Mayo Collaborative Services V. Prometheus Laboratories, Inc.
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Mayo Collaborative Services V. Prometheus Laboratories, Inc.
''Mayo v. Prometheus'', 566 U.S. 66 (2012), was a case decided by the Supreme Court of the United States that unanimously held that claims directed to a method of giving a drug to a patient, measuring metabolites of that drug, and with a known threshold for efficacy in mind, deciding whether to increase or decrease the dosage of the drug, were not patent-eligible subject matter.''Mayo Collaborative Servs. v. Prometheus Labs., Inc.'', . The decision was controversial, with proponents claiming it frees clinical pathologists to practice their medical discipline, and critics claiming that it destabilizes patent law and will stunt investment in the field of personalized medicine, preventing new products and services from emerging in that field.C&E News on SCOTUS Prometheus ruling: Patent Ruling Dismays Biotech' Parties to the case The case arose in a dispute between Mayo Collaborative Services and Prometheus Laboratories concerning a diagnostic test. Mayo Collaborative Services is ...
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Doing Business As
A trade name, trading name, or business name, is a pseudonym used by companies that do not operate under their registered company name. The term for this type of alternative name is a "fictitious" business name. Registering the fictitious name with a relevant government body is often required. In a number of countries, the phrase "trading as" (abbreviated to t/a) is used to designate a trade name. In the United States, the phrase "doing business as" (abbreviated to DBA, dba, d.b.a., or d/b/a) is used, among others, such as assumed business name or fictitious business name. In Canada, "operating as" (abbreviated to o/a) and "trading as" are used, although "doing business as" is also sometimes used. A company typically uses a trade name to conduct business using a simpler name rather than using their formal and often lengthier name. Trade names are also used when a preferred name cannot be registered, often because it may already be registered or is too similar to a name that is a ...
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Metabolism
Metabolism (, from el, μεταβολή ''metabolē'', "change") is the set of life-sustaining chemical reactions in organisms. The three main functions of metabolism are: the conversion of the energy in food to energy available to run cellular processes; the conversion of food to building blocks for proteins, lipids, nucleic acids, and some carbohydrates; and the elimination of metabolic wastes. These enzyme-catalyzed reactions allow organisms to grow and reproduce, maintain their structures, and respond to their environments. The word metabolism can also refer to the sum of all chemical reactions that occur in living organisms, including digestion and the transportation of substances into and between different cells, in which case the above described set of reactions within the cells is called intermediary (or intermediate) metabolism. Metabolic reactions may be categorized as ''catabolic'' – the ''breaking down'' of compounds (for example, of glucose to pyruvate by ce ...
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American Medical Association
The American Medical Association (AMA) is a professional association and lobbying group of physicians and medical students. Founded in 1847, it is headquartered in Chicago, Illinois. Membership was approximately 240,000 in 2016. The AMA's stated mission is "to promote the art and science of medicine and the betterment of public health." The Association also publishes the ''Journal of the American Medical Association'' (JAMA). The AMA also publishes a list of Physician Specialty Codes which are the standard method in the U.S. for identifying physician and practice specialties. The American Medical Association is governed by a House of Delegates as well as a board of trustees in addition to executive management. The organization maintains the AMA Code of Medical Ethics, and the AMA Physician Masterfile containing data on United States Physicians. The ''Current Procedural Terminology'' coding system was first published in 1966 and is maintained by the Association. It has also publi ...
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Biotechnology Industry Organization
The Biotechnology Innovation Organization (BIO) is the largest advocacy association in the world representing the biotechnology industry. It was founded in 1993 as the Biotechnology Industry Organization, and changed its name to the Biotechnology Innovation Organization on January 4, 2016. Biotechnology Innovation Organization serves more than 1,100 biotechnology firms, research schools, state biotechnology centers and related associations in the United States and in more than 30 other countries. Activities Annual Conference BIO holds its annual international conference each year in the United States. This conference provides networking, business development and partnering activities that are essential to the biotechnology industry, in which developing products take considerable time and resources and regulatory risks are high. In 2021, BIO shifted its in-person meetings to virtual, due to restrictions and difficulties arising from the COVID-19 pandemic. Lobbying In 2018, BIO s ...
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Inventive Step And Non-obviousness
The inventive step and non-obviousness reflect a general patentability requirement present in most patent laws, according to which an invention should be sufficiently inventive—i.e., non-obvious—in order to be patented. In other words, " henonobviousness principle asks whether the invention is an adequate distance beyond or above the state of the art". The expression "inventive step" is predominantly used in Europe, while the expression "non-obviousness" is predominantly used in United States patent law. The expression "inventiveness" is sometimes used as well. Although the basic principle is roughly the same, the assessment of the inventive step and non-obviousness varies from one country to another. For instance, the practice of the European Patent Office (EPO) differs from the practice in the United Kingdom. Rationale The purpose of the inventive step, or non-obviousness, requirement is to avoid granting patents for inventions which only follow from "normal product desi ...
