High Court Declines to Consider MSN’s Call for Clarity on CAFC’s After-Arising Technology Conflict

The U.S. Supreme Court on Monday denied certiorari to MSN Pharmaceuticals, Inc. v. Novartis Pharmaceuticals Corp., a case that asked the Justices to clarify U.S. Court of Appeals for the Federal Circuit (CAFC) precedent around using “after-arising technology” to hold a patent invalid in the context of patent-infringement suits.

The case arises from a  January 2025 precedential CAFC decision reversing a district court’s determination that certain claims of a patent for Novartis’ heart failure drug Entresto were invalid for lack of written description, and affirming a finding that the claims were not shown to be invalid for obviousness, lack of enablement, or indefiniteness.

MSN Pharmaceuticals, Inc. subsequently filed a petition for certiorari to the Supreme Court in August of this year, arguing that there is “doctrinal chaos” surrounding the topic of after-arising technology in the context of patent infringement suits. While some Federal Circuit decisions have held “that when a patentee secures a claim construction that ensnares, as infringing, an accused device that features after-arising technology, the patentee risks invalidating its own patent on written-description and enablement grounds,” other decisions have held in the same circumstance that “the patent may survive a validity attack—even if the patent does not describe or teach the after-arising technology.”

Here, the CAFC 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 ‘659 patent, is not what was claimed. The appellate court thus found that the district court clearly erred in its analysis of written description and reversed the district court’s holding.

Several amici weighed in supporting the petitioners or urging the Court to grant the petition, including two briefs from law professors, two from generic pharmaceutical companies and one from the Public Interest Patent Law Institute (PIPLI), among others.

Those amici agreed that there is conflicting precedent from the Federal Circuit on after-arising technology and urged the Court to take up the case. “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, Inc.

Novartis, on the other hand, told the Supreme Court in its opposing brief that the CAFC decision “reflects the straightforward application of well-settled law from this Court and the circuit courts.” According to Novartis, [i]t has long been established that a patent claiming a combination of A + B, such as the one here claiming the combination of the active pharmaceutical ingredients valsartan and sacubitril, need adequately describe and enable only that invention—and need not describe or enable later improvements that add to it…”

In a recent op-ed published by IPWatchdog, Peter Harter said that the CAFC’s conflicting precedent in this space is threatening U.S. competitiveness with China in the biopharma race. “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 data from the Financial Times showing that “China’s share of global innovative drug candidates in clinical trials has risen from 8 per cent in 2018 to 30 per cent this year, according to McKinsey,” while “the US share has fallen from 47 per cent to 36 per cent” in the same period.

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