Tag Archives: Written Description

2 ≠ 1: Enanta v. Pfizer

The U.S. Court of Appeals for the Federal Circuit (CAFC) issued another decision where they held an applicant to a narrow interpretation of one their application’s definitions.  

In Enanta Pharmaceuticals. Inc. v. Pfizer Inc., No. 2025-1427 (June 23, 2026), the court held that Enanta’s U.S. Patent No. 11,358,953 (“the ’953 Patent”) could not claim the benefit of priority to U.S. Provisional Patent No. 63/054,048 because the patent’s recitation of “NCH(O)-C1-C12-alkyl” in its definition of “substituent” could not be supported by the provisional applications disclosure of only “-NCH(O)-C2-C12-alkyl” in its own definition. Without that priority, Pfizer’s disclosure of a species that falls within the Enanta’s generic claim is invalidating, novelty-defeating prior art.   

Timeline:

  • July 20, 2020: Enanta filed a provisional patent describing a substituent comprising a “C2-C12 alkyl.”
  • April 6, 2021: Pfizer disclosed PF-07321332 (nirmatrelvir), which has a “C1” for the substituent.
  • November 9, 2021: Enanta filed the non-provisional correcting C2 to C1.

Enanta argued that “C2” was merely a typographical error that a skilled artisan would recognize the error as such and clearly conclude that the inventor was in possession of the full range of “C2-C12.” The court disagreed saying that the “disclosure of one chemical compound, or integer in this case, cannot necessarily be a disclosure of another, even one close by structurally.” They backed it up with the analogy of “asking whether a disclosure of ethanol, a two-carbon alcohol regularly consumed by people, would provide adequate written description support for methanol, a one-carbon alcohol that is highly toxic to people.”

Fair point. Magic-methyls are indeed real for various properties of certain chemical compounds. However, I think there is more nuance to discuss. I also think there are other lenses that the court could have used to view the facts in this case.

I intend to follow up this post with further analysis of this case.

Check back soon!

Gilead Wins Another Sofosbuvir Challenge: U. Minnesota v. Gilead

Regents of the U. of Minnesota v. Gilead Scis., Inc., 2021-2168, — F.4th — (Fed. Cir. Mar. 6, 2023)

The Court of Appeals for the Federal Circuit (CAFC) analyzed whether the written description found in UMN’s priority applications supported the claims in the resulting patent # US 8,815,830. The CAFC said no.

While the ‘830 patent claims covered sofosbuvir, The CAFC affirmed an IPR’s invalidation of U. Minnesota’s claims because they could not properly claim priority to its provisional application. The reasoning was that the provisional with its nebulous multiple dependent claims, that were themselves dependent on further multiple dependent claims, did not adequately describe the subgenus eventually claimed in the non-provisional application.

See Patently-O’s posts for more:

March 7, 2023 — Laundry Lists of Components are Insufficient Written Description for a Particular Combination | Patently-O (patentlyo.com)

March 9, 2023 — Multiple dependent claims, blaze marks, and ipsis verbis support | Patently-O (patentlyo.com)

SOVALDI® (soh-VAHL-dee) (sofosbuvir)