Elysium's Appellate Brief at the CAFC
Elysium has filed its appellate brief before the Court of Appeals for the Federal Circuit (CAFC) challenging the PTAB's decision upholding the validity of Claim 2 of the '086 Patent. You can read the brief here:
Just for orientation, there are two patents at issue, the '807 Patent (health supplements) and the '086 Patent (pharmaceuticals). In January 2018, the PTAB rejected Elysium's challenges to the '807 Patent entirely. But for the '086 Patent, in January 2019, the PTAB invalidated claims 1, 3, 4, and 5.
This appeal is Elysium's attempt to ALSO invalidate claim 2. ChromaDex's cross-appeal, for which we do not yet have briefing, will attempt to rescue claims 1, 3, 4, and 5.
Once this appeal is resolved, the '807 Patent and whatever is left of the '086 Patent (all, nothing, ,or some) will be re-adjudicated in the Patent Infringement action in Delaware, where Elysium will raise other non-infringement and invalidity arguments, and ChromaDex will attempt to recover damages. The Delaware action is currently stayed, but most likely the proceedings will continue in parallel. (Oral argument on the stay in Delaware was today, but we don't know the outcome yet.)
Elysium's primary argument on appeal is that the PTAB used the wrong definition of "isolated" when it upheld Claim 2. Elysium's argument seems to be that if the NR is isolated in any respect then it is "isolated" for patent purposes.
This argument was mocked below when ChromaDex pointed out that it isolated could hardly mean isolated from the cow that gave the milk. The PTAB decided that some level of purity was necessarily required, and chose the broadest level that they could find any support for in the patent.
In support of its argument, Elysium makes some moves that seem to me dicey.
First, Elysium asserts on page 5 that "NR is naturally present in high concentration in cow milk." That seems slippery to me, because it's actually present in a LOW concentration. Not only is it microscopic compared to what you'd get in a Niagen or Basis pill, but it's even lower than the amount of nicotinamide, the other NAD precursor in milk. I can't guess what "high" means in this context. Significant? Substantial? Effective? Maybe. High? No.
Second, Elysium repeatedly attributes to ChromaDex (Dartmouth) the idea that ChromaDex agrees that the PTAB's interpretation is incorrect. For example, Elysium says on page 9, "Dartmouth did not contend that claim 2 contained any purity requirement," and on page 11, "Dartmouth offered no evidence to support the Board's construction," and on page 12, "[ChromaDex's expert] did not contest Elysium's proposed construction of "isolated," and on page 19 "Dartmouth understood that claim 2 does not impose a 25% purity requirement or any other degree of purity," and on page 20, "Dartmouth...signed on o the Board's construction...because Dartmouth evidently concluded hat the narrower construction would allow it to avoid the prior art..."
I don't get why Elysium thinks that ChromaDex has any burden here, or why they think they need ChromaDex's assent to prove their case.
The tell, probably, is that Elysium cites a recent unpublished, non-precedential case -- Google v. Network-1 Tech, 726 Fed. Appx. 779 (March 26, 2018) to argue that even if Elysium's proposed definition of "isolated" is incorrect, it still should prevail as long as it is "reasonable." What the court actually said was "where two claim constructions are reasonable, the broader construction governs." I think it's a stretch to suggest that an incorrect construction can also be reasonable, but I don't think it's a stretch to guess that Elysium would like their interpretation to prevail even if it is neither reasonable nor correct.
I think the reason that the PTAB rejected Elysium's construction is because that construction was unreasonable. Here is what ChromaDex said about that in their final brief before the PTAB:
"The Board agreed that Petitioner’s proposed construction was unreasonable because it would permit “separation from ‘some’ – no matter how insignificant – amount of other components of the natural source of the nicotinamide riboside (e.g., cow’s milk).”
I didn't notice anything in Elysium's brief that addressed this concern; if anything, Elysium skirted the implications of its proposed construction, which is where "reasonableness" would live or die.
I expect ChromaDex's reply brief will highlight the unreasonableness, and I doubt that the CAFC will have any better or different ideas than the PTAB did about how best to construe the term. Although, since the review is de novo, the CAFC is free to adopt ChromaDex's original proposed construction of "isolated from a natural or synthetic source," which was “fractionated from other cellular components.”
The problem with Elysium's construction is that it makes the word "isolated" almost meaningless. The PTAB didn't like that, and I don't see why the CAFC will like it any better. So I don't expect Elysium to prevail on its appeal, especially if the essence of their argument is, you HAVE to accept our interpretation, even if you don't like it.
What's more interesting to me will be the cross appeal, when we evaluate whether ChromaDex was right when they argued below that the patent requires that NR be an "active agent," and no one knows whether the thing in the milk that cured the dogs was NAM, NR, or Tryptophan, and so NR as an active agent could not have been disclosed.
In fact, before Dr. Brenner's discovery of the NR Kinase Pathways, there would have been no reason for anyone to suppose that NR was an active agent in milk that could cure NAD-deficiency illnesses like pellagra. It is Dr. Brenner's discovery that the patent protects, not Dr. Goldberg's discovery.
That's why I think it's more likely that ChromaDex will prevail on its cross-appeal than that Elysium will prevail on its appeal. But we'll see.