The Current Status of the Inherency Doctrine to Meet the Written Description Requirement for Negative Claim Limitations in the United States

In the United States, the inherency doctrine has long been available to fulfill the written description requirement of 35 U.S.C. section 112(a). Following the Federal Circuit’s decision in Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc., 38 F.4th 1013 (Fed. Cir. 2022), the availability of the inherency doctrine to meet that requirement, and keep the patent valid and enforceable, has now been called into question, particularly with respect to negative claim limitations. While we wait for the Federal Circuit to decide whether to rehear the case en banc, this decision could greatly affect the validity and enforceability of countless granted patents.

In Novartis, a rehearing was granted following the Federal Circuit’s original opinion indicating that claims 1 through 6 of Novartis’s U.S. Patent No. 9,187,405, were not invalid for inadequate written description and were thus in compliance with 35 U.S.C. section 112(a) of the U.S. patent statute, which requires that “[t]he specification shall contain a written description of the invention, and of the manner and process of making and using it. . . .” The patent is directed to a method of treating multiple sclerosis (RRMS) by administering fingolimod at a daily dosage of 0.5 milligram (mg).

In particular, in the court’s original opinion, the majority agreed that a 0.5 mg/day dosage limitation in the claims was adequately described in the patent’s specification and that a skilled artisan would read the patent’s disclosure to describe a negative claim limitation reciting “absent an immediately preceding loading dose.” Chief Judge Moore dissented from this original opinion, expressing her view that 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.”

In response, Accord Healthcare et al. subsequently filed a combined petition for panel rehearing and rehearing en banc, arguing that, in the original decision, the court improperly found that the absence of disclosure is evidence of a negative claim limitation, thereby meeting the written description requirement.

In the interim, Judge O’Malley, part of the original panel, retired and was replaced by Judge Hughes. This change, along with the acceptance of the petition for panel rehearing, resulted in the court issuing a new decision reaching an opposite result. Chief Judge Moore, now in the majority and joined by Judge Hughes, vacated the court’s prior decision and held that the claims were invalid for inadequate written description.

The new panel majority held that, because the patent does not specifically and distinctly 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).” In support of this conclusion, 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.

Chief Judge Moore noted that, in her view, if silence were disclosure, then “every later-added negative limitation would be supported so long as the patent makes no mention of it.” Chief Judge Moore further explained that, generally, something in the specification must convey to a person of ordinary skill in the art that the inventor intended the exclusion and that the written description requirement “cannot be met through simple disregard of the presence or absence of a limitation.”

Chief Judge Moore further observed that the patent specification did not explicitly disclose the presence or absence of a loading dose and stated that this silence “does not support a later-added claim limitation that precludes loading doses.” Chief Judge Moore noted that “the disclosure of a daily dosage cannot amount to a disclosure that there can be no loading dose,” as such a finding is “at odds with prosecution history.”

This decision by Chief Judge Moore would seem to be counter to the evidence presented. Specifically, Novartis provided evidence to the court that loading doses in this area were common and that a person of ordinary skill in the art would have understood that, despite the lack of disclosure regarding a loading dose, the patent specification, taken as a whole, would have conveyed that the absence of loading doses was contemplated and intended as a part of the disclosure. This was corroborated by the prosecution history for the patent, in which a cited prior art reference was distinguished by adding a limitation to the claim of “a daily dosage of 0.5 mg, absent an immediately preceding loading dose regimen.” Despite this evidence and prosecution history, Chief Judge Moore held that “silence is not disclosure” and that the negative claim limitation was not inherently disclosed in the patent specification because it must not necessarily and always be present.

According to Chief Judge Moore, this decision did not “create a heightened standard for negative claim limitations.” In reality, however, the decision represents a significant tightening of the written description requirement for negative claim limitations that must be proven during litigation. Previously, the negative claim limitation did not need to be expressly stated, as such, in the patent specification for a court to find there to be sufficient written description and for the requirement to be met. A lack of literal basis in the specification for a negative claim limitation was previously seen as not necessarily being sufficient to establish a prima facie case of invalidity for lack of descriptive support. Ex parte Parks, 30 USPQ2d 1234, 1236 (B.P.A.I. 1993). Similarly, it has long been part of U.S. law that if alternative elements are positively recited in the specification, they may be explicitly excluded in the claims. See In re Johnson, 558 F.2d 1008, 1019, 194 USPQ 187, 196 (C.C.P.A. 1977) (“[The] specification, having described the whole, necessarily described the part remaining.”). See also Ex parte Grasselli, 231 USPQ 393 (Bd. App. 1983), aff’d mem., 738 F.2d 453 (Fed. Cir. 1984).

Now, however, according to the current majority opinion, to meet the written description requirement, a claim limitation must be either expressly disclosed in the specification or, technically, necessarily (inherently) present in some express disclosure, even if a person of ordinary skill in the art would otherwise read the specification to disclose possession of the claim limitation. However, it is very easy to see how Chief Judge Moore’s majority opinion would essentially preclude the possibility that an inherent disclosure would provide sufficient support to meet the written description requirement. This is a very challenging hurdle to overcome, particularly with respect to, as here, negative claim limitations. Because this would seem to be a new application of the law, any previously granted patent containing a negative claim limitation must be seen as having serious potential issues with validity and enforcement based on the written description requirement. Should this decision stand, before seeking to enforce a patent against a third party, it will be important to consider whether the patent has any negative claim limitations. If it does, the patent may have a fatal written description flaw according to the decision here.

Even further, while the current Novartis decision would initially seem to be limited to inherent disclosures supporting negative claim limitations, it is not hard to see this new doctrine being expanded to include any claim limitation, positive or negative. For that reason, it is now an open question as to whether an inherent disclosure in a patent provides sufficient support to meet the written description requirement for any claim limitation.

Of possibly as much concern to litigators, the history of this case would seem to imply that the law is not always the same but is entirely dependent on the composition of the three-judge panel hearing the case. Here, the initial panel upheld the validity and enforceability of the patent. The only difference between the initial decision and the current decision is the replacement of one judge on the panel with another judge.

In view of the serious issues involved, Novartis has already petitioned the Federal Circuit for an en banc rehearing of this case. Novartis Pharm. Corp. v. Accord Healthcare, Inc., No. 21-1070, petition for reh’g en banc of 38 F.4th 1013 (Fed. Cir. 2022). So it is certainly possible that this is not the end of the story, and the interpretation of the law we will all have to work under will once again change, hopefully for the better.

Ultimately, if this decision is upheld, we can expect a heightened amount of gamesmanship with respect to the makeup of any three-judge panel at the Federal Circuit, particularly for the party on the losing end of any case. This decision could open the floodgates for petitions for panel rehearing, requesting different members of the panel, in the hopes of obtaining a more favorable result. Should this happen, it would be contrary to the public interest, it would be a further erosion of stare decisis, and it could be seen as further weakening the public’s faith in our patent system. This would be bad for innovators and for society as a whole, as one could expect it would have a stifling effect on innovation and the creation of new products.