Fed Circuit Holds Claims Directed to Milk Not Patent-Eligible Under §101

101 patent patent eligible subject matter

On February 13, 2023, in ChromaDex, Inc. v. Elysium Health, Inc.,[1] the Court of Appeals for the Federal Circuit issued its first opinion of the year dealing with patent eligibility under 35 U.S.C. §101.  Unsurprisingly, the Fed Circuit held that the claims lacked patent-eligible subject matter, and concluded the claims were merely isolated formulations of milk.

Nicotinamide riboside

Claim 1 of the ‘807 patent is:

1.  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, 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 increased NAD+ biosynthesis upon oral administration.

ChromaDex had Patent No. 8,197,807 (“’807 patent”) issued with claims directed to isolates and compositions of nicotinamide riboside (“NR”), a naturally-occurring B3 derivative that is found in cow’s milk.  ChromaDex commercializes the isolated NR into vitamin supplements.  The Fed Circuit panel, comprised of Judges Prost, Chen, and Stoll, with Judge Prost authoring the unanimous opinion, noted the similarities between the claims and milk: 1) that milk is a composition itself, while the claims are directed to a composition; 2) milk contains naturally-occurring NR, and the claims are directed to an NR isolate; 3) milk naturally contains tryptophan and nicotinamide, and the claims are directed to tryptophan, nicotinic acid, or nicotinamide, in combination; 4) that milk is an admixture containing a sugar, while the claims are directed to an admixture containing, among other compounds, a sugar; and 5) milk is formulated for oral administration, while the claims are directed to an oral administration of the NR composition.  Essentially, the only difference between the claims and milk is the isolation of NR in the claimed invention.

Section 101 reads:

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor . . . .

As interpreted by U.S. Supreme Court precedent, “laws of nature, natural phenomena, and abstract ideas are not patentable.”[2]  Judge Prost wrote: “the asserted claims do not have characteristics markedly different than milk.  Both the claimed compositions and milk ‘increase[] NAD+ biosynthesis upon oral administration.’”  She continued, that embodiment of the claimed invention is so broad enough to cover milk – a product of nature – it is invalid under §101. 

The panel only glossed through a §101 analysis under the Alice/Mayo two-step regime.[3]  Judge Prost did analyze the present case with the Chakrabarty logic of “markedly different characteristics” than a naturally-occurring phenomenon,[4] and determined, as discussed above, that the ChromaDex’s ‘807 claims did not. 

Her opinion also noted that the claims were very broad.  Patent attorneys gravitate to drafting broader claims but in this case, the claims were too broad, and better drafting around the naturally-occurring milk compositions may have saved the ‘807 patent claims from ineligibility.  In this respect, the case is probably properly decided.

For more information on §101 patent-eligibility or the patenting process, please contact Yonaxis I.P. Law Group.

[1] ___F.4th___ (Fed. Cir. 2023), aff’g 561 F. Supp. 3d 460 (D. Del. 2021).

[2] Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589 (2013).

[3] See, Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 217 (2014); Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 77-80 (2012).

[4] See, Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980).