A Pharmaceutical Formulation as a Claim Term Cannot “Target” a Plasma Concentration-Time Profile Under 35 U.S.C. § 112: A Lesson from Horizon Pharma,Inc. v. Dr. Reddy's Laboratories Inc.

Abstract

Pharmacokinetics (PK) data acquired during clinical trials can provide a way to claim a pharmaceutical compound, composition, or medical treatment. While reciting a PK profile is a common practice in claim drafting, the Federal Circuit in Horizon Pharma, Inc. v. Dr. Reddy's Laboratories Inc., 839 F. App'x 500 (Fed. Cir. 2021), has taught that a phrase starting with a dose form followed by a verb “target” may cause a claim to be indefinite under 35 U.S.C. § 112. A pharmaceutical formulation is inanimate and, therefore, cannot “target” something. However, “target” can still be used as a verb followed by a recited PK profile, as long as the use does not follow an inanimate claim term. Notably, “produce,” “provide,” and “achieve” are practical choices of verbs in terms of reciting a PK profile.