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Supplementary Protection Certificate
In the European Economic Area (European Union member countries, Iceland, Liechtenstein and Norway), a supplementary protection certificate (SPC) is a ''sui generis'' intellectual property (IP) right that extends the duration of certain rights associated with a patent. It enters into force after expiry of a patent upon which it is based. This type of right is available for various regulated, biologically active agents, namely human or veterinary medicaments and plant protection products (e.g. insecticides, and herbicides). Supplementary protection certificates were introduced to encourage innovation by compensating for the long time needed to obtain regulatory approval of these products (i.e. authorisation to put these products on the market). A supplementary protection certificate comes into force only after the corresponding general patent expires. It normally has a maximum lifetime of 5 years. The duration of the SPC can, however, be extended to 5.5 years when the SPC relates ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Economic Area
The European Economic Area (EEA) was established via the ''Agreement on the European Economic Area'', an international agreement which enables the extension of the European Union's single market to member states of the European Free Trade Association (EFTA). The EEA links the EU member states and three of the four EFTA states (Iceland, Liechtenstein, and Norway) into an internal market governed by the same EU laws. These rules aim to enable free movement of persons, goods, services, and capital within the European single market, including the freedom to choose residence in any country within this area. The EEA was established on 1 January 1994 upon entry into force of the EEA Agreement. The contracting parties are the EU, its member states, and Iceland, Liechtenstein, and Norway. New members of EFTA would not automatically become party to the EEA Agreement, as each EFTA State decides on its own whether it applies to be party to the EEA Agreement or not. According to Article 1 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Switzerland
Switzerland, officially the Swiss Confederation, is a landlocked country located in west-central Europe. It is bordered by Italy to the south, France to the west, Germany to the north, and Austria and Liechtenstein to the east. Switzerland is geographically divided among the Swiss Plateau, the Swiss Alps, Alps and the Jura Mountains, Jura; the Alps occupy the greater part of the territory, whereas most of the country's Demographics of Switzerland, 9 million people are concentrated on the plateau, which hosts List of cities in Switzerland, its largest cities and economic centres, including Zurich, Geneva, and Lausanne. Switzerland is a federal republic composed of Cantons of Switzerland, 26 cantons, with federal authorities based in Bern. It has four main linguistic and cultural regions: German, French, Italian and Romansh language, Romansh. Although most Swiss are German-speaking, national identity is fairly cohesive, being rooted in a common historical background, shared ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
United Kingdom Patent Office
The Intellectual Property Office of the United Kingdom (often referred to as the UK IPO) is, since 2 April 2007, the operating name of The Patent Office. It is the official government body responsible for intellectual property rights in the UK and is an executive agency of the Department for Science, Innovation and Technology (DSIT). Responsibilities The IPO has direct administrative responsibility for examining and issuing or rejecting patents, and maintaining registers of intellectual property including patents, designs and trade marks in the UK. As in most countries, there is no statutory register of copyright and the IPO does not conduct any direct administration in copyright matters. The IPO is led by the Comptroller-General of Patents, Designs and Trade Marks, who is also Registrar of Trade Marks, Registrar of Designs and Chief Executive of the IPO: * ca. 1989-1999 Paul Hartnack * 1999–2003 Alison Brimelow (afterwards President of the European Patent Office) * 200 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Federation Of Pharmaceutical Industries And Associations
The European Federation of Pharmaceutical Industries and Associations (EFPIA) is a Brussels-based trade association and lobbying organisation, founded in 1978 and representing the pharmaceutical industry operating in Europe. Through its membership of 36 national associations and 39 leading pharmaceutical companies, the EFPIA represents 1,900 European companies. EFPIA priorities EFPIA priorities include speeding up regulatory approval and reimbursement processes for new medicines, creating a strong science base in Europe, joining forces with key stakeholders on political issues concerning health and addressing safety concerns. EFPIA also includes specialised groups like Vaccines Europe who produce approximately 80% of vaccines used worldwide and European Biopharmaceutical Enterprises harness biotechnology to develop approximately one-fifth of new medicines. Innovative Medicines Initiative The Innovative Medicines Initiative (IMI) is a public-private partnership designed by the Eur ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Orphan Drug
An orphan drug is a medication, pharmaceutical agent that is developed to treat certain rare medical conditions. An orphan drug would not be profitable to produce without government assistance, due to the small population of patients affected by the conditions. The conditions that orphan drugs are used to treat are referred to as orphan diseases. The assignment of orphan status to a disease and to drugs developed to treat it is a matter of public policy that depends on the legislation (if there is any) of the country. Designation of a drug as an orphan drug has yielded medical breakthroughs that might not otherwise have been achieved, due to the economics of drug medical research, research and development. Examples of this can be that in the U.S. and the EU, it is easier to gain marketing approval for an orphan drug. There may be other financial incentives, such as an extended period of exclusivity, during which the producer has sole rights to market the drug. All are intended to en ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Generic Pharmaceutical Price Decay
