Novartis Pharms. Corp. v. Accord Healthcare Inc.

Gilenya®/fingolimod

August 10, 2020

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

Case Name: Novartis Pharms. Corp. v. Accord Healthcare Inc., No. 18-1043-KAJ (D. Del. August 10, 2020) (Jordan, J.) 

Drug Product and Patent(s)-in-Suit: Gilenya® (fingolimod); U.S. Patent No. 9,187,405 (“the ’405 patent”)

Nature of the Case and Issue(s) Presented: Gilenya is an oral formulation that is used to treat relapsing-remitting multiple sclerosis (“RRMS”). The ’405 patent claims methods to treat RRMS with 0.5 mg of fingolimod absent an immediately preceding loading dose. Novartis sought to prevent defendants from launching generic equivalents to Gilenya. After a four-day bench trial, the court found that the ’405 patent was not invalid for lack of written description or anticipation, and that defendants induced and contributed to the infringement of the ’405 patent.

Why Novartis Prevailed: Defendants argued that the ’405 patent was invalid for lack of written description and anticipation. As to written description, Defendants claimed that the ’405 patent did not contain an adequate written description instructing physicians to omit a loading dose before administering the drug. Concerning anticipation, Defendants argued that the ’405 patent was anticipated by an abstract published in 2006. Plaintiff responded that the ’405 patent adequately described the invention, and that the 2006 published abstract did not anticipate because it was not prior art, did not disclose the claimed invention, and was not enabled.

The court found Defendants were liable for induced infringement as their proposed label instructed physicians and patients to perform every element of the patented method. A prescribing physician would understand the label to contain the complete dosing information, and the enclosed instructions dictated the dose of Defendants’ generic drug exactly as it is described in the ’405 patent—0.5 mg daily without a loading dose. Defendants were also found liable for contributory infringement, as Defendants knew of the ’405 patent and the treatment method it sets forth, and because Defendants’ generic drug had no other substantial non-infringing uses: if a user were to follow the instructions on the label there would be infringement.

Next, the court found that the patent’s written description was adequate when read as a whole, describing a daily dosage of 0.5 mg without a preceding loading dose. A POSITA would have understood that the invention contained a treatment purpose and that the treatment was for RMMS. Defendants’ anticipation arguments were also rejected, as the court found that declarations submitted by Defendants for the proposition that the 2006 abstract was publicly available in June 2006 were hearsay, and even if the 2006 abstract was prior art, it did not anticipate the ’405 patent because it did not preclude the use of a loading dose in the clinical trial it described.

Oren D. Langer

Partner

Managing Partner, New York Office
Member of Executive Board

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