Post-Amgen Enablement: How the Federal Circuit Is Policing Broad Mechanical Claims
When companies apply for and prosecute mechanical or industrial patents, broad claims often serve as the backbone of enforcement strategy. But recent Federal Circuit decisions, applying the Supreme Court’s 2023 ruling in Amgen v. Sanofi, are placing renewed pressure on patentees to justify such broad claims as supported by the patent’s disclosure. Although Amgen arose in biotechnology, courts are now applying its “full-scope enablement” principle to mechanical inventions, raising practical questions about how much guidance a patent must provide to sustain broad functional claims. Assessing Amgen v. Sanofi and two post-Amgen Federal Circuit decisions applying full-scope enablement in non-biotech contexts highlights how the court is evaluating the relationship between broad claims and corresponding technical disclosure across industries.
The Supreme Court’s 2023 decision in Amgen Inc. v. Sanofi, addressing broad functional antibody genus claims, reaffirmed that when a patent claims an entire class, the specification must enable the full scope of the invention as defined by the claims (“the more one claims, the more one must enable”).[1] In other words, if a patent claims a broad class of products or methods, the specification must teach skilled artisans how to make and use the entire class, not just a few disparate examples. The Supreme Court emphasized that some experimentation is permissible, but only so long as it is “reasonable” in light of “the nature of the invention and the underlying art.”[2] This clarification, though set in a biotech context, did not alter the legal standard so much as highlight the longstanding full-scope enablement rule.
Since Amgen, the Federal Circuit has treated the enablement mandate as business-as-usual, but with a renewed spotlight on claim breadth versus disclosure.[3] What Amgen adds is an emphatic reminder that the specification must enable the entire scope of the claims, especially pertinent for genus claims or broad functional claims.
Notably, the Federal Circuit has expressly acknowledged that Amgen did not announce a new test, but rather reinforced existing doctrine.[4] In a recent mechanical-patent appeal, the court observed that Amgen simply reiterated the “statutory enablement requirement” in place for over a century.[5] The panel also quoted Amgen’s assurance that a patent’s description may require only a “reasonable amount of experimentation” by the skilled artisan, with the caveat that what counts as “reasonable” varies with the technology.[6] In short, the Federal Circuit’s post-Amgen jurisprudence hews to long-established principles, while using the Supreme Court’s terminology of “full scope” to stress that broad claims demand commensurately broad disclosure.
Case Study: Industrial Diamond Patent – Enablement Upheld
The Federal Circuit found adequate enablement in US Synthetic Corp. v. Int'l Trade Comm'n, 128 F.4th 1272 (Fed. Cir. 2025), a case concerning polycrystalline diamond compacts used in drilling.[7] There, the patent claims were directed to a specific polycrystalline diamond compact, defined by structural components, dimensional constraints, and quantified magnetic properties that correlate to the compact’s microstructure.[8] The accused infringers argued, relying heavily on Amgen v. Sanofi, that the asserted claims were not enabled across their full scope, but the Federal Circuit rejected that challenge, concluding that the Commission correctly found no lack of enablement. [9] The Federal Circuit emphasized that Amgen did not alter the enablement standard, but instead “applied the same” statutory test long enforced by the Supreme Court, and held that the ITC properly adhered to those “long-standing principles” in concluding that the challengers failed to prove the claims were not enabled.[10]
Importantly, the patent disclosed detailed manufacturing conditions and multiple working examples, and there was no error in the Commission’s conclusion that challengers failed to carry their burden of showing that practicing the claimed invention would require undue experimentation.[11] Echoing Amgen’s theme, the court reiterated in its review of the enablement analysis that a specification may require a reasonable amount of experimentation, so long as that experimentation is not undue.[12] Although some experimentation may have been required, it was not undue, and the challengers failed to prove a lack of enablement by clear and convincing evidence.[13] The U.S. Synthetic decision thus demonstrates that when a patent’s guidance is coextensive with its claims’ breadth, the Federal Circuit will uphold it post-Amgen. For companies relying on industrial materials patents, the decision underscores that detailed process parameters and working examples can meaningfully insulate broad claims from enablement challenges.
