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HEC Pharm Wins Key Reversal In US Gilenya Dosing Patent Fight

Novartis Mulling Plans For Full Federal Circuit Review

Executive Summary

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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