News & Analysis as of

Settlement Food and Drug Administration (FDA) Pharmaceutical Patents

Venable LLP

Stelara® Biosimilar Updates: Settlement of IPR and FDA Review of Proposed Biosimilar

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On March 4, 2024, the PTAB granted Biocon and Janssen’s joint motion to terminate IPR2023-01444 due to a settlement reached prior to an institution decision. The parties announced in a press release that their settlement and...more

Goodwin

Alvotech Announces More Settlements and Expected Launch Dates Regarding Biosimilar to STELARA (ustekinumab), AVT04

Goodwin on

On February 15, Alvotech announced that it reached more settlement agreements with Johnson & Johnson for ATV04, Alvotech’s biosimilar to STELARA (ustekinumab). The settlements cover Canada, the European Economic Area, and...more

Robins Kaplan LLP

ANDA Litigation Settlements - Winter 2021

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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

ANDA Litigation Settlements - Spring 2020

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Please see Chart below for more information. ...more

Robins Kaplan LLP

ANDA Litigation Settlements - Fall 2019

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Please see full Chart below for more information....more

Robins Kaplan LLP

ANDA Litigation Settlements - Summer 2019

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Please see full Chart below for more information....more

McDermott Will & Emery

Contractual Duty to Deal Does Not Equal Antitrust Duty to Deal

Addressing for the first time whether a patent holder under a contractual duty to deal is also subject to an antitrust duty to deal, the U. S. Court of Appeals for the Second Circuit upheld dismissal of a putative antitrust...more

Robins Kaplan LLP

GENERICally Speaking - Vol. 4, No. 1

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The Hatch-Waxman Litigation and Life Sciences practice groups at Robins, Kaplan, Miller & Ciresi L.L.P. are pleased to offer the latest edition of their quarterly publication regarding ANDA patent litigation issues and the...more

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