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Biotechnology
Biotechnology is the integration of natural sciences and engineering sciences in order to achieve the application of organisms, cells, parts thereof and molecular analogues for products and services. The term ''biotechnology'' was first used by Károly Ereky in 1919, meaning the production of products from raw materials with the aid of living organisms. Definition The concept of biotechnology encompasses a wide range of procedures for modifying living organisms according to human purposes, going back to domestication of animals, cultivation of the plants, and "improvements" to these through breeding programs that employ artificial selection and hybridization. Modern usage also includes genetic engineering as well as cell and tissue culture technologies. The American Chemical Society defines biotechnology as the application of biological organisms, systems, or processes by various industries to learning about the science of life and the improvement of the value of materials ...
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Machine-or-transformation Test
In United States patent law, the machine-or-transformation test is a test of patent eligibility under which a claim to a process qualifies for consideration if it (1) is implemented by a particular machine in a non-conventional and non-trivial manner or (2) transforms an article from one state to another.Stefania Fusco "Is In re Bilski a Deja Vu?" ''2009 Stan. Tech. L. Rev.'' P1 The test was first articulated under its present form in the government's brief in ''Gottschalk v. Benson''. In its reply brief on the merits in that case, the government said, "we submit that the cases follow such a rule—implicitly or explicitly—and that they cannot be rationalized otherwise." The court declined to adopt the proposed rule as categorical and as an exclusive test. It opined that future cases might present fact patterns calling for a different rule from that applicable to past cases, and therefore the machine-or-transformation test was just a "clue" to eligibility for a patent. The ...
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GVR Order
A grant, vacate, remand order (GVR order) is a type of order issued by the Supreme Court of the United States in which the Court grants a petition for certiorari, vacates the decision of the court below, and remands the case for further proceedings (hence the acronym by which they are known). An order of this sort is typically appropriate when there has been a change in legal circumstances subsequent to the lower court or agency's decision, such as a change in the law, a precedential ruling, or a confession of error Confession of error is a legal practice whereby the Solicitor General of the United States in his or her role representing the federal government before the Supreme Court of the United States admits a lower court incorrectly decided a case and it i ...; the Supreme Court simply sends the case back to the lower court to be reconsidered in light of the new law or the new precedent. GVR orders are designed to be efficient and thus are not full explications of the law, and ...
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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 and 20th cen ...
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In Re Bilski
''In re Bilski'', 545 F.3d 943, 88 U.S.P.Q.2d 1385 (Fed. Cir. 2008), was an ''en banc'' decision of the United States Court of Appeals for the Federal Circuit (CAFC) on the patenting of method claims, particularly business methods. The Federal Circuit court affirmed the rejection of the patent claims involving a method of hedging risks in commodities trading. The court also reiterated the machine-or-transformation test as ''the'' (meaning ''sole'') applicable test for patent-eligible subject matter, and stated that the test in '' State Street Bank v. Signature Financial Group'' should no longer be relied upon. The Supreme Court of the United States issued an opinion on appeal (as '' Bilski v. Kappos'') that affirmed the judgment of the CAFC, but revised many aspects of the CAFC's decision. In its decision, handed down on June 28, 2010, the Supreme Court rejected the machine-or-transformation test as the sole test of process patent eligibility based on an interpretation of the ...
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Appeal
In law, an appeal is the process in which cases are reviewed by a higher authority, where parties request a formal change to an official decision. Appeals function both as a process for error correction as well as a process of clarifying and interpreting law. Although appellate courts have existed for thousands of years, common law countries did not incorporate an affirmative right to appeal into their jurisprudence until the 19th century. History Appellate courts and other systems of error correction have existed for many millennia. During the first dynasty of Babylon, Hammurabi and his governors served as the highest appellate courts of the land. Ancient Roman law recognized the right to appeal in the Valerian and Porcian laws since 509 BC. Later it employed a complex hierarchy of appellate courts, where some appeals would be heard by the emperor. Additionally, appellate courts have existed in Japan since at least the Kamakura Shogunate (1185–1333 CE). During this time, ...
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Patentable Subject Matter
Patentable, statutory or patent-eligible subject matter is subject matter which is susceptible of patent protection. The laws or patent practices of many countries provide that certain subject-matter is excluded from patentability, even if the invention is novel and non-obvious. Together with criteria such as novelty, inventive step or nonobviousness, utility, and industrial applicability, which differ from country to country, the question of whether a particular subject matter is patentable is one of the substantive requirements for patentability. Legislations The subject-matter which is regarded as patentable as a matter of policy, and correspondingly the subject-matter which is excluded from patentability as a matter of policy, depends on the national legislation or international treaty. Canada According to the Canadian Intellectual Property Office (CIPO) patents may only be granted for physical embodiments of an idea, or a process that results in something that is tangi ...
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