“like innumerableUnder the circumstances presented here, the act of isolating the NR compared to the way it naturally occurs in milk is not, by itself, sufficient to grant patent eligibility. – CAFC
The U.S. Court of Appeals for the Federal Circuit (CAFC) today issued a precedent decision upholding the Delaware court’s grant of summary judgment against Elysium Health for the alleged claims of ChromaDex, Inc.’s patent on an isolated form of vitamin B3 Did. Unpatentable Subject Matter Under Section 101. Judge Prost prepared an opinion.
US Patent No. 8,197,807 is entitled “Nicotinamide Riboside Kinase Compositions and Methods of Use Thereof.” Nicotinamide riboside (NR) is a form of vitamin B3 that occurs naturally in milk. The present invention encompasses compositions containing isolated NRs that, upon oral administration, result in increased biosynthesis of the coenzyme nicotinamide adenine dinucleotide (NAD+).
ChromaDex, which sells nutritional supplements embodying patents licensed from Dartmouth College, sued Elysium for patent infringement in 2018. natural phenomena, specifically “compositions of isolated things” [NR]is a natural vitamin found in milk. ”
Nothing “significantly different” here
In its discussions, the CAFC reached an agreement with the United States District Court for the District of Delaware that the claims are directed against products of nature. Ass’n for Molecular Pathology v. Myriad Genetics, Inc. and Diamond vs Chakrabarty. “like innumerableUnder the circumstances presented here, the act of isolating NR compared to the way it occurs naturally in milk is not, by itself, sufficient to grant patent eligibility,” the court wrote. . A suitable inquiry is Chakra Bhatithe opinion continued, and the Supreme Court said:[ve] However, NR, which is naturally present in milk, increases NAD+ biosynthesis upon oral ingestion, similar to the claimed invention.
Distinction between cases and cases Natural Alternatives Int’l, Inc. v. Creative Compounds, LLC, CAFC explained that the patents here are not significantly different from milk. Appellant argues that isolating NR allows for more NAD+ biosynthesis than is found in milk alone, and that only isolated NR can increase his NAD+ biosynthesis, thus the composition claimed to be preferable to cow’s milk, but the CAFC said: The NR and 2) claims attribute the increase in NAD+ solely to the composition, not just the isolated NR. The court further explained that:
“Certainly, the claim covers several different compositional embodiments, some of which are structurally different from milk. Also includes at least one embodiment directed to milk, except that The claim is invalid under § 101 because it is broad enough to encompass products of nature. “
ChromaDex argued that this claim has markedly different characteristics than milk. (2) Because it is bound to the lactalbumin whey protein, “a small amount of NR in milk is not bioavailable.” The Federal Circuit explained that milk increased her NAD+ biosynthesis due to the presence of tryptophan, despite trace amounts of NR. No significant difference, as the only therapeutic effect claimed by the patent claims is an increase in NAD+ biosynthesis. Second, the court held that the district court’s undisputed construction of “separated NR” did not require that NR be separated from lactalbumin whey protein, rather than “of other ingredients associated with its source.” He said he would demand that he be separated only from “some”. [NR]”
no help from Alice May
The court said the debate could end there, but then addressed the connection of the two parts. Alice May analysis. “[I]If Alice/Mayo must be relied upon, step 1 concludes that the asserted claim is directed to a product of nature for the reasons given above, and step 2 finds inventive step since the claim is only a composition. conclude that it is missing. It increases NAD+ biosynthesis, a very natural principle that makes the claim ineligible,” the court said.
Court Rejects ChromaDex’s Argument that Recognizing the Health Benefits of NR and the Wisdom of Isolating NR for Enhancing Concentrations Compared to Those Found Naturally in Milk Represents Inventive Step Did. The opinion concluded that:
“[R]Recognizing the usefulness of NR is nothing less than recognizing a natural phenomenon, which is not original. Similarly, (although the specification makes it clear that it was conventional), it does not turn an otherwise unpatentable product of nature into a patentable invention. Therefore, the claim will fail at step 2 as well. ” [citations omitted]
Elysium and ChromaDex have been involved in litigation on several fronts since 2016.
