PACER went down last night before Elysium filed its brief and exhibits in opposition to ChromaDex's summary judgment motion, so Baker Hostetler had a late night and eventually got the documents uploaded to PACER and wrote an explanation/apology to the judge. You can read them here:
I'm probably not the right person to lecture Elysium about waiting until the last minute, but I do have a few comments about the substance of their brief.
I did not attempt to summarize or excerpt ChromaDex's brief, because it was too-perfectly crafted for that. As Salieri observed of Mozart's work in Amadeus, "Displace one note and there would be diminishment. Displace one phrase and the structure would fall."
I don't feel that way about Elysium's brief, not because it isn't artfully crafted, but because it lacks the other of being true.
Elysium predictably grips tight to Judge McMahon's suggestion that the possibility of ChromaDex's awareness of the toluene in pterostilbene could render the FDA petition objectively baseless. But that fact, even if proven, can't really render the petition objectively baseless, because ChromaDex's "awareness" -- the apparent hypocrisy of complaining about the very thing that oneself does -- goes to subjective intent, not to objective baselessness.
ChromaDex's brief squashes down that argument in other ways, too, noting for example that its PteroPure ingredient was not sold directly to consumers, and in fact was subsequently combined with other ingredients during the manufacturing process, so that the toluene in the finished consumer product resulting from PteroPure fell below measurable levels, unlike the toluene in Elysium's finished consumer product. And in any case, even if the toluene numbers mattered they were not comparable to Basis, but were lower. ranging from 7-93 ppm, instead of 96-144 ppm.
The kind of arguments I don't like in Elysium's brief are the ones where Elysium says that "Evidence demonstrates that ChromaDex's competing product was sold without an NDIN at the time ChromaDex submitted the sham petition." Even if that were true, it overlooks that ChromaDex did have NDINs approved both before and after, which hardly seems like an irrelevant detail. It also omits that Niagen was GRAS and therefore did not need an NDIN.
Similarly, Elysium says that "the relief ChromaDex sought in its Sham Petition was not available through the citizen petition process." Even if that were true, it overlooks the other types of relief ChromaDex sought that were quite obviously available through the citizen petition process. Or, as ChromaDex said,
Elysium alleges that “no reasonable petitioner would expect to obtain the relief that ChromaDex sought” because ChromaDex asked for enforcement action and the regulations provide that enforcement actions do not fall within the scope of the citizen petition process. (Complaint ¶¶ 7, 38-42 (citing 21 C.F.R. § 10.30(k)).) Not so. As the Court recognized, the real ask in the Petition was for the FDA to make two determinations; enforcement was merely a requested remedy, within the FDA’s jurisdiction, that would flow from those determinations. See In re Elysium, 2018 WL 4907590 at *2 (noting that CMDX asked the FDA for two determinations, and further asked that the FDA take appropriate remedial action). (Dormer Decl. ¶¶ 14-18.)
The Supplemental Petition exposes the hollowness of Elysium’s claim. (See supra at 5 n.2 (supplemental petition is considered together with the original)). In that submission, ChromaDex clarified the nature of the relief it sought, including that the FDA issue (1) public guidance regarding the use of the ICH Guidelines for dietary supplements; (2) an order under the Federal Food, Drug, and Cosmetic Act regarding the safety of nicotinamide riboside chloride containing new impurities not reviewed under the NDIN process; and (3) final guidance regarding compliance with NDIN requirements. (Decl. ¶ 74.) It is undisputed that each of these requests are within the scope of the Citizen Petition process. (Dormer Decl. ¶ 18.)
The only way to make sense of Elysium's argument is to re-cast it as, "Unless every single type of relief is available, then the entire petition is a sham." That doesn't make sense, either, which is probably why they don't outright say it, but it's not the kind of argument that is likely to get past the judge, or a panel of judges.
This selective disclosure is apparent again when Elysium asserts, "Two COAs that accompanied ChromaDex's shipments of pTeroPure...revealed the presence of toluene at levels of 93 and 74 parts per million."
Compare that to the fuller disclosure in ChromaDex's brief: "ChromaDex sold nine lots of pTeroPure to Elysium, to be used as an ingredient in a manufactured product; four lots showed detectible amounts of toluene in the following amounts: 74, 7, 93, and 8 ppm." The evidence missing from Elysium's account certainly casts light on ChromaDex's subjective understanding.
I'm not a Paul Harvey fan, but it's hard to not notice that Elysium keeps forgetting to tell us "The Rest of the Story."
A third trick in Elysium's bag is to assert that Summary Judgment is improper prior to Discovery.
I don't know what the law is on this, and it shows a weakness in the current process that Elysium has made a legal argument that ChromaDex does not have a chance to respond to.
I do know that it is is within the sound discretion of a trial court to convert a motion to dismiss into a motion for summary judgment, with notice, and I wonder if Judge McMahon will find that Elysium waived this argument by making an evidence-based objection to the motion to dismiss -- it seems like it was Elysium's comments, not ChromaDex's, that justified the conversion.
So we'll see if Judge McMahon rules on the motion, or decides it is premature. I am still predicting that the arguments in ChromaDex's brief will win the day.