virginia, after a 2005 move from the Crystal City area of neighboring Arlington, Virginia. The USPTO is "unique among federal agencies because it operates solely on fees collected by its users, and not on taxpayer dollars". Its "operating structure is like a business in that it receives requests for services—applications for patents and trademark registrations—and charges fees projected to cover the cost of performing the services tprovide . The Office is headed by the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office, a position last held by Andrei Iancu until he left office on January 20, 2021. Commissioner of Patents Drew Hirshfeld is performing the funct ...
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Generic Drug
A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active chemical substance is the same, the medical profile of generics is equivalent in performance. A generic drug has the same active pharmaceutical ingredient (API) as the original, but it may differ in some characteristics such as the manufacturing process, formulation, excipients, color, taste, and packaging. Although they may not be associated with a particular company, generic drugs are usually subject to government regulations in the countries in which they are dispensed. They are labeled with the name of the manufacturer and a generic non-proprietary name such as the United States Adopted Name (USAN) or International Nonproprietary Name (INN) of the drug. A generic drug must contain the same active ingredients as the original brand-name ...
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Native Americans In The United States
Native Americans, also known as American Indians, First Americans, Indigenous Americans, and other terms, are the Indigenous peoples of the mainland United States ( Indigenous peoples of Hawaii, Alaska and territories of the United States are generally known by other terms). There are 574 federally recognized tribes living within the US, about half of which are associated with Indian reservations. As defined by the United States Census, "Native Americans" are Indigenous tribes that are originally from the contiguous United States, along with Alaska Natives. Indigenous peoples of the United States who are not listed as American Indian or Alaska Native include Native Hawaiians, Samoan Americans, and the Chamorro people. The US Census groups these peoples as " Native Hawaiian and other Pacific Islanders". European colonization of the Americas, which began in 1492, resulted in a precipitous decline in Native American population because of new diseases, wars, ethni ...
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Sovereignty
Sovereignty is the defining authority within individual consciousness, social construct, or territory. Sovereignty entails hierarchy within the state, as well as external autonomy for states. In any state, sovereignty is assigned to the person, body, or institution that has the ultimate authority over other people in order to establish a law or change an existing law. In political theory, sovereignty is a substantive term designating supreme legitimate authority over some polity. In international law, sovereignty is the exercise of power by a state. ''De jure'' sovereignty refers to the legal right to do so; ''de facto'' sovereignty refers to the factual ability to do so. This can become an issue of special concern upon the failure of the usual expectation that ''de jure'' and ''de facto'' sovereignty exist at the place and time of concern, and reside within the same organization. Etymology The term arises from the unattested Vulgar Latin's ''*superanus'', (itself derived ...
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United States Court Of Appeals For The Federal Circuit
The United States Court of Appeals for the Federal Circuit (in case citations, Fed. Cir. or C.A.F.C.) is a United States court of appeals that has special appellate jurisdiction over certain types of specialized cases in the Federal judiciary of the United States, U.S. federal court system. It has exclusive appellate jurisdiction over all U.S. federal cases involving patents, trademarks, government procurement, government contracts, veterans' benefits, public safety officers' benefits, federal employees' benefits, and various other categories. Unlike other federal courts, the Federal Circuit has no jurisdiction over cases involving Federal crime in the United States, criminal, Bankruptcy in the United States, bankruptcy, Immigration to the United States, immigration, or State law (United States), U.S. state law. Headquartered in Washington, D.C., the Federal Circuit was created in 1982 with passage of the Federal Courts Improvement Act, which merged the United States Court of Cus ...
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