“As the majority concedes, we have long held that silence cannot support a negative limitation; for if the specification is silent there is no evidence that the inventor actually possessed the invention.” – Chief Judge Kimberly Moore
Earlier today, the U.S. Court of Appeals for the Federal Circuit issued a precedential decision in Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc. granting a petition for rehearing from appellant HEC Pharm Co., Ltd. In granting HEC’s petition, the panel majority of Chief Judge Kimberly Moore, who authored the decision, and Circuit Judge Todd Hughes vacated a previous January ruling by the Federal Circuit, which had affirmed the District of Delaware’s final judgment that Novartis patent claims covering its Gilenya treatment for multiple sclerosis were not invalid for failing to satisfy the written description requirement under 35 U.S.C. § 112. Senior Circuit Judge Richard Linn authored a dissent arguing that the panel majority had improperly adopted a heightened written description standard and failed to take into account expert testimony from Novartis regarding a negative claim limitation that the district court found was supported by ample evidence.
Chief Judge Moore’s Majority Opinion Reiterates Her January Dissent: Silence Isn’t Disclosure
The patent-at-issue in the present appeal is U.S. Patent No. 9187405, S1p Receptor Modulators for Treating Relapsing-Remitting Multiple Sclerosis. The patent covers a method of preventing or alleviating relapses in relapsing-remitting multiple sclerosis (RRMS) by administering fingolimod, the active ingredient in Novartis’ Gilenya treatment. Novartis’ lawsuit against HEC came after HEC filed an abbreviated new drug application (ANDA) with the U.S. Food & Drug Administration (FDA) to market a generic version of Gilenya.
HEC appealed to the Federal Circuit after the Delaware district court found that HEC’s ANDA infringed all asserted claims of the ‘405 patent. Although a panel majority affirmed the Delaware court’s ruling on Section 112’s written description requirement, Chief Judge Moore, who authored the recent decision vacating the CAFC’s January ruling, had dissented to the January decision based on what she found was inadequate written description support for a negative claim limitation precluding the use of loading doses, a higher initial dose of a treatment that allows for smaller maintenance doses, in administering the RRMS treatment to patients.
“There is no disclosure in the specification of preventing a loading dose. Loading doses—whether to be used or not— are never discussed. As the majority concedes, we have long held that silence cannot support a negative limitation; for if the specification is silent there is no evidence that the inventor actually possessed the invention.” – Chief Judge Kimberly Moore
Santarus Doesn’t Require In Haec Verba, But Does Require Some Discussion
In the recent ruling vacating the CAFC’s January decision, the panel majority noted that adequate written description for a negative claim limitation exists when “the specification describes a reason to exclude the relevant [element],” citing to the Federal Circuit’s 2012 per curiam ruling in Santarus, Inc. v. Par Pharmaceutical, Inc. “Silence is generally not disclosure,” wrote Chief Judge Moore, reiterating a point she raised in her January dissent. While the negative limitation is not required to be recited by the written description in haec verba, or by verbatim incorporation from the claims into the specification, the written description must include some discussion regarding the negative limitation, such as disadvantages or alternatives, to convey that the inventor meant to exclude that particular element.
While the Delaware district court had found that the negative claim limitation excluding loading doses was supported by the written description’s discussion of “initially” administering a daily dosage, the recent CAFC ruling found that the district court clearly erred as that discussion referred to the initial length of treatment, not the initial dosage of the treatment to a patient. The Federal Circuit also noted that Novartis’ expert witness admitted to this understanding of the phrase “[i]nitially patients receive treatment from 2 to 6 months.” The appellate court disregarded testimony from another Novartis expert witness on the proper meaning of “initially” as the panel majority found the testimony to be inconsistent with the unambiguous intrinsic evidence within the specification.
The written description’s lack of discussion on loading doses was made even more relevant because artisans skilled in the art of treating MS patients often use loading doses when initially treating patients. As a result, the Federal Circuit found no evidence that the written description’s silence about loading doses would not convey to a skilled artisan that loading doses were necessarily excluded. While the panel majority acknowledged that certain circumstances can establish support for a negative claim limitation’s disclosure within the written description, but that the present case contained none of those circumstances.
Judge Linn: Heightened Written Description Requirement for Negative Limitations is Improper
Judge Linn’s dissent argued that the Delaware district court applied the correct standard in assessing whether the written description disclosed the negative claim limitation. Part of Judge Linn’s divergence from the panel majority comes down to a different interpretation of the holding in Santarus: whereas Chief Judge Moore’s majority opinion found Santarus to stand for the proposition that the written description must include some discussion about the negative claim limitation, Judge Linn found that Santarus did not exclude other methods of satisfying the written description requirement without a reason to exclude the limitation expressly identified in the specification. Judge Linn noted that the holding in Santarus found the written description requirement satisfied by relying on expert testimony to explain a skilled artisan’s understanding of the patent specification.
Judge Linn then noted a series of cases decided by the Federal Circuit in which negative claim limitations were supported by expert testimony or other extrinsic evidence without direct mention in the patent specification, including In re Bimeda Research & Development Ltd. (2013) and Inphi Corp. v. Netlist, Inc. (2015). The Federal Circuit has also reiterated since Santarus that there is no heightened written description requirement for negative claim limitations in Nike, Inc. v. Adidas AG (2016), a decision later overruled by Aqua Products v. Matal (2017) but on other grounds.
While the U.S. Patent and Trademark Office’s Manual of Patent Examining Procedure (MPEP) is not binding on the Federal Circuit, Judge Linn found it persuasive that MPEP sections regarding the written description requirement requires no specific form of disclosure and allows for implicit written description. Judge Linn found that the majority’s decision to ignore the context of the understanding of a skilled artisan was in tension with the U.S. Supreme Court’s obviousness ruling in KSR International Co. v. Teleflex Inc. (2007) as it denies the factfinder the ability to use common sense when making a validity determination based on Section 112’s written description requirement.
The district court’s objective inquiry into the four corners of the ‘405 patent and found adequate written description support for the negative limitation precluding a loading dose in both the results of a rat experiment as well as a prophetic human trial that were disclosed in the patent specification. Whereas the majority found the specification’s discussion of “initially” to be limited to the length of treatment, Judge Linn found that other reasonable interpretations supported the district court’s finding that the “daily dosage of 0.5… mg” of fingolimod administered “initially” to an RRMS patient supported the negative claim limitation precluding the initial loading dose. Judge Linn explained:
“The majority asserts that ‘the question is not whether the patentee intended there to be a loading dose; the question is whether the patentee precluded the use of a loading dose.’ I submit that the question posed by the majority is misstated. 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.”