News & Analysis as of

Life Sciences Pharmaceutical Industry Amgen

Venable LLP

Spotlight On: Neulasta® (pegfilgrastim) / Fulphila® (pegfilgrastim-jmdb) / Udenyca® (pegfilgrastim-cbqv) / Ziextenzo®...

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Pegfilgrastim Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Venable LLP

Spotlight On: Enbrel® (etanercept) / Erelzi® (etanercept-szzs) / Eticovo® (etanercept-ykro) - August 2025

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Etanercept Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Venable LLP

PTAB Director Discretionarily Denies Opdivo® IPRs Based on Settled Expectations of Patent Owner

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On July 24, 2025, the PTO Acting Director Coke Morgan Stewart discretionarily denied Amgen’s IPR2025-00601 and IPR2025-00602 challenging Bristol-Myers Squibb’s (“BMS”) U.S. Patent Nos. 9,856,320 (“the ’320 patent”) and...more

Goodwin

EMA Issues Positive CHMP Opinions for Fresenius Denosumab Biosimilars

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On May 27, 2025, Fresenius Kabi (“Fresenius”) announced that the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) had issued positive opinions for Fresenius’s two denosumab biosimilar candidates....more

Venable LLP

Prolia® / Xgeva® (denosumab) Biosimilar Updates: Celltrion Biosimilar Approval, Amneal aBLA Filing, and Fresenius Kabi Litigation...

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On February 28, 2025, the FDA approved Celltrion’s Stoboclo® / Osenvelt® (denosumab-bmwo) as the third company to receive FDA approval of biosimilars of Amgen’s Prolia® / Xgeva® (denosumab). ...more

Venable LLP

Amgen Challenges Opdivo® / Yervoy® Combination Treatment Patents in Three IPRs

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On February 28, 2025, Amgen filed three IPRs against Bristol-Myers Squibb’s patents covering methods of treatment using a combination of Opdivo® (nivolumab), an anti-PD-1 antibody, and Yervoy® (ipilimumab), an anti-CTLA-4...more

Goodwin

EU Biosimilar Regulatory and Launch Updates

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CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars:  On January 30, 2025, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending...more

Venable LLP

Amgen Plans At-Risk Launch of EYLEA® Biosimilar Pavblu™ After Federal Circuit Lifts Temporary Injunction

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On October 22, 2024, the Federal Circuit (CAFC Case No. 24-2351) denied Regeneron’s request for an injunction pending appeal for Amgen’s EYLEA® (aflibercept) biosimilar Pavblu™ (aflibercept-ayyh), concluding that “Regeneron...more

Goodwin

Antitrust and Competition Life Sciences Quarterly Update Q2 2024

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To date, 2024 has not yet seen the type of mega-merger (Pfizer/Seagen) or level of agency enforcement (Sanofi/Maze or Amgen/Horizon) as 2023. But two notable investigations — one still active — show the Federal Trade...more

Goodwin

Antitrust & Competition Life Sciences Year in Review 2023

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Despite increasingly aggressive rhetoric from the agencies, 2022 was largely characterized as “business as usual” in the antitrust world. In contrast, 2023 featured a significant step up in enforcement activity, including...more

Herbert Smith Freehills Kramer

Law360: Supreme Court Amgen Ruling's Major Effect On Enablement

Eight months ago, the U.S. Supreme Court interpreted the enablement requirement in the May 18, 2023, Amgen Inc. v. Sanofi decision.[1] Although the court did not change the law, affirming the U.S. Court of Appeals for the...more

WilmerHale

The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences - September 2023

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This marks the first issue of WilmerHale’s The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences, a monthly bulletin that will highlight developments in the antitrust and life sciences space. We will...more

BakerHostetler

Now What? The Supreme Court Addresses Enablement

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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

Wilson Sonsini Goodrich & Rosati

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

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

Goodwin

Antitrust & Competition Life Sciences Quarterly Update - Q1 2023

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Our prior updates covered how FTC enforcement activity largely proceeded “as usual” during 2022 in the life sciences industry, with large pharmaceutical players buying or licensing promising, but still risky, assets from...more

Goodwin

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

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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

Procopio, Cory, Hargreaves & Savitch LLP

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

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

Fish & Richardson

Amgen v. Sanofi

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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

Womble Bond Dickinson

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

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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

McDonnell Boehnen Hulbert & Berghoff LLP

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

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

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

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

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

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

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

4 Potential Paths For High Court In Amgen Patent Case

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

Axinn, Veltrop & Harkrider LLP

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

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

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