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
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
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 Friday, August 25, 2023, the U.S. Court of Appeals For The District Of Columbia Circuit affirmed dismissal of an antitrust action brought by the Federal Trade Commission regarding Endo Pharmaceuticals’s grant of an...more
9/22/2023
/ Antitrust Litigation ,
Appeals ,
Dismissals ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
FTC Act ,
FTC v Actavis ,
Licenses ,
Patent Act ,
Pharmaceutical Patents ,
SCOTUS ,
Sherman Act
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 April 8, 2022, the U.S. Court of Appeals for the Ninth Circuit, sitting en banc, re-certified three classes of packaged tuna buyers, rejecting a Ninth Circuit panel-majority’s per se rule regarding a de minimis number of...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
The U.S. Court of Appeals for the 9th Circuit recently weighed in on the effect of uninjured class members on class certification—decertifying three classes in Olean Wholesale Grocery Coop. v. Bee Foods LLC. Olean concerned...more
In the world of technology, Standard Setting Organizations (“SSOs”) play a crucial role in helping to facilitate innovation. They do so by creating industry standards that ensure quality and promote and enable the development...more
On Tuesday, August 11, 2020, the Ninth Circuit reversed and vacated Judge Lucy Koh’s controversial, post-bench trial decision in FTC v. Qualcomm Inc., 411 F. Supp. 3d 658 (N.D. Cal. 2019), regarding whether Qualcomm violated...more
8/17/2020
/ Anticompetitive Behavior ,
Antitrust Violations ,
Appeals ,
Cell Phones ,
Federal Trade Commission (FTC) ,
FRAND ,
FTC Act ,
Injunctive Relief ,
Intellectual Property Protection ,
IP License ,
Monopolization ,
OEM ,
Patent Royalties ,
Popular ,
Qualcomm ,
Remand ,
Reversal ,
Sherman Act ,
Standard Essential Patents
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