Whether a composition containing an isolated natural substance that exhibits markedly different characteristics from the substance as it appears in nature and possesses significant utility is patent-eligible subject matter under 35 U.S.C. § 101, or whether the act of isolation alone is insufficient to confer patent eligibility absent additional human intervention or transformation

No question identified. : expire on August 8, 2023. This Application is filed at least ten days prior to that date pursuant to Supreme Court Rule 13.5. The jurisdiction of this Court would be invoked under 28 U.S.C. § 1254(1). Attached are copies of the Federal Circuit’s opinion (Exhibit A) and its order denying the Combined Petition (Exhibit B). 1. This case presents important questions about the framework for determining patent eligibility. In particular, the case concerns whether compositions are patent-eligible when they contain a natural substance that has been isolated and incorporated into a dosage form, but have different characteristics than and can be used in a different manner than the substance as it appears in nature. This Court addressed a related, but distinct question in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), and the Federal Circuit has applied Myriad inconsistently. 2. At issue in this case is U.S. Patent No. 8,197,807 (“the ’807 patent”), owned by Trustees of Dartmouth College and licensed exclusively to ChromaDex, Inc. Claim 1 of the ’807 patent is representative and recites: A composition comprising isolated nicotinamide riboside in combination with one or more of tryptophan, nicotinic acid, or nicotinamide, wherein said combination is in admixture with a carrier comprising a sugar, starch, cellulose, powdered tragacanth, malt, gelatin, talc, cocoa butter, suppository wax, oil, glycol, polyol, ester, agar, buffering agent, alginic acid, isotonic saline, Ringer's solution, ethyl alcohol, polyester, polycarbonate, or polyanhydride, wherein said composition is formulated for oral administration and increases NAD+ biosynthesis upon oral administration. (emphasis added). While nicotinamide riboside exists in nature, it is undisputed that isolated nicotinamide riboside does not. 2. This Court has held that a claim to a manufacture or composition of matter made from a natural product is not directed to the natural product—and is thus patent-eligible subject matter—where it has “markedly different characteristics” and “the potential for significant utility.” Diamond v. Chakrabarty, 447 U.S. 303, 310 (1980). In Myriad, this Court held that patents claiming isolated DNA segments were invalid where Myriad “found an important and useful gene” but “did not create anything” because “separating that gene from its surrounding generic material is not an act of invention.” 569 U.S. at 591. The Court contrasted Myriad’s claims with those at issue in Chakrabarty, which claimed something “with markedly different characteristics from any found in nature.” Id. at 590-91 (citing Chakrabarty, 447 U.S. at 310). 3. In the decision below, the Federal Circuit held that the patent claims were “invalid for claiming a patent-ineligible product of nature.” ChromaDex v. Elysium Health, Inc., 59 F.4th 1280, 1284 (Fed. Cir. 2023). Specifically, the Federal Circuit held that the “claims are very broad and read on milk,” except that “[m]ilk contains [nicotinamide riboside], but the [nicotinamide riboside] is not isolated.” Id. at 1283. Citing this Court’s decision in Myriad, 569 U.S. at 590-93, the Federal Circuit concluded that “the act of isolating the [nicotinamide riboside] compared to how [nicotinamide riboside] naturally exists in milk is not sufficient, on its own, to confer patent eligibility.” Id. at 1284. Because, in the Federal Circuit’s view, the “claimed compositions do not exhibit markedly different characteristics from natural milk,” id. 1284, it deemed the claims invalid under 35 U.S.C. § 101. Applicants are considering seeking this Court’s review of that decision, which conflicts with other rulings of the Federal Circuit on the same question. See, e.g., Natural Alternatives Int'l, Inc. v. Creative Compounds, LLC, 918 F.3d 1338 (Fed. Cir. 2019). 4. There is good cause to grant a 30-day extension of Applicants’ time to file a petition for a writ of certiorari. First, Appellants’ couns