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Hart-Scott-Rodino Act Pharmaceutical Industry

The Hart-Scott Rodino Antitrust Improvements Act is a United States federal statute enacted in 1976 establishing the federal premerger notification program. Under the Act, parties contemplating mergers or... more +
The Hart-Scott Rodino Antitrust Improvements Act is a United States federal statute enacted in 1976 establishing the federal premerger notification program. Under the Act, parties contemplating mergers or acquisitions must notify the Department of Justice and the Federal Trade Commission prior to completing the transaction. Once notified, the DOJ and FTC investigate and make a determination as to whether the proposed transaction will adversely impact U.S. commerce and competition within the market. less -
Ballard Spahr LLP

Antitrust In Flux: What's Shaping the Life Sciences Industry

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Under the current administration, there have been significant shakeups at the antitrust enforcement agencies, including the FTC and the DOJ Antitrust Division, which have led to uncertainty regarding enforcement priorities....more

Troutman Pepper Locke

Exclusive Licensing May Offer Biotechs a Financial Lifeline

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With volatile market conditions and recent FDA shakeups, biotech companies are increasingly focused on bolstering cash runways and accelerating R&D efforts. But fierce competition for financing has some biotechs turning to...more

Troutman Pepper Locke

Embattled Biotechs Facing Uncertainty at the FDA Look to Collaborative Deal Structures

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Biotechs have faced several challenging years with slumping valuations and a competitive funding environment. However, the latest slew of retirements and layoffs at the FDA could present their greatest challenge yet....more

Sheppard Mullin Richter & Hampton LLP

2025 Top-of-Mind Issues for Life Sciences Companies

DTC Telehealth Platforms - Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more

Ropes & Gray LLP

[Podcast] New HSR Rules: Impacts to the Pharma Industry

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On this Ropes & Gray podcast, strategic transactions partner Hannah England is joined by antitrust partners Jackie Grise and Zak Goodwin to discuss the practical implications of the new Hart–Scott–Rodino (“HSR”) Act rules,...more

BakerHostetler

California Pharmacies Put on Notice: California’s Pharmacy Transaction Notice Requirement

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As of January 1, 2025, parties to transactions involving pharmacies located in California may also need to file a written notice with the California Attorney General. Assembly Bill 853 (AB 853), codified at Part 14 to...more

Morrison & Foerster LLP

Latest Symptom of the Health Care Crackdown: DOJ Announces New Task Force Targeting Sector’s Anti-Competitive Conduct

On May 9, 2024, the U.S. Department of Justice’s Antitrust Division (DOJ) announced it is “upping [its] game” on health care enforcement through the Task Force on Health Care Monopolies and Collusion (HCMC). The most recent...more

Wilson Sonsini Goodrich & Rosati

Navigating the Maze in Pharma Transactions: FTC Blocks Sanofi’s Exclusive License with Maze Therapeutics

Amidst a wave of challenges to mergers on novel theories of harm, proposals to revamp both the HSR Filing rules and the Merger Guidelines used for assessing the competitive impact of mergers, and taking steps to enlarge the...more

Goodwin

Antitrust & Competition Life Sciences Quarterly Update - Q3 2023

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The FTC’s Amgen/Horizon Lawsuit Ends With a Whimper - We covered the FTC’s investigation into (and litigation challenging) Amgen’s $28.3 billion acquisition of rare disease specialist Horizon Therapeutics in our Q1 and...more

McDermott Will & Schulte

Antitrust M&A Snapshot - Q2 2023

APRIL – JUNE 2023: KEY THEMES AND TAKEAWAYS - UNITED STATES - • Federal Trade Commission Unveils Proposal Detailing Significant Changes to Hart-Scott-Rodino Act Merger Notifications On June 27, 2023, the Federal Trade...more

McDermott Will & Schulte

Antitrust M&A Snapshot - Q2 2022

APRIL – JUNE 2022: KEY THEMES AND TAKEAWAYS - UNITED STATES - • An Overview of Agency Merger Challenges from January 2021 through June 2022 Parties continue to be cautious in litigating challenged transactions. Since...more

Goodwin

Antitrust + Competition Life Sciences Quarterly Update - Q1 2022

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Despite the aggressive rhetoric, the change in the leadership and composition at the U.S. Federal Trade Commission (FTC) did not result in more enforcement in 2021. As the calendar turned to 2022, the FTC seems to be stepping...more

