Medical Device Legal News with Sam Bernstein: Episode 11
A Conversation With NAAG Executive Director Brian Kane - Regulatory Oversight Podcast
Podcast: The Briefing by the IP Law Blog - Chipotle and Sweetgreen Settle Food Fight Over CHIPOTLE Trademark
The Briefing by the IP Law Blog: Chipotle and Sweetgreen Settle Food Fight Over CHIPOTLE Trademark
The Justice Insiders Podcast: Feds Danske to a New Tune
State AG Pulse | Money, Money, Money: Where does it go and why?
The Chartwell Chronicles: Occupational Exposure Claims
The Chartwell Chronicles: An Overview of New Jersey Workers' Compensation
Patient Steering and Charting
A Look at the Unique Features of State AG Investigations and What Companies Should Consider in Selecting Outside Counsel - Regulatory Oversight Podcast
A Close Look at the Justice Department’s Settlement with Meta (Formerly Facebook) to Resolve Alleged Fair Housing Act Violations Arising from Meta’s Targeted Advertising System
Settlement and Mediation Strategy
An Overview of South Carolina Workers' Compensation
An Overview of New Jersey Workers' Compensation
Protecting Trade Secrets When Facing Lawsuits or Alternative Dispute Resolution Procedures
No Harbor is Limitless: Restrictions of the Federal Anti-Kickback Statute's Safe Harbor Provisions
Episode 149 -- A Deep Dive into Alexion's SEC Settlement for FCPA Violations
Developments in New York State Labor and Employment Law – What You Need to Know in 2020
DOL Sets Enforcement Records Again - Employment Law This Week® - Trending News
Jones Day Presents: Large Business & International Examination Strategies: Fast Track Settlements
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
The ECJ confirms its intolerance against conduct that is viewed as originator companies buying off competition from generic companies about to enter the market and thereby unduly prolonging their monopoly. Such conduct, which...more
On Monday, May 13, 2024, the U.S. Court of Appeals for the Second Circuit affirmed Judge Lewis Liman’s decision dismissing Plaintiffs’ reverse payment class actions for failure to state a claim. In re Bystolic Antitrust...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
In DexCom, Inc., v. Abbott Diabetes Care, Inc., 89 F.4th 1370 (Fed. Cir. 2024), the U.S. Court of Appeals for the Federal Circuit affirmed a district court’s denial of a preliminary injunction, finding that a patentee could...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
It has been reported that Celltrion has finalized a settlement with Johnson & Johnson (“J&J”) in the United States relating to CT-P43, Celltrion’s ustekinumab biosimilar to J&J’s STELARA®, which would permit Celltrion to...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
On November 12, 2020, Genentech filed a complaint in the Eastern District of Texas alleging that the Centus Biotherapeutics, Ltd., Fujifilm Kyowa Kirin Biologics Co., Ltd., Fujifilm Corp., and Kyowa Kirin Co, Ltd....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
As we previously reported, in October 2018, Pfizer persuaded the Patent Trial and Appeal Board (PTAB) that the claims of Biogen’s U.S. Patent No. 8,821,873, directed to a method of treating lymphoma with anti-CD20 antibodies...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 Chart below for more information. ...more
Following last month’s dismissal of the Amgen v. Kashiv filgrastim biosimilar litigation, yesterday Amgen and Tanvex filed a joint stipulation of dismissal in their BPCIA litigation concerning Tanvex’s filgrastim biosimilar...more
Please see full Chart below for more information....more
On May 23, 2019, the Federal Trade Commission (FTC) published its annual report on pharmaceutical patent settlements filed with the FTC under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA),...more
On October 11, 2018, AbbVie and Sandoz announced that they reached a global resolution of all intellectual property-related litigation concerning Sandoz’s Hyrimoz™, a proposed biosimilar of Humira® (adalimumab). According to...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
Today, AbbVie and Samsung Bioepis announced that they have reached a global resolution of all intellectual property-related litigation relating to Samsung Bioepis’ biosimilar of Humira® (adalimumab), SB5, clearing the way for...more
On April 6, 2017, the Federal Court of Appeal overturned the Federal Court’s finding that Apotex failed to mitigate the damage it incurred as the result of Health Canada’s misfeasance in public office and negligence in its...more