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Finally, the Orange Book lists patents that are purported to protect each drug. Patent listings and use codes are provided by the drug application owner, and the FDA is obliged to list them.
Many of the patents at issue in the Food and Drug Administration's Orange Book listing of approved products were for devices such as asthma inhalers and epinephrine autoinjectors, the FTC...
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.
When a company is ready to file its ANDA, the Act requires it to declare how its activities when it begins to market the drug will relate to patents listed in the Orange Book; there are four options, or "certifications": it can state that there never were patents listed, that listed patents have expired, that it will not market the drug until ...
Pharmaceutical companies layer on patents for drug delivery devices to maintain market exclusivity, according to a new study.
The negotiating process for FRAND licenses places requirements on the patent owner and the envisioned patentee. The terms for these negotiations were set in German case law in a case regarding the Orange-Book-Standard, and these terms are often used in licensing negotiations.
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