Supreme Court Declines Patent Case That Could Impact Heart Failure Drug Entresto and Pharmaceutical Innovation
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The U.S. Supreme Court denied certiorari in MSN Pharmaceuticals (search) v. Novartis, a case seeking clarity on Federal Circuit precedent regarding "after-arising technology" in patent infringement disputes.
The case centered on Novartis' heart failure drug Entresto, where the Federal Circuit reversed a district court's finding that certain patent claims were invalid for lack of written description.
Legal experts argue the conflicting Federal Circuit precedent on after-arising technology creates "doctrinal chaos" that may threaten U.S. competitiveness in biopharmaceutical innovation against China.
The U.S. Supreme Court on Monday denied certiorari in MSN Pharmaceuticals (search), Inc. v. Novartis Pharmaceuticals Corp., leaving unresolved a contentious legal issue that pharmaceutical companies argue creates uncertainty in patent litigation and potentially threatens American competitiveness in drug development.
The case arose from disputes over Novartis' heart failure medication Entresto, specifically regarding patent claims that the Federal Circuit found valid despite lacking description of certain molecular complexes discovered years after the original patent filing.
Federal Circuit Reverses District Court on Entresto Patent
The controversy stems from a January 2025 precedential Federal Circuit decision that reversed a district court's determination that certain claims of Novartis' patent were invalid for lack of written description. The appellate court also affirmed findings that the claims were not invalid for obviousness, lack of enablement, or indefiniteness.
The Federal Circuit ultimately found that Novartis' patent's lack of description for a complexed form of valsartan and sacubitril "does not affect the validity of the patent" because that complex, which wasn't discovered until four years after the priority date of the patent, is not what was claimed. The court concluded that the district court clearly erred in its written description analysis.
"Doctrinal Chaos" in After-Arising Technology Cases
MSN Pharmaceuticals (search) filed a petition for certiorari in August, arguing that "doctrinal chaos" surrounds the topic of after-arising technology in patent infringement suits. The company highlighted conflicting Federal Circuit decisions: some have held that when a patentee secures a claim construction that captures an accused device featuring after-arising technology, the patentee risks invalidating its own patent on written-description and enablement grounds. Other decisions have held that in the same circumstance, the patent may survive a validity attack even if it does not describe or teach the after-arising technology.
Several amici supported the petition, including law professors, generic pharmaceutical companies, and the Public Interest Patent Law Institute. These supporters agreed that conflicting Federal Circuit precedent exists and urged the Supreme Court to provide clarity.
"The Court's ruling creates an unfair situation: for infringement a patentee can ask the court for a broader claim construction to ensnare the infringer through later developed technology, but then not suffer the consequence that such technology need not be described in the specification," wrote Biophore Pharma (search), Inc. in its amicus brief.
Novartis Defends Established Patent Law
Novartis countered in its opposing brief that the Federal Circuit decision "reflects the straightforward application of well-settled law from this Court and the circuit courts." The company argued that it has long been established that a patent claiming a combination of active pharmaceutical ingredients like valsartan and sacubitril need only adequately describe and enable that specific invention, not later improvements that add to it.
Implications for U.S. Pharmaceutical Competitiveness
Legal experts have raised concerns that the unresolved precedent may impact American pharmaceutical innovation. In a recent analysis, Peter Harter argued that the Federal Circuit's conflicting precedent threatens U.S. competitiveness with China in the biopharmaceutical sector.
"While U.S. companies bleed billions litigating 20-year-old genus claims, Chinese innovators are sprinting ahead in antibody-drug conjugates, bispecific antibodies, cell therapies, and next-generation obesity drugs," Harter wrote, citing Financial Times data showing that China's share of global innovative drug candidates in clinical trials has risen from 8 percent in 2018 to 30 percent this year, according to McKinsey, while the U.S. share has fallen from 47 percent to 36 percent in the same period.
The Supreme Court's denial of certiorari leaves pharmaceutical companies and patent practitioners without clear guidance on how courts should handle cases where patent claims are construed broadly enough to cover technologies developed after the original patent filing date.