On Jan. 03, 2022, Federal Circuit affirmed district court and found MOU patent valid and infringed by ANDA filer.

Novartis owns US 9,187,405 patent, which is listed in Orange Book for Gilenya (Fingolimod). The medication is used to treat relapsing remitting multiple sclerosis (“RRMS”), a form of multiple sclerosis (“MS”). The ’405 patent claims methods to treat RRMS with fingolimod, at “a daily dosage of 0.5 mg” “without an immediately preceding loading dose”. HEC filed ANDA for 0.5 mg strength with USFDA to market generic version. Novartis subsequently sued HEC pharma. District court after trial concluded that HEC had not shown that the ’405 patent is invalid for insufficient written description for the no-loading-dose limitation and for the claimed 0.5 mg daily dose. With respect to the written description for the claimed 0.5 mg daily dose, the district court found that a skilled artisan would understand that the inventors possessed a 0.5 mg daily dose based on one of the successful doses in the EAE experiment results, 0.3 mg/kg weekly and based on prophetic human trial that mentioned 0.5 mg dose. With respect to the written description for the “absent an immediately preceding loading dose” limitation, the district court again found sufficient written description in the EAE model and the Prophetic Trial. Neither the Prophetic Trial nor the EAE model recite a loading dose. You can read the district court decision summary “here”.

Upon appeal, Federal Circuit did not find any error in district court’s analysis and affirmed. With respect to 0.5 mg limitation, Court said that the Prophetic Trial describes dosing RRMS patients with fingolimod hydrochloride at daily dosages of 0.5, 1.25, or 2.5 mg. The EAE model describes a dosage of 0.3 mg/kg per week as effective dose. POSA would have arrived at the claimed 0.5 mg/day human dosage from the EAE experiment’s 0.3 mg/kg per week rat dosage. With respect to negative limitation of absent preceding loading dose, Court said that it is well established that there is no “new and heightened standard for negative claim limitations.” [Inphi Corp. v. Netlist, Inc., 805 F.3d 1350, 1356 (Fed. Cir. 2015)]. And, while HEC asserts that “[i]t is well-settled law that silence alone cannot serve as a basis for” a negative limitation, HEC identifies no case that actually supports that proposition. In doing so, it ignores a central tenet of our written description jurisprudence—that the disclosure must be read from the perspective of a person of skill in the art—as well as precedent stating that the disclosure need not describe a limitation in haec verba. The Prophetic Trial describes giving RRMS patients fingolimod hydrochloride “at a daily dosage of 0.5, 1.25 or 2.5 mg p.o.” It further states that: “Initially patients receive treatment for 2 to 6 months.” Dr. Steinman, one of Novartis’s expert witnesses, testified from the perspective of a skilled artisan that, if the Prophetic Trial included a loading dose, the patent would explicitly state as much. the “EAE model and the Prophetic Trial . . . both indicate to a person of ordinary skill that the claimed invention did not include the administration of a loading dose.”

Federal Circuit thus affirmed the district court’s decision.