Generic pharmaceutical price decay is what happens (in the UK) once the originator brand has lost its Generic drug#Generic drug exclusivity in the US, patent exclusivity (patent expiry) and generic versions of the originator brand have been launched. The number of license holders entering the market is controlled by the ease of manufacture and the number of companies making the Active pharmaceutical ingredient, active pharmaceutical ingredient (API). For many easy-to-manufacture solid dose tablets and capsules the manufacturing is done in India and China as the costs of production in these countries is significantly lower than in the US or Europe. On day one of generic launch the first to market the generic product usually gets more market share than late entrants. Both manufacturers (who make their own generic products) and license only holders (who use other companies to do the manufacturing) may be represented. If only one company is able to release a generic product into th ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
German Federal Court Of Justice
The Federal Court of Justice ( , ) is the highest court of civil and criminal jurisdiction in Germany. Its primary responsibility is the final appellate review of decisions by lower courts for errors of law. While, legally, a decision by the Federal Court of Justice is only binding with respect to the individual case in which it enters, '' de facto'' the court's interpretation of the law is followed by lower courts with almost no exception. Decisions handed down by the Federal Court of Justice can only be vacated by the Federal Constitutional Court for violating a provision of the German constitution, the Basic Law. In addition to the court's appellate duties, a few judges of the Federal Court of Justice act as investigating judges in criminal investigations led by the Public Prosecutor General for a small number of exceptional offenses (such as crimes against humanity and the formation of terrorist organisations). As such, they are responsible for issuing search and arres ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Sitagliptin
Sitagliptin, sold under the brand name Januvia among others, is an anti-diabetic medication used to treat type 2 diabetes. It is in the dipeptidyl peptidase-4 (DPP-4) inhibitor class and works by increasing the production of insulin and decreasing the production of glucagon by the pancreas. In the United Kingdom it is listed as less preferred than metformin or a sulfonylurea. It is taken by mouth. It is also available in the fixed-dose combination medication sitagliptin/metformin (Janumet, Janumet XR). Common side effects include headaches, swelling of the legs, and upper respiratory tract infections. Serious side effects may include angioedema, low blood sugar, kidney problems, pancreatitis, and joint pain. Whether use in pregnancy or breastfeeding is safe is unclear. Sitagliptin was developed by Merck & Co. and approved for medical use in the United States in 2006. In 2022, it was the 86th most commonly prescribed medication in the United States, with more than 7 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
RAJ Pharma
''The Regulatory Affairs Journal Pharma (RAJ Pharma)'' is an English language international pharmaceutical information and analysis service published by Informa plc. First published as a monthly print magazine in 1992, it includes articles covering worldwide regulatory affairs within the pharmaceutical industry. The journal has now developed into an online global business intelligence and analysis service. It provides daily news and analysis of developments in regulation of the pharmaceutical industry worldwide, including regulatory agencies and legislation, application requirements and guidelines, patents and intellectual property, research and development, international harmonisation, paediatric legislation, pharmacovigilance and pharmacoeconomics Pharmacoeconomics refers to the scientific discipline that compares the value of one pharmaceutical drug or drug therapy to another. It is a sub-discipline of health economics. A pharmacoeconomic study evaluates the cost (expres ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Court Of Justice
The European Court of Justice (ECJ), officially the Court of Justice (), is the supreme court of the European Union in matters of European Union law. As a part of the Court of Justice of the European Union, it is tasked with interpreting EU law and ensuring its uniform application across all EU member states under Article 263 of the Treaty of the Functioning of the European Union (TFEU). The Court was established in 1952, and is based in Luxembourg. It is composed of one judge per Member State – currently – although it normally hears cases in panels of three, five or fifteen judges. The Court has been led by president Koen Lenaerts since 2015. The ECJ is the highest court of the European Union in matters of Union law, but not national law. It is not possible to appeal against the decisions of national courts in the ECJ, but rather national courts refer questions of EU law to the ECJ. However, it is ultimately for the national court to apply the resulting interpre ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Liechtenstein
Liechtenstein (, ; ; ), officially the Principality of Liechtenstein ( ), is a Landlocked country#Doubly landlocked, doubly landlocked Swiss Standard German, German-speaking microstate in the Central European Alps, between Austria in the east and north and Switzerland in the west and south. Liechtenstein is a semi-constitutional monarchy headed by the prince of Liechtenstein of the House of Liechtenstein, currently led by Hans-Adam II. It is List of European countries by area, Europe's fourth-smallest country, with an area of just over and a population of 40,023. It is the world's smallest country to border two countries, and is one of the few countries with no debt. Liechtenstein is divided into Municipalities of Liechtenstein, 11 municipalities. Its capital is Vaduz, and its largest municipality is Schaan. It is a member of the United Nations, the European Free Trade Association, and the Council of Europe. It is not a member state of the European Union, but it participates i ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Medicines Agency
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA).Set up by EC Regulation No. 2309/93 as the European Agency for the Evaluation of Medicinal Products, and renamed by EC Regulation No. 726/2004 to the European Medicines Agency, it had the acronym EMEA until December 2009. The European Medicines Agency does not call itself EMA either – it has no official acronym but may reconsider if EMA becomes commonly accepted (secommunication on new visual identity an). The EMA was set up in 1995, with funding from the European Union and the pharmaceutical industry, as well as indirect subsidy from member states, its stated intention to harmonise (but not replace) the work of existing national medicine regulatory bodies. The hope was that this plan would ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
