News & Analysis as of

Enablement Inquiries Intellectual Property Protection Life Sciences

Sterne, Kessler, Goldstein & Fox P.L.L.C.

PTAB Year in Review – PTAB Trends in 2024: Challenges to Genus Claims

In the biotechnology and chemical spaces, genus claims are often sought by patent applicants to protect not only a specific product of interest, but also as a means to protect against others making related products that...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Federal Circuit IP Appeals: Summaries of Key 2023 Decisions (8th Edition): Amgen Inc. v. Sanofi, 598 U.S. 594 (2023)

The Supreme Court’s lone patent case from last term does not break new ground on enablement law. The Court’s core holdings—that a patent specification must enable the full scope of the claimed invention and therefore that...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

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

Sunstein LLP

Enablement Enigma: The Supreme Court Weighs In

Sunstein LLP on

In a unanimous decision, the Supreme Court has affirmed the lower court’s ruling that Amgen’s broad genus claims to cholesterol-lowering antibodies are invalid for lack of enablement....more

Buckingham, Doolittle & Burroughs, LLC

Amgen is Not the End of Chemical Innovation

Some chemical innovators have found the recent Supreme Court decision in Amgen v. Sanofi to suggest that chemical inventions will be subject to new and draconian disclosure standards going forward. A few have even suggested...more

Levenfeld Pearlstein, LLC

Enablement Unchanged: Amgen v. Sanofi and the Future of Software Patents

In a unanimous ruling, the Supreme Court of the United States (SCOTUS) addressed the enablement requirement under Section 112 of the Patent Act, placing this into sharper focus with the Amgen v. Sanofi case. This landmark...more

Schwabe, Williamson & Wyatt PC

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

Bradley Arant Boult Cummings LLP

Supreme Court Delivers the Final Blow to Amgen

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

McDonnell Boehnen Hulbert & Berghoff LLP

Amicus Briefing in Amgen v. Sanofi: The Rest of the Story - Part II

The Supreme Court's consideration of the standards for satisfying the enablement provisions of 35 U.S.C. § 112(a) has been occasioned for the first time in over a century by the Court's granting certiorari in Amgen v....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

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