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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The multiple sclerosis drug market is more competitive than ever, though new options work through existing mechanisms of action. Unmet need remains despite numerous drugs, and competition clustered in the same classes creates pressure.
The latest decision in US litigation with HEC Pharma over multiple sclerosis treatment Gilenya means that generics will be kept off the market for at least two years, according to originator Novartis.
The AMR Industry Alliance has formalized its years-old Common Antibiotic Manufacturing Framework by publishing an antibiotic manufacturing standard, in what it terms a “groundbreaking step” in the drive for responsible manufacturing.