Novartis upholds MS drug patent at Fed Circ
Novartis Pharmaceuticals has prevailed against China’s HEC Pharm at the US Court of Appeals for the Federal Circuit, after a majority panel of judges held that a patent covering the multiple sclerosis drug Gilenya (fingolimod hydrochloride) was valid.
The precedential decision was handed down yesterday, January 3, with Chief Judge Kimberly Moore dissenting.
Novartis markets a 0.5 mg daily dose of fingolimod hydrochloride under the brand name Gilenya. The top-selling medication treats relapsing remitting multiple sclerosis, a disease in which the immune system attacks the myelin coating the nerves in the central nervous system.
Two years ago, Novartis sued HEC Pharm for patent infringement at a federal court in Delaware, along with other generic makers who sought to make copies of the drug, including Apotex, Bionpharma, Emcure Pharmaceuticals, Heritage Pharmaceuticals, and Glenmark Pharmaceuticals.
The other cases were all settled or were stayed before the trial, which meant that it eventually only addressed claims levied against HEC in August 2020.
During the proceedings, the generic drug maker countered that the '405 patent was invalid due to its lack of written description.
But the US District Court for the District of Delaware found in favour of Novartis and blocked HEC from selling a generic version of the drug until 2027 when the patent-in-suit expires.
Yesterday, Circuit Judges Kathleen O’ Malley and Richard Linn upheld this finding, holding that the disputed patent’s written description of the dosage regimen was sufficient.
But Chief Judge Moore dissented, arguing that the majority had dramatically expanded a patentee’s ability to add, years after filing a patent application, negative claim limitations that have “zero support” in a patent’s written description.
“By doing so, it contradicts our well-established precedent and nullifies the patent office’s guidance in the Manual of Patent Examining Procedure (MPEP). I would reverse the district court’s finding that there exists written description support as it is inconsistent with our established precedent. Silence is not disclosure,” she said.
She further held that the the ’405 patent “provides nothing to signal to the public that the inventors possessed a treatment excluding a loading dose when a loading dose was a known possibility”, contending that the patent was “eerily silent” on this point.
The majority, however, rejected this argument and the assertion that it had set out a new precedent.
“In deciding that the district court did not clearly err in finding written description for the negative limitation in the ’405 patent, we do not establish a new legal standard that silence is disclosure, as the dissent asserts,” opined O’ Malley.
The majority opinion contended that: “The district court’s holding is supported by the specification and ample expert testimony interpreting that specification.”
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