News & Analysis as of November 17, 2024

Supreme Court of the United States › 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 -

[Podcast] Biotechnology, Chemical and Pharmaceutical: Supreme Showdown

BakerHostetler on 5/9/2024

In 2023, a lawsuit that had wound its way through the judicial system for nearly 10 years finally had its day in the U.S. Supreme Court – and made waves in the biotechnology, chemical and pharmaceutical communities. Our...more

Securities and Derivative Litigation: Quarterly Update - February 2024

Dechert LLP on 2/20/2024

As we close out 2023 and begin the first quarter of 2024, securities and derivative litigation continues to evolve. In this quarterly update, we examine trends in federal securities class action filings, which saw an uptick...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

In the Wake of the Supreme Court's Amgen v. Sanofi decision: What’s Next for Biotechnology Claims?

McDonnell Boehnen Hulbert & Berghoff LLP on 10/3/2023

Section 112 of the patent statute, which in earlier years was something of a backwater in patent law, has had a tumultuous quarter century beginning with the Federal Circuit decision in Regents of the University of California...more

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

Harris Beach 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

Now What? The Supreme Court Addresses Enablement

BakerHostetler on 6/2/2023

What do telegraphic communications, incandescent lamps, wood veneering glues, and antibodies have in common? Nothing. That is of course, until May 18, 2023, when the Supreme Court ruled that Amgen’s antibody claims, like...more

Amgen v. Sanofi and Points Beyond

Burns & Levinson LLP on 5/31/2023

A week ago Thursday, the Supreme Court issued its decision in the Amgen v. Sanofi case, affirming the judgment of the Court of Appeals for the Federal Circuit, that the claims of the two patents Amgen asserted against Sanofi...more

Broad Genus Patents Must Be Enabled over the Full Scope of the Claims

Wilson Sonsini Goodrich & Rosati on 5/26/2023

Amgen Inc. et al. v. Sanofi et al., No. 22-157 (U.S. 2023) - The U.S. Supreme Court, in a unanimous decision, has affirmed the Federal Circuit’s decision invalidating Amgen’s patent claims covering a genus of antibodies...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

The Supreme Court Kept the Door Open to Genus Claims

Proskauer - Life Sciences on 5/24/2023

The U.S. Supreme Court on May 18, 2023 delivered its decision on the scope of the patent enablement requirement, set forth in 35 U.S.C. § 112, in the antibody dispute Amgen, Inc. v. Sanofi. While the parties obtained...more

Supreme Court Affirms Amgen Patents’ Invalidity in Closely Watched Enablement Case

Goodwin on 5/24/2023

The U.S. Supreme Court has decided a closely watched case regarding patent law’s enablement requirement, Amgen Inc. v. Sanofi. The Supreme Court affirmed the Federal Circuit’s decision that Amgen’s patent claims were invalid,...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

Amgen v. Sanofi

Fish & Richardson on 5/22/2023

On May 18, the Supreme Court sided with Sanofi in Amgen v. Sanofi, 598 U.S. ____ (2023), a dispute concerning broad functional genus claims for antibodies. The ruling affirmed the Federal Circuit’s reading of the Patent Act’s...more

Supreme Court Focuses Scope of Patent Enablement - What Patent Owners Need to Know

Womble Bond Dickinson on 5/22/2023

A closely watched and hotly debated life sciences patent dispute saw the U.S. Supreme Court affirm a narrow interpretation of patent enablement when filing for patent protection....more

Supreme Court Renders Decision in Amgen v. Sanofi: Three Takeaways

McDonnell Boehnen Hulbert & Berghoff LLP on 5/19/2023

The Supreme Court handed down its decision in Amgen v. Sanofi today. In Justice Gorsuch’s unanimous opinion, the Court held that the scope of the claims at issue were much broader than the 26 expressly disclosed 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

Is SCOTUS Poised to Deliver TKO to Amgen?

Bradley Arant Boult Cummings LLP on 3/29/2023

As a follow up to our post last week, the Supreme Court heard oral arguments in Amgen, Inc. v. Sanofi (No. 21-757). While we obviously don’t have a crystal ball, the questions from the high court suggest that Amgen’s claims...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

U.S. Supreme Court to Decide on Enablement Standard for Biotech Antibody Patents in Amgen v. Sanofi

Harris Beach PLLC on 11/23/2022

In 2021, the Federal Circuit determined that Amgen’s biotech antibody patents lack enablement, i.e., the specification did not teach one of ordinary skill in the art how to make and use the invention without undue...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

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Supreme Court of the United States › Biotechnology

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