Coalition for Affordable Drugs II, LLC (Petitioner; “CA”) v. NPS Pharmaceuticals, Inc. (Patent Owner)

IPR2015-00990 and IPR2015-010193
U.S. Pat. No. 7,056,886B2
October 23, 2015

Brief Summary: CA’s two petitions to institute IPRs against NPS’ U.S. Pat. No. 7,056,886B2 relating to NPS/Shire’s drug Gattex granted based on allegations of obviousness.

Summary: CA filed two petitions to institute IPRs against NPS’ U.S. Pat. No. 7,056,886B2 relating to NPS/Shire’s drug Gattex (teduglutide [rDNA origin], glucagon-like peptide-2 (“GLP-2”)) “for the long-term treatment of adults with SBS who need parenteral support”. IPR ‘990 challenged claims 46-52 and 61-75 encompassing “GLP-2 peptide or an analog thereof” formulations, kits, and methods of treatment on obviousness grounds in view of four different combinations of prior art documents. IPR ‘193 challenged claims 1-45 encompassing “GLP-2 peptide or an analog thereof” formulations encompassing on obviousness grounds in view of four combinations of prior art documents. The Board determined CA established a reasonable likelihood of success in each petition by showing (not using the exact same arguments in each petition) the prior art disclosed therapeutically effective amounts of GLP-2 peptide analogs, glucagon formulations stabilized by histidine, freeze-drying of proteins using a stabilizer/bulking agent such as sucrose or mannitol, assays for identifying GLP-2 analogs, and packages/kits including GLP-2 or analogs thereof. Acknowleding the arguments regarding the similarities and differences between GLP-2 and other protein drugs, the Board found “that Petitioner has offered sufficient evidence to institute” IPR. And it was not persuaded by NPS’ arguments regarding secondary considerations (e.g., no nexus (“We cannot tell from the record before us if the asserted commercial success was due to the sale of a buffered formulation of GLP-2 generally, as compared to a buffered GLP-2 formulation comprising L-histidine and mannitol or sucrose, as recited in the challenged claims.”)) NPS also unsuccessfully argued that the petition was deficient under 35 USC § 312(a)(2) because all of the real parties in interest were not named (i.e., CA’s shareholders), and that “the Petition was filed for an improper purpose” (“not using…IPR…as an alternative to court proceedings, as Congress intended”). NPS also requested the Board to exercise its discretion under 35 U.S.C. § 325(d) to deny the petition because it relies upon prior art and arguments that are the same or substantially the same as considered during…prosecution” which was denied because the same combinations of art and arguments were not addressed during prosecution. Thus, the Board decided to institute both IPRs.

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