IP Alerts

June 16, 2023

On May 9, in Sanofi-Aventis Deutschland GMBH v. Mylan Pharmaceuticals Inc., the Federal Circuit found that the Patent Trial and Appeals Board’s (PTAB) factual findings regarding analogousness with respect to a cited reference, U.S. Patent No. 4,144,957 (“de Gennes”), were not supported by substantial evidence. Thus, the Federal Circuit held that Mylan had not met its burden of showing unpatentability and reversed the PTAB’s determination that claims 1–18 of Sanofi’s U.S. Patent No. RE47,614 (“the ’614 patent”) were unpatentable as obvious.

For purposes of establishing obviousness under § 103, a party must show the cited references are analogous art to the claimed invention. References are considered analogous art if: (1) the reference is from the same field of endeavor as the claimed invention; or (2) the reference is reasonably pertinent to the problem with which the inventor was faced. MPEP 2141.01(a). Because de Gennes was in a different field of endeavor (clutch bearings in cars) than the ’614 patent (drug delivery or medical devices), Mylan had to show that the de Gennes was reasonably pertinent to the problem faced by the inventor of the ’614 patent. Instead, however, Mylan argued that de Gennes was reasonably pertinent to the problem faced by the inventor in Burren, a separate prior art reference. Because in Mylan’s view the inventors in Burren and in the ’614 patent faced the same problem—axially fixing and supporting two components relative to one another—it argued that this was a distinction without a difference and the evidence and arguments underlying the Board’s finding applied the same to either Burren or to the ’614 patent.

But, to the Federal Circuit, the distinction made all the difference. The court explained that mere conclusory statements that “the same analysis would have applied to other prior art” are insufficient for carrying a petitioner’s burden in establishing obviousness. As implied in the decision, the PTAB cannot “raise, address, and decide unpatentability theories never presented by the petitioner and not supported by the record evidence,” which is what the PTAB was doing here in transmuting Mylan’s argument of reasonable pertinence from Burren to the ’614 patent.

This decision serves as a cautionary reminder of the importance of properly addressing the relationship between prior art and the patent-at-issue when advancing invalidity arguments in post-grant proceedings, such as inter partes reviews. As the court pointed out, Mylan could have used its reply to explain how de Gennes was analogous to the ’614 patent. Instead, Mylan disputed that it needed to frame its arguments as to the ’614 patent and accused Sanofi of misunderstanding the law.

For more information on this holding, please contact Fitch Even associate Alvaro Cure Dominguez, author of this alert.


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