Novartis plans to take the case on the validity of a patent for its sales engine Gilenya (fingolimod) up to the United States Supreme Court, in the wake of an unfavorable decision handed down in June.
The Court of Appeals for the Federal Circuit (CAFC) then overturned a ban made in 2020 on Chinese HEC Pharma to launch a generic version of this treatment against multiple sclerosis before the expiry of said patent, in 2027.
For some time now, the Rhine multinational has made the achievement of its financial objectives conditional on the absence of the launch across the Atlantic of generic versions of Gilenya, which brought in $2.79 billion last year. The appearance of this year of such competition is likely to burden the turnover of the group of nearly a third of a billion dollars, currency a press release released Wednesday.
The roadmap for 2022 remains otherwise topical, including at constant exchange rates an increase in revenue and adjusted operating surplus of around 5%.
Novartis recalls having already concluded agreements with other generic producers wishing to launch their own versions of fingolimod in the land of Uncle Sam on a date to do so, not specified but scheduled before the expiry of the disputed patent. HEC Pharma remains the only competitor opposed to this compromise.
The Court of Appeal’s decision opened the door in June to the immediate launch of any substitute version of Gilenya, by HEC but also by any other generic producer, as of its approval by the FDA health officer.
/ATS