A ruling by the US District court for the district of Delaware, dated 10 August and unsealed on Monday, upheld the validity of a patent for Novartis’s MS drug Gilenya and rejected a lawsuit from HEC and backed by other generic drugmakers claiming that the patent was no longer valid.
In the ruling, the court stated that HEC had written an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) seeking the body’s approval to create a generic copy of Gilenya before the expiration of Novartis’s patent.
A decade after its approval by the FDA, Gilenya is Novartis’s second-largest revenue generator, having brought in sales revenue of over $3.2 billion during 2019. Novartis’s highest earner, its immunosuppressant drug Cosentyx, accrued $3.5 billion during the same year.
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Novartis had entered into settlement agreements with other organisations to produce generic copies of the Gilenya drug before the expiration of its patent, though the terms of these agreements – including when the generics would be allowed – were not explored in the court ruling.
In December, the FDA approved three generic copies of the Gilenya drug.
