Swiss pharma company reveals SCOTUS appeal plans

Federal Circuit denies petition to rehear dispute over multiple sclerosis medicine | Company will petition highest court over invalidity ruling.

Switzerland-based Novartis has announced that it plans to appeal against a “negative decision” handed down by the US Court of Appeals for the Federal Circuit to the highest court in the US.

In a press release issued yesterday, 20 September, Novartis said that the Federal Circuit had denied its petition to rehear a dispute involving a dosing regiment patent for its multiple sclerosis drug Gilenya (fingolimod).

Novartis now plans to file a petition seeking further review of the Federal Circuit’s decision with the US Supreme Court.

Two years ago, Novartis accused generic makers, including China’s HEC Pharm, of patent infringement. The dispute with HEC continued, while the other cases were stayed or settled.

In August 2020, the US District Court for the District of Delaware issued a permanent injunction was granted against HEC until the expiration of the '405 patent in December 2027 (including paediatric exclusivity).

Then, in June this year, the Federal Circuit concluded that US patent number 9,187,405—which covers a dosing regimen for 0.5mg Gilenya—was invalid, potentially opening the floodgates for the introduction of generic versions of the drug.

The June ruling had reversed a prior ruling by the Federal Circuit, which had held that the patent was valid, concluding that the patent’s written description of the dosage regimen was sufficient.

At the time of the June ruling, Novartis said it would appeal against the decision. However, the Federal Circuit has now rejected Novartis’ bid for a rehearing.

Novartis said that if generic versions of Gilenya were to launch in the US, it expects financial year 2022 sales to be negatively impacted by $0.3 billion.

Now, with this decision, HEC and other Abbreviated New Drug Application (ANDA) filers with Food and Drug Administration approval will potentially be able to launch a generic version imminently, pending any other judicial actions.

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