A brief filed with the Supreme Court of the United States yesterday urged the judges to refuse a application to the Court he argues that the United States Court of Appeals for the Federal Circuit (CAFC) has made a habit of reaching its own factual findings rather than simply discussing and analyzing the district court’s findings, as is required.

The motion was filed on September 11, 2024 by Salix Pharmaceuticals and stems from an April 2024 report. unprecedented decision of the Federal Circuit upholding a district court’s final judgment that certain claims in several patents owned by Salix for a drug used to treat irritable bowel syndrome (IBS) and other conditions were invalid because they were obvious. Justice Tiffany Cunningham disagreed with the majority’s opinion on the invalidity of the patents, in part because she said the majority made findings of fact at trial as to the references to the state of technique that had not been relied upon by the district court for its reasonable expectation of success analysis.

The questions posed by the petition are:

“1. When a district court’s findings of fact are not supported by the evidence relied upon by the district court, a court of appeal may uphold its decision on the basis of other evidence filed in the district court. record, particularly when the relevance of that evidence depends on unresolved factual disputes.

2. When a district court’s findings of fact are based on inadmissible evidence, what standard applies in determining whether the error is harmless.

The United States District Court for the District of Delaware has found several claims regarding Salix’s patents invalid as obvious. It also found that Norwich had failed to prove certain other allegations invalid and concluded that Norwich had committed infringement. Three of the patents relate to the treatment of hepatic encephalopathy (HE), while two relate to the treatment of IBS with diarrhea (IBS-D) and two others are polymorphic patents. For a full analysis of the underlying case, see our coverage here.

On appeal, Salix argued that the district court made its ruling that the IBS-D and polymorphic patents were invalid due to plain error. Norwich had asserted two key pieces of prior art called “the Protocol” and “Pimentel”. But the CAFC ultimately said there was no clear error in the district court’s conclusion that “a skilled craftsman would have had a reasonable expectation of success in administering the claimed 1,650 mg/day regimen for treatment of IBS-D” (which Salix argued was 40% higher than the 1,200 mg/day dosage contemplated in the prior art); and that Grunenthal GMBH v Alkem Laboratories Ltd.919 F.3d 1333 (Fed. Cir. 2019) and Pharmacyclics LLC v. Alvogen, Inc., No. 2021-2270, 2022 WL 16943006 (Fed. Cir. Nov. 15, 2022) does “not exclude the possibility that polymorphic patents may be deemed obvious.”

The CAFC stated that Pharmacyclics The case did not constitute binding precedent for the district court and it was the prerogative of the district court to disagree with the decision. Pharmacycline decision, even in light of the CAFC’s subsequent ruling that upheld the district court’s view in this case, since it was not precedent-setting.

Salix focused primarily in his petition to the Supreme Court on the Federal Circuit’s reliance on evidence that Salix said was “never credited by the district court.” Specifically, the CAFC majority focused on a 2006 Pimentel statement that said: “Recent data suggest that the optimal dose of rifaximin may, in fact, be higher than that used in our study.” »

But Salix pointed to the dissent from Judge Cunningham, who noted that “the district court relied solely on this phrase in its motivation to combine the analysis and did not rely on this phrase in its reasonable expectation of success of the analysis. This error then led the majority to rely on “an inadmissible piece of evidence”, Salix said, namely a press release presented by Norwich as prior art which, according to Salix, had not been properly established as being “by others” under the America Invents Act. rules. Salix said the CAFC determined such an error was harmless because other evidence established the obvious.

The petition urges the Supreme Court to hear the case in order to “realize the Federal Circuit’s appellate process with that of other circuits and ensure that the same procedures – and the same rules of appellate review – apply to appeals in patent matters as in all other civil matters. » ; and to “provide useful clarification regarding bench trial review, both with respect to evidence not cited by the district court and improper evidence relied upon by the district court.”

However, Norwich’s opposition brief, filed Nov. 12, said the Federal Circuit’s decision was “not based on new facts” and “failed to apply the harmless error standard that the request, is inappropriate.”

“The fundamental premise of the petition – that the majority’s assertion is based on a ‘flawed approach to appellate review’ – is simply incorrect,” the brief states.

Furthermore, Norwich said, the cases invoked in the motion to establish a pattern of “persistent fact-finding” are not compelling. Two of the cases date back almost 40 years, and an additional piece of evidence in the form of a quote from a speech given by Judge Lourie of the CAFC 2 4 years ago “is at best anecdotal evidence of the practice judicial,” indicates the brief. The relevant extract from this speech is as follows:

“Although in a particular case a remand rather than a reversal may be considered in order, we are hesitant to send the case back to the district court when we are clear what the outcome will be. I think most district judges would rather have the case decided by us than for us to be too picky about reversal and send the case back for another trial.

Salix argued that this demonstrates “a particular temptation to go beyond the ordinary limits of appellate review and decide patent appeals to achieve what he considers the correct result”, but Norwich stated that ” the full speech expresses a practice of deference to the facts of the trial courts. discovery. »

Finally, Norwich said, the obviousness determination was simply correct and does not warrant further review.

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