Search results
Results from the WOW.Com Content Network
Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a publication produced by the United States Food and Drug Administration (FDA), as required by the Drug Price and Competition Act (Hatch-Waxman Act). The Hatch-Waxman Act was created to '"strike a balance between two competing policy interests ...
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 established the modern system of generic drug regulation in the United States. The Act's two main goals are to facilitate entry of generic drugs into the market and to compensate the ...
Orange-Book-Standard, issued in 2009 by the German Federal Court of Justice on the interaction between patent law and standards. Orange Book, a local area networking protocol based on the Cambridge Ring and one of the UK Coloured Book protocols. Handbook of Directives and Permitted Conventions for the English Bridge Union.
Fingolimod, sold under the brand name Gilenya, is an immunomodulating medication, used for the treatment of multiple sclerosis. [3] Fingolimod is a sphingosine-1-phosphate receptor modulator, which sequesters lymphocytes in lymph nodes, preventing them from contributing to an autoimmune reaction. It has been reported to reduce the rate of ...
Joseph Fuisz is an American attorney, inventor, and entrepreneur of Slovenian descent. He works predominantly in the pharmaceutical industry as the founder of Fuisz Pharma LLC. As of October 2015, he is named on 32 medical patents, [3] [4] and over forty patents. [5]
Orange-Book-Standard. Orange-Book-Standard (Az. KZR 39/06) is a decision issued on May 6, 2009 by the Federal Court of Justice of Germany ( German: Bundesgerichtshof, BGH) on the interaction between patent law and technical standards, and more generally between intellectual property law and competition law.
The Lens, formerly called Patent Lens, is a free searcheable online patent and scholarly literature database, provided by Cambia, an Australia -based non-profit organization. The Lens has been hailed as the “most comprehensive scholarly literature database, that exceeds in its width and depth two leading commercial databases ( Web of Science ...
In March 2012, the company filed a patent infringement lawsuit against three companies that had filed Abbreviated New Drug Applications with the US FDA, claiming infringement of Depomed's six US patents listed for Gralise in the FDA's Orange Book. In August 2018, Purdue Pharma paid
In 2006, McAndrews, Held & Malloy partner Aaron F. Barkoff, Ph.D., founded the "Orange Book Blog", which is a respected weblog reporting on new developments in pharmaceutical patent law and FDA law. Barkoff has extensive experience in Abbreviated New Drug Application litigation, from pre-filing investigations and strategy to dispositive motions ...
Reasonable and non-discriminatory ( RAND) terms, also known as fair, reasonable, and non-discriminatory ( FRAND) terms, denote a voluntary licensing commitment that standards organizations often request from the owner of an intellectual property right (usually a patent) that is, or may become, essential to practice a technical standard. [1]