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Pharmaceuticals / Regulatory Affairs

FTC Settles Lawsuit Involving Alleged Generic Stifling

March 8, 2019
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The Federal Trade Commission reached a settlement in a case that involved alleged generic-delaying agreements between three generic drugmakers and Solvay, an AbbVie subsidiary.

The complaint, which was filed in 2009 by the FTC, was initially shot down in district court. That decision was affirmed by an appellate court, but the U.S. Supreme Court rejected the rulings in 2013, establishing that “reverse-payment” patent settlements are open to antitrust scrutiny.

The settlement bars AbbVie from forming certain “patent infringement settlement agreements” that intentionally slow down generic entry and come with forms of reverse payments, such as a no-authorized generic commitment in which a brand name company agrees not to compete with an authorized generic for a time in return for compensation.

The settlement nullifies licenses to enter the market on a later date, compensation for future litigation expenses, continuation or renewal of a pre-existing agreement and other types of agreements expected to disrupt drug competition. The settlement applies to products that Solvay may have been selling or developing before its 2010 purchase by Abbott Laboratories.

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