2022-06-22| Licensing

US Court Rules Novartis Blockbuster Multiple Sclerosis Drug’s Patent Invalid

by Fujie Tham
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A US appeals court deemed that a patent related to Swiss-based Novartis’ multiple sclerosis drug Gilenya (fingolimod) was invalid, potentially opening doors for generics of the immunomodulating medication. Judges revived a previous appeal made by a Chinese drugmaker HEC Pharma in January and reversed its last decision. 

The Gilenya ‘405 patent covers a dosing regimen for the drug in treating multiple sclerosis, however, court documents said the patent’s file fails to mention loading doses, which are the higher doses or more frequent administration of the drug before start of treatment.

Related article: Bristol Myers Squibbs Requests $1.2 Billion Patent Revival From Supreme Court 


Novartis’ 3rd Best-Selling Drug


Gilenya, first approved for use in 2010, is an oral disease-modifying therapy (DMT) for controlling disease activity in relapsing multiple sclerosis (RMS). It works by reducing the immune system’s attack on the central nervous system by retaining certain white blood cells (lymphocytes) in the lymph nodes. 

The therapeutic accounted for $2.8 billion in sales last year, making Gilenya the third best-selling drug after Cosentyx and Entresto. 

Unsatisfied with the ruling, Novartis said it plans to file a petition seeking further review of this decision. It said “Novartis intends to vigorously defend the validity of the patent and is considering all available options, including current plans to seek review of this decision by the full CAFC, a process which may take several months,” in a statement.

While the appeal process remains available, a permanent injunction against HEC Pharma is still in place, which the company “believes” will stop HEC Pharma and other concerned parties from launching Gilenya generics at this time.

Novartis has settled patent cases with several other generic drugmakers, allowing them to launch Gilenya generics on an agreed-upon date before the expiration of the dosing patent or even earlier under certain circumstances.

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