Novartis has lost a patent appeal for a multiple sclerosis drug

Novartis loses patent appeal for multiple sclerosis drug, opening the door for a cheaper generic version. A US court ruling invalidates Novartis AG's patent for Gilenya, paving the way for Chinese pharmaceutical company HEC Pharm Co to develop a generic alternative. Despite Novartis's plans to defend the patent, the appeal process could take months. Currently, no Gilenya generics are expected to be available in the US for the next two years.

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On Tuesday, a US court gave a ruling that a patent for Novartis AG's multiple sclerosis medicine Gilenya was not valid, making the way for a less expensive generic version of the drug.


The case was overturned by the Federal Circuit Court of Appeals, which hears patent appeals.

The panel's decision revives the bid of Chinese pharmaceutical company HEC Pharm Co to develop a generic variant of the medicine.

Last year, Novartis made nearly 2.8 billion dollars in sales from Gilenya, making it the Swiss manufacturer's  3rd best-selling medicine.


The company stated that it will consider "every option available" to defend its patent and is planning to request that the decision be reviewed by the Federal Circuit, which could take many months.

Novartis believes that while the appeals process is ongoing, HEC and others will be unable to launch a generic variant of Gilenya.

In January, the Federal Circuit upheld the earlier decision that Novartis' patent is valid. The patent covers the use of Gilenya at a specific dosage for relapsing multiple sclerosis (fingolimod).


On Tuesday, a panel of 2 of the same judges changed their decision.

Novartis has reached patent settlements with various other generic drugmakers, that allowed Gilenya generics to be released before the patent expires in 2027.

Following the January decision, Novartis stated that no Gilenya generics would be available in the United States for the next 2 years.

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