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Latest From HEC Pharm
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.
The Swiss firm expects no generic versions of Gilenya in the US market "for at least the next two years" after a court again ruled against HEC Pharma, the only remaining company challenging its patent.
Domestic companies have won most of the bids in China's latest government procurement round for 62 drugs, marking an end to the previous dominance of off-patent products from multinationals.
Imminent generic competition to Novartis’ Gilenya blockbuster in the US now seems impossible after a US district court held that the company’s dosage-regimen patent was both valid and infringed by HEC’s ANDA product. The Chinese firm may yet appeal the decision.
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