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Drug Price Competition and Patent Term Restoration Act; Long title: An Act to amend the Federal Food, Drug, and Cosmetic Act to revise the procedures for new drug applications, to amend title 35, United States Code, to authorize the extension of the patents for certain regulated products, and for other purposes.
In one study of the prescription drug market, Feldman found that 78% of new patents associated with prescription drugs were for existing drugs. [ 2 ] In 2002, the US Federal Trade Commission (FTC) found that generic drug manufacturers intending to manufacture new drugs were subjected to legal action by the owner of the original patent up to 75% ...
In order for a generic drug manufacturer to win approval of a drug under the Hatch-Waxman Act, the generic manufacturer must certify that they will not launch their generic until after the expiration of the Orange Book-listed patent, or that the patent is invalid, unenforceable, or that the generic product will not infringe the listed patent ...
Pharmaceutical companies layer on patents for drug delivery devices to maintain market exclusivity, according to a new study. How Drug Makers Manipulate Patents to Keep Insulin Prices High Skip to ...
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AstraZeneca owes Pfizer $107.5 million in damages, a Delaware federal jury said on Friday after finding that AstraZeneca's blockbuster lung cancer drug Tagrisso violated its Wyeth unit's patent ...
The original patent term under the 1790 Patent Act was decided individually for each patent, but "not exceeding fourteen years". The 1836 Patent Act (5 Stat. 117, 119, 5) provided (in addition to the fourteen-year term) an extension "for the term of seven years from and after the expiration of the first term" in certain circumstances, when the inventor hasn't got "a reasonable remuneration for ...
In the United States, for utility patents filed on or after June 8, 1995, the term of the patent is 20 years from the earliest filing date of the application on which the patent was granted and any prior U.S. or Patent Cooperation Treaty (PCT) applications from which the patent claims priority (excluding provisional applications). For patents ...