U.S. Pat. No. 7,829,595 B2
April 13, 2016
Brief Summary: Complex Innovations (CI) requested IPR of claims 1-25 of Amgen’s US 7,829,595B2 relating to secondary hyperparathyroidism (cinacalcet (Sensipar®)) denied.
Summary: Complex Innovations (CI) requested IPR of claims 1-25 of Amgen’s US 7,829,595B2 relating to secondary hyperparathyroidism (cinacalcet (Sensipar®)). The ‘595 patent claims “[a] pharmaceutical composition comprising” about 10-40% cinacalcet, about 40-75% microcrystalline cellulose, about 1-5% povidone, about 5-35% starch, about 1-10% crospovidone, about 0.05-1.5% colloidal silicon dioxide, and about 0.05-1.5% magnesium stearate. CI argued the ‘595 claims would have been obvious in view of US 6,211,244 B1 (Van Wagenen), the Handbook of Pharmaceutical Excipients (HPE) and the “general knowledge of a person of ordinary skill in the art”. The PTAB found none of the claim terms needed to be construed. Regarding obviousness, the decision explained “a patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art” (KSR) and “there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness” (In re Kahn). CI argued Van Wagenen disclosed cinacalcet but “points to the ‘595 patent, not Van Wagenen itself, to support this contention” and through an expert that the percentage weight of API in a tablet is determined by routine experimentation. Amgen argued CI cannot rely on general knowledge in the art to fill deficiencies in the prior art. The PTAB found insufficient evidence of a reasonable likelihood of prevailing in their argument because “CI did not identify any disclosure in the prior art that an amount by weight of cinacalcet HCl within the claimed range should be used”, “relies exclusively on the Specification of the ‘595 patent to support a finding that Van Wagenen discloses cinacalcet”, CI’s expert “fail[ed] to articulate a reason why a skilled artisan would choose” the claimed amount and was otherwise unpersuasive, and did not establish a reason to combine the other components of the composition (no “articulated reasoning”).