Intellectual Property Protection, Enablement Inquiries, Pharmaceutical Industry

Practical Guide to Claiming Small Molecules with Functional Language

Wolf, Greenfield & Sacks, P.C. on 6/6/2025

Patent claims reciting compounds where at least one group of a compound genus is defined by its function are common. For example, familiar claim terms such as “chelating moiety,” “linker,” and “binding moiety” describe a...more

United Therapeutics Corp. v. Liquidia Technologies, Inc. (Fed. Cir. 2023)

McDonnell Boehnen Hulbert & Berghoff LLP on 7/28/2023

In earlier times, the Federal Circuit, responding to efforts by the U.S. Patent and Trademark Office to reject patent applications directed to biotechnology-related inventions, held (In re Brana) that utility of such...more

Supreme Court confirms full scope enablement standard in Amgen v. Sanofi

Axinn, Veltrop & Harkrider LLP on 6/13/2023

This month, the Supreme Court issued its opinion in Amgen Inc. v. Sanofi, the closely watched case involving the enablement standard for patent claims, particularly as applied to functionally defined genus claims. Genus...more

The More You Claim, The More You Must Enable: SCOTUS Delivers Amgen v. Sanofi Opinion

Dinsmore & Shohl LLP on 6/8/2023

In May, the Supreme Court of the United States handed down its decision in Amgen Inc. v. Sanofi, which addressed the statutory enablement requirement for patents. The decision is consistent with ongoing efforts to strike a...more

Supreme Court Affirms Lack of Enablement for Amgen’s Patent Claims

Ballard Spahr LLP on 5/23/2023

Summary - In Amgen v. Sanofi, the Supreme Court unanimously affirmed the District of Delaware and Federal Circuit findings that Amgen’s functionally defined patent claims to a class of therapeutic antibodies are invalid as...more

SUPREME COURT RULING: Amgen Inc. et al. v. Sanofi et al, May 18, 2023

Schwabe, Williamson & Wyatt PC on 5/19/2023

Amgen Inc. et al. v. Sanofi et al, No. 21-757 (S. Ct. May 18, 2023) The Supreme Court issued a long-awaited decision today concerning the enablement requirement found in Section 112 of the Patent Act. Specifically, the...more

Supreme Court Delivers the Final Blow to Amgen

Bradley Arant Boult Cummings LLP on 5/19/2023

The questions from the high court during oral argument at the end of March 2023 were fairly telling of the 9-0 ruling that came down yesterday in Amgen, Inc. v. Sanofi (No. 21-757). In fact, it did not come as much of a...more

Hepatitis C Patent Falls for Non-Enablement, Wiping Out $2.5 Billion Infringement Verdict

Patterson Belknap Webb & Tyler LLP on 3/9/2018

In a hard-fought patent battle involving “groundbreaking” work by both parties, Chief Judge Stark of the U.S. District Court for the District of Delaware ruled that plaintiff Idenix’s patent for treating Hepatitis C virus...more

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