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
On May 29, 2024, the U.S. Food and Drug Administration (“FDA”) released draft guidance titled Platform Technology Designation Program for Drug Development. The draft guidance describes the process for requesting and receiving...more
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
This past Thursday, the Board of Appeals of the European Patent Office released the minutes of oral proceedings in which the Board rendered a decision in closely watched appeals relating to Broad patents directed to...more
Illumina Agrees to Unwind Acquisition of Grail Following Fifth Circuit Decision. On December 15, 2023, the Fifth Circuit vacated the FTC’s order that Illumina unwind its acquisition of Grail—a developer of a multi-cancer...more
1/18/2024
/ Acquisitions ,
Administrative Law Judge (ALJ) ,
Antitrust Litigation ,
Antitrust Provisions ,
Appeals ,
Class Action ,
Competition ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Insurance ,
Life Sciences ,
Orange Book ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Reimbursements ,
Sherman Act ,
United Healthcare Insurance Co.
This past Friday, a federal district court held that the mere fact of combining certain natural products – such as isolated, naturally occurring AAV sequences and a heterologous non-AAV sequence – and putting them into a...more
European Commission Orders Unprecedented Unwinding Of Illumina’s Acquisition of GRAIL. For the first time, the European Commission has ordered reversal of a consummated transaction, Illumina Inc.’s 2021 acquisition of GRAIL...more
11/10/2023
/ Acquisitions ,
Antitrust Investigations ,
Antitrust Provisions ,
EU ,
EU Merger Directive ,
European Commission ,
Federal Trade Commission (FTC) ,
Life Sciences ,
Member State ,
Multidistrict Litigation ,
Patents ,
Pfizer ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Reversal
This marks the second issue of WilmerHale’s The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences, a monthly bulletin that will highlight developments in the antitrust and life sciences space. We will...more
10/16/2023
/ Acquisitions ,
Criminal Prosecution ,
CVS ,
Department of Justice (DOJ) ,
Drug Pricing ,
False Marking ,
Federal Trade Commission (FTC) ,
Hatch-Waxman ,
Industry Consolidation ,
Life Sciences ,
Mergers ,
Orange Book ,
Partnerships ,
Pharmaceutical Industry ,
Pharmacies ,
Policy Statement ,
Section 340B ,
TPAs
This marks the first issue of WilmerHale’s The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences, a monthly bulletin that will highlight developments in the antitrust and life sciences space. We will...more
9/15/2023
/ Acquisitions ,
Amgen ,
Antitrust Litigation ,
Antitrust Provisions ,
Competition ,
Consent Order ,
Endo Pharmaceuticals ,
Federal Trade Commission (FTC) ,
Gilead Sciences ,
License Agreements ,
Life Sciences ,
Patent Act ,
Pharmaceutical Industry ,
Popular