Enforcement agencies and courts in the United States have long dealt with high-profile antitrust cases in the pharmaceutical sector. However, until recently, major antitrust or merger cases in the medical device sector were relatively rare. This has changed significantly in the past few years, with the relevant agencies considering several high-profile medical device mergers. Indeed, the sector looks set to be a focus of enforcement and litigation activity throughout 2015 and beyond. This update highlights three key antitrust-related developments for medical device companies to look out for in 2015.
Close review of medical device mergers
The Federal Trade Commission has been stepping up its review of mergers in this space, focusing in particular on implants and orthopaedic products. Antitrust observers are watching closely to see how the agency defines relevant product markets – often the determining issue in a merger review. Given the intense focus on healthcare costs generally, there is unlikely to be any let-up in the scrutiny of mergers in the medical device sector.
Interface of IP rights and antitrust law
Intellectual property continues to play a major role in antitrust litigation, enforcement and policy. High-tech companies in other sectors have long fought over the question of when the assertion of IP rights constitutes misuse of those rights subject to the antitrust laws. Patents play an important role in the medical device sector and the interface of IP rights and antitrust law will likely be a major focus in this area for years to come. As with the review of mergers, expect healthcare costs to be considered as part of the enforcement equation.
Exclusive dealing and monopolisation
The law on monopolisation and exclusive dealing continues to evolve. Indeed, it remains one of the most contentious and unresolved areas of antitrust law. The appellate courts are split on some of the basic questions of what standards to apply to a firm's dealings with downstream partners and the circumstances under which it is illegal to induce loyalty from customers. Some of the largest litigations in this area have involved medical devices. The Supreme Court is long overdue to intervene; if or when it eventually agrees to do so, such intervention may well be in the context of medical devices, given the amount of ongoing litigation.
For further information on this topic please contact Ken Glazer at Sidley Austin LLP by telephone (+1 202 736 8000) or email (firstname.lastname@example.org). The Sidley Austin website can be accessed at www.sidley.com.
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