Alexandra Valenti, JD: Regulatory Scrutiny and Biosimilar Settlements

Alexandra Valenti, JD, partner at Goodwin, discusses whether drug makers are given pause by the possibility of regulatory scrutiny of patent settlements.


So, the [Federal Trade Commission, FTC] and the [Department of Justice, DOJ] did an analysis following both the [Medicare Modernization Act, MMA’s] enactment of the regulatory review provision as well as the Supreme Court’s decision in FTC v Actavis that held that “pay-for-delay” agreements can be subject to antitrust review.

So, FTC’s analysis showed that both of those things did result in a decrease in the number of potentially problematic settlement agreements, again in the small-molecule context, that were being submitted for review. So, in terms of whether this will affect biologics’ patent settlement agreements, I think we’ll have to see what comes of the enhanced regulatory scrutiny. And there is also an open question as to whether the reasoning of the Supreme Court’s decision in FTC v Actavis regarding the antitrust issue extends to biologics. And so, it’s kind of a wait and see, I think.

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