Takeaway: A reference that supports a finding that one skilled in the art “hopes” a certain result will be useful in treating a disorder does not constitute applicable prior art because a “hope” may or may not come to pass.

In its Decision, the Board declined to institute inter partes review because it found that Petitioner had failed to establish a likelihood of success as to any challenged claim. The Board then dismissed Patent Owner’s Motion for Additional Discovery, finding that with the case over, authorizing additional discovery at this time would be not be consistent with a speedy and inexpensive resolution of the matter.

Petitioner (Coalition for Affordable Drugs V LLC plus ten other entities) had sought inter partes review of every one of claims 1-20 of the ‘514 patent. Although the Petition referenced a single “Ground 1,” the Board treated this as three separate challenges, namely: (1) obviousness of claims 1-20 under 35 U.S.C. § 103(a) in view of Kappos and ICH Guideline; (2) obviousness of claims 1-20 under 35 U.S.C. § 103(a) in view of ClinicalTrials and ICH Guideline; and (3) obviousness of claims 1-20 under 35 U.S.C. § 103(a) in view of Prior Art Admissions and ICH Guideline. The 514 patent relates to a method of treating a subject in need of treatment for multiple sclerosis.

With respect to challenge (1), the Board found that the primary reference to Kappos concerned a pilot study. The Board identified multiple deficiencies associated with the pilot study of Kappos, ultimately finding that “Petitioner [had] failed to establish that Kappos teaches that DMF would be useful for treating MS[.]”

As for challenge (2), the Board assumed, but did not find, that ClinicalTrials was a prior art printed publication. Nonetheless, even under this assumption, the Board found ClinicalTrials to be “deficient as a prior art teaching of DMF being useful to treat MS for many of the same reasons that Kappos is deficient.”

Regarding challenge (3), the Board declined to address the issue of whether an “admission” per se can form the basis of an inter partes review challenge. Instead, the Board indicated that even if an “admission” could be relied upon for this purpose, the alleged “admission” in the instant proceeding fared no better than Kappos and ClinicalTrials.

Coalition for Affordable Drugs V LLC v. Biogen MA Inc., IPR2015-01136

Paper 23: Decision Denying Institution of Inter Partes Review

Dated: September 2, 2015

Patent: 8,399,514 B2

Before: Fred E. McKelvey, Sally Gardner Lane, and Deborah Katz

Written by: McKelvey

Related Proceedings: Biogen MA Inc. v. Forward Pharma AS, Interference 106,023 (PTAB Declared 13 Apr. 2015)