What is the purpose of patent term extension under 35 U.S.C. 156?

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Source: FAQ (MPEP-Based) BlueIron Update: 2024-09-30 10 Rules 5 Related FAQs This page is an FAQ based on guidance from the Manual of Patent Examining Procedure. It is provided as guidance, with links to the ground truth sources. This is information only: it is not legal advice. 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 the terms of those patents some of the time lost while awaiting premarket government approval from a regulatory agency.” This provision aims to address two distortions in the normal patent term: Loss of patent term during early years due to inability to commercialize without regulatory approval Delayed market entry for competitors after patent expiration due to regulatory requirements Related Rules from the Manual of Patent Examining Procedure 10 rules Collapse Patent Term Extension for Delays at Other Agencies MPEP 2750 Patent Term Extension for Delays Due to Regulatory Review MPEP 2750 Patent Term Extension for Animal Drugs and Veterinary Biologics MPEP 2750 Permitted Extension for Delays in Regulatory Approval MPEP 2750 Required Patent Term Lost Due to Regulatory Review MPEP 2750 Prohibited Patent Term Extension for FDA Approval Activities MPEP 2750 Patent Owners Can Extend Patent Terms for Approved Products MPEP 2750 Biotechnology Manufactured Animal Drugs Excluded from PTE MPEP 2750 Patent Term Not Limited to Claims MPEP 2750 Patent Term Extension Only Applies to Active Ingredient of Approved Product MPEP 2750 Other Related FAQs 5 FAQs Collapse What types of products are eligible for patent term extension? How does the Hatch-Waxman Act affect patent infringement related to regulatory approval? What is the scope of rights during the extended patent ...