HEC Pharm Wins Key Reversal In US Gilenya Dosing Patent Fight
Novartis Mulling Plans For Full Federal Circuit Review
China’s HEC Pharm, the last ANDA filer for fingolimod standing in patent litigation, has won a key invalidity challenge against a dosing-regimen patent shielding the multiple sclerosis treatment. However, the Federal Circuit was split on whether it had applied a heightened standard for negative claim limitations.
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Justice Kavanaugh voted to grant Teva’s petition for certiorari. It is unknown if other justices voted with him. The high court last month declined to hear Novartis's Gilenya patent case and Sanofi’s antitrust allegations against Mylan’s EpiPen rebate agreements.
Novartis has been rejected in its attempt to convince the US Supreme Court to review litigation over Gilenya, the outcome of which has seen generic versions of fingolimod hit the market.
Novartis, which reportedly generates $3.8m per day in US Gilenya sales, is once again facing up to the prospect of imminent generic competition to its blockbuster treatment for relapsing-remitting multiple sclerosis, following the latest order by the US Supreme Court.