Fresh From the Bench: Latest Precedential Patent Cases

CASE OF THE WEEK

Merck Serono S.A. v. Hopewell Pharma Ventures, Inc., Appeal Nos. 2025-1210, -1211 (Fed. Cir. Oct. 30, 2025)

In our Case of the Week, the Federal Circuit upheld a Patent Trial and Appeal Board decision invalidating claims on Merck’s multiple sclerosis drug Mavenclad®, an oral formulation of the compound cladribine.  This precedential opinion is one of two decisions issued last week affirming inter partes review findings on Merck’s claimed cladribine treatments in favor of challengers Hopewell and TWi Pharmaceuticals, Inc.  The Federal Circuit’s opinion in this case turned largely on whether the PTAB’s primary obviousness reference was prior art to Merck’s patents, as the reference pre-dated Merck’s application by less than one year, and Merck contended the disclosure relied on had been the work of at least some of its own inventors.

In affirming the PTAB’s finding that the reference was prior art, the Court examined and clarified its precedent concerning when prior disclosure of an invention is “by others” or “by another” under pre-AIA 35 U.S.C. §§ 102(a) and (e).  Ultimately, the Court reaffirmed the rule of In re Land, 368 F.2d 866 (CCPA 1966), that any difference in the “inventive entity” between the reference disclosure and the challenged claims—whether adding or subtracting inventors—rendered the reference a disclosure “by another” and therefore available as prior art.

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ALSO THIS WEEK

Aortic Innovations LLC v. Edwards Lifesciences Corp., Appeal No. 2024-1145 (Fed. Circ. Oct. 27, 2025)

The Federal Circuit reviewed a stipulated judgment of non-infringement following claim construction in a District of Delaware infringement case concerning devices for transcatheter aortic valve replacements. The Court affirmed the district court’s constructions and its judgment as to three of the asserted patents.  Judgment as to a fourth was dismissed for lack of subject matter jurisdiction because the USPTO had issued a certificate cancelling all of the claims asserted in the case.  Accordingly, the Court found “there [was] no actual case or controversy between the parties.”  The Court otherwise affirmed because the district court did not err in construing “outer frame” as necessarily referring to a “self-expanding frame.”  The Court noted that the patent specifications referred to certain structures as an “outer frame” and “self-expanding frame” interchangeably, and that “when a patent repeatedly and consistently characterizes a claim term in a particular way, it is proper to construe the claim term in accordance with that characterization.” A skilled artisan thus would understand the claimed term “outer frame” to be a “self-expanding frame.”  Aortic also presented an alternative argument that Edwards was judicially estopped from arguing its construction, which the Court rejected for not having been presented in the proceedings below.

The opinion can be found here.

Editors:

Nika Aldrich, IP Litigation Group Leader, Schwabe

Jason A. Wrubleski, Shareholder

Contributors:

Julia Davis, Associate