News & Analysis as of

Amgen

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

Venable LLP

Fifth EYLEA® Biosimilar FDA-Approved: Amgen’s Pavblu™ (aflibercept-ayyh)

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On August 23, 2024, the FDA approved Amgen’s Pavblu™ (aflibercept-ayyh) as the fifth biosimilar of Regeneron’s EYLEA® (aflibercept). Pavblu™ was approved with a skinny label that includes neovascular (wet) age-related macular...more

Venable LLP

Amgen Files BPCIA Lawsuit Against Samsung Bioepis Prolia® / Xgeva® Proposed Biosimilar SB16

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On August 12, 2024, Amgen filed Case No. 1:24-cv-08417 (D.N.J.) against Samsung Bioepis, alleging SB16 (denosumab), its proposed Prolia® / Xgeva® (denosumab) biosimilar, would infringe 34 of Amgen’s patents....more

MoFo Life Sciences

The PTAB Axes Skin Treatment Patent Under Amgen

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The Patent Trial and Appeal Board (“PTAB”) recently invalidated a University of Massachusetts (“UMass”) patent related to the treatment of the skin disease vitiligo in a post-grant review. (See Forte Biosciences Inc v....more

Goodwin

Amgen Files BPCIA Complaint Against Samsung Bioepsis Regarding Denosumab

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On August 12, 2024, Amgen filed a BPCIA complaint in the District Court for the District of New Jersey against Samsung Bioepis and Samsung Biologics related to Samsung Bioepis’s proposed biosimilar of Amgen’s PROLIA and...more

Miller Canfield

Watch the Scope of Your IRS Closing Agreement

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The rules relating to delegated authority are complex. A taxpayer is well advised to ensure that the scope of a closing agreement the taxpayer signs is what the taxpayer expects, and that an IRS official who signs the...more

WilmerHale

Amgen Hasn’t Resolved Questions on AI Medical Invention Patents

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Personalized medical intervention is in a transformative phase as artificial intelligence algorithms are increasingly deployed to tailor treatments for individual patients based on their unique characteristics. Developers...more

Lathrop GPM

Broad Biotech Patent Claims-the Saga Continues

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There now is increased interest about the written description and enablement requirements for patent applications claiming antibodies. This may stem from the recent U.S. Supreme Court decision in Amgen v. Sanofi, finding lack...more

Goodwin

FDA Approves Amgen’s BKEMV, the First Eculizumab Biosimilar

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​​​​​​​On May 28, 2024, the FDA approved Amgen’s BKEMV (eculizumab-aeeb), the first approved biosimilar of Alexion’s SOLIRIS (eculizumab).  BKEMV was approved by the FDA as a 300 mg/30 mL (10 mg/mL) injection, for intravenous...more

Goodwin

Amgen Files BPCIA Complaint Against Celltrion Regarding Denosumab

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On May 28, Amgen filed a BPCIA complaint in the District Court for the District of New Jersey against Celltrion related to its denosumab biosimilar of Amgen’s PROLIA and XGEVA. This is the second BPCIA litigation regarding...more

Goodwin

Denosumab Biosimilar Updates - June 2024

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On May 21, Alvotech announced that it had entered into a license and supply agreement with Dr. Reddy’s Laboratories SA for the commercialization of AVT03, a proposed denosumab biosimilar. Denosumab, sold by Amgen under the...more

Venable LLP

Amgen Files BPCIA Lawsuit Against Celltrion’s Proposed Prolia® / Xgeva® (Denosumab) Biosimilar CT-P41

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On May 28, 2024, Amgen filed a BPCIA litigation, Case No. 1:24-cv-06497 (D.N.J.), against Celltrion’s proposed Prolia® / Xgeva® (denosumab) biosimilar CT-P41 alleging infringement of 29 of Amgen’s patents, including one...more

Manatt, Phelps & Phillips, LLP

Supreme Court Holds Invalid Cholesterol Drug Patent That Covered Millions of Undisclosed Antibodies

In Amgen Inc. v. Sanofi, the Supreme Court unanimously held that “[i]f a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent specification must enable a person skilled in...more

Venable LLP

Amgen and Sandoz Settle Prolia® / Xgeva® Biosimilar Litigation

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Amgen and Sandoz reached a settlement in Case No. 1:23-cv-02406 (D.N.J.) on April 29 just hours before a New Jersey District Court Judge (Christine O’Hearn) was scheduled to announce her ruling on Amgen’s preliminary...more

Goodwin

Court Cancels Injunction Hearings In Aflibercept BPCIA Litigation; Regeneron May Seek Temporary Restraining Orders

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As we previously reported, the Judicial Panel on Multidistrict Litigation recently granted Regeneron Pharmaceutical’s (“Regeneron”) motion to establish a multi-district litigation (“MDL”) for its aflibercept BPCIA litigation....more

Goodwin

MDL Panel Grants Transfer of Aflibercept BPCIA Case

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As we previously reported, on January 11, 2024, Regeneron Pharmaceuticals, Inc. (“Regeneron”) moved to establish a multi-district litigation (“MDL”) for its aflibercept BPCIA litigation, and to transfer its case against...more

Axinn, Veltrop & Harkrider LLP

The Pleading Standard for Complex Technology? It's Complex.

Can a patentee really just take a pass on alleging that an accused product meets a limitation in an asserted claim, even where the case involves complex technology? That's the upshot of the court's decision in Lindis Biotech,...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

AEON Law

Patent Poetry: Patent Office Issues Guidelines for Enablement after Amgen

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The United States Patent and Trademark Office (USPTO) has published new Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al. ...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

Goodwin

Updates on Aflibercept BPCIA Litigation - January 2024

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On January 10, 2024, Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed a Complaint in the U.S. District Court for the Central District of California against Amgen Inc. (“Amgen”) alleging infringement of 32 patents under the...more

Kramer Levin Naftalis & Frankel LLP

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

McDermott Will & Emery

PTO Continues to Wave Wands in Assessing Enablement

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In light of the 2023 Supreme Court of the United States decision in Amgen Inc. v. Sanofi, the US Patent & Trademark Office (PTO) published guidelines for PTO employees to use, regardless of technology, to ascertain compliance...more

Venable LLP

First Biosimilar and Interchangeable of Stelara® (ustekinumab) Approved in the U.S.

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On October 31, 2023, the FDA approved Amgen’s Wezlana™ (ustekinumab-auub) as the first biosimilar and interchangeable of Johnson & Johnson / Janssen’s Stelara® (ustekinumab).  In May 2023, Amgen and Janssen settled their...more

Morgan Lewis

Blockbuster Biologics Review | Issue 21

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Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. Since the enactment of the Biologics Price Competition and Innovation Act...more

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