In a landmark decision, the European Court of Justice (ECJ) has limited the European Commission’s (EC) ability to review mergers that fall outside thresholds at the EC level and in the Member States seeking to refer the...more
9/6/2024
/ Competition Authorities ,
Court of Justice of the European Union (CJEU) ,
EU ,
European Commission ,
European Merger Control Regulation ,
Jurisdiction ,
Jurisdictional Thresholds ,
Member State ,
Merger Controls ,
Merger Reviews ,
Mergers ,
Threshold Requirements
In this episode of In the Public Interest, co-host Felicia Ellsworth is joined by WilmerHale Partner Lee Greenfield to discuss the Supreme Court’s recent decision in Department of State v. Muñoz. The case concerns the due...more
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
On June 28, the Supreme Court handed down its decision in Loper Bright Enterprises v. Raimondo, overruling Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc. In its 1984 Chevron decision, the Court held that...more
7/9/2024
/ Chevron Deference ,
Chevron v NRDC ,
Federal Trade Commission (FTC) ,
Final Rules ,
Government Agencies ,
Hart-Scott-Rodino Act ,
Judicial Review ,
Loper Bright Enterprises v Raimondo ,
Non-Compete Agreements ,
Proposed Rules ,
Reasonable Interpretations ,
Regulatory Authority ,
SCOTUS ,
Section 5 ,
Statutory Interpretation
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
On April 23, 2024, the Federal Trade Commission (FTC), in a highly anticipated vote, passed the Non-Compete Clause Rule, 16 CFR § 910 (the Rule), which purports to bar all non-competes in the United States, subject to limited...more
4/26/2024
/ Chamber of Commerce ,
Constitutional Challenges ,
Employer Liability Issues ,
Employment Contract ,
Federal Bans ,
Federal Trade Commission (FTC) ,
Final Rules ,
Highly Compensated Employees ,
Non-Compete Agreements ,
Restrictive Covenants ,
Unfair Competition
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
The healthcare industry remains a focal point of President Biden’s antitrust agenda. The president’s July 2021 Executive Order on Promoting Competition in the American Economy called on federal agencies to focus antitrust...more
Parties contemplating transactions in the defense sector need to know about a new obligation to provide materials to the Department of Defense (DOD) that will substantially affect their obligations for transactions that are...more
2/8/2024
/ Antitrust Investigations ,
Antitrust Provisions ,
Competition ,
Defense Sector ,
Department of Defense (DOD) ,
Department of Justice (DOJ) ,
Federal Trade Commission (FTC) ,
GAO ,
Hart-Scott-Rodino Act ,
Merger Reviews ,
Mergers ,
NDAA
On January 22, 2024, the Federal Trade Commission (FTC) announced revised thresholds for merger notifications under the Hart-Scott-Rodino (HSR) Act. Effective 30 days after the official publication date in the Federal...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.
On December 18, 2023, the Federal Trade Commission and the Department of Justice jointly released their final Merger Guidelines. The Guidelines “identify the procedures and enforcement practices [the agencies] most often use...more
Under their current leadership, the U.S. federal antitrust agencies have shown antipathy to resolving merger investigations through remedy undertaking that are embodied in consent decrees, preferring instead to seek to...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
On October 12, 2023, the European Commission (EC) ordered Illumina to unwind its already completed acquisition of the cancer-test provider GRAIL Inc. This is the first time that the EC has ordered a reversal of an...more
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 July 19, 2023, the Federal Trade Commission and the Department of Justice released a draft update of the Merger Guidelines. The draft Guidelines describe how the agencies “review...mergers and acquisitions to determine...more
7/21/2023
/ Antitrust Division ,
Comment Period ,
Competition ,
Department of Justice (DOJ) ,
Federal Trade Commission (FTC) ,
Guidance Update ,
Horizontal Mergers ,
Merger Reviews ,
Mergers ,
Rulemaking Process ,
Vertical Mergers
As described in our Client Alert of July 6, 2023, the Federal Trade Commission (FTC) and the Department of Justice (DOJ) proposed on June 27, 2023, a massive overhaul of the Hart-Scott-Rodino Act (HSR) pre-merger notification...more
7/19/2023
/ Antitrust Division ,
Comment Period ,
Department of Justice (DOJ) ,
Federal Trade Commission (FTC) ,
Hart-Scott-Rodino Act ,
Merger Reviews ,
Mergers ,
Notice Requirements ,
NPRM ,
Premerger Notifications ,
Private Equity ,
Private Equity Funds ,
Proposed Amendments ,
Required Forms
For the first time in 45 years, the Federal Trade Commission (FTC) and the Antitrust Division of the US Department of Justice (DOJ) proposed on June 27, 2023, a massive overhaul of the Hart-Scott-Rodino Act (HSR) pre-merger...more
On May 16, 2023, the Federal Trade Commission filed a complaint in the Northern District of Illinois seeking to enjoin closing of Amgen Inc.’s proposed $28 billion acquisition of Horizon Therapeutics. This is the first time...more
On 20 April 2023, the European Commission (EC) adopted a package of measures to “simplify” its merger control procedures. The reform expands the scope of the EU’s simplified merger control procedure, introduces a new...more
Senior officials at the US Department of Justice Antitrust Division (DOJ) and the US Federal Trade Commission (FTC) have made clear that they will not entertain or will sharply limit resolutions of merger investigations...more