Novartis had previously requested that competition be barred as the presiding judges were considering whether to hear the company’s appeal. The Supreme Court overturned an earlier order, according to relevant court documents. This paves the way for competitors to release generic versions of the drug.
At the end of September, Novartis announced that it wanted an earlier decision of the US Federal Court of Appeals (CAFC) to be reviewed by the US Supreme Court.
Novartis doesn’t give up
The group also confirms this in a recent statement submitted to the AWP news agency. “Novartis will continue to vigorously defend the validity of the Gilenya patent and plans to petition the U.S. Supreme Court to review the Federal Circuit’s decision,” he said.
The patent dispute goes back several years. In August 2020, the US District Court in Delaware still upheld the Novartis patent. Competitor HEC Pharma, which wants to market a generic version of the blockbuster product, has been granted a permanent injunction through December 2027. A complaint from HEC Pharma in early 2022 threw the CAFC out.
annulment of the court
But the comeback took place in mid-June. CAFC overturned its own previous decision by ruling against Novartis.
Should generic versions of Gilenya become available in the United States, Novartis expects sales to drop by $0.3 billion in fiscal 2022, as the company announced in September.
According to previous court documents, Novartis could face up to 20 generic competitors for the drug.
The blockbuster Gilenya brought in more than $3 billion in annual sales to Novartis in its best years, and $2.8 billion in 2021. The patent protection of Gilenya’s active ingredient has already expired.
(SDA)