The Patent Trials and Appeals Board issued a decision denying institution under of inter partes review for U.S. Patent No. 10,080,788 (the “’788 patent”). CSL Behring GmbH and CSL Behring LLC (“CSL”) filed a Petition requesting inter partes review of claims 1–30 on December 21, 2018, alleging obviousness of the challenged claims. In exercising its discretion to deny institution under 35 U.S.C. § 325(d), the Board concluded that the same or substantially the same prior art or arguments that CSL advanced in its Petition were already presented to—and rejected by—the Office.

Shire has asserted the ’788 patent and other related patents, including U.S. Patent 9,616,111 (the ’111 patent) (parent of the ’788 patent) against CSL in the following consolidated cases pending before the U.S. District Court for the District of Delaware: Shire ViroPharma Inc. v. CSL Behring LLC, Case Nos. 17-414 and 18-1476 (D. Del.). Haug Partners previously successfully defended CSL’s challenge of the ’111 patent against institution (IPR2017-01512).

The Board denied institution on the ’788 patent because the Patent Office had considered the same or substantially the same prior art and arguments on three separate occasions: first, during the prosecution of the ’111 patent; second, during CSL’s challenges in IPR2017-01512 concerning the ’111 patent; and third, during the prosecution of the application that issued as the ’788 patent. The Board noted that during prosecution of both the ’111 and ’788 patents, the Office also considered CSL’s third party observations from foreign proceedings addressing substantively identical issues.

Additionally, the Board dismissed the expert declaration evidence that CSL presented in an attempt establish obviousness. The Board concluded that CSL’s expert testimony did not demonstrate that (i) the Examiner made a clear factual error, or (ii) the applicant made a materially false or incomplete statement during prosecution in order to obtain allowance of the patent. Rather, the Board found that CSL’s experts “merely express[ed] a difference of opinion” as to the obviousness of the challenged claims.

The decision can be found here.