News & Analysis as of

Pharmaceutical Patents Enablement Inquiries Patent Trial and Appeal Board

Rothwell, Figg, Ernst & Manbeck, P.C.

One is the Loneliest Number: Can Single-Patient Case Studies Provide an Enabling Basis for Patent Claims?

The U.S. Court of Appeals for the Federal Circuit recently issued a non-precedential Rule 36 affirmance of the Patent Trial and Appeal Board (PTAB) in In re Adhami, No. 2024-1218, 2025 WL 1949797 (Fed. Cir. July 16, 2025)....more

BakerHostetler

In the Wake of the Amgen Decision, the USPTO Will Continue To Use the Wands Factors when Evaluating Enablement

BakerHostetler on

In the wake of the U.S. Supreme Court’s decision in Amgen Inc. v. Sanofi, 598 U.S. 594 (2023) (Amgen), in which the Court addressed whether Amgen’s functional antibody genus claims satisfy the enablement requirement, the U.S....more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - September 2023 #3

Baxalta Inc. v. Genentech, Inc., Appeal No. 22-1461 (Fed. Cir. Sept. 20, 2023) Our Case of the Week focuses on the enablement requirement. It’s the first case to come before the Federal Circuit following the Supreme...more

McDonnell Boehnen Hulbert & Berghoff LLP

The Supreme Court Grapples with Patent Enablement - April 2023

The Supreme Court heard oral argument in Amgen v. Sanofi last week in an extended session with argument from the parties and the U.S. government.  Petitioner was represented by Jeffrey Lamken, Respondents by Paul Clement, and...more

McDonnell Boehnen Hulbert & Berghoff LLP

Regents of the University of Minnesota v. Gilead Sciences, Inc. (Fed. Cir. 2023)

The Supreme Court's (re)consideration of the enablement requirement expected in its decision later this year in Amgen v. Sanofi may be the most closely watched patent case since AMP v. Myriad Genetics.  But in a decision...more

McDonnell Boehnen Hulbert & Berghoff LLP

Sanofi and Regeneron File Respondents' Brief on Amgen v. Sanofi

Sanofi and Regeneron filed their brief at the Supreme Court in Amgen v. Sanofi, in which Amgen seeks to have the Court overturn the District Court's grant of JMOL in the issue of whether Amgen's claims were invalid for...more

Goodwin

Year in Review: Top Legal Developments of 2022

Goodwin on

As we ring in the new year, we look back at the top legal developments of 2022 that could influence the market for biologics and biosimilars. There were many interesting decisions and other developments in district court, at...more

American Conference Institute (ACI)

[Event] 20th Advanced Summit on Life Sciences Patents - June 2nd - 3rd, New York, NY

ACI’s Advanced Summit on Life Sciences Patents is back in person on June 2–3 in New York City. Our reimagined 2022 conference will provide practical insights on how to implement bullet-proof patent prosecution tactics,...more

Knobbe Martens

Federal Circuit Review - October 2019

Knobbe Martens on

The PTAB Cannot Approve or Deny Certificates of Correction - In Honeywell International, Inc. v. Arkema Inc., Arkema France, Appeal Nos. 2018-1151, -1153, the Patent Trial and Appeal Board (“Board”) does not have the...more

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