Federal Circuit rejects Dartmouth College bid to overturn patent ruling
Dietary supplements containing a form of vitamin B3 found in cow’s milk are unpatentable | Judge cites Myriad noting that the “act of isolating the NR compared to how NR naturally exists in milk is not sufficient, on its own, to confer patent eligibility”.
The US Court of Appeals for the Federal Circuit has affirmed a lower court’s decision to find a patent owned by Dartmouth College unpatentable.
In a precedential ruling handed down yesterday, 13 February, the Federal Circuit concluded that the asserted claims of US patent number 8,197,807—which covers a dietary supplements containing isolated nicotinamide riboside (NR), a form of vitamin B3—were unpatentable.
NR, in a non-isolated form, is naturally present in cow’s milk and other products.
Dartmouth College and licensee ChromaDex failed to convince the Federal Circuit to overturn the US District Court for the District of Delaware’s decision to grant Elysium Health’s motion for summary judgment that the asserted claims are directed to unpatentable subject matter.
In 2018, ChromaDex accused Elysium, a former ChromaDex customer, of patent infringement. Elysium, in response, moved for summary judgment.
The Delaware court concluded that the patent claims were directed to a natural phenomenon, namely, “compositions comprising isolated [NR], a naturally occurring vitamin present in cow milk”.
In outlining the lower court’s decision, the Federal Circuit said: “It rejected ChromaDex’s argument that the characteristics of isolated NR purportedly different from naturally occurring NR— stability, bioavailability, sufficient purity, and therapeutic efficacy—render the claims patent-eligible, observing that none of those characteristics were part of the claims.”
The Delaware court concluded that “the decision to create an oral formulation of NR after discovering that NR is orally bioavailable is simply applying a patent-ineligible law of nature.”
Dartmouth College and ChromaDex appealed against the decision, but the Federal Circuit affirmed the Delaware court’s ruling.
Circuit Judge Sharon Prost, on behalf of the court, cited Myriad and noted that the “act of isolating the NR compared to how NR naturally exists in milk is not sufficient, on its own, to confer patent eligibility”.
Prost added: “The claimed compositions remain indistinguishable from natural milk because, other than separation from some other components, the isolated NR is no different structurally or functionally from its natural counterpart in milk.”
While the court explained that the enquiry could end there, it continued and applied the Alice/Mayo two-step framework.
"If resort to Alice/Mayo is necessary, then at step one we conclude the asserted claims are directed to a product of nature for the reasons stated above, and at step two the claims lack an inventive step because they are directed to nothing more than compositions that increase NAD+ bio-synthesis, which is the very natural principle that renders the claims patent-ineligible,” said Prost.
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