Goodwin

Biden Executive Order Calls for Heightened Antitrust Scrutiny

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On July 9, 2021, President Joe Biden announced a broad executive order (the “Order”) intended to boost what it characterizes as stagnant competition across the U.S. economy. The Order, among other things, encourages the...more

Seyfarth Shaw LLP

Antitrust Pitfalls: FTC Orders Unwinding of Two-Year-Old Acquisition

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In a unanimous Opinion and Final Order issued on November 1, 2019, the Federal Trade Commission (“FTC”) upheld an administrative law judge’s determination that the acquisition by one leading US supplier of lower-limb...more

Cadwalader, Wickersham & Taft LLP

Buyer Beware: FTC Orders Unwinding of a Consummated Transaction

What happened? On November 6, 2019, the Federal Trade Commission (“FTC”) voted 5-0 to uphold Administrative Law Judge D. Michael Chappell’s initial decision that Otto Bock HealthCare GmbH’s (“Otto Bock”) acquisition of rival...more

Perkins Coie

Mergers and Acquisitions Takeaways From the 2017 ABA Antitrust Law Spring Meeting

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The American Bar Association’s 65th Antitrust Law Spring Meeting held at the end of March included a number of sessions with representatives from federal and state antitrust enforcement agencies. In the first article in a...more

McDermott Will & Schulte

THE LATEST: Losing Bidder for Pharmaceutical Triggers FTC Investigation, Fix, and $100 Million Fine in Non-HSR-Reportable...

A private lawsuit filed by Retrophin Inc. (Retrophin), under then-CEO Martin Shkreli, likely triggered an investigation by the FTC into a consummated transaction. Both the private lawsuit and the FTC complaint resulted in...more

Hogan Lovells

Antitrust, Competition and Economic Regulation Quarterly Newsletter - Winter 2017

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FTC takes another look at merger remedies - On 3 February 2017, the U.S. Federal Trade Commission (“FTC”) released its Merger Remedies Study, which analyzed the success of merger remedies imposed by the FTC from 2006 to...more

Cooley LLP

Alert: Antitrust 2017: Trends and Developments to Watch

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1. Transition to a Trump Administration is top of the agenda - President-elect Donald Trump's DOJ and FTC transition team appointments and public short list of candidates to run the agencies indicate that antitrust...more

WilmerHale

Developments in Merger Control: It Ain't Over 'til It's Over

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Two recent enforcement actions are reminders that there are antitrust risks to be addressed after the deal is signed and even after it has closed. In the United States, the Federal Trade Commission (FTC) challenged Valeant...more

Proskauer Rose LLP

Expanded HSR Antitrust Reporting for Pharma Licensing Deals Is Here to Stay

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On June 9, 2015, the U.S. Court of Appeals for the D.C. Circuit, in its ruling in Pharm. Research & Mfrs. of Am. v. FTC, upheld the FTC's expansion of HSR reporting requirements for pharmaceutical companies, and solidified...more

Kelley Drye & Warren LLP

Expanded FTC Premerger Notification Rules Specific to the Pharmaceutical Industry are Upheld by the D.C. Circuit

The D.C. Circuit recently affirmed a lower court’s decision upholding regulations adopted by the Federal Trade Commission (FTC) requiring a Hart Scott Rodino (HSR) Act premerger notification filing for transfers of patent...more

Faegre Drinker Biddle & Reath LLP

Your Drug Patent Rights Transfer May Be Reportable, Court of Appeals Confirms

On Nov. 6, 2013, the Federal Trade Commission (FTC or Commission) modified its Hart-Scott-Rodino Act (HSR) rules to clarify that transfers of patent rights within the pharmaceutical industry constitute potentially reportable...more

Goodwin

Federal Appeals Court Upholds FTC HSR Rule on Pharma Patent Licenses

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Background – the HSR Act: Under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (the HSR Act), acquisitions of voting securities, assets and other commercial interests which exceed certain monetary thresholds...more

Mintz - Intellectual Property Viewpoints

D.C. Circuit Affirms: FTC Can Change HSR Rules Targeted at Pharmaceutical Patents

In a confluence of IP and antitrust law, a three judge panel for the D.C. Circuit recently affirmed a lower court decision upholding the Federal Trade Commission’s (“FTC”) 2013 modification of regulations under the Hart Scott...more

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