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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 ...
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.
"Wrongfully listed Orange Book patents by pharma companies can raise drug prices for Americans, harm fair competition, and delay better drugs," FTC Chair Lina Khan said on X, formerly known as ...
t. e. 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 ...
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]
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Patent infringement, the commission of a prohibited act with respect to a patented invention; Patent thicket, a negatively connotated term for an overlapping set of patent rights; Orange-Book-Standard, a German decision on the interaction between patent law and technical standards; Standardization, the process of creating technical standards
A 2021 analysis of the most valuable US pharmaceutical patents published in the Orange Book between 2000 and 2018 showed that ca. 25% of these patents end up litigated in courts, but only 26% of these litigated patents are invalidated, well below the overall patent invalidation rate of 43%. 94% of these invalidated patents are not the highly ...
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 ...
Mr. Justice Aftab Alam [1] Novartis v. Union of India & Others is a landmark decision by a two-judge bench of the Indian Supreme Court on the issue of whether Novartis could patent Gleevec in India, and was the culmination of a seven-year-long litigation fought by Novartis. The Supreme Court upheld the Indian patent office's rejection of the ...