Ethicon Endo-Surgery, Inc. v. Covidien LP

Docket Nos. 2014-1771 (IPR2013-00209)

January 13, 2016

Update (6/22/16):  Petition for rehearing en banc denied (Judge Newman dissented arguing different panels should institute and decide on the merits).

Brief Summary: FC concluded same Board panel may both decide whether to institute IPR and render the final decision on the merits. It also affirmed Board decision of obviousness (no nexus between claims and commercial product, no evidence of long-felt and unmet need associated with the claims).

Summary: Ethicon appealed Board finding claims 1-14 of US 8,317,070 directed to a surgical stapling device obvious. Ethicon argued “the Board’s final decision is invalid because the same Board panel made both the decision to institute and the final decision” and that it erred in finding the claims obvious. The FC panel first determined that is has jurisdiction to hear the challenge to the Board’s authority since “[h]ere, Ethicon does not challenge the institution decision, but rather alleges a defect in the final decision” (35 USC § 314(d); In re Cuozzo, FC 2015 and Versata, FC 2015). Ethicon argued having the same panel make both decisions “raises ‘serious due process concerns’” since “there is a risk that the panel may prejudge a case before seeing a full record” (no “impartial decision maker”). The FC panel disagreed, citing e.g. Withrow (US 1975) in which a physician’s due process rights was found not to have been violated by a state medical board that both investigated and adjudicated the issue (this “does not raise constitutional concerns” and there is a “presumption of honesty and integrity”), finding the IPR procedure to be “directly analogous to a [DC] determining whether there is ‘a likelihood of success on the merits’ and then later deciding the merits of the case.” The FC panel also disagreed with Ethicon’s statutory arguments, noting “the longstanding rule that agency heads have implied authority to delegate to officials within the agency, even without explicity statutory authority and even when agency officials have other statutory duties.” Regarding obviousness, the opinion explained that “the purported inventive aspect of the ‘070 patent is the combination of” using “staples of different pre-formed and formed height (i.e., heights before and after stapling) and the use of staples with non-parallel legs” which were each separately “well-known in the prior art”. The opinion notes that “[t]he patent discloses no particular synergy resulting from the combination.” Ethicon argued the Board did not properly take into account the secondary considerations of non-obviousness.” The FC panel disagreed, however, finding no nexus between Covidien’s commercial success and the ‘070 claims (“the Covidien products contained numerous unclaimed features…which may instead have been responsible for the commercial success…”) and that Ethicon’s “evidence demonstrating a long-felt but unresolved need” only demonstrated “a long-felt need for staples of different heights (a feature in the prior art), not the combination of features that is the invention here.” Thus, the Board decision was affirmed. Judge Newman’s dissent argued the statutes (§ 314, § 316(c) and § 318) require the decision to institute and the decision on the merits must be made by the Director and the Board, respectively.

This entry was posted in America Invents Act, Inter Parties Review (IPR), IPR, Obviousness. Bookmark the permalink.

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