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 ...
JD Supra

FDA Clarifies ANDA Active Ingredient Sameness Evaluation In Draft Guidance

On November 8, 2022, FDA issued a draft guidance document on Sameness Evaluations in an ANDA — Active Ingredients (“Draft Guidance”). In the Draft Guidance, FDA indicated that the active ingredient’s ...