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
Introduction Pharmacy benefit managers (PBMs) are the healthcare system players most patients have never heard of. Yet, PBMs represent a multibillion-dollar industry that touches the majority of Americans’ lives. Known as...more
Six months after the Department of Justice (“DOJ”), United States Patent and Trademark Office (“USPTO”), and the National Institute of Standards and Technology (“NIST”) issued a Draft Policy Statement on Licensing...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 November 10, 2021, the European Union’s General Court issued a decision largely upholding the European Commission’s finding that Google abused its dominant position by favoring results from its own comparison-shopping...more
1/5/2022
/ Abuse of Dominance ,
Antitrust Violations ,
Competition ,
Corporate Counsel ,
Enforcement Actions ,
EU ,
European Commission ,
Federal Trade Commission (FTC) ,
Google ,
Search Results ,
Vertical Integration ,
Vertical Mergers
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 Federal Trade Commission (“FTC”) sued AbbVie and Besins Healthcare, co-owners of a patent that covered brand AndroGel, in 2017. The FTC claimed that the manufacturers had brought “sham” patent infringement litigation in...more
10/20/2021
/ Abbreviated New Drug Application (ANDA) ,
AbbVie ,
Antitrust Violations ,
Federal Trade Commission (FTC) ,
FTC Act ,
Hatch-Waxman ,
Monopolization ,
Noerr-Pennington Doctrine ,
Patent Infringement ,
Petition for Writ of Certiorari ,
Reverse Payment Settlement Agreements ,
Sham Litigation Exception ,
Teva Pharmaceuticals
On September 10, 2021, Janet Woodcock, Acting Commissioner of the U.S. Food and Drug Administration (FDA), sent a letter to Andrew Hirshfeld, Director of the U.S. Patent and Trademark Office (USPTO), which raised several of...more
10/12/2021
/ AbbVie ,
Biden Administration ,
Competition ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Intellectual Property Protection ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
USPTO
Biologics are revolutionizing the pharmaceutical industry, and in doing so, garnering an increasing share of antitrust attention. In recent years, the FTC, FDA, and antitrust plaintiffs’ bar have raised concerns about a...more
On June 10, 2021, the Federal Circuit issued a precedential order in Chandler v. Phx. Servs. LLC, No. 2020-1848 (Fed. Cir. Jun. 10, 2021) that clarified the scope of its jurisdiction over Walker Process1 claims of...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
A federal district court recently dismissed a lawsuit against AbbVie and biosimilar manufacturers of adalimumab involving a novel antitrust claim against the Humira patent estate. Attorneys with Haug Partners LLP take an...more
7/20/2020
/ AbbVie ,
Amgen ,
Anticompetitive Behavior ,
Antitrust Litigation ,
Antitrust Violations ,
Biosimilars ,
BPCIA ,
Defense Strategies ,
Dismissals ,
Drug Pricing ,
EU ,
Federal Trade Commission (FTC) ,
Foreign Patent Applications ,
Indirect Purchasers ,
Litigation Strategies ,
Noerr-Pennington Doctrine ,
Orange Book ,
Patent Dance ,
Patent Portfolios ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Product Exclusivity
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