Novartis Pharms. Corp. v. Accord Healthcare, Inc.

Gilenya® (fingolimod HCl)

January 3, 2022

GENERICally Speaking

Case Name: Novartis Pharms. Corp. v. Accord Healthcare, Inc., No. 2021-1070, 2022 WL 16759 (Fed. Cir. Jan. 3, 2022) (Circuit Judges Moore, Linn, and O’Malley presiding; Opinion by O’Malley, J.; Dissenting Opinion by Moore, J.) (Appeal from D. Del., Jordan, C.J.)

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

Nature of the Case and Issue(s) Presented: Novartis marketed fingolimod HCl under the trade name Gilenya for treating relapsing remitting multiple sclerosis (“RRMS”), a form of multiple sclerosis (“MS”). Most MS patients initially presented as RRMS patients, but many eventually developed a secondary progressive form of MS, causing them to experience growing disability. The disease was managed by reducing or preventing relapses and thereby slowing disability. The ’405 patent claimed methods to treat RRMS with fingolimod HCl, at a daily dosage of 0.5 mg without an immediately preceding loading dose. A loading dose was a higher than daily dose “usually given as the first dose.” Defendant HEC filed an ANDA seeking approval to market a generic version of Gilenya. Novartis sued. The district court found the ’405 patent not invalid, and infringed. HEC appealed, arguing that the district court erred in finding that the ’405 patent claims did not fail the written-description requirement. Finding no clear error, the Federal Circuit affirmed the district court’s decision.

Why Novartis Prevailed: HEC argued that, as of the 2006 priority date, the inventors did not possess a 0.5 mg daily dose of fingolimod because that dosage was considered too low to be effective to treat RRMS. It further argued that the clinical trial described in the specification, which listed a 0.5 mg daily dose along with two other dosages, did not provide sufficient written description of the 0.5 mg dose. The Federal Circuit disagreed. That the clinical trial disclosed two other dosages did not detract from the written description of the claimed dose. Nor did disclosures of dosage ranges in other areas of the specification lead away from the claimed dose. Further, the district court had credited correctly the testimony of Novartis’s experts that a POSA could arrive at the claimed 0.5 mg/day human dosage from the disclosed animal dosage.

Next, HEC argued that there was no written description of the negative limitation, “without an immediately preceding loading dose,” because the ’405 specification contained no recitation of a loading dose or its potential benefits or disadvantages. The Federal Circuit noted first that there was no “new and heightened standard for negative claim limitations.” “To the contrary, we repeatedly have resisted imposition of heightened written description standards for negative limitations, such as that urged by HEC.” Again, the Federal Circuit credited Novartis’s experts when they had testified from the perspective of a POSA, if the clinical trial described in the specification had included a loading dose, the patent would have explicitly stated as much, and that a POSA “would have viewed the patent as a document, as a complete document, that should give you all the information you need to carry out the claims, and that information of having a loading dose is not there, and what’s instead there is [sic] examples of daily dose, daily dose, daily dose.” Therefore, the district court concluded correctly that the “absence of an immediately preceding loading dose from the specification, and from the Prophetic Trial, would tell a person of skill that loading doses are excluded from the invention.”

Moreover, as a granted patent, the ’405 patent was presumed valid, and it was also presumed to have a complete written description. That presumption did not exist for the prior art, which HEC relied on to prove the existence of the negative limitation.  Thus, although neither the ’405 specification nor the prior art included the phrase “loading dose,” it was not clear error for the district court to find that a skilled artisan would read the specification as not including a loading dose and would read the prior art as silent on the presence or absence of a loading dose.

Judge Moore issued a dissenting opinion because “the majority dramatically expands a patentee’s ability to add, years after filing a patent application, negative claim limitations that have zero support in the written description.” She would have reversed the district court’s finding that there existed written description for the negative limitation because “[s]ilence is not disclosure.” Loading doses—whether to be used or not—were never discussed or mentioned in the specification. Nowhere in the patent did it say a loading dose should not be administered. Nowhere did it discuss alternatives (including or not including a loading dose). Nowhere did it give advantages or disadvantages of including a loading dose. An inventor could not satisfy the written-description requirement through silence. “While the negative limitation need not be recited in the specification in haec verba, there must be something in the specification that conveys to a skilled artisan that the inventor intended the exclusion: disadvantages, alternatives, inconsistencies, just something. … After this case, negative limitations are supported by a specification that simply never mentions them.”

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