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

Gilenya® (fingolimod HCl)

June 21, 2022

GENERICally Speaking

Case Name: Novartis Pharms. Corp. v. Accord Healthcare, Inc., No. 2021-1070, 2022 WL 2204163 (Fed. Cir. June 21, 2022) (Circuit Judges Moore, Linn, and Hughes presiding; Opinion by Moore, J.; Dissenting Opinion by Linn, 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: The ’405 patent disclosed methods of treating relapsing-remitting multiple sclerosis (RRMS) using fingolimod. Each claim of the ’405 patent required administering fingolimod “at a daily dosage of 0.5 mg, absent an immediately preceding loading dose regimen.” A loading dose is a “higher-than-daily dose ... usually given as the first dose.” The specification does not mention loading doses or the lack thereof. After HEC filed an ANDA seeking approval to market a generic equivalent to Gilenya, Novartis sued for patent infringement. The district court found that HEC’s ANDA infringed and that the claims were not invalid for inadequately describing the no-loading-dose limitation. The Federal Circuit affirmed. HEC petitioned for rehearing. In the interim, Judge O’Malley, who was on the merits panel, retired and was replaced on the rehearing panel by Judge Hughes. The rehearing panel found 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” added during prosecution to overcome prior art satisfies the written description requirement of 35 U.S.C. § 112(a). The Federal Circuit granted HEC’s petition for panel rehearing, vacated its prior decision, and reversed the district court’s judgment that the asserted claims were not invalid for inadequate written description.

Why HEC Prevailed: The district court found that because there is no recitation of a loading dose in the specification, the no-loading-dose limitation is supported. The district court further found that the no-loading-dose limitation is disclosed in the specification because the clinical trial described therein instructs “giving a ‘daily dosage of 0.5 ... mg’ fingolimod to treat RRMS, started ‘initially.’” The district court’s finding that the specification discloses “initially” starting with a daily dose was clearly erroneous. The term “initially” in the specification “speaks to the initial length of treatment, not the dosage with which treatment begins.” The ’405 patent specification discloses neither the presence nor absence of a loading dose. “Loading doses—whether to be used or not—are simply not discussed.” The fact that the specification is silent about loading doses does not support a later-added claim limitation that precludes loading doses.
The district court also found that the specification’s disclosure of a daily dosage combined with its silence regarding a loading dose would “tell a person of skill that loading doses are excluded from the invention.” This was also clearly erroneous. 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. On the record before the district court, “there is no evidence that a skilled artisan would understand silence regarding a loading dose to necessarily exclude a loading dose.”

The majority concluded:

We do not today create a heightened standard for negative claim limitations. Just as disclosure is the hallmark of written description for positive limitations, … so too for negative limitations. That disclosure need not rise to the level of disclaimer. Nor must it use the same words as the claims. Rather, as with positive limitations, the disclosure must only reasonably convey to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date. While silence will not generally suffice to support a negative claim limitation, there may be circumstances in which it can be established that a skilled artisan would understand a negative limitation to necessarily be present in a disclosure. This is not such a case. (citation and internal quotations omitted)

In dissent, Judge Linn took issue with the majority’s opinion because it nonetheless applied a heightened written description standard to the facts in requiring not only a “reason to exclude” but a showing that the negative limitation in question was “necessarily excluded.” Judge Linn believed that the district court applied the correct standard and found ample support in the written description for the no-load limitation. “[C]ontext and the knowledge of those skilled in the art matter.” The district court made findings concerning the patent specification and credited expert testimony in support of its opinion. “The district court thus made the unremarkable, and factually supported, determination that starting with a daily dose plainly implies that there is no loading dose.”

Oren D. Langer


Managing Partner, New York Office

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