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Antitrust Provisions Medical Devices

Goodwin

Antitrust Life Sciences Quarterly Update 2025 Q1

Goodwin on

While M&A activity slowed in the first quarter of 2025, including in life sciences, there have been plenty of noteworthy developments in the antitrust space in the first 100 days of the Trump administration....more

Goodwin

FTC’s First Merger Challenge Under New Leadership Signals Return to Traditional Antitrust Theories in Private Equity Deals

Goodwin on

On March 6, 2025, the Federal Trade Commission (FTC) filed a lawsuit in federal court challenging GTCR BC Holdings, LLC's (GTCR) proposed acquisition of Surmodics, Inc. (Surmodics). The complaint alleges that the transaction...more

Goodwin

How the Trump Administration Could Reshape Regulation in the Life Sciences Sector

Goodwin on

Based on recent policy signals and statements from incoming administration officials, a picture of potential regulatory and policy changes that could affect biotech, pharmaceutical, and medical device companies in coming...more

Polsinelli

The FTC’s Challenge to the Listing of Device Patents in the Orange Book: What Challenge?

Polsinelli on

On September 23, 2023, the FTC issued a policy statement advising it would be putting market participants on notice that it intends to scrutinize improper Orange Book listings to determine whether such actions constitute...more

Knobbe Martens

"Improper” Listing of Patents in the FDA’s Orange Book

Knobbe Martens on

As we previously discussed, on November 7, 2023, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listings of device patents in the Food and Drug...more

Foley & Lardner LLP

Collusion & Competition: What Antitrust Means for AI in Health Care

Foley & Lardner LLP on

Health care companies are increasingly using artificial intelligence (AI) to create innovations, set prices, and compete with rivals. At the same time, federal and state antitrust enforcers are finding new ways to apply...more

Knobbe Martens

Medtronic acquires Intersect ENT, sells Fiagon to Hemostasis LLC as required by FTC

Knobbe Martens on

On May 13, 2022, Medtronic, Inc. announced that it completed the acquisition of Intersect ENT, Inc. The transaction was only able to gain approval of the Federal Trade Commission (FTC) upon the agreement that Medtronic sell...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 53

Jones Day on

This regular alert covers key regulatory EU developments related to the COVID-19 situation. It does not purport to provide an exhaustive overview of developments and contains no analysis or opinion. LATEST KEY DEVELOPMENTS -...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 52

Jones Day on

LATEST KEY DEVELOPMENTS - Competition & State Aid - • European Commission adopts first positive assessments of Recovery and Resilience Plans from 8 Member States • European Commission approves new and amended Member...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 51

Jones Day on

LATEST KEY DEVELOPMENTS - Competition & State Aid - • Executive Vice-President and Competition Commissioner Margrethe Vestager addresses competition policy’s role in supporting Europe’s recovery • EU General Court...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 50

Jones Day on

This regular alert covers key regulatory EU developments related to the COVID-19 situation. It does not purport to provide an exhaustive overview of developments and contains no analysis or opinion. LATEST KEY DEVELOPMENTS -...more

White & Case LLP

For COVID-19 Competitor Collaborations, DOJ Antitrust Division’s “Business Review Letter” Offers Easy and Likely Effective...

White & Case LLP on

On April 4, 2020, the Antitrust Division of the Department of Justice issued its first Business Review Letter under the DOJ-FTC joint expedited COVID-19 competitor collaboration review procedures, blessing several medical...more

Skadden, Arps, Slate, Meagher & Flom LLP

President Trump Uses the Defense Production Act To Compel Production of Ventilators, Prohibit Hoarding in Response to COVID-19

After first invoking the Defense Production Act (DPA) on March 18, 2020, President Donald Trump has taken several actions to formally deploy the authorities we discussed in our March 20, 2020, client alert, “President Trump...more

Cozen O'Connor

First Circuit Permits Antitrust Claims for Improperly Listing a Device Patent on the FDA’s Orange Book to Move Forward

Cozen O'Connor on

In a holding that could significantly broaden the antitrust inquiry in the context of the Hatch-Waxman regulatory scheme, on February 13, 2020, the U.S. Court of Appeals for the First Circuit issued an opinion that may have...more

Seyfarth Shaw LLP

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

Seyfarth Shaw LLP on

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

Hogan Lovells

The European Commission Is Considering Opening an Antitrust Probe for Parallel Imports in the Pharmaceutical Sector

Hogan Lovells on

The European Commission is looking into several parallel imports cases, including in the life sciences industry, with a view to opening formal antitrust investigations, which may eventually lead to fines being imposed....more

Hogan Lovells

The life sciences industry under the antitrust spotlight in China: two practical points

Hogan Lovells on

The simple fact is that the Chinese antitrust regulators are determined to up their enforcement activities in the life sciences industry. Almost immediately after drug pricing was liberalised in 2015, an antitrust enforcement...more

Thomas Fox - Compliance Evangelist

Four Things Compliance Practitioner Should Know About the Eurasian Economic Union

Four Things Compliance Practitioner Should Know About the Eurasian Economic Union - An effective Compliance risk management at emerging markets for any business significantly depends on timeous observation of changes in...more

Knobbe Martens

Sorin-Cyberonics Deal Gets US Antitrust Clearance

Knobbe Martens on

Sorin S.p.A. and Cyberonics, Inc. recently announced that the waiting period required under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 for their pending merger has ended. In February, the two companies...more

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