The Sound Of Silence And The Inherency Doctrine For Written Description

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The basic issue in Novartis v. Accord is quite familiar. A new limitation was added to the claims during prosecution that is not found expressly in the specification, but would be expected by someone of skill in the art. Does the claim violate the written description requirement of 35 U.S.C. 112? In its most recent statement, the Federal Circuit finds failure of written description unless the invention is either expressly or inherently disclosed in the original specification. Novartis Pharm. Corp. v. Accord Healthcare, Inc., 38 F.4th 1013 (Fed. Cir. 2022) (rehearing decision). One quirk here is that the court identifies the particular limitation as a “negative claim limitation” and there are wide ranging policy views on how those limitations should be treated. However, the Novartis court explained that its express-or-inherent holding here applies regardless of whether claim limitations are expressed in positive or negative form. Novartis has no petitioned for en banc rehearing.

The appellate procedure in this case is strange and important to its current status: The district court sided with Novartis (infringed + not-invalid) and the Federal Circuit affirmed on appeal in a January 2022 decision. That original CAFed decision was penned by Judge O’Malley and joined by Judge Linn. Chief Judge Moore wrote in dissent — arguing that the majority had been way too lenient.

By January 2022, Judge O’Malley had already announced her plans to retire from the judiciary in early March 2022. The appellant’s rehearing petition would have ordinarily been due on Groundhog Day, February 2, but HEC requested and was granted a 21-day delay and that meant that Novartis’s response would not be due until after Judge O’Malley’s retirement. Rather than waiting for the deadline, Novartis filed its responsive brief with a four-day turn around. But to no avail; Judge O’Malley retired before acting on the rehearing petition.

After Judge O’Malley’s retirement, the court added Judge Hughes to the panel to decide the rehearing. Of any judge that might have been added, Judge Hughes was one very likely to find against the patentee in this situation. My understanding is that the court did not announce Judge Hughes addition to the panel until it issued a revised panel opinion on June 21, 2022. Presumably in this case, there was some randomness in Judge Hughes’ selection, but the rules don’t expressly require that.

The panel re-composition flipped the outcome. Chief Judge Moore had previously written in dissent, but now Judge Hughes joined her opinion–putting her in the majority. With the loss of Judge O’Malley, Judge Linn’s position flipped to the dissent. Thus, the new opinion sided with the accused infringer–concluding that the district court “clearly erred” in finding the claims not invalid. The decision here is apparently the first time that a Federal Circuit panel has flipped the outcome following a change in panel composition.

Now, Novartis has filed its petition for rehearing. The petition raises two issues: one on the merits of the written description issue; and a second focusing on the unusual appellate procedure.

Lets start with procedure and panel dependence. The other circuits have an internal rule or practice that a panel rehearing will not be ordered unless at least one judge in the majority votes for the rehearing. The idea behind a panel rehearing to raise issues that the majority can recognize that it “overlooked or misapprehended.” FRAP 40(a)(2). But, no one in the majority changed their outlook. Rather, the addition of Judge Hughes provided an end-run around the majority by adding a new panel member.

The Federal Circuit has previously written about this issue – but not in a self-reflective way. Rather the court was in its then supervisory role of the US Claims Court. Universal Restoration, Inc. v. U.S., 798 F.2d 1400 (Fed. Cir. 1986). In Universal, one panel member of the Claims Court had been replaced following its original determination. That recomposition resulted in a flipped the outcome on rehearing. On appeal, the Federal Circuit reversed on the merits, but in a footnote explained that the recomposition was improper:

Where the original panel reconsiders and changes a decision, a member of the original majority must vote for the change. In the Supreme Court where less than a majority may order rehearing, a member of the original majority must vote for the rehearing. These procedures are readily acceptable as “fair.” Sup.Ct.R. 51.1 (1980); Ambler v. Whipple , 90 U.S. (23 Wall.) 278, 281–82 (1874). . . . What appears to be the case here is that there was in fact no reconsideration. A different panel simply disagreed with the first decision.

Id. The Federal Circuit does have a rule regarding replacement of a missing panel member. Federal Circuit Rule 47.11. That rule calls for the Chief Judge to secure an additional judge in situations where “a judge of a panel that has heard oral argument or taken under submission any appeal, petition, or motion is unable to continue with consideration of the matter.” If the remaining two judges are unable to resolve the matter, then the chief judge should appoint another judge. Id. In its petition, the Novartis argues that this rule is inapplicable based upon the aforementioned general tradition and because panel rehearing petitions are not “argued” or “taken under submission.”

On the merits: The petition argues that the new majority opinion improperly creates an “express-or-inherent rule:” That the invention as claimed must be either expressly or inherently disclosed within the specification. Chief Judge Moore explained:

[I]t is possible that the written description requirement may be satisfied when a skilled artisan would understand the specification as inherently disclosing the negative limitation. . . [However], testimony from a skilled artisan as to possibilities or probabilities that the recited element would be excluded would not suffice, lest such testimony could effectively eliminate the written description requirement. If silence were generally sufficient, all negative limitations would be supported by a silent specification. If, however, 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, the written description requirement would be satisfied despite the specification’s silence.

Id. The petition argues that Judge Moore has improperly created a bright-line rule in an area where “there are no bright-line rules.”

The new majority’s inflexible heightened standard conflicts with a substantial body of precedent. It makes written description turn not on what the specification “reasonably conveys to those skilled in the art,” but on what the specification expressly or necessarily discloses. And because the new majority expressly declined to limit its holding to negative claim limitations, that holding could be applied to reverse any written-description finding.

What is the invention: Fingolimod was a known immune suppressant. In its patent, Novartis claims a method of treating multiple sclerosis (RRMS) by administering fingolimod at a particular daily dosage of 0.5 mg.

Many drug regimens begin with a loading-dose to quickly raise the blood-level. The dosage is then reduced to a lower maintenance dosage. During prosecution some prior art was uncovered that started with a loading dose and then reduced dosage down to a level close to that claimed by Novartis. But the Novartis invention did not require a loading dose. Prosecutors amended the claims to make that clear: “a daily dosage of 0.5 mg, absent an immediately preceding loading dose regimen .”

The Sound of Silence: The problem identified by Chief Judge Moore is that the Novartis patent application documents never mention loading doses or the absence of loading doses. They don’t say anything one-way-or-the-other. Novartis provided evidence that loading doses in this area were common and that PHOSITA would have understood that silence regarding loading doses was actually a disclosure that no-such loading doses were required. Judge Moore rejected this argument; holding instead that “Silence is not disclosure.” Further, Judge Moore adopted the inherency doctrine as a limiting rule. That doctrine is quite tight and only finds disclosures inherent if they necessarily flow from express teachings.

Law Professor at the University of Missouri School of Law. View all posts by Dennis Crouch →

I think that express or inherent is a bit rough, implied should also be included. There are many things that are implied in a disclosure and should be fair game for claiming imo.