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In a legal saga that has kept the biotech sector on the edge of its seat, the U.S. Supreme Court delivered a stunning blow to Dartmouth College's bid to resurrect a contested vitamin B3 patent. This landmark decision, with far-reaching implications, centered on the eligibility of a vitamin patent at the heart of a contentious dispute with dietary supplement manufacturer Elysium Health.

Dartmouth Denied Supreme Court Review

On Monday, the highest court in the land decisively rejected a petition from Dartmouth College and licensee ChromaDex Inc., both stakeholders in the creation of dietary supplements. This petition was an attempt to overturn a circuit court's affirmation of a district court's 2021 ruling, which invalidated Dartmouth's vitamin B3 patent, known as U.S. Patent No. 8,197,807, in the ongoing legal battle against Elysium Health.

The Supreme Court, without providing specific reasons for their decision, struck down Dartmouth's case in a move that shocked many legal experts and industry insiders.

Milk Vitamin Patent Eligibility Case : Alice Test vs. One-Step Test

Central to Dartmouth's petition was their argument that the Federal Circuit had erred in its application of the Alice test, a two-step evaluation process to determine patent eligibility. Dartmouth contended that the court should have examined whether the vitamin B3 patent contained ineligible material and, subsequently, whether it had been transformed into a patent-eligible application.

Instead, the Federal Circuit utilized a one-step test derived from a different Supreme Court eligibility decision known as Myriad. This one-step test focused solely on whether the patented invention was "markedly different" from a natural phenomenon, and it ultimately concluded that the milk vitamin patent did not meet this criterion.

Dartmouth's petition highlighted the critical importance of applying the Alice test uniformly across different domains, emphasizing that the Federal Circuit's approach threatened to undermine the biotechnology sector's long-standing recognition that novel uses and applications of a patent-ineligible concept can still be deemed patentable.

Milk Vitamin Patent Eligibility Case : The Dispute Unveiled

The roots of this complex legal battle stretch back to September 2018, when Dartmouth and ChromaDex initiated a legal confrontation against Elysium Health in a Delaware federal court. The lawsuit revolved around Dartmouth's '807 patent and a related vitamin B3 patent, U.S. Patent No. 8,383,086.

Dartmouth and ChromaDex asserted that Elysium's dietary supplement, "Basis," infringed on both the '807 and '086 patents, which ChromaDex held an exclusive license for as they competed with their supplement, "Niagen NR."

ChromaDex argued that their patented compositions of nicotinamide riboside (NR), a vitamin B3 derivative, differed significantly from the naturally occurring form. They claimed their isolated form was more stable, bioavailable, and purer. However, U.S. Chief District Judge Colm Connolly ruled against their argument.

In September 2021, Judge Connolly invalidated both patents, asserting that they were directed to a naturally occurring form of vitamin B3 found in cow's milk. Dartmouth and ChromaDex subsequently appealed this ruling at the Federal Circuit in November.

As the legal battle unfolded, the appellants decided to voluntarily withdraw the appeal regarding the '086 patent, leaving only the '807 patent under review by a judicial panel.

Radio Silence from Parties Involved

In the wake of this stunning Supreme Court decision, neither the legal counsel for the parties nor the involved stakeholders have issued immediate comments or reactions.

The focal point of this legal storm, U.S. Patent No. 8,197,807, now lies in a state of uncertainty, and the ramifications of this Supreme Court decision will be closely watched by the biotechnology sector and legal experts alike.