Federal Circuit Allows Teva Patents to Remain in Orange Book. -
The Federal Circuit recently granted Teva Pharmaceutical’s motion for a stay of removal of its patents from the Orange Book in its ongoing dispute with...more
8/1/2024
/ Antitrust Litigation ,
Class Action ,
Consumer Protection Laws ,
Distributed Ledger Technology (DLT) ,
Federal Trade Commission (FTC) ,
Generic Drugs ,
Health Insurance ,
Life Sciences ,
Orange Book ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Pharmacy Benefit Manager (PBM) ,
Sherman Act ,
Teva Pharmaceuticals ,
The Clayton Act
Court Orders Delisting of Patents from Orange Book and Denies Motion to Dismiss Antitrust Counterclaims for Improper Orange Book Listings. On June 10, Judge Stanley Chesler of the District of New Jersey entered judgment on...more
7/3/2024
/ Abbreviated New Drug Application (ANDA) ,
America Invents Act ,
Antitrust Provisions ,
Cartels ,
Comment Period ,
EU ,
European Commission ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medicare ,
Monopolization ,
Orange Book ,
Patents ,
Pharmaceutical Industry ,
Price-Fixing ,
Reverse Payments ,
Settlement Agreements ,
Sherman Act ,
USPTO
Second Circuit Affirms “Pay for Delay” Dismissal: On May 13, 2024, the Second Circuit affirmed dismissal of antitrust claims brought by wholesalers, retailers, and employee benefit funds that alleged they overpaid for the...more
5/31/2024
/ Antitrust Provisions ,
Dismissals ,
Fair Value Standard ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Investment Funds ,
Life Sciences ,
Monopolization ,
Orange Book ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Prescription Drugs ,
Retailers ,
Settlement ,
Wholesale
This week, the FTC continued its intense regulatory focus on pharmaceutical patents listed in the FDA’s Orange Book. As reported in earlier editions of The Interplay, the FTC issued a policy statement in September 2023,...more
5/7/2024
/ Anti-Competitive ,
Antitrust Provisions ,
Class Action ,
Class Certification ,
Competition ,
Drug Pricing ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Orange Book ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Prescription Drugs ,
Settlement Agreements ,
Sherman Act ,
Warning Letters
The United Kingdom (UK) left the European Union (EU) on 31 January 2020. Since then, under the EU-UK Withdrawal Agreement, a transition period has been in force, in principle until 1 January 2021. During this period most EU...more
Today, as part of the Trump Administration's stated goal to lower drug prices, the Food and Drug Administration (FDA) published a list of pharmaceutical companies that have allegedly refused to sell samples of their drugs to...more
On August 28, 2017, in King Drug Company of Florence, Inc., et al. v. Cephalon, Inc., et al., the Eastern District of Pennsylvania denied class certification for direct purchasers asserting Hatch-Waxman reverse-payment...more