59 F.4th 1280
Fed. Cir.2023Background
- The ’807 patent claims compositions comprising isolated nicotinamide riboside (NR) combined with tryptophan, nicotinic acid, or nicotinamide and a listed carrier, formulated for oral administration to increase NAD+ biosynthesis.
- ChromaDex (patentee, licensed from Dartmouth) sued Elysium for infringement; the district court construed “isolated [NR]” as NR separated or substantially free from at least some components of its source.
- Elysium moved for summary judgment under 35 U.S.C. § 101; the district court held claims 1–3 patent-ineligible as directed to a product of nature and entered judgment for Elysium.
- The court compared the claimed compositions to natural cow’s milk (which contains NR, tryptophan, and lactose and increases NAD+ biosynthesis via tryptophan), observing the claims differ from milk only by requiring NR to be “isolated.”
- The Federal Circuit affirmed: isolation alone did not impart patent eligibility because the claimed compositions lacked “markedly different characteristics” from milk and, under Alice/Mayo, lacked an inventive concept.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether the asserted claims are patent-eligible under § 101 | Claims to compositions with isolated NR are eligible because isolation and resulting advantages (stability, purity, bioavailability, efficacy) make them inventions | Claims are directed to a natural product (milk) and isolation alone does not make a product of nature patentable | Invalid under § 101; claims are products of nature and not patent-eligible |
| Whether the claimed compositions have “markedly different characteristics” from natural milk | Isolated NR yields substantially higher, bioavailable NR producing greater NAD+ biosynthesis—a marked difference | Claims do not require minimum NR amounts or bioavailability; milk already increases NAD+ (via tryptophan); no marked differences in the claims | No; claims do not show markedly different characteristics and thus cover a natural product |
| Effect of claim construction of “isolated [NR]” (does it require separation from lactalbumin / bioavailability?) | NR in milk is trace and bound to lactalbumin; isolation is necessary to achieve bioavailability and efficacy | The court’s construction requires only separation from some source components, not separation from lactalbumin or a bioavailability requirement | District construction stands; claims do not require bioavailability and therefore can encompass milk-like embodiments |
| If analyzed under Alice/Mayo, do the claims contain an inventive concept? | Recognizing NR’s utility and isolating it to concentrate NR are inventive steps that supply an inventive concept | Recognizing a natural property and isolating a natural product are not inventive; both are routine or discoveries of nature | Fail Alice/Mayo: directed to natural principle and lacking an inventive concept |
Key Cases Cited
- Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (U.S. 2013) (isolated naturally occurring DNA is a product of nature and not patent-eligible)
- Diamond v. Chakrabarty, 447 U.S. 303 (U.S. 1980) (genetically engineered organism with markedly different characteristics is patentable)
- Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (U.S. 2012) (laws of nature and natural phenomena are not patentable; inventive concept required)
- Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208 (U.S. 2014) (two-step framework for patent-eligibility analyses)
- Nat. Alts. Int'l, Inc. v. Creative Compounds, LLC, 918 F.3d 1338 (Fed. Cir. 2019) (upheld supplements where isolation plus formulation produced different characteristics from the natural product)
- In re BRCA1- and BRCA2, 774 F.3d 755 (Fed. Cir. 2014) (applied Myriad/Chakrabarty distinctions between compositions of matter and natural phenomena)