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Merck KGaA V. Integra Lifesciences I, Ltd.
''Merck KGaA v. Integra Lifesciences I, Ltd.'', 545 U.S. 193 (2005), is a United States Supreme Court case with ramifications for patent law. The dispute dates to approximately 1996 and centers on a federal law known as the " FDA safe harbor" (§ 271(e)(1)). While the Court refused to "quibble" with the Court of Appeals over its conclusion that the exemption “does not globally embrace all experimental activity that at some point, however attenuated, may lead to an FDA approval process,” the Court held that: :Basic scientific research on a particular compound, performed without the intent to develop a particular drug or a reasonable belief that the compound will cause the sort of physiological effect the researcher intends to induce, is surely not “reasonably related to the development and submission of information” to the FDA. It does not follow from this, however, that §271(e)(1)’s exemption from infringement categorically excludes either (1) experimentation on drugs tha ...
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Bloomberg BNA
Bloomberg Industry Group (formerly known as Bloomberg BNA, The Bureau of National Affairs, Inc., and BNA) is an affiliate of Bloomberg L.P. and a source of legal, tax, regulatory, and business information for professionals. It is headquartered in Arlington County, Virginia. The CEO of the company is Josh Eastright. The company was founded in 1929 by David Lawrence (publisher), David Lawrence and became employee-owned in 1947. When it was acquired by Bloomberg in September 2011, it was the oldest employee-owned company in the United States. History Early history (1929–2011) The Bureau of National Affairs, Inc. (BNA) was founded in 1929 by newsman David Lawrence as a subsidiary of ''United States Daily'', now known as the ''U.S. News & World Report''. BNA's first publication was U.S. Patent, Trademark & Copyright Reports (now United States Patent Quarterly). In 1946, Lawrence sold BNA to five of his top editors: Dean Dinwoodey, John D. Stewart, Ed Donnell, Adolph Magidson and ...
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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 U.S. federal court system. It has exclusive appellate jurisdiction over all U.S. federal cases involving patents, trademarks, 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 criminal, bankruptcy, immigration, or 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 Customs and Patent Appeals and the appellate division of the United States Court of Claims, making the judges of the former courts into circuit judges. The court occupies the Howard T. M ...
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Certiorari
In law, ''certiorari'' is a court process to seek judicial review of a decision of a lower court or government agency. ''Certiorari'' comes from the name of an English prerogative writ, issued by a superior court to direct that the record of the lower court be sent to the superior court for review. The term is Latin for "to be made certain", and comes from the opening line of such writs, which traditionally began with the Latin words "''Certiorari volumus''..." ("We wish to be made certain..."). Derived from the English common law, ''certiorari'' is prevalent in countries utilising, or influenced by, the common law''.'' It has evolved in the legal system of each nation, as court decisions and statutory amendments are made. In modern law, ''certiorari'' is recognized in many jurisdictions, including England and Wales (now called a "quashing order"), Canada, India, Ireland, the Philippines and the United States. With the expansion of administrative law in the 19th an ...
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United States Constitution
The Constitution of the United States is the supreme law of the United States of America. It superseded the Articles of Confederation, the nation's first constitution, in 1789. Originally comprising seven articles, it delineates the national frame of government. Its first three articles embody the doctrine of the separation of powers, whereby the federal government is divided into three branches: the legislative, consisting of the bicameral Congress ( Article I); the executive, consisting of the president and subordinate officers ( Article II); and the judicial, consisting of the Supreme Court and other federal courts ( Article III). Article IV, Article V, and Article VI embody concepts of federalism, describing the rights and responsibilities of state governments, the states in relationship to the federal government, and the shared process of constitutional amendment. Article VII establishes the procedure subsequently used by the 13 states to ratify it. It is ...
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Merck KGaA
The Merck Group, branded and commonly known as Merck, is a German multinational science and technology company headquartered in Darmstadt, with about 60,000 employees and present in 66 countries. The group includes around 250 companies; the main company is Merck KGaA in Germany. The company is divided into three business lines: Healthcare, Life Sciences and Electronics. Merck was founded in 1668 and is the world's oldest operating chemical and pharmaceutical company, as well as one of the largest pharmaceutical companies in the world. Merck operates in Europe, Africa, Asia, Oceania and the Americas. It has major research and development centres in Darmstadt, Boston, Tokyo and Beijing, as well as other Research and Development units in Taiwan, France, Israel, South Korea, India and in the UK. Merck pioneered the commercial manufacture of morphine in the 19th century and for a time held a virtual monopoly on cocaine. Merck was privately owned until going public on the Frank ...
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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 State ...
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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 sufficiency of disclosure, 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 ...
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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 exem ...
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United States Patent Law
Under United States law, a patent is a right granted to the inventor of a (1) process, machine, article of manufacture, or composition of matter, (2) that is new, useful, and non-obvious. A patent is the right to exclude others, for a limited time (usually, 20 years) from profiting of a patented technology without the consent of the patent-holder. Specifically, it is the right to exclude others from: making, using, selling, offering for sale, importing, inducing others to infringe, applying for an FDA approval, and/or offering a product specially adapted for practice of the patent. United States patent law is codified in Title 35 of the United States Code, and authorized by the U.S. Constitution, in Article One, section 8, clause 8, which states: Patent law is designed to encourage inventors to disclose their new technology to the world by offering the incentive of a limited-time monopoly on the technology. For U.S. utility patents, this limited-time term of pate ...
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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 n ...
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United States Biotechnology Case Law
United may refer to: Places * United, Pennsylvania, an unincorporated community * United, West Virginia, an unincorporated community Arts and entertainment Films * ''United'' (2003 film), a Norwegian film * ''United'' (2011 film), a BBC Two film Literature * ''United!'' (novel), a 1973 children's novel by Michael Hardcastle Music * United (band), Japanese thrash metal band formed in 1981 Albums * ''United'' (Commodores album), 1986 * ''United'' (Dream Evil album), 2006 * ''United'' (Marvin Gaye and Tammi Terrell album), 1967 * ''United'' (Marian Gold album), 1996 * ''United'' (Phoenix album), 2000 * ''United'' (Woody Shaw album), 1981 Songs * "United" (Judas Priest song), 1980 * "United" (Prince Ital Joe and Marky Mark song), 1994 * "United" (Robbie Williams song), 2000 * "United", a song by Danish duo Nik & Jay featuring Lisa Rowe Television * ''United'' (TV series), a 1990 BBC Two documentary series * ''United!'', a soap opera that aired on BBC One from 1965-1 ...
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United States Supreme Court Cases
This page serves as an index of lists of United States Supreme Court cases. The United States Supreme Court is the highest federal court of the United States. By Chief Justice Court historians and other legal scholars consider each Chief Justice of the United States who presides over the Supreme Court of the United States to be the head of an era of the Court. These lists are sorted chronologically by Chief Justice and include most major cases decided by the Court. * Jay, Rutledge, and Ellsworth Courts (October 19, 1789 – December 15, 1800) * Marshall Court (February 4, 1801 – July 6, 1835) * Taney Court (March 28, 1836 – October 12, 1864) * Chase Court (December 15, 1864 – May 7, 1873) * Waite Court (March 4, 1874 – March 23, 1888) * Fuller Court (October 8, 1888 – July 4, 1910) * White Court (December 19, 1910 – May 19, 1921) * Taft Court (July 11, 1921 – February 3, 1930) * Hughes Court (February 24, 1930 – Ju ...
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