Enablement, Anticipation, And Claim Strategy: Rethinking Biotech Patent Drafting Post-Agilent

Published: 2025-07-01 06:12:17 ET A

Published on 07/01/2025 at 06:12

For anticipation under 35 U.S.C. § 102, a prior art reference must disclose each and every element of the claimed invention, and such disclosure must be enabling. The recent Federal Circuit decision in Agilent Technologies, Inc. v. Synthego Corp., Nos. 2023-2186, 2023-2187 (Fed. Cir. June 11, 2025) addressed whether the enablement requirement for anticipation under § 102 should mirror the heightened enablement standard of Amgen Inc. v. Sanofi, 598 U.S. 594 (2023) requiring the full scope support to satisfy the enablement under 35 U.S.C. § 112. The Federal Circuit held that a reference can anticipate even if it would not function in the real world, so long as it teaches enough for a person of ordinary skill in the art to replicate the invention without undue experimentation.

Agilent v. Synthego involved patents on CRISPR gene-editing technology. Agilent held patents relating to chemically modified gRNAs used in CRISPR gene-editing, and Synthego challenged the patents' validity at the Patent Trial and Appeal Board (PTAB). The PTAB invalidated all of Agilent's claims, and Agilent appealed, arguing, among other things, that the cited prior art was not enabling.

The Federal Circuit affirmed the PTAB's decision. The court held that the cited patent application qualified as an enabling, anticipatory reference because a reference need only enable a single embodiment of the asserted claims to satisfy the enabling disclosure under § 102. The court distinguished Amgen on two grounds. First, Amgen addressed enablement under § 112, not whether prior art is enabled under § 102. Second, in contrast to Amgen, the combination of the state of the art and the cited reference provided sufficient guidance to avoid undue experimentation. Accordingly, the heightened Amgen standard does not apply to anticipation under § 102.

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