Patent No. 7,895,059B2
July 28, 2015
Brief Summary: Par’s petition for IPR U.S. Pat. No. 7,895,059 relating to Jazz’s Xyrem® granted, the PTAB finding reasonable likelihood Par would prevail on the basis of obviousness. FDA Advisory Committee records found to have been publicly available based on records obtained from the “Internet Archive: Wayback Machine.
Summary: Par requested IPR of U.S. Pat. No. 7,895,059, an Orange Book (OB) patent for Jazz’s Xyrem® (sodium oxybate, a form of gamma hydroxybutyrate (GHB) for treating narcolepsy) on the basis of two different obviousness arguments. The decision explains that the ‘059 patent relates to “a method for controlling access to a sensitive prescription drug prone to potential abuse or diversion, by utilizing a central pharmacy and database to track all prescriptions for the sensitive drug.” Litigation including this patent has been ongoing with Par and other pharmaceutical entities. IPR Petitions for four other OB patents and covered business method (CBM) Petitions were also identified as related. The decision notes the CBM petitions have all been denied. It also notes that IPR2015-01018 has been filed by another party regarding the ‘059 patent. The decision first reviewed Jazz’s argument that the Petition should be dismissed because the real party-in-interest was not identified because Par’s parent companies exercise control over the Petitioner and therefore should have been named, but the PTAB was not convinced (see pp. 12-17). Claim construction was reviewed under the “broadest reasonable interpretation” standard (In re Cuozzo, FC July 8, 2015) without much controversy. Jazz also unsuccessfully argued the Petition should be denied because the prior art and arguments here “are the same or substantially the same as those considered in previous CBM petitions relating to the ‘059 patent and other patents in the same family.” The PTAB was not convinced because those decisions simply found the ‘059 patent was not qualified as a CBM patent. The public availability of records relating to an FDA Advisory Committee meeting (“Advisory Committee Art” or “ACA”) was debated (“The key inquiry is whether a reference was made ‘sufficiently accessible to the public interested in the art’ before the critical date….” (In re Cronyn, FC 1989; In re Lister, FC 2009; Bruckelmeyer, FC 2006)). The PTAB concluded the records were publicly available, based in part on evidence from the “Internet Archive: Wayback Machine” indicating availability on the web more than one year before the earliest claimed ‘059 priority date. Par argued claims 1-16 of the ‘059 patent would have been obvious over the ACA and the PTAB was persuaded, finding a “reasonable likelihood that it would prevail”. Persuasive evidence included expert testimony found not to be simply conclusory (“Dr. Valuck describes where each aspect of the claim limitation is found in the ACA.”) and that a person of ordinary skill would have understood “the Xyrem® closed distribution system disclosed in the ACA…to be computerized”. Par’s argument that the claims would have been obvious over four other references were not persuasive, however, because, e.g., “[t]he evidence of record does not support Petitioner’s statement that ‘Honigfled teaches using a single computer database to receive prescriptions and distribute prescription drugs….’ Honigfeld’s centralized computer database is controlled by the drug manufacturer, not a pharmacy.”