Novartis secures victory as MS drug patent is upheld
In a win for Novartis Pharmaceuticals, the US District Court for the district of Delaware has upheld the patent on its top-selling multiple sclerosis drug Gilenya.
In a decision handed down on August 10, the court ruled that the generic-drug maker HEC Pharm infringed the patent for Gilenya, US number 9,187,405, which expires in 2027.
Gilenya was Novartis’ second best-selling pharmaceutical during 2019, with a total revenue of $3.22 billion dollars worldwide.
In January, Novartis sued HEC Pharm for patent infringement, along with an array of other generic makers who sought to make copies of its blockbuster drug, including Apotex, Bionpharma, Emcure Pharmaceuticals, Heritage Pharmaceuticals, and Glenmark Pharmaceuticals.
HEC had argued that its label does not instruct physicians to “omit a loading dose from the dosing regimen, so it is not practicing one of the elements of the patent claims in suit”.
The generic drug maker also brought a counterclaim that the '405 patent is invalid due to its “lack of written description” and because it was “anticipated by an abstract published in the Journal of Neurology and “presented at the European Neurologic Society Meeting in 2006”.
The court disagreed, finding HEC “liable for contributory and induced infringement because the label for its generic version of Gilenya instructs physicians to perform each limitation in the asserted claims of the patent”.
It further concluded that the disputed patent was valid because it “contains an adequate written description, and it was not anticipated by the abstract”. The ruling can be appealed.
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