Lessons From Recent Pharma & Med Device Federal Circuit Decisions

Patent law in the life sciences industry evolves rapidly, with several recent Federal Circuit decisions showing how those shifts can impact intellectual property strategy. The cases discussed below touch on everything from dosing regimen claims and what qualifies as prior art to claim construction and patent term extensions. Each decision offers practical patent insights for pharma and med device innovators.

Bayer Pharma v. Mylan Pharmaceuticals (C.A. No. 2023-2434)

Bayer appealed a Patent Trial and Appeal Board (PTAB) decision invalidating claims of U.S. Patent No. 10,828,310 directed to methods for reducing cardiovascular risk in patients with coronary artery disease or peripheral artery disease by administering rivaroxaban and aspirin. The claims specified exact dosages (2.5 mg rivaroxaban twice daily and 75–100 mg aspirin daily) and dosing regimen, both of which were known in the art. Indeed, prior art references (Foley and Plosker) disclosed the same dosing regimens in clinical trials. As the basis for purported novelty, the claims included the additional limitation that the claimed rivaroxaban and aspirin amounts were “clinically proven effective.” Bayer argued that “clinically proven effective” was a limiting clause analogous to the efficacy clauses upheld in Allergan v. Sandoz (935 F.3d 1370 (Fed. Cir. 2019)).

The Federal Circuit held that “clinically proven effective” did not add a new functional relationship to the claimed method. The claims already specified the exact dosages and regiment and "clinically proven effective” did nothing further to define the dosages. It was therefore a functionally unrelated limitation, like the “informing the patient” limitations at issue in King Pharmaceuticals (616 F.3d 1267 (Fed. Cir. 2010)). It therefore could not rescue anticipated claims.

Key takeaways

• This case highlights the pitfalls of waiting for clinical trial results before filing patent applications. It is ideal to file patent applications before clinical trial disclosures, if possible.
• When relying on performance-based outcomes for novelty in patent claims, the performance of the claimed method should have a new and nonobvious functional relationship with the claimed regimen.

Merck Serono S.A. v. Hopewell Pharma Ventures, Inc. (No. 2025-1210)

Merck partnered with IVAX to develop oral cladribine for multiple sclerosis under a joint research agreement: Merck would conduct clinical trials and IVAX would develop oral dosage formulations. IVAX employees filed a Patent Cooperation Treaty application (later U.S. Patent No. 7,888,328, “Bodor”) disclosing a seven-line regimen for oral cladribine and included only two IVAX employees. Within a year, Merck filed priority applications leading to the patents-in-suit listing four inventors from Serono (which became Merck).

Merck argued Bodor was not a work “by another” because three of its inventors collaborated on the disclosure. The PTAB found Merck failed to show that all four inventors contributed to Bodor’s seven-line disclosure at issue. The PTAB relied on pre-America Invents Act § 102(e) law that says any incongruity in inventive entity makes the reference prior art.

The Federal Circuit upheld that Bodor was prior art, emphasizing that only complete identity of inventive entities can exclude a reference as “not by another.”

Key takeaways

• Strict standard: Complete identity of inventive entity is required to exclude a reference as “not by another.”
• Burden on patentee: Must provide corroborated evidence of joint contribution by all inventors.
• Strategic advantage for challengers: Even minor inventorship differences strengthen invalidity defenses under § 102(e).

Aortic Innovations LLC v. Edwards Lifesciences Corp. (C.A. No. 2024-1145)

This dispute involved transcatheter aortic valve replacement devices. Aortic Innovations appealed a stipulated judgment of non-infringement based on claim construction of “outer frame.” The specification described dual-frame embodiments and used the terms “outer frame,” “self-expanding frame,” and “self-expanding outer frame” interchangeably when referring to structures in Figures 9 and 20. The district court construed “outer frame” as “self-expanding frame,” leading to non-infringement because Edwards’ device lacked a self-expanding frame.

The Federal Circuit affirmed the district court’s construction, finding that consistent interchangeable use in the specification redefined “outer frame” and that a skilled artisan would understand the claimed term to mean “self-expanding frame.”

Key takeaways

• Beware of unintended lexicography; interchangeable use of terms in the specification and in describing embodiments can override plain and ordinary meaning and narrow claim scope.

Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc. (C.A. No. 23-2254)

This case addresses whether patent term extensions (PTE) under 35 U.S.C. § 156 for a reissued patent should be calculated based on the issue date of the original patent or the reissue patent. Merck’s ’340 patent issued in 2003 and covered sugammadex, the active ingredient in BRIDION®. Regulatory review lasted until 2015, delaying market entry for 12 years. Merck reissued the patent in 2014, retaining the original claims and adding narrower claims. Merck then sought a five-year PTE based on the original patent’s issue date. Aurobindo argued that PTE should be calculated from the reissue date, which would drastically shorten the extension.

The Federal Circuit held that PTE for a reissued patent is based on the original patent’s issue date, provided both patents include the same claims directed to the drug product subject to FDA review. In reaching this holding, the Federal Circuit explained that construing “the patent” in § 156(c) as the original patent aligns with the Hatch-Waxman Act’s purpose of compensating patent owners for regulatory delay.

Key takeaways

• For PTE and reissued patents, it’s the original patent’s issue date that matters, provided that both the original patent and the reissued patent have claims covering the approved drug product.
• Reissue does not negate entitlement to full PTE under the Hatch-Waxman Act.

In summary

These decisions underscore important lessons for life sciences companies seeking to protect and enforce their intellectual property assets. From Bayer’s reminder to file before clinical disclosures, to Merck Serono’s strict inventorship standard, Aortic Innovations’ caution on unintended lexicography, and Merck Sharp & Dohme’s clarification on patent term extensions, the lessons are clear: Diligence in drafting, timing, and claim language is essential to protect innovation and maintain exclusivity in a competitive regulatory landscape.