The Hart-Scott Rodino Act requires parties to certain mergers and acquisitions to file a premerger notification with FTC and DOJ. On June 27, 2023, FTC and DOJ jointly published proposed changes to the HSR form and its corresponding rules. The proposed changes include the following: (1) Parties must provide details about the transaction rationale, including details related to investment vehicles or corporate relationships; (2) Parties must provide information related to products or services in both horizontal products and services and non-horizontal business arrangements; (3) Parties must provide details related to revenue, transaction analyses, internal documents describing market conditions, and structure of entities involved; (4) Parties must provide details regarding previous acquisitions; and (5) Parties must disclose information related to employees and their Standard Occupational Classification System categories. The proposed changes could significantly transform the regulatory review of mergers and acquisitions in the future.
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FTC and DOJ summarize workshop on antitrust enforcement in the pharmaceutical industry. |
On June 1, 2023, FTC and DOJ published a summary of a workshop held in June 2022 on potential changes to antitrust enforcement in the pharmaceutical industry. The workshop included participants from the U.S. antitrust agencies, state attorneys general, international enforcement partners, academics, and other experts. Underpinning the workshop was the trend of increased concentration in the pharmaceutical industry. The panelists and speakers discussed a wide range of topics, including the concerns of consolidation (e.g., monopolization, pay-for-delay tactics, product hopping, deceptive practices, and sham petitioning), remedies and possible alternatives (e.g., ongoing monitoring of R&D and patent output post-merger), innovation (e.g., incentives of non-merging firms to innovate), and prior bad acts as factors in pharmaceutical merger reviews.
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FTC approves changes to the Commission’s Rules of Practice. |
On June 2, 2023, FTC unanimously voted (3-0) to approve changes to the Commission’s Rules of Practice. Several minor changes were made to reflect the new Office of Technology. Administrative Law Judges (ALJs) now will issue “recommended” decisions rather than “initial” decisions. Under the Administrative Procedure Act (APA), an agency must automatically review “recommended decisions” and may affirm or reject the ALJ’s recommended decision, in whole or in part, and issue its own findings of fact or conclusions of law. In addition, ALJs no longer will have the ability to rule on motions for summary decisions in accordance with the Commission’s practice since 2009. Finally, , FTC amended the rules to reflect procedures more clearly for making Touhy and Privacy Act requests. FTC also approved other minor changes to fix misspellings, cross-references, and other ministerial changes.
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FTC finalizes consent order preventing Anchor Glass Container Corp. from entering and enforcing employee noncompete restrictions. |
FTC filed a complaint against Anchor Glass Container Corp. in March 2023 related to the company’s noncompete restrictions on more than 300 workers with more than 139 job titles, including personnel in accounting, human resources, engineering, quality assurance, technology, and more. The consent order, approved June 2, 2023, prevents Anchor Glass from entering or enforcing noncompete restrictions on such employees. Anchor Glass must also notify all relevant employees that they are no longer subject to noncompete restrictions and make clear to all new hires that they will not be subject to noncompete restrictions.
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FTC comments on pending North Carolina Bill that would shield UNC Health from antitrust scrutiny. |
On May 1, 2023, the North Carolina State Senate unanimously passed Senate Bill 743, which includes a provision that would shield University of North Carolina Health Care System and any entity it seeks to collaborate with from antitrust scrutiny. The bill is pending before the North Carolina House. FTC submitted a comment on the bill to the North Carolina House Health Committee on June 5 expressing its concerns that the bill would authorize anticompetitive conduct that would lead to higher health care costs, lower quality, reduced innovation, reduced access to care, and lower wages for hospital employees.
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FTC continues to study pharmacy benefit managers and issues compulsory order to third group purchasing organization, Emisar Pharma Services LLC. |
On June 8, 2023, FTC issued ordered Emisar Pharma Services, LLC, requiring the group purchasing organization (GPO) to provide information and records on its business practices. The order comes as part of the FTC’s ongoing effort to study pharmacy benefit managers (PBMs) and their impact on the accessibility and affordability of prescription drugs. FTC has previously issued such orders to six PBMs and two other GPOs. Emisar is a UnitedHealth Group subsidiary and negotiates rebates with drug manufactures on behalf of OptumRx, another UnitedHealth Group subsidiary.
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FTC Office of Policy Planning Director applauds Maine for the repeal of its law allowing health care providers to obtain antitrust immunity through certificates of public advantage. |
On April 24, 2023, Maine’s governor signed a bill into law that repealed the state’s Hospital and Health Care Provider Cooperation Act. The now-repealed law had allowed certain hospital and health care provider agreements to avoid antitrust scrutiny by obtaining a Certificate of Public Advantage (COPA) from the state. On June 13, 2023, FTC Office of Policy Planning Director Elizabeth Wilkins issued a statement commending the state’s repeal and noting that FTC has found that “COPAs can be difficult for states to implement and monitor over time and are often unsuccessful in mitigating merger-related price and quality harms.”
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FTC files amicus brief supporting plaintiffs in Bystolic antitrust litigation—a “pay-for-delay” case against Forest Laboratories Inc. and six generic drug manufacturers. |
On June 20, 2023, FTC filed an amicus brief to the U.S. Court of Appeals for the Second Circuit. The case relates to alleged reverse-payment settlements (or pay-for-delay agreements) between Forest Laboratories Inc. and six generic drug manufacturers that prevented generic competitors from challenging Forest’s patents and entering the market in competition with Forest’s Bystolic—a once-daily pill to treat high blood pressure—for at least eight years. FTC’s brief argues that the legal standard for plaintiffs challenging reverse payment settlements need to plead only market power and facts from which the court can infer a large and unjustified reverse payment was made. FTC argues that the U.S. District Court for the Southern District of New York erred in dismissing the case and wrongly offered hypothetical justification for Forest’s agreements with the generic manufacturers.
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In re HIV Antitrust Litigation, Case No. 3:19-cv-02573 (N.D. Cal. June 30, 2023). |
A California jury cleared Gilead and Teva of liability in an alleged “pay-for-delay” deal that allegedly artificially raised prices for two HIV drugs. The jury concluded that plaintiffs failed to show that Gilead had the requisite market power or that it had paid Teva to delay bringing its generic version of the medications to market. The lawsuit, brought by health plans, insurers, and others, stems from a settlement of patent litigation between Teva and Gilead in which Gilead granted Teva a six-month contract to be the exclusive seller of the generic versions of Gilead’s Truvada and Atripla drugs. Plaintiffs in the antitrust claim argued that the exclusive arrangement constituted a “payment,” on the theory that the Gilead patents were weak and Teva would have won that patent litigation, thus allowing generics into the market sooner than under the settlement agreement. Gilead argued that the deal allowed Teva and others to enter the market early, before the patents at issue had expired, not late. The jury agreed.
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Jeffrey Sulitzer D.M.D et al. v. Joseph Tippins et al., Case No. 2:19-cv-08902 (D.C. Cal. June 16, 2023). |
SmileDirectClub dropped its antitrust suit against the California state board of dentistry where it had claimed the Board had attempted to stifle competition through an “aggressive, anti-competitive campaign of harassment and intimidation” against the company. The trial court dismissed the case, which was originally filed in 2019, in 2020 on the grounds that the conduct about which SmileDirect complained could have just been the regulator doing its job. However, in 2022 the Ninth Circuit overturned that decision, concluding that the company had alleged sufficient anticompetitive conduct in that it is possible for a group of regulators to form an anti-competitive conspiracy. No settlement details were disclosed.
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