News & Analysis as of

Life Sciences Patent Trial and Appeal Board Prescription Drugs

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

Robins Kaplan LLP

New ANDA Cases

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Federal district court cases that are filed pursuant to the Hatch-Waxman Act - This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to...more

Venable LLP

FDA Approves Third Actemra® Biosimilar, Celltrion’s Avtozma® (tocilizumab-anoh)

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On January 24, 2025, the FDA approved Celltrion’s Avtozma® (tocilizumab-anoh), in intravenous and subcutaneous formulations, as the third biosimilar of Genentech’s Actemra® (tocilizumab)...more

Robins Kaplan LLP

ANDA Litigation Settlements - Winter 2024

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This chart summarizes the case name, drug, patents-in-suit, and publicly available terms for reported settlements in federal district court cases that are filed pursuant to the Hatch-Waxman Act....more

Robins Kaplan LLP

New ANDA Cases - Federal District Court Cases That Are Filed Pursuant to the Hatch-Waxman Act

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This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to the Hatch-Waxman Act. It also includes the same information for proceedings...more

Foley & Lardner LLP

Cancer Drugs: Antibody-Drug Conjugate Litigation

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Antibody-drug conjugates (ADCs) are typically composed of a monoclonal antibody attached to a cytotoxic drug via a chemical linker. The antibody is able to identify biomarkers on and attach to cancer cells, allowing targeted...more

Venable LLP

Venable’s BiologicsHQ Monthly Injection - July 2024

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Welcome to Venable’s BiologicsHQ Monthly Injection – July 2024...more

MoFo Life Sciences

Federal Court Invalidates Dosing Patent Based On Clinical Trials Disclosure

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As an essential component of the drug development process, human clinical trials assist in determining whether a given drug will serve its intended purpose, but patent applicants should consider disclosure of such trials in...more

Goodwin

Year in Review: Top Legal Developments of 2023

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​​​​​​​As we settle into 2024, we reflect on the significant legal developments of 2023 that hold potential impact on the biologics and biosimilars market. The following is a recap of some of the top five legal decisions and...more

Robins Kaplan LLP

Sanofi-Aventis U.S. LLC v. Apotex Corp. Jevtana® (Cabazitaxel)

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Case Name: Sanofi-Aventis U.S. LLC v. Apotex Corp., C.A. No. 20-cv-804-RGA, 2022 WL 2643532 (D. Del. July 8, 2022) (Hall, J.)  Drug Product and Patent(s)-in-Suit: Jevtana® (cabazitaxel); U.S. Patents Nos. 8,927,592 (“the ’592...more

American Conference Institute (ACI)

[Event] 13th Summit on Biosimilars & Innovator Biologics - June 28th - 29th, Boston, MA

This June, join the “who’s who” of the biosimilars and innovator biologics industries as they gather in Boston for ACI’s 13th Annual Summit on Biosimilars & Innovator Biologics....more

Robins Kaplan LLP

New ANDA Cases - Spring 2021

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This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to the Hatch-Waxman Act. It also includes the same information for proceedings...more

Robins Kaplan LLP

New ANDA Cases - Winter 2021

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Federal District Court Cases That Are Filed Pursuant To The Hatch-Waxman Act - This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to...more

Herbert Smith Freehills Kramer

Biosimilar Litigation Trends and Lessons Learned in 2019

It has been nearly 10 years since the U.S. Biosimilars Pathway (the Biologics Price Competition and Innovation Act) was enacted. The first biosimilar product in U.S. history was approved and launched in 2015. Ten biosimilars...more

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