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Evergreening
Evergreening is any of various legal, business, and technological strategies by which producers (often pharmaceutical companies) extend the lifetime of their patents that are about to expire in order to retain revenues from them. Often the practice includes taking out new patents (for example over associated delivery systems or new pharmaceutical mixtures), or by buying out or frustrating competitors, for longer periods of time than would normally be permissible under the law. Robin Feldman, a law professor at UC Hastings and a leading researcher in intellectual property and patents, defines evergreening as "artificially extending the life of a patent or other exclusivity by obtaining additional protections to extend the monopoly period." Overview Evergreening is not a formal concept of patent law; it is best understood as a social idea used to refer to the myriad ways in which pharmaceutical patent owners use the law and related regulatory processes to extend their high-earning ... [...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 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Apotex
Apotex Inc. is a Canadian pharmaceutical corporation. Founded in 1974 by Barry Sherman, the company is the largest producer of generic drugs in Canada, with annual sales exceeding . By 2016, Apotex employed over 10,000 people as one of Canada's largest drug manufacturers, with over 300 products selling in over 115 countries. Revenues were about CA$1.19 billion annually. Apotex manufactures and distributes generic medications for a range of diseases and health conditions that include cancer, diabetes, high cholesterol, glaucoma, infections and blood pressure. Apotex is a member of the Canadian Generic Pharmaceutical Association (CGPA), the Generic Pharmaceutical Association (GPhA), an associate member of the Canadian Animal Health Institute (CAHI), the Canadian Association for Pharmacy Distribution Management (CAPDM), as well as the Greater Toronto Area's Partners in Project Green. History Apotex began with limited staff in a 5,000-square-foot warehouse. When Barry Sherman star ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Risk Evaluation And Mitigation System
In simple terms, risk is the possibility of something bad happening. Risk involves uncertainty about the effects/implications of an activity with respect to something that humans value (such as health, well-being, wealth, property or the environment), often focusing on negative, undesirable consequences. Many different definitions have been proposed. The international standard definition of risk for common understanding in different applications is “effect of uncertainty on objectives”. The understanding of risk, the methods of assessment and management, the descriptions of risk and even the definitions of risk differ in different practice areas (business, economics, Environmental science, environment, finance, information technology, health, insurance, safety, security etc). This article provides links to more detailed articles on these areas. The international standard for risk management, ISO 31000, provides principles and generic guidelines on managing risks faced by organi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
CREATES Act
The CREATES Act of 2019 is a U.S. federal law which includes measures intended to reduce prices and increase the competitiveness of generic pharmaceutical drugs. Originally standalone legislation sponsored by Patrick Leahy in the Senate and David Cicilline in the House of Representatives, those bills were incorporated into the Further Consolidated Appropriations Act, 2020 which was signed into law on December 20, 2019. The bill had been drafted in some form since 2016. Measures in the bill are intended to prevent pharmaceutical companies from blocking companies from producing generic drugs by refusing to sell drugs to the new companies, or taking advantage of safety regulation to block new drugs. Generic drug companies would be allowed to sue to gain access to samples. The resulting impact of the bill would be a reduction in generic drug prices via increased market competition. The Congressional Budget Office estimated that the bill would save $3.8 billion over a 10-year period by ... [...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, sta ... [...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 of ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Office Of The US Trade Representative
The Office of the United States Trade Representative (USTR) is an agency of the Federal government of the United States, United States federal government responsible for developing and promoting Trade policy of the United States, American trade policy. Part of the Executive Office of the President of the United States, Executive Office of the President, it is headed by the U.S. Trade Representative, a Cabinet of the United States, Cabinet-level position that serves as the U.S. President's primary advisor, negotiator, and spokesperson on trade matters. USTR has more than two hundred employees, with offices in Geneva, Switzerland, and Brussels, Belgium. USTR was established as the Office of the Special Trade Representative (STR) by the Trade Expansion Act of 1962, leads trade negotiations at bilateral and multilateral levels, and coordinates trade policy with other government agencies through the Trade Policy Committee (TPC), Trade Policy Committee Review Group (TPCRG), and Trade ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Republic Of Korea-United States Free Trade Agreement
