News & Analysis as of

Patents Settlement Pharmaceutical Industry

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

Goodwin

Amgen and Fresenius Settle Denosumab BPCIA Case

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On March 7, 2025, the District Court for the District of New Jersey entered a Stipulation and Order of Dismissal Without Prejudice in view of a settlement agreement between Amgen and Fresenius Kabi resolving the BPCIA...more

Troutman Pepper Locke

California's Ban on Reverse Payment Settlements Partially Survives After a Five-Year Battle

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As state legislatures introduce legislation expanding the reach of their antitrust laws and state attorneys general ramp up their use of antitrust investigations and litigation, the legal landscape continues to become more...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

Smart & Biggar

New PMPRB Draft Guidelines outline administrative process for excessive price hearing recommendations

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As we previously reported, on December 19, 2024, the Patented Medicine Prices Review Board (PMPRB) released its Draft Guidelines for PMPRB Staff regarding Administrative Process for Excessive Price Hearing Recommendation...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

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

Venable LLP

Alexion and Samsung Bioepis Settle Soliris® Biosimilar Patent Proceedings for Epysqli®

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On August 30, 2024, Alexion and Samsung Bioepis filed voluntary dismissals in all of their pending patent proceedings related to Soliris® (eculizumab) biosimilar Epysqli® (eculizumab-aagh), including Case No. 1:24-cv-00005...more

WilmerHale

The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences - May 2024

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Second Circuit Affirms “Pay for Delay” Dismissal:  On May 13, 2024, the Second Circuit affirmed dismissal of antitrust claims brought by wholesalers, retailers, and employee benefit funds that alleged they overpaid for the...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

Fresenius Kabi and Formycon Reach Settlement Agreement for Ustekinumab Biosimilar Candidate in Europe and Canada

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On March 18, 2024, Fresenius Kabi (“Fresenius”) and Formycon announced a settlement agreement with Johnson & Johnson regarding FYB202, a proposed ustekinumab biosimilar to STELARA in Europe and Canada. The terms of the...more

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

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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

Goodwin

Genentech BPCIA Trastuzumab Case Against Tanvez Dismissed After Settlement

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As previously reported, Genentech and Tanvex reached an agreement in January 2022 to settle BPCIA litigation relating to Tanvex’s biosimilar of HERCEPTIN (trastuzumab). On February 9, the court entered an order dismissing all...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

Proskauer - Minding Your Business

$264 Million Settlement in EpiPen Price Gouging Litigation

On July 11, 2022, the United States District Court for the District of Kansas approved a $264 million settlement against Mylan and certain of its subsidiaries in the case In Re EpiPen (Epinephrine Injection, USP) Marketing,...more

White & Case LLP

Federal District Court holds that California's anti reverse payment law is enforceable, but only against settlements "negotiated,...

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In February 2022, the US District Court for the Eastern District of California held that California Assembly Bill 824—which established a first-of-its kind presumption that certain pharmaceutical patent settlements are...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

Goodwin

FDA Approves Pfizer’s Adalimumab Biosimilar ABRILADA

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On November 15, the FDA approved Pfizer’s Humira® biosimilar, ABRILADA (adalimumab-afzb). The acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, Sarah...more

Robins Kaplan LLP

ANDA Litigation Settlements - Summer 2019

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

Fenwick & West LLP

Top SCOTUS Cases that Matter for Tech, Life Sciences and Games Industries – 2018 Term Preview

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As the U.S. Supreme Court kicks off its 2018 term this week, it prepares to take up a series of firsts, including questions about the America Invents Act, securities fraud and privacy-related class action litigation. At the...more

Goodwin

Senate Passes MMA Amendment Requiring FTC and DOJ Review of Biosimilar Patent Litigation Settlements

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Yesterday, the Senate overwhelmingly (98-2) passed the “Patient Right to Know Drug Prices Act” (S.2554), which includes amendments to the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (“MMA”) that...more

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