“Plasma Concentration-Time Profile” as an Indefinite Claim Term: A Lesson from Forest Labs., Inc. v. Teva Pharm. USA, Inc.

Abstract

Forest Labs., Inc. v. Teva Pharm. USA, Inc., 716 F. App`x 987 (Fed. Cir. 2017), teaches that when “human pharmacokinetic study” is read into a claim, the specification should identify the experimental conditions for such human pharmacokinetic (PK) study in detail to prevent the claim from being held indefinite under 35 U.S.C. § 112. The description of such a human PK study should include a route of administration, dosage regimen, blood sampling technique, and characteristics of subjects, as required in the academic context. For those pending applications where the specification fails to provide a particular human PK study, a declaration made by the inventors may be submitted to clarify that.