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
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 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
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 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