The Patent Trial and Appeal Board (PTAB) denied Pfizer, Inc.’s (“Petitioner”) petition to institute an inter partes review (IPR) of the sole claim of Biogen Inc.’s (“Patent Owner”) U.S. Patent 8,329,172 (the “’172 Patent”). That claim covers a method of treating B-cell lymphoma by using a certain chemotherapy followed by maintenance therapy with the drug Rituxan. The petition relied on three potential prior art references, including a document identified as IDEC Pharmaceuticals and Genentech, Inc.’s 1997 product label for Rituxan. Patent Owner argued that the record contained no evidence that the document identified as the product label was publicly available before the patent’s priority date.
Plaintiff FairWarning sued defendant Iatric Systems for infringement of U.S. Patent No. 8,578,500 (the “’500 patent”), titled “System and Method of Fraud and Misuse Detection”. The ’500 patent discloses ways to detect fraud and misuse by identifying unusual patterns in users’ access of sensitive data, including detecting fraud by an otherwise-authorized user of a patient’s protected health information (PHI). The claimed systems and methods record data of users’ access to PHI, analyze it against a rule and provide a notification if the analysis detects misuse. The district court granted defendant’s 12(b)(6) motion to dismiss and held that the claims of the ’500 patent were invalid for being directed to patent-ineligible subject matter. FairWarning appealed.