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The DrugPatentWatch website offers a "Free DrugPatentWatch Orange Book PDF Library" from which the public can download digital copies of every FDA Orange Book, from the 1st Edition in 1980 to the most recent (as of 2020).
The FTC says companies sometimes improperly list patents in the Orange Book that can delay market entry of lower priced generics. Teva and GSK said they were aware of the letters.
The Act also requires the drug innovator to give the FDA the numbers of patents it believes cover its drug; the FDA does not evaluate whether the patents cover the drug, but publicly lists them in the Orange Book, and these are the patents the life of which is extended if there are regulatory delays.
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.
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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.