In this issue:
In the antitrust debate arena, health care topics are the gifts that just keep on giving—always something new to discuss, analyze, or understand. This issue focuses primarily on two segments, product hopping and pay-for-delay. The first paper describes and analyzes, while the next two papers contrast regulatory approaches. Then we present case studies of two countries presenting novel twists in the field—Canada, which has introduced criminal charges to pay-for-delay cases—and India, which has targeted the distribution chain, rather the manufacturers, for its antitrust focus.
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Pharm Update
Pharmaceutical Antitrust Complexity
With layer piled upon layer, and defenses based on patents, innovation, and settlement that cannot easily be dismissed, brands are using complexity to their advantage. Michael Carrier (Rutgers Law School)
“Product Hopping” on Both Sides of the Pond: A Survey of U.S. and EU Case Law
The approaches in the United States and the European Union with respect to “product hops” appear to be similar in that direct, affirmative steps that prevent generic competition could give rise to antitrust scrutiny. Ingrid Vandenborre, Julia K. York, & Michael J. Frese (Skadden, Arps)
“Good Luck” Post-Actavis: Current State of Play on “Pay-for-Delay” Settlements
This article examines the current quagmire in the courts, the FTC’s recent activities, and finally explores growing interest outside the United States in getting into the “pay-for-delay” fray. Seth Silber, Jonathan Lutinski, & Ryan Maddock (Wilson Sonsini)
Competition Issues in the Canadian Pharmaceutical Industry
One approach to help determine whether a Settlement has created an SPLC is to consider whether the value transfer to the generic is in excess of what the patentee could have been expected to pay in the event it had lost the litigation. Alan Gunderson (Canadian Competition Bureau)
The Rising Tide: Competition Law Enforcement in the Indian Pharmaceutical Sector
Notably, in India, it is the distribution chain that has been in the limelight for anticompetitive practices. Kalyani Singh (Luthra and Luthra Law Offices)
