561 F.Supp.3d 460
D. Del.2021Background
- Plaintiffs ChromaDex, Inc. and Trustees of Dartmouth College sued Elysium Health for infringement of U.S. Pat. Nos. 8,197,807 (#807) and 8,383,086 (#086), asserting composition claims directed to isolated nicotinamide riboside (NR) formulated for oral administration.
- Asserted claims: #807 claims 1–3 (composition of isolated NR with carriers, formulated for oral use and increasing NAD+ biosynthesis); #086 asserted claim 2 (dependent on claim 1) recites NR isolated from natural or synthetic source.
- Elysium moved for summary judgment that the asserted claims are invalid under 35 U.S.C. § 101 as directed to patent-ineligible subject matter.
- ChromaDex argued the claimed compositions differ from NR in nature because the isolated NR in the claims is stable, bioavailable, sufficiently pure, and therapeutically effective, and that the inventive concept is recognizing NR’s utility and making oral formulations.
- The court applied the Alice/Mayo framework, concluded the claims are directed to a natural product (NR), rejected ChromaDex’s attempt to import unclaimed properties (stability, bioavailability, purity), and held there is no inventive concept beyond the natural phenomenon or its routine isolation and formulation.
- Court granted summary judgment for Elysium; claims 1–3 of #807 and claim 2 of #086 held invalid under § 101.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether asserted composition claims are directed to patent-ineligible subject matter under § 101 | Claims recite isolated NR in formulations that have different characteristics than NR in nature (stability, bioavailability, purity, therapeutic effect) and thus are not merely natural products | Claims are directed to NR, a naturally occurring vitamin, and recite nothing that materially changes or adds to the natural product | Court: Claims are directed to a natural product; ChromaDex’s asserted distinguishing characteristics are not required by the claims and cannot be imported into the claim scope |
| Whether the claims contain an "inventive concept" to transform the natural product into a patent-eligible application | Inventive concept is recognizing NR’s therapeutic utility and creating oral formulations; pioneering decision to formulate isolated NR for oral use | Isolation and routine formulation techniques are conventional; discovering a natural property (oral bioavailability) and applying it is not an inventive concept | Court: No inventive concept; isolation and formulation are routine, and claiming the natural property amounts to claiming the natural phenomenon |
| Whether the "isolated" limitation saves the claims | Isolation makes NR sufficiently pure/stable/bioavailable and thus patent-eligible | Isolation alone is not inventive; Myriad forecloses eligibility simply by isolating a natural product | Court: Isolation as claimed (separated from some source components) does not impose the claimed functional properties and thus does not confer eligibility |
| Applicability of precedents that found patent-eligibility where discovery was applied | ChromaDex cites CellzDirect and similar cases where applying a discovery in a new way provided eligibility | Elysium distinguishes those cases as method/process claims, not composition claims; composition claims governed by Myriad | Court: CellzDirect is distinguishable (process claims); composition claims here are controlled by Myriad and related authorities |
Key Cases Cited
- Alice Corp. Pty. v. CLS Bank Int'l, 573 U.S. 208 (establishing two-step Alice/Mayo § 101 framework)
- Mayo Collaborative Servs. v. Prometheus Labs., 566 U.S. 66 (holding mere application of a law of nature is insufficient; framework for inventive concept)
- Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (products of nature, including isolated naturally occurring molecules, are not patent-eligible merely by isolation)
- Rapid Litig. Mgmt. Ltd. v. CellzDirect, Inc., 827 F.3d 1042 (Fed. Cir.) (distinguishing process claims that applied a discovery from composition claims)
- Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138 (Fed. Cir.) (§ 101 inquiry focuses on claim language)
- Berkheimer v. HP Inc., 881 F.3d 1360 (Fed. Cir.) (presumption of validity; factual issues in § 101 may require clear-and-convincing proof)
- Genetic Techs. Ltd. v. Merial L.L.C., 818 F.3d 1369 (Fed. Cir.) (inventive concept cannot be the unpatentable law of nature itself)
- ChargePoint, Inc. v. SemaConnect, Inc., 920 F.3d 759 (Fed. Cir.) (cannot import unclaimed details from the specification to avoid § 101)