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 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
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
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 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
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
On January 23, 2023, the Federal Trade Commission (FTC) announced revised thresholds for merger notifications under the Hart-Scott-Rodino (HSR) Act. Effective on February 27, 2023, the lowest size-of-transaction filing...more
2/3/2023
/ Acquisitions ,
Antitrust Provisions ,
Federal Trade Commission (FTC) ,
Filing Fees ,
Hart-Scott-Rodino Act ,
Mergers ,
Pre-Merger Filing Requirements ,
Premerger Notifications ,
Size of Persons Test ,
Size of Transaction Test ,
The Clayton Act ,
Threshold Requirements
On December 29, 2022, President Biden signed into law the Consolidated Appropriations Act of 2023 (the Act), which changes the fee structure for transactions that are notified under the Hart-Scott-Rodino Antitrust...more
1/9/2023
/ Antitrust Provisions ,
China ,
Department of Justice (DOJ) ,
Federal Trade Commission (FTC) ,
Filing Fees ,
Foreign Subsidies ,
Hart-Scott-Rodino Act ,
Mergers ,
Pre-Merger Filing Requirements ,
Russia ,
Size of Transaction Test ,
Threshold Requirements
Since March 2021, the Federal Trade Commission (FTC or Commission) has challenged three proposed acquisitions based on vertical competitive concerns. The parties in two of those transactions - Nvidia/Arm and Lockheed...more
In an August 3 blog post, the Federal Trade Commission (FTC) announced a change to the FTC’s merger review process with potentially far-reaching effects. Emphasizing the agency’s constrained capacity resulting from a “tidal...more
8/17/2021
/ Antitrust Division ,
Antitrust Investigations ,
Antitrust Provisions ,
Biden Administration ,
Federal Trade Commission (FTC) ,
Hart-Scott-Rodino Act ,
Mergers ,
Premerger Notifications ,
Strategic Enforcement Plan ,
Threshold Requirements ,
Warning Letters
On July 9, 2021, the Biden Administration issued an Executive Order on “Promoting Competition in the American Economy.” The Order is notable in its breadth and commitment to a coordinated federal government approach to...more
It has long been recognized that patent pools can create licensing efficiencies by establishing “onestop shops” for patents owned by multiple rights owners. There is also broad consensus that patentee collaboration in patent...more
1/26/2021
/ Antitrust Provisions ,
Big Data ,
Connected Cars ,
Department of Justice (DOJ) ,
Intellectual Property Protection ,
Internet of Things ,
IP License ,
Patent Ownership ,
Patent Pools ,
Patents ,
Standard Essential Patents ,
Universities
In recent years, both Republican and Democratic-led antitrust agencies have pursued aggressive merger enforcement programs, litigating many cases and settling many more. However, “populist” and other progressive critics have...more
For the last several years, debate over the proper role of antitrust has not been limited to academics, economists, lawyers, and judges, but routinely includes politicians, journalists, and increasingly the general public....more
The first half of 2020 was a busy time for antitrust in the United States. The Department of Justice (DOJ) and the Federal Trade Commission (FTC) implemented expedited procedures for reviewing collaborations during the...more
8/27/2020
/ Antitrust Investigations ,
Antitrust Provisions ,
Coronavirus/COVID-19 ,
Corporate Counsel ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Merger Controls ,
Mergers ,
Pharmaceutical Industry ,
Popular ,
Technology Sector ,
Vertical Mergers
On January 28, 2020, the Federal Trade Commission (FTC) announced revised thresholds for merger notifications under the Hart-Scott-Rodino (HSR) Act. Parties to transactions that close on or after February 27, 2020 are subject...more
2/6/2020
/ Acquisitions ,
Antitrust Provisions ,
Federal Trade Commission (FTC) ,
Hart-Scott-Rodino Act ,
Mergers ,
Premerger Notifications ,
Section 8 ,
Size of Persons Test ,
Size of Transaction Test ,
The Clayton Act ,
Threshold Requirements
A month ago, we covered recent European competition law developments on pre-merger information sharing and “gun jumping” among merging parties. In a timely reminder that the same questions also are relevant in the United...more
Earlier this week, the Antitrust Division of the Department of Justice (DOJ) filed a lawsuit seeking to unwind Parker-Hannifin's $4.3 billion consummated acquisition of Clarcor. This is a notable challenge for two reasons. ...more
More than 21 years ago, the US antitrust agencies issued guidance to the business community on two critical topics of antitrust enforcement: (1) the licensing of intellectual property rights and (2) international enforcement...more