A republic () is a "state in which power rests with the people or their representatives; specifically a state without a monarchy" and also a "government, or system of government, of such a state." Previously, especially in the 17th and 18th centuries, the term was used to imply a state with a democratic or representative constitution (constitutional republic), but more recently it has also been used of autocratic or dictatorial states not ruled by a monarch. It is now chiefly used to denote any non-monarchical state headed by an elected or appointed president. , 159 of the world's 206 sovereign states use the word "republic" as part of their official names. Not all of these are republics in the sense of having elected governments, nor is the word "republic" used in the names of all states with elected governments. The word ''republic'' comes from the Latin term ''res publica'', which literally means "public thing", "public matter", or "public affair" and was used to refer ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Indian Supreme Court
The Supreme Court of India ( IAST: ) is the supreme judicial authority of India and is the highest court of the Republic of India under the constitution. It is the most senior constitutional court, has the final decision in all legal matters except for personal laws and interstate river disputes, and also has the power of judicial review. The Chief Justice of India is the Head and Chief Judge of the Supreme Court, which consists of a maximum of 34 judges, and has extensive powers in the form of original, appellate and advisory jurisdictions. New judges here are uniquely nominated by existing judges and other branches of government have neglible say as the court follows collegium system for appointments. As the apex and most powerful constitutional court in India, it takes up appeals primarily against verdicts of the High Courts of various states of the Union and other courts and tribunals. It is required to safeguard the fundamental rights of citizens and settles dispute ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Landmark Decision
Landmark court decisions, in present-day common law legal systems, establish precedents that determine a significant new legal principle or concept, or otherwise substantially affect the interpretation of existing law. "Leading case" is commonly used in the United Kingdom and other Commonwealth jurisdictions instead of "landmark case", as used in the United States. In Commonwealth countries, a reported decision is said to be a ''leading decision'' when it has come to be generally regarded as settling the law of the question involved. In 1914, Canadian jurist Augustus Henry Frazer Lefroy said "a 'leading case' sone that settles the law upon some important point". A leading decision may settle the law in more than one way. It may do so by: * Distinguishing a new principle that refines a prior principle, thus departing from prior practice without violating the rule of ''stare decisis''; * Establishing a "test" (that is, a measurable standard that can be applied by courts in fut ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Novartis V
Novartis AG is a Swiss-American multinational pharmaceutical corporation based in Basel, Switzerland and Cambridge, Massachusetts, United States (global research).name="novartis.com">https://www.novartis.com/research-development/research-locations It is one of the largest pharmaceutical companies in the world. Novartis manufactures the drugs clozapine (Clozaril), diclofenac (Voltaren; sold to GlaxoSmithKline in 2015 deal), carbamazepine (Tegretol), valsartan (Diovan), imatinib mesylate (Gleevec/Glivec), cyclosporine (Neoral/Sandimmune), letrozole (Femara), methylphenidate (Ritalin; production ceased 2020), terbinafine (Lamisil), deferasirox (Exjade), and others. In March 1996, the companies Ciba-Geigy and Sandoz merged to form Novartis; the pharmaceutical and agrochemical divisions of both companies formed Novartis as an independent entity. Other Ciba-Geigy and Sandoz businesses were sold, or, like Ciba Specialty Chemicals, spun off as independent companies. The Sandoz bran ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Indian Patent Office
The Office of the Controller General of Patents, Designs and Trade Marks (CGPDTM) generally known as the Indian Patent Office, is an agency under the Department for Promotion of Industry and Internal Trade which administers the Indian law of Patents, Designs and Trade Marks. History Foundation On 28 February 1856, the Government of India promulgated legislation to grant what was then termed as "exclusive privileges for the encouragement of inventions of new manufactures". On 3 March 1856, a civil engineer, George Alfred DePenning of 7, Grant's Lane, Calcutta petitioned the Government of India for grant of exclusive privileges for his invention — "An Efficient Punkah Pulling Machine". On 2 September, DePenning, submitted the Specifications for his invention along with drawings to illustrate its working. These were accepted and the invention was granted the first ever Intellectual Property protection in India. Amendments to the Patents Act & Rules Amendments (in 1999, 2002, 2 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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