Novartis wins appeal over MS drug Gilenya patent: Bloomberg
The issue on appeal was whether the patent clearly explained the dosage regimen for fingolimod, the active ingredient in Gilenya, without the need for a higher first dose to get therapeutic levels up quickly.;
New Delhi: Novartis AG won a U.S. appeals court ruling that would block HEC Pharm Co. from selling a generic version of the blockbuster multiple sclerosis drug Gilenya until 2027.
In a 2-1 ruling, the U.S. Court of Appeals for the Federal Circuit on Monday affirmed the validity of a patent on the dosage regimen for the drug. HEC was a holdout among two dozen generic-drug makers Novartis sued in 2018, most of which have reached confidential settlements with the Swiss pharmaceutical giant.
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Gilenya generated $2.13 billion in sales in the first nine months of 2021, as Novartis was able to ward off generic competition to a drug that brings in about 5% of its revenue.
The issue on appeal was whether the patent clearly explained the dosage regimen for fingolimod, the active ingredient in Gilenya, without the need for a higher first dose to get therapeutic levels up quickly. HEC argued the patent never explained that the so-called "loading dose" wasn't needed, so the patent was unclear.
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