JD Supra

Federal Circuit Focuses On Active Ingredient, Not Active Moiety, For Scope Of Patent Term Extension

In Biogen International GmbH v. Banner Life Sciences LLC, the Federal Circuit construed language of the Hatch-Waxman patent term extension statute in a manner Biogen argued was inconsistent with the ...
PharmExec

Patent Term Extension: Challenges with Defining and Claiming Approved Biologics

Once the active ingredient is defined, an Applicant must select which patent, or patents, to put forward for extension. The statute permits only one PTE per regulatory review period, so the choice is ...
JD Supra

Congress Passes Legislation Codifying FDA’s “Active Moiety” Approach to Exclusivity Determinations

On April 23, 2021, President Biden signed into law the “Ensuring Innovation Act,” which modifies section 505 of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 355, by codifying the ...
Healio

‘Sunscreen doping’: Why companies ‘hack the system’ to hide active ingredients

The practice of “sunscreen doping” has emerged as a workaround to the FDA’s burdensome regulations for sunscreen ingredients, ...