HEC Pharm Awaits Fate As Novartis Petitions On US Gilenya Victory
Credit Suisse: High Probability Of 2024 Delay
Novartis is sticking to its plan to continue fighting HEC Pharm in court, after it recently lost a key decision for its Gilenya (fingolimod) blockbuster treatment for multiple sclerosis.
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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.
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.
Difficulties around damages, fears over first-dose observations and criticism of invalidity challenges all contributed to a US district court judge issuing a preliminary injunction to stop leading generics players launching rivals to Novartis’ Gilenya fingolimod multiple sclerosis brand after the molecule patent expires in August this year.