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Research Exemption
In patent law, the research exemption or safe harbor exemption is an exemption to the rights conferred by patents, which is especially relevant to drugs. According to this exemption, despite the patent rights, performing research and tests for preparing regulatory approval, for instance by the FDA in the United States, does not constitute infringement for a limited term before the end of patent term. This exemption allows generic manufacturers to prepare generic drugs in advance of the patent expiration. In the United States, this exemption is also technically called § 271(e)(1) exemption or Hatch-Waxman exemption. In 2005, the U.S. Supreme Court considered the scope of the Hatch-Waxman exemption in '' Merck v. Integra''. The Supreme Court held that the statute exempts from infringement ''all'' uses of compounds that are reasonably related to submission of information to the government under any law regulating the manufacture, use or distribution of drugs. In Canada, this exempti ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Patent
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] |
Doctrine
Doctrine (from la, doctrina, meaning "teaching, instruction") is a codification of beliefs or a body of teachings or instructions, taught principles or positions, as the essence of teachings in a given branch of knowledge or in a belief system. The etymological Greek analogue is " catechism". Often the word ''doctrine'' specifically suggests a body of religious principles as promulgated by a church. ''Doctrine'' may also refer to a principle of law, in the common-law traditions, established through a history of past decisions. Religious usage Examples of religious doctrines include: * Christian theology: ** Doctrines such as the Trinity, the virgin birth and atonement ** The Salvation Army ''Handbook of Doctrine'' **Transubstantiation and Marian teachings in Roman Catholic theology. The department of the Roman Curia which deals with questions of doctrine is called the Congregation for the Doctrine of the Faith. ** The distinctive Calvinist doctrine of "double" predesti ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Agreement On Trade-Related Aspects Of Intellectual Property Rights
The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is an international legal agreement between all the member nations of the World Trade Organization (WTO). It establishes minimum standards for the regulation by national governments of different forms of intellectual property (IP) as applied to nationals of other WTO member nations. TRIPS was negotiated at the end of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT) between 1989 and 1990 and is administered by the WTO. The TRIPS agreement introduced intellectual property law into the multilateral trading system for the first time and remains the most comprehensive multilateral agreement on intellectual property to date. In 2001, developing countries, concerned that developed countries were insisting on an overly narrow reading of TRIPS, initiated a round of talks that resulted in the Doha Declaration. The Doha declaration is a WTO statement that clarifies the scope of TRIPS, stat ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
World Trade Organization
The World Trade Organization (WTO) is an intergovernmental organization that regulates and facilitates international trade. With effective cooperation in the United Nations System, governments use the organization to establish, revise, and enforce the rules that govern international trade. It officially commenced operations on 1 January 1995, pursuant to the 1994 Marrakesh Agreement, thus replacing the General Agreement on Tariffs and Trade (GATT) that had been established in 1948. The WTO is the world's largest international economic organization, with 164 member states representing over 98% of global trade and global GDP. The WTO facilitates trade in goods, services and intellectual property among participating countries by providing a framework for negotiating trade agreements, which usually aim to reduce or eliminate tariffs, quotas, and other restrictions; these agreements are signed by representatives of member governmentsUnderstanding the WTO' Handbook at WTO officia ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Case Law In The United States
The law of the United States comprises many levels of codified and uncodified forms of law, of which the most important is the nation's Constitution, which prescribes the foundation of the federal government of the United States, as well as various civil liberties. The Constitution sets out the boundaries of federal law, which consists of Acts of Congress, treaties ratified by the Senate, regulations promulgated by the executive branch, and case law originating from the federal judiciary. The United States Code is the official compilation and codification of general and permanent federal statutory law. Federal law and treaties, so long as they are in accordance with the Constitution, preempt conflicting state and territorial laws in the 50 U.S. states and in the territories. However, the scope of federal preemption is limited because the scope of federal power is not universal. In the dual sovereign system of American federalism (actually tripartite because of the pres ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Circuit Split
In United States federal courts, a circuit split occurs when two or more different circuit courts of appeals provide conflicting rulings on the same legal issue. The existence of a circuit split is one of the factors that the Supreme Court of the United States considers when deciding whether to grant review of a case.https://www.supremecourt.gov/ctrules/2013RulesoftheCourt.pdf Some scholars suggest that the Supreme Court is more likely to grant review of a case to resolve a circuit split than for any other reason. Despite the desire of the Supreme Court to resolve conflicts between circuit courts, legal scholars disagree about whether circuit splits are ultimately detrimental or beneficial. Some argue that circuit splits are harmful because they create confusion and encourage forum shopping, while other scholars argue that variation among circuits allows local courts to experiment with new laws that reflect the values of the local residents. Scholars have also observed that re ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
United States Supreme Court
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 C ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Merck KGaA V
Merck refers primarily to the German Merck family and three companies founded by the family, including: * the Merck Group, a German chemical, pharmaceutical and life sciences company founded in 1668 ** Merck Serono (known as EMD Serono in the United States and Canada), a pharmaceutical company headquartered in Darmstadt, Germany, and a brand and division of Merck focused on biopharmaceuticals * Merck & Co., Inc. (known as MSD (''Merck Sharp & Dohme'') outside North America), an American pharmaceutical company and a former subsidiary of the German Merck company, as founded in 1891/1917 * H. J. Merck & Co., a German bank founded in 1799 Merck may also refer to: People * Carl Merck (1809–1880), Syndicus (foreign affairs head) of the Free City of Hamburg * Ernst Merck (1811–1863), German businessman and politician *George W. Merck (1894–1957), American president of Merck & Co. * Heinrich Emanuel Merck (1794–1855), German apothecary whose descendants were the founders of Merc ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Duke University
Duke University is a private research university in Durham, North Carolina. Founded by Methodists and Quakers in the present-day city of Trinity in 1838, the school moved to Durham in 1892. In 1924, tobacco and electric power industrialist James Buchanan Duke established The Duke Endowment and the institution changed its name to honor his deceased father, Washington Duke. The campus spans over on three contiguous sub-campuses in Durham, and a marine lab in Beaufort. The West Campus—designed largely by architect Julian Abele, an African American architect who graduated first in his class at the University of Pennsylvania School of Design—incorporates Gothic architecture with the Duke Chapel at the campus' center and highest point of elevation, is adjacent to the Medical Center. East Campus, away, home to all first-years, contains Georgian-style architecture. The university administers two concurrent schools in Asia, Duke-NUS Medical School in Singapore (established in ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
University
A university () is an institution of higher (or tertiary) education and research which awards academic degrees in several academic disciplines. Universities typically offer both undergraduate and postgraduate programs. In the United States, the designation is reserved for colleges that have a graduate school. The word ''university'' is derived from the Latin ''universitas magistrorum et scholarium'', which roughly means "community of teachers and scholars". The first universities were created in Europe by Catholic Church monks. The University of Bologna (''Università di Bologna''), founded in 1088, is the first university in the sense of: *Being a high degree-awarding institute. *Having independence from the ecclesiastic schools, although conducted by both clergy and non-clergy. *Using the word ''universitas'' (which was coined at its foundation). *Issuing secular and non-secular degrees: grammar, rhetoric, logic, theology, canon law, notarial law.Hunt Janin: "The university ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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