News & Analysis as of May 17, 2025

Biotechnology

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The United States Supreme Court is the highest court of the United States and is charged with interpreting federal law, including the United States Constitution. The Court's docket is largely discretionary with only a limited number of cases granted review each term. The Court is comprised of one chief justice and eight associate justices, who are nominated by the President and confirmed by the Senate to hold lifetime positions. less -

Patenting Microbial Products: Pitfalls, Value, and Special Concerns

Maynard Nexsen on 5/8/2025

The use of microorganisms in human industry is ancient, but has increased markedly in recent years. The modern recognition of the role of microbial communities in the human body has intensified innovation in fields like...more

USPTO Says Wands Still Controls Enablement Analysis Post-Amgen

Knobbe Martens on 1/25/2024

On January 9, 2024, the USPTO published guidelines for its patent examiners when evaluating compliance with the enablement requirement in light of the U.S. Supreme Court’s recent decision in Amgen Inc. et al. v. Sanofi et...more

USPTO Provides Guidance in Light of Amgen v. Sanofi

Procopio, Cory, Hargreaves & Savitch LLP on 1/19/2024

The U.S. Supreme Court’s May 2023 decision in Amgen, Inc. v. Sanofi (Amgen) sent shock waves through the patent world, particularly in the chemical and biotech segments, due to its invalidation of Amgen patents based on a...more

Amgen Inc. v. Sanofi: U.S. Supreme Court Addresses Enablement for Biotechnology Inventions

Harris Beach Murtha PLLC on 6/6/2023

I’m a bit behind and therefore am not part of the slew of commentary that flowed from the Supreme Court’s decision in Amgen Inc. v. Sanofi, 143 S. Ct. 1243, 1248 (2023), addressing Amgen’s claims to “antibodies that (1) bind...more

Supreme Court Upholds Patent Law Precedent

Dorsey & Whitney LLP on 5/25/2023

The case of Amgen Inc. v. Sanofi, U.S., No. 21-757 dealt with patent law’s “enablement” requirement. Essentially, the Court affirmed 150 years of precedent requiring the invention to be described “‘in such full, clear,...more

5 Takeaways from the U.S. Supreme Court Decision in Amgen v. Sanofi

Procopio, Cory, Hargreaves & Savitch LLP on 5/23/2023

The U.S. Supreme Court’s unanimous decision in Amgen Inc. v. Sanofi (referred to as the Amgen decision) likely makes it more difficult for life sciences companies to obtain broad patents claiming an entire genus of antibodies...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

Supreme Court Affirms Federal Circuit’s Decision in Amgen v. Sanofi

Sterne, Kessler, Goldstein & Fox P.L.L.C. on 5/19/2023

This morning, the US Supreme Court issued its opinion in Amgen v. Sanofi, a closely watched case concerning patent law’s enablement requirement. Under that requirement, codified at 35 U.S.C. § 112(a), a patent specification...more

4 Potential Paths For High Court In Amgen Patent Case

Sterne, Kessler, Goldstein & Fox P.L.L.C. on 4/4/2023

On March 27, the U.S. Supreme Court heard oral argument in Amgen v. Sanofi, a closely watched case concerning the appropriate legal standard for patent law's enablement requirement. That requirement is found in Title 35...more

The Supreme Court Hears Arguments About the Enablement Standard in Amgen v. Sanofi

Axinn, Veltrop & Harkrider LLP on 3/29/2023

The Supreme Court heard arguments this week in Amgen v. Sanofi, the closely-watched case involving the enablement standard for patent claims, particularly as applied to functionally-defined genus claims. The question raised...more

Amgen Inc. v. Sanofi Live Coverage

Sterne, Kessler, Goldstein & Fox P.L.L.C. on 3/24/2023

On Monday, March 27, 2023, at 10:00 a.m. EDT, the Supreme Court of the United States will hear oral arguments in Amgen Inc. v. Sanofi, No. 21-757. William H. Milliken, a director in Sterne Kessler’s Trial & Appellate Practice...more

Pharma-Related Patent Enablement Reaches the Highest Court

Procopio, Cory, Hargreaves & Savitch LLP on 11/11/2022

The U.S. Supreme Court has agreed to hear a case that is extremely significant for companies that operate in the biotechnology, pharmaceutical, and chemical sectors. At issue in Amgen v. Sanofi is a determination of the...more

In re Adler (Fed. Cir. 2013)

McDonnell Boehnen Hulbert & Berghoff LLP on 7/25/2013

Ever since the Supreme Court handed down its decision in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), both the U.S. Patent and Trademark Office and the courts have found it easier to render a decision that a claimed...more

Post-Myriad Strategies for Claiming Biotech Inventions in the United States

Akerman LLP on 7/16/2013

The United States Supreme Court recently ruled that genes or other naturally-occurring pieces of DNA are patent ineligible subject matter in Association for Molecular Pathology, et al. v. Myriad Genetics, Inc., et al. No....more

Supreme Court Decision: Board of Trustees of the Leland Stanford Junior University v. Roche Molecular Systems, Inc.

Patterson Belknap Webb & Tyler LLP on 6/15/2011

In its decision announced yesterday in Board of Trustees of the Leland Stanford Junior University v. Roche Molecular Systems, Inc., 563 U.S. ___ (2011), the Supreme Court clarified the ownership of inventions resulting from...more

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Supreme Court of the United States › Inventions › Biotechnology

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