What types of patents are eligible for patent term extension?
Patents eligible for extension under 35 U.S.C. 156 include those that: Claim a product as defined in 35 U.S.C. 156(f)(1) Claim a method of using such a product Claim a method of manufacturing such a product The product must be one of the following: A human drug product A medical device A food additive A…
Read MoreHow is the approval date determined for drug products in patent term extension applications?
For drug products, the approval date used in patent term extension applications is determined based on the Food and Drug Administration’s (FDA) communication. According to MPEP 2754.01: “For drug products the approval date is the date of a letter by the Food and Drug Administration indicating that the application has been approved, even if the…
Read MoreWhat 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 More