Last week, we reported that the Federal Circuit issued a relatively rare opinion granting panel rehearing in a patent case, Novartis Pharmaceuticals v. Accord Healthcare Inc. In the original, now-vacated opinion, a panel comprised of Judges O’Malley and Linn, with Chief Judge Moore dissenting, indicated the court would affirm a district court’s judgment that claims are not invalid for inadequate written description. Notably, however, a different panel ruled on the motion for panel rehearing. In particular, with Judge O’Malley’s retirement from the court, Judge Hughes joined the panel. The new panel, and in particular Chief Judge Moore (no longer dissenting) and Judge Hughes, with Judge Linn now dissenting, granted the petition for panel rehearing, vacated the panel’s prior decision, and, in the new opinion, now reverse the district court’s judgment. Perhaps most importantly, the changed outcome reflects a difference of view regarding application of the written description requirement. Here is an update on the case.
Novartis originally filed suit against HEC Pharm Co., Ltd. and HEC Pharm USA Inc. (collectively, “HEC”) for alleged infringement of claims 1–6 of a Novartis patent based on HEC’s filing of an Abbreviated New Drug Application (“ANDA”). In response, HEC filed declaratory judgment counterclaims against Novartis alleging invalidity and non-infringement of the patent. Resolving the parties’ contentions, the district court found that claims 1–6 of the patent are not invalid and that HEC infringes them.
In the Federal Circuit’s original, now-vacated opinion, a panel majority including Judges O’Malley and Linn affirmed the district court, finding no clear error in the district court’s holding with respect to the written description requirement. In particular, the majority agreed that a 0.5 mg/day dosage limitation in the claims is adequately described in the patent’s specification and that a skilled artisan would read the patent’s disclosure to describe a negative limitation reciting “absent an immediately preceding loading dose.” Chief Judge Moore dissented, 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.” Chief Judge Moore argued that doing so contradicts the court’s established precedent and nullifies the Manual of Patent Examining Procedure.
HEC subsequently filed a combined petition for panel rehearing and rehearing en banc. In its petition, HEC argued that “the majority jettisoned foundational jurisprudence [by] holding the absence of disclosure is evidence of a negative claim limitation.” HEC explained that the majority allowed “expert testimony to replace the plain language of the specification,” which is a “fundamental legal error.” In response, Novartis argued that the original panel decision was based “on the district court’s finding . . . that a person of skill would read this specification as not silent.” Novartis further argued that “the panel properly applied [the clear-error] standard here in refusing to substitute its own judgement for the district court’s fact findings.”
The parties completed their briefing on the combined petition on March 4. Notably, however, Judge O’Malley retired on March 11, and Judge Hughes subsequently joined the panel. This (along with inaction on the fully-briefed petition for over a week) apparently made all the difference.
Last week the Federal Circuit granted panel rehearing and denied as moot the petition for rehearing en banc. Chief Judge Moore, who originally dissented, wrote the opinion for the reconstituted panel. The panel majority, comprised now of Chief Judge Moore and Judge Hughes, vacated the court’s prior decision and reversed the district court’s judgment that the claims are not invalid for inadequate written description.
The new panel majority held that, because the patent does not 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’ adding during prosecution to overcome prior art satisfies the written description requirement of 35 U.S.C. § 112(a).”
In her opinion for the court, Chief Judge Moore now notes that if silence were disclosure then “every later-added negative limitation would be supported so long as the patent makes no mention of it.” She further explains that, generally, something in the specification must convey to a skilled artisan that the inventor intended the exclusion, and she states that the written description requirement “cannot be met through simple disregard of the presence or absence of a limitation.”
She then explains that the specification does not disclose the presence or absence of a loading dose and that this silence “does not support a later-added claim limitation that precludes loading doses.” She further notes 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.” She further highlights that the court does not “create a heightened standard for negative claim limitations.”
Judge Linn, once a part of the majority, now dissents, expressing his view that the majority 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 further contends that the district court “applied the correct standard and found ample support in the written description for the no-load limitation.”
If there is one major procedural takeaway, it is this: if you lose an appellate case 2-1 and one of the judges in the majority has announced her intention to retire within a few months of the decision, a motion for an extension of time and a petition for panel rehearing just might prove successful.
If there is one major substantive takeaway, it is that the Federal Circuit has taken another step (notably, again over Judge Linn’s objection) to tighten application of the written description requirement, this time with respect to negative limitations.