Brand-Generic Pay-For-Delay Deals May Become Extinct, FTC Finds
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.
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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.
US off-patent industry association the AAM has blasted as unconstitutional a groundbreaking California law banning so-called ‘pay-for-delay’ deals under which brand companies pay rivals to keep generics off the market.
A recent study by the AAM’s Biosimilars Council has found that delayed access to biosimilars has cost the US healthcare system $7.6bn since 2015; meanwhile, Medicare has foregone more than $1.2bn in savings from biosimilars since 2015.