What is the purpose of patent term extension under 35 U.S.C. 156?
The purpose of patent term extension under 35 U.S.C. 156 is to compensate patent owners for time lost during the premarket regulatory review process. As stated in the MPEP: “The statute enables the owners of patents on certain human drugs, food or color additives, medical devices, animal drugs, and veterinary biological products to restore to…
Read MoreHow does the Hatch-Waxman Act affect patent infringement related to regulatory approval?
The Hatch-Waxman Act, codified in part as 35 U.S.C. 271(e), provides a safe harbor for certain activities that would otherwise be considered patent infringement. According to the MPEP: “Congress legislatively overruled Roche Products v. Bolar Pharmaceuticals, 733 F.2d 858, 221 USPQ 937 (Fed. Cir. 1984) as to products covered by 35 U.S.C. 271(e) and provided…
Read MoreHow can I request a patent term extension under the Hatch-Waxman Act?
Patent term extensions under the Hatch-Waxman Act are available for certain patents related to drug products, medical devices, and food additives. According to MPEP 1002.02(b), these requests are handled by the Deputy Commissioner who oversees the Office of Petitions or assigned staff: Applications relating to Hatch-Waxman patent term extension, 37 CFR 1.710 – 1.791 and…
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