Case Study: Water Filters – Broad Claims Struck Down
Brita LP v. Int'l Trade Comm'n, 156 F.4th 1326 (Fed. Cir. 2025), which involved a water filtration patent, provides contrast through its use of performance to define its claimed subject matter. The core dispute was whether the patent taught how to achieve the claimed performance across all filter media covered by the claims.[14] The Federal Circuit invoked Amgen’s full-scope mandate, noting that “[i]f a patent claims an entire class” of compositions or methods, then “specification must enable . . . the full scope of the invention as defined by the claims.”[15] In reviewing the disclosure, the court found a significant gap. The specification provides working examples and detailed formulations only for carbon-block filters, while tested mixed-media filters failed to satisfy the claimed performance range and the specification offers no “road map” for achieving those results using non-carbon-block media.[16] In fact, the specification acknowledges the “drawbacks,” “problems,” and “disadvantages” of non-carbon-block filter media, yet provides no teaching or solution for how such non-carbon-block filters could achieve the claimed results.[17] Given the disconnect between the claims’ broad, functionally defined scope and the specification’s working disclosure limited to carbon-block embodiments, the court affirmed the Commission’s finding that enabling non-carbon-block filters within the claim scope would require undue experimentation, and thus the claims were not enabled across their full scope.[18]
The Federal Circuit affirmed the Commission’s enablement determination, holding that “the ’141 patent required undue experimentation to enable the full scope of the asserted claims.”[19] The result was that the claims were held invalid for lack of enablement. The decision reflects the Federal Circuit’s continued application of full-scope enablement principles to broad mechanical claims. Additionally, the decision illustrates how functional performance ranges, when untethered from concrete guidance across materially different embodiments, can expose mechanical claims to invalidity.
Key Takeaways for Mechanical Inventions
Taken together, the Federal Circuit’s post-Amgen jurisprudence reflects an exacting enablement standard for mechanical patents. Patent drafters and portfolio managers should carefully assess whether broad functional or genus claims are supported by disclosures that provide meaningful guidance across all claimed embodiments, particularly for patents central to enforcement strategy or long-term portfolio value.
Broad mechanical claims, particularly those defined by functional performance or results rather than concrete structure, remain enforceable where the specification provides guidance that is commensurate with the full scope of the claims. As illustrated by U.S. Synthetic, disclosures that include detailed parameters, working examples, and manufacturing conditions aligned with the breadth of the claims can withstand post-Amgen enablement challenges.
At the same time, decisions such as Brita demonstrate that broadly drafted mechanical claims are vulnerable where the specification enables only a narrow subset of embodiments, leaving other claimed configurations to be achieved through undue experimentation. In practical terms, companies should carefully evaluate whether broad functional or genus claims are supported by disclosures that teach how to achieve the claimed results across all materially distinct embodiments. Where claim scope sweeps widely, specification support must run just as deep—particularly for patents relied upon in enforcement or central to a company’s portfolio strategy.
[1] Amgen, 598 U.S. at 610.
[2] Id. at 612 (citing Minerals Separation v. Hyde, 242 U.S. 261, at 270–71 (1916); Mowry v. Whitney, 81 U.S. 620, 644 (1871)).
[3] US Synthetic Corp. v. Int’l Trade Comm’n, 128 F.4th 1272, 1286 (Fed. Cir. 2025).
[4] Id.
[5] Id.
[6] Id.
[7] Id. at 1276.
[8] Id. at 1282–85.
[9] Id. at 1284–86.
[10] Id. at 1286 (citing Amgen, 598 U.S. at 612, 616).
[11] Id. at 1280, 84, 86.
[12] Id. at 1286–87
[13] Id. at 1286–87
[14] Id. at 1329, 32.
[15] Id. at 1336 (citing Amgen, 598 U.S. at 610).
[16] Id. at 1330, 32, 38.
[17] Id. at 1333, 38.
[18] Id. at 1332–33, 37, 39.
[19] Id. at 1339.
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