News & Analysis as of

Patent Infringement Pharmaceutical Industry Settlement

Venable LLP

Amgen and Accord Settle Prolia® / Xgeva® BPCIA Litigation over INTP23

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On July 16, 2025, Amgen and Accord settled Case No. 1:25-cv-01305 (D.N.J.) / MDL 1:25-md-03138 (D.N.J.) alleging infringement of 34 of Amgen’s patents by Accord’s proposed Prolia® / Xgeva® (denosumab) biosimilar INTP23...more

Robins Kaplan LLP

ANDA Litigation Settlements

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Reported settlements in federal district court cases - 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...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

Goodwin

Amgen and Celltrion Settle Denosumab BPCIA Case

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​​​​​​​On January 23, 2025, the District Court for the District of New Jersey entered a Consent Judgment and Injunction in view of a settlement agreement between Amgen and Celltrion resolving the BPCIA litigation regarding...more

Wilson Sonsini Goodrich & Rosati

Navigating Pharmaceutical Patent Settlements and Reverse Payments: Key Takeaways from the FTC’s Latest MMA Reports

On January 16, 2025, the Federal Trade Commission (FTC) Bureau of Competition published four reports on pharmaceutical patent settlement agreements filed under the Medicare Prescription Drug, Improvement, and Modernization...more

Robins Kaplan LLP

ANDA Litigation Settlements - Reported Settlements in Federal District Court Cases

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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

Proskauer Rose LLP

FTC Focus: What Access To Patent Settlements Would Mean

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The Federal Trade Commission has pursued aggressive and creative expansion of its antitrust enforcement efforts under the Biden administration, and the pharmaceutical industry is no exception. Indeed, in a recent interview,...more

Goodwin

Genentech and Tanvex Reach Settlement in Principle in Trastuzumab BPCIA Litigation

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On January 6, 2023, Genentech and Tanvex reached a settlement in principle to resolve all claims with respect to Genentech’s BCPIA complaint. As we previously reported, Genentech filed a complaint against Tanvex in June 2022,...more

Patterson Belknap Webb & Tyler LLP

Fifth Circuit Impax Decision Validates FTC’s Post-Actavis Approach to Reverse Payments

On April 13, 2021, the Court of Appeals for the Fifth Circuit issued its long-anticipated decision in Impax v. FTC, marking the first time an appellate court has weighed in on the merits of a so-called reverse payment case...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 - 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

McGuireWoods LLP

More on Patent Settlements Including Litigation at the European Courts

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Last week I posted on the European Commission’s (EC) latest report into patent settlement agreements between originator and generic companies in the European Union (EU). The EC says each time it produces these reports that...more

Patterson Belknap Webb & Tyler LLP

Better Early than Never: SDNY Dismisses Lawsuit over Patent Settlement where Generics were Granted Early-Entry Licenses with...

On September 22, Judge Ronnie Abrams of the Southern District of New York dismissed an antitrust lawsuit against Takeda Pharmaceuticals and three generic drug manufacturers based on settlements they had reached regarding a...more

Sheppard Mullin Richter & Hampton LLP

Federal Trade Commission Continues March “to Set a Standard for the Industry” with Cephalon Settlement

On May 28, the Federal Trade Commission (“FTC”) announced it had reached a $1.2 billion settlement with Teva Pharmaceuticals, which acquired Cephalon in 2012, over reverse payment for its narcolepsy drug, Provigil. The...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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