Fed Circuit reverses Novartis’ drug patent win
The US Court of Appeals for the Federal Circuit has held that a patent covering Novartis’ multiple sclerosis drug Gilenya is invalid, potentially opening the floodgates for the introduction of generic versions of the drug.
In a precedential ruling handed down Monday, June 20, the Federal Circuit reversed its own earlier ruling in the dispute between Novartis and China’s HEC Pharm.
Two years ago, Novartis accused a number of generic makers, including HEC Pharm, of patent infringement. While the other cases were stayed or settled, the dispute with HEC continued.
During proceedings, HEC argued that the ‘405 patent was invalid due to its lack of written description. However, the US District Court for the District of Delaware sided with Novartis and blocked HEC from selling a generic version of the drug until 2027 (when the patent expires).
Then, in January this year, the Federal Circuit held that the patent was valid, concluding that the patent’s written description of the dosage regimen was sufficient.
HEC appealed against the decision and, earlier this week, the Federal Circuit overturned its earlier ruling.
Monday’s split decision found that the claims of US patent 9,187,405—which discloses methods of treating relapsing-remitting multiple sclerosis using the immunosuppressant fingolimod—were invalid.
Each claim of the ‘405 patent requires administering fingolimod “at a daily dosage of 0.5 mg, absent an immediately preceding loading dose regimen”. However, the patent fails to mention loading doses, which are higher or more frequent doses at the start of treatment.
"If reciting ‘daily dosage’ without mentioning a loading dose necessarily excluded a loading dose, there would have been no reason for the applicants to add the no-loading-dose limitation,” said Chief Judge Kimberly Moore on behalf of the court.
Moore added: “Neither the applicants nor the examiner understood the words ‘daily dosage’ without the words ‘no loading dose’ to convey the absence of a loading dose. Accordingly, the district court’s contrary finding was clearly erroneous.”
The Federal Circuit concluded that because the ‘405 patent failed to disclose the absence of a loading dose, the district court “clearly erred” in finding that the negative claim limitation (“absent an immediately preceding loading dose”) satisfied the written description requirement.
Dissenting, Circuit Judge Richard Linn claimed that the majority had applied a “heightened written description standard” to the case, by not only requiring a “reason to exclude” but a showing that the negative limitation in question was “necessarily excluded”.
Novartis plans to file a petition seeking further review of this ruling.
“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 Federal Circuit, a process which may take several months,” said a press release from Novartis.
Novartis also said that it believes HEC and other Abbreviated New Drug Applications filers are not permitted to launch a generic version during the ongoing appeal process.
