What is the “covered date” for certain drug products in patent term extension applications?
The “covered date” is a specific term used in patent term extension applications for certain drug products. According to 35 U.S.C. 156(i)(2), the covered date is defined as the later of: The date an application is approved under specific sections of the Public Health Service Act or Federal Food, Drug, and Cosmetic Act The date…
Read MoreHow is the approval date determined for drug products under the Controlled Substances Act?
For drug products that the Secretary of Health and Human Services intends to recommend controls under the Controlled Substances Act, the approval date is determined differently. According to MPEP 2754.01: “Where the regulatory review is of a drug product for which the Secretary of Health and Human Services intends to recommend controls under the Controlled…
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