No-Authorized Generic Commitments Disappear From US Settlements
Likely Anticompetitive Deals ‘Remain Very Low’ FTC Report Finds
Compiling data from the 2017 fiscal year, a new US Federal Trade Commission report reveals that no patent-litigation settlement agreement contained a no-AG commitment, although several did contain extraordinary forms of compensation or side deals that went beyond the payment of litigation fees.
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The FTC has won the backing of an appeals court over its 2019 decision that found a reverse-payment settlement deal between Impax and Endo over Opana ER to be anti-competitive and illegal.
Only one of 232 brand-generic patent suit settlements in the US during FY 2016 contained a side deal or commitment not to market an authorized generic.
Agreeing a deal that it would not face an authorized generic during its 180-day market exclusivity for generic Opana ER contributed to Amneal's Impax striking an illegal pay-for-delay settlement, the FTC is alleging