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Roche Products V. Bolar Pharmaceutical
''Roche Products, Inc. v. Bolar Pharmaceutical Co.'', 733 F.2d 858 (Fed. Cir. 1984), was a court case in the United States related to the manufacturing of generic pharmaceuticals. Bolar was a generic drug manufacturer. Roche was a brand-name pharmaceutical company which made and sold a sleep aid Dalmane, the active ingredient of which Flurazepam was protected by patent. Before patent expiration, Bolar used the patented chemical in experiments to determine if its generic product was bioequivalent to Dalmane in order to obtain FDA approval for its generic version of Dalmane. Bolar argued that its use of the patented product was not infringement under the experimental use exception to the patent law. The Court of Appeals for the Federal Circuit rejected Bolar’s contention holding that the experimental use exception did not apply because Bolar intended to sell its generic product in competition with Roche’s Dalmane after patent expiration and, therefore, Bolar’s experiments h ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
United States District Court For The Eastern District Of New York
The United States District Court for the Eastern District of New York (in case citations, E.D.N.Y.) is the federal district court whose territorial jurisdiction spans five counties in New York State: the four Long Island counties of Nassau, Suffolk, Kings (Brooklyn), and Queens, as well as Richmond (Staten Island), the latter three being among New York City's five boroughs. The court also has concurrent jurisdiction with the Southern District of New York over the waters of New York (Manhattan) and Bronx Counties (including New York Harbor and the East River). Its courthouses are located in Brooklyn and Central Islip. Appeals from the Eastern District of New York are taken to the United States Court of Appeals for the Second Circuit (except for patent claims and claims against the U.S. government under the Tucker Act, which are appealed to the Federal Circuit). The United States Attorney's Office for the Eastern District of New York represents the United States in civil and ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Howard Thomas Markey
Howard Thomas Markey (November 10, 1920 – May 3, 2006) was an American jurist who served as the first Chief United States circuit judge of the United States Court of Appeals for the Federal Circuit. He is often credited with establishing that court's renown and competence in intellectual property law. Early life, military and legal career Markey was born in Chicago, Illinois to Thomas Joseph and Vera Marie (Dryden) Markey. He served in the United States Army Air Forces during World War II as a test pilot, flying P-38s and P-59 jets in extreme cold-weather. He left the army in 1946 as a major, and became a lieutenant colonel in the United States Air Force Reserve. Markey subsequently earned his undergraduate degree and a Bachelor of Laws in an accelerated one-year program at Loyola University Chicago School of Law in 1949, and a Master of Laws in patent law in 1950 from John Marshall Law School in Chicago. He returned to active military service in the Korean War, in which he s ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Philip Nichols, Jr
Philip, also Phillip, is a male given name, derived from the Greek (''Philippos'', lit. "horse-loving" or "fond of horses"), from a compound of (''philos'', "dear", "loved", "loving") and (''hippos'', "horse"). Prominent Philips who popularized the name include kings of Macedonia and one of the apostles of early Christianity. ''Philip'' has many alternative spellings. One derivation often used as a surname is Phillips. It was also found during ancient Greek times with two Ps as Philippides and Philippos. It has many diminutive (or even hypocoristic) forms including Phil, Philly, Lip, Pip, Pep or Peps. There are also feminine forms such as Philippine and Philippa. Antiquity Kings of Macedon * Philip I of Macedon * Philip II of Macedon, father of Alexander the Great * Philip III of Macedon, half-brother of Alexander the Great * Philip IV of Macedon * Philip V of Macedon New Testament * Philip the Apostle * Philip the Evangelist Others * Philippus of Croton (c. 6th cent ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Shiro Kashiwa
Shiro Kashiwa (October 24, 1912 – March 13, 1998) was an American lawyer and judge who was the first Attorney General of Hawaii to be appointed after it became a state in 1959. He served as a judge of the United States Court of Claims, then as a United States circuit judge of the United States Court of Appeals for the Federal Circuit in Washington, D.C. from 1982 to 1986. He was the first federal judge of Japanese-American descent, the first Asian American judge on the Federal Circuit and was a member of the Jōdo Shinshū sect of Buddhism. Education and career Born in Kohala, Hawaii, Kashiwa received a Bachelor of Science degree from University of Michigan in 1935, and was a member of Phi Kappa Phi. He received a Juris Doctor from University of Michigan Law School in 1936. He was in private practice of law in Honolulu, Hawaii from 1937 to 1959. He was the first state attorney general of Hawaii, from 1959 to 1963. He was in private practice of law in Honolulu from 1963 to 19 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
United States
The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country primarily located in North America. It consists of 50 states, a federal district, five major unincorporated territories, nine Minor Outlying Islands, and 326 Indian reservations. The United States is also in free association with three Pacific Island sovereign states: the Federated States of Micronesia, the Marshall Islands, and the Republic of Palau. It is the world's third-largest country by both land and total area. It shares land borders with Canada to its north and with Mexico to its south and has maritime borders with the Bahamas, Cuba, Russia, and other nations. With a population of over 333 million, it is the most populous country in the Americas and the third most populous in the world. The national capital of the United States is Washington, D.C. and its most populous city and principal financial center is New York City. Paleo-Americ ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Flurazepam
Flurazepam (marketed under the brand names Dalmane and Dalmadorm) is a drug which is a benzodiazepine derivative. It possesses anxiolytic, anticonvulsant, hypnotic, sedative and skeletal muscle relaxant properties. It produces a metabolite with a long half-life, which may stay in the bloodstream for days. Flurazepam was patented in 1968 and came into medical use the same year. Flurazepam, developed by Roche Pharmaceuticals was one of the first benzo hypnotics (sleeping pills) to be marketed. Medical uses Flurazepam is officially indicated for mild to moderate insomnia and as such it is used for short-term treatment of patients with mild to moderate insomnia such as difficulty falling asleep, frequent awakening, early awakenings or a combination of each. Flurazepam is a long-acting benzodiazepine and is sometimes used in patients who have difficulty in maintaining sleep, though benzodiazepines with intermediate half-lives such as loprazolam, lormetazepam, and temazepam ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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] |
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] |
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 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
