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
Calls for Removal of Device Patents Listed in the Orange Book Continue. FTC and Congressional action scrutinizing allegedly “improper” Orange Book listings continued apace in the first few months of 2024. ...more
4/2/2024
/ AbbVie ,
Antitrust Litigation ,
AstraZeneca ,
Boehringer ,
Class Action ,
CVS ,
Delisting ,
Federal Trade Commission (FTC) ,
Generic Drugs ,
GlaxoSmithKline ,
Hospitals ,
Medical Devices ,
Monopolization ,
Mylan Pharmaceuticals ,
Orange Book ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Prescription Drugs ,
Rebates ,
Sherman Act ,
Teva Pharmaceuticals
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.
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
On December 8, 2021, a federal district court granted a preliminary injunction temporarily enjoining enforcement of the California state law Preserving Access to Affordable Drugs, which attempts to sanction reverse-payment...more
12/14/2021
/ Article III ,
Constitutional Challenges ,
Dormant Commerce Clause ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Preliminary Injunctions ,
Prescription Drugs ,
Settlement Agreements ,
Settlement Negotiations ,
State Attorneys General
A new California law, Preserving Access to Affordable Drugs, AB-824 (the Act), which is aimed at curbing reverse-payment patent settlements, took effect on January 1. The Act codifies a presumption that any transfer of value...more
1/9/2020
/ Actavis Inc. ,
Anti-Competitive ,
Appeals ,
Biosimilars ,
Burden-Shifting ,
Constitutional Challenges ,
Dormant Commerce Clause ,
Due Process ,
Eighth Amendment ,
Federal Trade Commission (FTC) ,
FTC v Actavis ,
Generic Drugs ,
Hatch-Waxman ,
New Legislation ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pay-For-Delay ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Preemption ,
Prescription Drugs ,
Reverse Payment Settlement Agreements ,
Rule-of-Reason Analysis
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
On Sept. 28, 2016, in Mylan Pharmaceuticals Inc. v. Warner Chilcott Public Limited Co. (Doryx), the Third Circuit affirmed the lower court’s grant of summary judgment rejecting antitrust claims brought against Warner Chilcott...more
On September 28, 2016, in Mylan Pharmaceuticals Inc. v. Warner Chilcott Public Limited Co. (Doryx), the Third Circuit affirmed the lower court's grant of summary judgment against antitrust claims by generic manufacturer Mylan...more