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
I. Introduction -
No pharmaceutical antitrust decision has had more impact than the Supreme Court’s 2013 decision in Federal Trade Commission v. Actavis, a decision which officially defined the term “reverse payment...more
10/11/2023
/ Abbreviated New Drug Application (ANDA) ,
Anti-Competitive ,
Antitrust Litigation ,
AstraZeneca ,
Causation ,
Food and Drug Administration (FDA) ,
FTC v Actavis ,
Generic Drugs ,
Hatch-Waxman ,
Motion to Dismiss ,
Orange Book ,
Pharmaceutical Industry ,
Popular ,
RanBaxy ,
Reverse Payment Settlement Agreements ,
SCOTUS ,
Settlement
On October 19, 2022, U.S. District Judge Mitchell Goldberg in the Eastern District of Pennsylvania granted Aquestive Therapeutics Inc.’s (f/k/a MonoSol Rx LLC) motion for summary judgment in the long-running Suboxone MDL,...more
On Wednesday, March 30, 2022, Judge Royce C. Lamberth of the U.S. District Court for the District of Columbia, released a redacted opinion dismissing the Federal Trade Commission’s follow-on antitrust suit regarding Endo...more
For nearly a decade, the Supreme Court’s FTC v. Actavis decision has guided pharmaceutical litigators and advisors exploring the antitrust risks inherent in settling pharmaceutical patent lawsuits, especially when such...more
3/3/2022
/ Anti-Competitive ,
Biosimilars ,
Dormant Commerce Clause ,
Federal Trade Commission (FTC) ,
FTC v Actavis ,
Hatch-Waxman ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Reverse Payment Settlement Agreements
On August 13, 2021, in a decision that largely flew under antitrust and patent practitioners’ radars, U.S. District Judge Lucy H. Koh mostly denied a motion to dismiss in the alleged “reverse payment” case, In Re Xyrem...more
On July 8, 2020, Judge Alison Burroughs granted-in-part Defendants Shire and Actavis’s motion to decertify a direct purchaser plaintiff class in an alleged reverse payment antitrust case pending in the Federal District Court...more
7/13/2020
/ Antitrust Violations ,
Chapter 11 ,
Class Action ,
Class Certification ,
Class Representatives ,
Commercial Bankruptcy ,
Conflicts of Interest ,
Decertification ,
Defense Strategies ,
Direct Purchasers ,
Disqualified Persons ,
Pharmaceutical Industry ,
Popular ,
Wholesale
On February 3, 2020, the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued a joint statement announcing their plans to collaborate in promoting competitive biological product markets and...more
2/10/2020
/ Antitrust Violations ,
Biologics ,
Biologics Price Competition and Innovation Act of 2009 ,
Citizens Participation Acts ,
Competition ,
Drug Pricing ,
Expedited FDA Approval ,
False Statements ,
FDA Approval ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Joint Statements ,
Patents ,
Pay-For-Delay ,
Pharmaceutical Industry ,
Prescription Drugs ,
Reverse Payment Settlement Agreements