SCOTUS Denial of Novartis Petition for Cert Returns Focus Toward ‘Procedural Insanity’ at the Federal Circuit

On April 17, the U.S. Supreme Court sought to overturn a rehearing decision by the Court of Appeals for the Federal Circuit that invalidated a patent claim directed to a blockbuster multiple sclerosis (MS) treatment, prompting a drug development company to Denied motion for ruling filed by Novartis. , Guilenia. The certificate rejection leaves in place a CAFC decision derided as “procedural insanity” by commentators, and raises the profile of a specific conspiracy in the appellate court with the fingerprints of Chief Justice Kimberly Moore.

The first Federal Circuit ruling on this matter was delivered in January 2022, in which Novartis’ asserted patent claims directed to methods of treatment for relapsing-remitting multiple sclerosis (RRMS) were dismissed in written description at 35 USC. Affirmed the previous judgment of the United States District Court for the District of Delaware that the requirements of § 112. Responding to the panel majority, Chief Judge Moore found that the negative claim limitation excluding the loading dose in administering fingolimod to treat RRMS was supported by the specification of the patent. claimed no. According to Chief Justice Moore, Novartis’ specification would have been required to explicitly provide reasons for excluding loading doses to satisfy section 112, but would have required Novartis’ expert testimony to support the alleged doses. The Delaware District Court’s decision to admit was not clearly erroneous by the majority. regimen.

Then, in June 2022, the Federal Circuit reversed course and issued a panel rehearing decision barring Novartis’ § 112 patent claims. In the interim between sentencing, Justice Kathleen O’Malley retired from the Federal Circuit and took up a position in his trial.original Novartis The panel was replaced by Circuit Judge Todd Hughes. This time, Chief Justice Moore wrote a majority opinion that largely reiterated her stance from that January that “silence cannot uphold negative restrictions.” Circuit Judge Richard Lynn, part of the supporting panel majority, found in the rehearing decision that the majority had improperly formulated the enhanced Section 112 standard for the limitation of negative claims. I objected for that reason.

IPWatchdog president and CEO Gene Quinn didn’t chop words when assessing the importance of the Federal Circuit’s reversal at the hearing.

“Without hyperbole, this procedural insanity is literally unprecedented … It only makes sense that at least one member of the majority should approve a panel rehearing … if the Federal Circuit Unless this monstrous act is reversed on a large scale, today’s majority dissent–tomorrow’s approach to “justice”–will undermine the rest of the credibility that the Federal Circuit currently clings to. . ”

HEC Pharma: No Cyclic Division on Section 46 Procedural Issues

After several Amicus briefs filed in late February supported Novartis’ application for accreditation in SCOTUS, defendant HEC Pharma filed a counter brief on March 3 to appeal to an appeals panel under 28 USC § 46. Novartis’ “freshly drafted” procedural questions posed on the requirements of the 2010 Statute “deserve Supreme Court review.” Not only does it provide for the appointment of a third judge if it does not, HEC Pharma argued that the precedents and statutes identified by Novartis did not necessitate the dismissal of the petition by the rest of the panel. ‘s two judges hearing when they were split.

HEC Pharma’s dissenting opinion refuted Novartis’ claim that division exists in the practice of appointing judges to decide petitions for rehearing. Defendants allege that Novartis ignored the Second Circuit and Tenth Circuit cases, undermining plaintiffs’ claims that there is a uniform practice of nominating judges for retrials. In addition, HEC Pharma said Novartis’ proposed rule could be used in situations where the two judges of the original panel are absent, or where a panel of two judges decides the matter before a third judge decides. It argued that it precludes the appellate court’s discretion to act if it feels it is. on the panel.

Defendants’ dissenting opinion further denounced Novartis’ second question submitted for review in the Federal Circuit’s following decision on strengthening the Section 112 standard. This “fallback question” from Novartis, according to HEC Pharma, “doesn’t merit attestation in the slightest,” and Novartis expert testimony argues that the specification disclosure excludes loading doses. The Court of Appeals for the Federal Circuit was right to dismiss this testimony, HEC Pharma argued. This is because it contradicts the inherent records of the specification and patent. The HEC overview was added as follows:

“Novartis has erroneously sought to reconstruct this fact-specific investigation as a dispute over legal standards. plug.”

Petitioner Novartis Reply: Local Rules Must Follow Acts of Parliament

In a response filed with the Supreme Court on March 21, Novartis said that HEC Pharma’s analysis of procedural issues was flawed because the Court of Appeal’s local rules must be consistent with Congressional action. I claimed. Novartis argued that under the plain language of Section 46(c), Congress only allowed a rehearing decided by his panel of three judges or the court as a whole. to the bankInstead of granting the appellate court the “wide discretionary powers” ​​characteristic of HEC Pharma, Novartis Western Pacific Railroad Corp. vs. Western Pacific Railroad Co. (1952) stated that the procedural discretion of the Court of Appeals was to the bank Check your practices.

On the circuit division issue, Novartis said at HEC Pharma’s own briefing that the DC, 6th and 8th Circuit Courts of Appeals each split the panel 1:1 and refused a rehearing without appointing a new judge. claimed to have admitted to In addition, Novartis flatly refused to reconsider the panel after the judge was removed from the majority, where the remaining panel was split 1:1. He claimed that HEC Pharma had rejected the order. Given that he has 12 of his 19 Federal Circuit judges eligible for retirement, Novartis told the Supreme Court that the issue could be repeated before the Federal Circuit Court of Appeals in patent cases. said to be high.

On the issue of patentability in Section 112, Novartis argues that the Supreme Court has long regarded the written description requirement as a flexible standard allowing implied descriptions understandable to skilled craftsmen, dating back to the 1943 ruling of 1943. claimed to have seen Marconi Wireless Telegraph Co. of America v. United StatesHEC Pharma argued that Novartis’ patent specification could cover either loading or no loading, but Novartis countered:[a] Any discussion that includes either option will necessarily cover both. Although the new majority in the Federal Circuit’s rehearing decision said it did not strengthen the Section 112 standard for the limitation of negative claims, Judge Lynn’s dissent from the rehearing was: It indicated that legal disagreements existed and supported the idea that the CAFC had created such a new standard. , according to Novartis.

CAFC Optics Gets Even Darker Under Chief Justice Moore

The denial of the Supreme Court certificate in this case reveals that Federal Circuit Judge Pauline Newman is about to be removed from the ranks of the Federal Circuit, and has recently called into question her leadership on the Federal Circuit. The focus is further on Chief Justice Moore, who Numerous sources close to Judge Neumann and the Federal Circuit have indicated that Neumann has shown no mental inadequacy for her job, pushing the Biden administration to fill vacancies on the Federal Circuit. In a recent IP Watchdog editorial, Jean Quinn told Chief Justice Moore that she would be exempt from an investigation that could be imposed on Justice Newman. asked to pull

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