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

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.