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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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.
Teva’s carve-out fight with GSK over generic Coreg will see the Solicitor General weigh in. Amgen and Juno’s patent petitions remain pending, and the high court stays a Federal Circuit decision invalidating Novartis’ Gilenya patent.
Are US Gilenya generics set to flood the US market? HEC Pharm is hoping so, following a favorable Federal Circuit denial. However, in a bid to maintain its monopoly and avoid a potential $300m hit to its top line, Novartis is taking its fight to the US Supreme Court.