PTAB denies generic drug maker's cbm review

PTAB denied a petition for CBM review from a generic drug maker facing a Hatch-Waxman litigation on the grounds that the claims did not relate to a "financial product or service."  Par Pharm., Inc. v. Jazz Pharm., Inc., Nos. CBM2014-00149, -0150, -0151 and -0153 (PTAB Jan. 13, 2015). Jazz Pharmaceuticals owns patents relating to methods of controlling access to a prescription drug which is prone to being abused.  Par Pharma was sued by Jazz for infringement under Hatch-Waxman Act.  Because invalidity challenges under 35 USC 101 cannot be raised in an IPR review, Par Pharma filed petitions for CBM review arguing that the claimed methods in the patents would be used in commerce, are financial in nature and involve running the business of mail order pharmacy that ships directly to consumers.  Further, Par Pharma argued that PTO's classification of one of the patents as Class 705 (including "billing systems based on entered medical codes") and the examiner citing prior art billing systems during prosecution were grounds for CBM eligibility.  Rejecting the petitioner's arguments, PTAB concluded the following: (1) method steps of contacting the patient's insurance company and flagging that the patient paid cash are steps performed for purposes of preventing abuse of a prescription drug, and not for purposes of verifying payment for insurance coverage of the drug; and (2) the actual claim language is the key feature to be considered and that the claims did not recite method steps used in billing or payment.