False Claims Act Insights - The Mathematics of Nuclear FCA Verdicts
A Counterintuitive Approach to Winning Without Litigation: One-on-One with Haley Morrison
Daily Compliance News: July 7, 2025 the Disaster on the River Edition
10 For 10: Top Compliance Stories For the Week Ending June 28, 2025
The Trend of Threatening Physicians for Personal Gain
Daily Compliance News: June 13, 2025. The All Boeing Edition
Facial Recognition and Legal Boundaries: The Clearview AI Case Study — Regulatory Oversight Podcast
Divorce Fees: When Your Spouse Might Have to Pay
How Much Will My Divorce Cost?
PODCAST: Williams Mullen's Trending Now: An IP Podcast - NCAA Name, Image, Likeness (NIL) Update – Effects of House Settlement
False Claims Act Insights - How Payment Suspensions Can Impact FCA Litigation
State AG Pulse | Massive Google Settlement Shows AGs Serious About Privacy
Can Tattoos Be Copyrighted? The Legal Battle Over Mike Tyson's Iconic Ink — No Infringement Intended Podcast
Fair Lending Shake-Ups: CFPB Vacates Townstone Settlement, FHFA Ends GSEs' Special Purpose Credit Programs — The Consumer Finance Podcast
False Claims Act Insights - DOJ’s Reliance on FCA to Pursue Covid-Related Fraud
House Final Settlement Hearing: Key Insights and Future Implications for NIL — Highway to NIL Podcast
Essentials for Balancing Taxes and Legal Risk
Podcast - The 3 Core Themes of Trial Law: Know Your Court
Daily Compliance News: April 8, 2025, The End of Monitors Edition
Medical Device Legal News with Sam Bernstein: Episode 11
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
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
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
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
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
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
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
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
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
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
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
Alexion Pharmaceuticals’ SOLIRIS (eculizumab) is approved in the U.S. for the treatment of paroxysmal nocturnal hemoglobinuria (PHN), atypical hemolytic uremic syndrome (aHUS), myasthenia gravis (gMG), and neuromyelitis...more
Please see full Chart below for more information....more
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
We have previously noted that the increasing rate of pre-institution settlement may in part be responsible for the declining institution rate in IPR proceedings because stronger petitions may drive earlier settlements,...more
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
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
In the lastest instance of a plaintiff attempting to extend the Supreme Court's holding in FTC v. Actavis that "reverse payment" settlement agreements in ANDA litigation could be anticompetitive and violate the antitrust...more
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
Last year’s Supreme Court decision in FTC v. Actavis cleared the way for more antitrust challenges to settlements between generic and branded pharmaceutical companies resolving Hatch-Waxman patent litigation. As a result,...more
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