IP Law Daily, TOP STORY—Fed. Cir.: Panel reverses its prior decision upholding validity of Novartis patent infringed by generic version of Gilenya MS treatment drug, (Jun 21, 2022)

By Cheryl Beise, J.D.

Because the patent failed to disclose the absence of a loading dose, the no-loading-dose limitation was without adequate written description support.

A divided Federal Circuit panel has reconsidered and reversed a prior decision finding that a patent owned by Novatis for administering a drug to treat relapse multiple sclerosis was not invalid for lack of written description support. Upon reconsideration of expert testimony and the prosecution history, the panel concluded that the district court’s finding that the no-loading-dose limitation met the written description requirement was clearly erroneous. The court granted a petition for rehearing filed by HEC Pharm Co., Ltd. and HEC Pharm USA Inc., vacated its prior decision, and reversed the district court’s judgment that the claims of patent at issue were not invalid (Novartis Pharmaceuticals Corporation. v. Accord Healthcare, Inc., June 21, 2022, Moore, K.).

Novartis Pharmaceutical owns U.S. Patent No. 9,187,405 (the ’405 patent), entitled "S1P receptor modulators for treating relapsing-remitting multiple sclerosis.” The patent discloses methods of treating relapsing-remitting multiple sclerosis (RRMS) using the immunosuppressant fingolimod. Each claim of the ’405 patent requires administering fingolimod “at a daily dosage of 0.5 mg, absent an immediately preceding loading dose regimen.” Novartis’s brand name drug Gilenya practices the patent.

The case arose when HEC Pharm Co., Ltd. and HEC Pharm USA Inc. (together, “HEC”), two U.S. subsidiaries of German R&D company HEC Pharm GmbH, sought to bring to market a generic form of Gilenya. Novartis filed suit against HEC in the District of Delaware, asserting infringement of all claims of the ’405 patent. HEC admitted infringement but defended on the ground that the patent’s claims were invalid, either as anticipated or for inadequate written description. After a four-day bench trial, the district found for Novartis. HEC appealed.

On January 3, 2022, a divided Federal Circuit panel affirmed the district court’s judgment, specifically finding that the specification of the ’405 patent was adequate. Circuit Judge Kathleen O’Malley authored the original opinion, joined by Circuit Judge Richard Linn. Chief Judge Kimberly A. Moore dissented, arguing that the lack of reference to the loading dose limitation rendered the claims invalid for lack of written description. HEC petitioned for rehearing on the issue of written description. The panel granted the petition for rehearing. The new opinion was authored by Chief Judge Moore. Circuit Judge Todd Hughes, who replaced now retired Judge O’Malley on the panel, joined with Judge Moore, while Judge Linn filed a dissenting opinion.

Written description. To satisfy the written description requirement, a patent’s specification must “reasonably convey[ ] to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). For negative claim limitations, like the no-loading-dose limitation at issue in this case, there is adequate written description when, for example, “the specification describes a reason to exclude the relevant [element].” Santarus, Inc. v. Par Pharm., Inc., 694 F.3d 1344, 1351 (Fed. Cir. 2012).

The Federal Circuit explained that “[w]hile a description’s silence about a negative claim limitation is a useful and important clue and may often be dispositive, it is possible that the written description requirement may be satisfied when a skilled artisan would understand the specification as inherently disclosing the negative limitation.” The court noted that it is conceivable that a patent owner could establish that a particular limitation would always be understood by skilled artisans as being necessarily excluded from a particular claimed method or apparatus if that limitation is not mentioned.

In this case, there was no recitation of a loading dose in the specification. The district court nevertheless found that no-loading dose limitation was supported because the specification indicated that the dosing regimen starts by “initially” administering a daily dosage. However, this was clearly erroneous. The specification nowhere described “initially” administering a daily dosage. Rather, the specification stated, “Initially patients receive treatment for 2 to 6 months.” This sentence addressed the initial length of treatment, not the dosage with which treatment begins, the appeals court noted. “The fact that the specification is silent about loading doses does not support a later added claim limitation that precludes loading doses,” the court said. Dr. Lublin, one of Novartis’ physician experts, admitted this. The contrary testimony of Novartis’ second physician expert carried no weight in the court’s view because it was inconsistent with the plaint text of the specification.

Moreover, the disclosure of a daily dosage could not amount to a disclosure that there could be no loading dose, because such a finding was at odds with the prosecution history. The Patent Office allowed the claims only after the applicants added the no-loading-dose limitation. The applicants explained that they added the limitation “to specify that the [daily dosage] cannot immediately follow a loading dose regimen” and “to further distinguish their claims from the disclosure of [prior art].” Neither the applicants nor the examiner understood the words “daily dosage” without the words “no loading dose” to convey the absence of a loading dose, the court observed.

The question was not whether the patentee intended there to be a loading dose; the question was whether the patentee precluded the use of a loading dose. “On this record, there is no evidence that a skilled artisan would understand silence regarding a loading dose to necessarily exclude a loading dose,” the Federal Circuit said.

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 satisfied 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 Novartis’ claims were not invalid for inadequate written description. The court did not reach HEC’s alternate argument that the district court also clearly erred in finding adequate written description for the “daily dosage of 0.5 mg” limitation.

“We do not today create a heightened standard for negative claim limitations,” the panel said. “Just as disclosure is the ‘hallmark of written description’ for positive limitations … so too for negative limitations.” The court explained that disclosure “need not rise to the level of disclaimer,” but it must “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,” the court said (citations omitted).

Dissenting opinion. Circuit Judge Richard Linn filed a dissenting opinion to the majority’s revised opinion to express his view that the district court applied the correct standard and found ample support in the written description for the no-load limitation. Despite recognizing that written description support is a fact-based inquiry based on the under standings of a person of ordinary skill in the art and that the standard for negative limitations is the same as for any other limitation, the majority “nonetheless applies a heightened written description standard to the facts of this case in requiring not only a ‘reason to exclude’ but a showing that the negative limitation in question was ‘necessarily excluded,’” Judge Linn said. “The question is not whether the patentee precluded the use of a loading dose but whether the claim language that precludes the administration of a loading dose is supported by the written description passages that disclose the effective administration of nothing more than a ‘daily dose.’” In context, this disclosure, according to the testimony of Novartis’s experts, implied the absence of a loading dose to the ordinarily skilled artisan. Noting the deference afforded to a district court’s factual interpretations, this was all that was required, Judge Linn said.

The case is No. 2021-1070.

Attorneys: Jane M. Love (Gibson, Dunn & Crutcher LLP) for Novartis Pharmaceuticals Corp. Paul Skiermont (Skiermont Derby LLP) for HEC Pharm Co., Ltd. and HEC Pharm USA Inc.

Companies: Novartis Pharmaceuticals Corp.; HEC Pharm Co., Ltd.; HEC Pharm USA Inc.

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