Last week ChromaDex unexpectedly and without explanation abandoned its cross-appeal of the PTAB's decision to invalidate as anticipated Claims 1, 3, 4, and 5 of the '086 Patent. Here is the official paperwork:
This surprises me because I thought ChromaDex had very strong arguments below, and the CAFC has not been shy about reigning in the PTAB.
It could be that Dartmouth and ChromaDex decided their odds were long on appeal, or it could be that Dartmouth and ChromaDex decided that Claim 2 was enough to build their Pharma business, and the incremental additional value of rescuing Claim 1 or the other dependent claims wasn't worth the cost.
Or maybe Dartmouth has to eventually pay the legal fees and didn't find it worthwhile. We might never know.
In any case, I don't think there is another legal mechanism to revive those invalidated patent claims, so I think going forward the '086 Patent applies to isolated NR, and the damage done to that patent is simply permanent harm inflicted on the Dartmouth/ChromaDex IP by Elysium in its not-entirely-futile attempt to destroy ownership of the science. In this respect, at least, Elysium has certainly delivered on its in initial promise of being a different kind of health supplement company.
However, just to be clear, Claim 2 -- pharmaceutical compositions comprising isolated NR -- looks like plenty for Dartmouth and ChromaDex to eventually have a pharmaceutical business, assuming Elysium does no additional harm to '086 with its pending appeal.
So, let's take a look at whether Elysium's appeal is likely to do additional harm.
Here is how ChromaDex frames the issue:
Dr. Charles M. Brenner, the inventor of the ’086 patent, was an Associate Professor (2003-2007) and Professor (2007-2009) of Genetics and of Biochemistry at Dartmouth’s Medical School, and assigned his inventions in the ’086 patent to Dartmouth. People of skill in the art at the time of the invention of the ’086 patent believed that NR was part of the NAD+ biosynthetic pathway only in bacteria, and were not aware that NR could also synthesize NAD+ in humans. Dr. Brenner made this discovery. In fact, scientific literature in this area reveals that those of skill in the art attributed the discovery of nicotinamide riboside as an NAD+ precursor in humans to Dr. Brenner...
Despite the significance of the ’086 patent invention and its impact on the advancements in the NAD+ supplement market, Elysium filed an inter partes review petition at the Board seeking to render these important inventions unpatentable. Moreover, notwithstanding the extensive disclosures of how the inventor isolated NR from cow’s milk, the sole prior art references presented by Elysium in the IPR proceedings relate to milk and buttermilk, respectively, and not isolated NR.
Accordingly, the fundamental question on appeal is whether claim 2 of the ’086 patent, which requires NR to be isolated from a natural (e.g., cow’s milk) or synthetic source, can be read to cover that same milk or buttermilk. The ’086 patent specification discloses cow’s milk as a source of NR and discloses how to isolate NR from that cow’s milk so that it may be effectively used in the claimed pharmaceutical compositions. In short, claim 2 of the ’086 patent cannot cover either the milk or buttermilk of Elysium’s proffered prior art references and, as a result, the Board was correct to conclude that claim 2 of the ’086 patent is not anticipated over those references.
Sun Tsu advises that one first win the war, and then fight it. That's what this introduction appears to do. How obvious is this?
Persons of skill in the art understood that Dr. Brenner did not purport to discover or claim milk, but that milk was a source for the NR compositions made possible by the discovery of NR as a precursor to NAD+.
I honestly do not understand why we are even wasting time before the CAFC.
And it still torques me that the other wrongly invalidated claims have been abandoned, although at least the shareholders who worry that ChromaDex is being cavalier with legal costs can be reassured that the opposite is true. However, the lack of money to continue the cross-appeal seems to have stopped the wheels of justice in their tracks, and as a result there will be no fine grinding of the foul fruits of Elysium's Inter Partes Review petition -- or at least we will never know for sure what would have happened.
Sigh.
But the central issue on this appeal is Elysium's proposed definition of "isolated," which Elysium claims is so much better than the PTAB's and than ChromaDex's that the PTAB had a legal obligation to accept it.
But ChromaDex effectively attacks Elysium's proposed definition of "isolated" as both overbroad and inconsistent with the patent:
In other words, under Elysium’s proposed definition, the NR contained in milk that is still inside of a cow would not be “isolated” as that term is used in the ’086 patent, but as soon as that same milk has been removed from the cow’s udder, the NR in that milk would be “isolated.” Moreover, in applying its construction to the prior art, Elysium did not address how its proposed construction could be reconciled with the explicit teachings of the ’086 patent specification regarding isolating NR from cow’s milk. (emphasis in original)
ChromaDex reminds the CAFC that the PTAB said,
“it would be unreasonable under the broadest reasonable interpretation standard to construe ‘isolated’ to only require separation from ‘some’—no matter how insignificant—amount of other components of the natural source of nicotinamide riboside (e.g., cow’s milk).”
The essence of it is this, says ChromaDex:
A construction that is unreasonably broad must be rejected. Elysium’s proposed construction suffers from this very problem. It is so unreasonably broad that it would to lead to an interpretation squarely contradicted by the ’086 patent. On this basis alone, Elysium’s proposed construction should be rejected.
ChromaDex's attempt in the cross-appeal to narrow the meaning of "isolated" in "Claim 2 to exclude Horse Pill products containing 24% NR and 76% filler would have been interesting. And ChromaDex's attempt to revive claims 1, 3, 4, and 5 would have been interesting.
But defending against Elysium's further attacks on Claim 2 is not interesting As I said before, the PTAB is the most receptive audience Elysium will ever have for this argument, and if the PTAB rejected it, which it did, the odds of the CAFC ruling otherwise are very slim.
The power and clarity of ChromaDex's arguments in this brief show just how slim.
We'll tell you how it eventually comes out.