Prior Product Use Limits "Pharmaceutical Batches" Claims To Process Disclosed In Patent Example

The US Court of Appeals for the Federal Circuit concluded that claims directed to "pharmaceutical batches" must be produced in accordance with a particular patent example, upholding a finding of non-infringement as to one patent and reversing a finding of infringement as to another. The Medicines Co. v. Mylan, Inc., Case Nos. 15-1113; -1151; -1181 (Fed. Cir., Apr. 6, 2017) (Dyk, J).

Medicines has sold ANGIOMAX^®, which is used to prevent blood clotting in patients undergoing cardiac catheterization, since 2001—"well before the critical date of the patents in suit." The original manufacturing process for ANGIOMAX^® resulted in "variable and sometimes high levels" of the impurity recited in the claims (Asp9), so Medicines developed an improved production process that employs an "efficient mixing" method to consistently produce batches with less than 0.6 percent Asp9. This improved process is the subject of the patents in suit.