Zoledronic acid – USA

PGR decision (Jun. 22, 2018):

AIA Review	Institution Date	Petitioner	Patent No.	Final Written Decision
PGR2017-00008	07/07/2017	Grunenthal GmbH	9,283,239	Claims 1–17 are unpatentable

This is a Final Written Decision in a post-grant review challenging the patentability of claims 1–17 of U.S. Patent No. 9,283,239 B2.

Petitioner contended that claims 1–17 are unpatentable for insufficient written description of the dosing regimen limitation “about 80 to about 500 mg of zoledronic acid within a period of six months” as recited in independent claim 1. Petitioner separately challenged claim 17 for lacking written description of an oral dosage form containing “at least 10% zoledronic acid.” PTAB held that the specification discloses the range of “about 50 mg to about 500 mg,” thereby giving literal support to this range and to the endpoint of “about 500 mg.” However, the ’239 patent specification does not clearly allow persons of ordinary skill in the art to recognize the “about 80 mg” endpoint as part of invention described in the ’239 patent. There is no disclosure of “about 80 mg” as a preferred endpoint, no disclosure of a specific embodiment including a dose of 80 mg, nor any other description suggesting the importance or criticality of the “about 80 mg” endpoint. Moreover, PTAB noted that the claims do not merely require administration of a dose of about 80 mg to about 500 mg of zoledronic acid, they also require that dose to be administered “within a six month period.”

Thus, PTAB concluded that Petitioner has shown by a preponderance of the evidence that claims 1–17 are unpatentable for a lack of written description.