Claim Constructions in Delaware
It's been about two months since we have had anything substantive to report on in any of the litigations (as opposed to just procedural issues, like calendar delays).
It's not that nothing has been going on -- Discovery has been very active in Delaware, and probably in New York -- and the parties have exchanged infringement and invalidity contentions in Delaware -- but we can't see the substance of what's going on.
Thomas Jefferson University Subpoena
Instead, we just get cryptic clues, like this docket notation in Delaware:
This says that Elysium is trying to get discovery information from Thomas Jefferson University, and the University maybe gave them stuff or maybe not.
The question for us is whether we can get a clue as to what Elysium is asking for, or why, simply based on who they are asking. As far as we know, Thomas Jefferson University has nothing to do with NR.
My initial assumption was that Dr. Brenner must have had some prior affiliation with Thomas Jefferson, and Elysium was trying to find evidence that Dr. Brenner had had a dream about NR more than six months before the patent application, and that Dr. Brenner had been talking in his sleep, and someone had heard it, and this would count as a prior disclosure that could threaten the patent's validity.
And that appears to be correct.
Although I don't see it on Dr. Brenner's CV, this podcast summary includes the following note:
"Dawn asks about the work Charles did from 1996 to 2003 on nicotinamide adenine dinucleotide (NAD) during his time on the faculty at Thomas Jefferson University." (emphasis added)
Somebody can visit Dr. Brenner's twitter page and ask him whether he is prone to talking in his sleep.
Amended Answer in Delaware
Another interesting filing was Elysium's amended answer in Delaware that was filed on July 10. Normally, an amended answer is the kind of thing I'd be covering timely in this blog, even though Answers are typically content-free. But there's almost nothing new in Elysium's latest filing, and I have -- although Elysium doesn't believe it -- a day job.
But we do nonetheless have the amended answer. You can read it:
Elysium's Second Amended Answer in Delaware
It's almost the same as Elysium's First Amended Answer, only it's hard to know that because Elysium does not give the Court or anyone the courtesy of a red-lined copy.
Still, I was able to notice a couple things by comparing page corners.
First, Elysium has added a 14th affirmative defense, which is "Reverse Doctrine of Equivalents."
The Doctrine of Equivalents allows a court to hold a party liable for patent infringement even though the infringing device or process does not fall within the literal scope of a patent claim, but nevertheless is equivalent to the claimed invention.
So the Reverse Doctrine of Equivalents allows a court to hold that a device that appears to literally infringe a patent claim nonetheless does not infringe the patent, because the accused device operates on a different principle -- it performs the same or a similar function in a substantially different way.
Presumably Elysium's argument would be something like this: NR is present in Basis, but it is the PT that raises the NAD, or the combination of the PT and the NR, and that synergistic combination acts so differently from straight NR that it is essentially a different invention that operates in a different way. We can see shadows of this argument in Elysium's Third Amended Counterclaims in New York, in which Elysium suggests that Niagen does not raise NAD ("its own study showed Tru Niagen failed to raise NAD") and that there is some synergistic interaction between NR and PT ("the proven efficacy of the synergistic combination of NR and pterostilbene").
Good luck with that. It feels to me like barrel-scraping.
The new complaint also includes a sniveling pout that Elysium's copies of the '807 and '086 patents lacked certificates of correction that were issued in January 2020. I call this a sniveling pout because Elysium obviously is aware of the existence of the certificates and has access to them since they are public records. So I don't see any purpose to comment besides to alert bystanders like us to the existence of the certificates of correction.
So let's go take a look.
If you visit the USPTO.gov website and search for patent number 8,197,807, you will discover that the following certificate of correction was issued on January 28, 2020:
It says that the patent should have said that the invention was made with support from an NIH grant, and the government has certain rights in the invention, and so the patent is now corrected to say that, signed and sealed by the Director of the USPTO.
Presumably Elysium was trying to dig up formal errors that might invalidate the patent, and they found this one, but the result does not seem to be invalidation, but simply a correction, signed by the Director of the USPTO.
More signs of barrel-scraping.
Third Party Subpoena: Laurus Synthesis
And one more thing: Yesterday ChromaDex sent a third-party subpoena to Laurus Synthesis asking for all details relating to their production of NR for Elysium. So we now know a third Mystery NR supplier. Laurus Synthesis seems to be located in India.
Proposed Claim Constructions
But now we have a new filing this week in Delaware that actually has some substance to it, so this is a good time to remind the world that I am NOT a patent attorney and I am NOT giving legal advice, nor am I giving financial advice. I am just providing access to public records regarding this public dispute and trying to be a responsible journalist and to describe what the records say and what they might mean. The implications of that meaning -- what will happen, or what anyone should do -- are quite beyond me.
On June 12, the parties told each other which words or phrases in the patent they want legally construed (claim constructions) by the Court at the December "Markman" hearing.
But this week they actually filed their proposed constructions. That means we get a glimpse at the upcoming legal disputes, and what kind of interpretations Elysium is hoping for that might allow it to show invalidity or non-infringement.
In normal patent litigations, the Markman hearing is very significant, because once you know how the claims are going to be construed, the writing is on the wall for one side or the other, and settlement tends to follow. Or so I am told by patent practitioners. But our litigation is anything but normal, so I don't assume that there is any path to settlement, no matter who wins the Markman hearing.
You can read the parties proposed constructions here:
Joint Claim Construction Chart
These are the claims to be construed:
1. "Nicotinamide Riboside"
2. "Isolated Nicotinamide Riboside"
3. "The nicotinamide riboside is isolated from a natural or synthetic source"
4. "In combination with one or more of tryptophan, nicotinic acid, or nicotinamide"
5. "Increases NAD biosynthesis upon oral administration"
6. "Pharmaceutical composition"
And here is each party's proposed construction:
ChromaDex says: "No construction necessary. The term should be construed according to its plain and ordinary meaning."
Elysium says: "nicotinamide riboside or a derivative (e.g., L-valine or L-phenylalanine esters) of nicotinamide riboside"
Analysis: I do not have a guess as to what advantage Elysium thinks it might get by expanding the definition of NR to expressly include derivatives, or why that would be a reasonable construction. Maybe it somehow would wreck the patent.
Isolated nicotinamide riboside:
ChromaDex says: "nicotinamide riboside that is separated or substantially free from at least some of the other components associated with the source of the molecule such that the weight of the nicotinamide riboside is at least 25% of the total weight of the nicotinamide riboside and any other components associated with the source of the molecule in said composition."
Elysium says: "nicotinamide riboside that has been separated or is substantially free from at least some of the other molecules commonly associated with it."
Analysis: ChromaDex seems to be adopting the PTAB definition, or something like it. Elysium's very broad definition might be a setup for the kind of prior art argument we have already seen, for example if any distillation of milk would eliminate any type of molecules at all -- say, turning whole milk into skim milk -- then the NR in the whole milk would have been isolated from the fat, and thus "isolated NR" was anticipated by skim milk.
The nicotinamide riboside is isolated from a natural or synthetic source
ChromaDex says: "nicotinamide riboside that is separated from at least some of the other components associated with the source of the molecule such that the weight of the nicotinamide riboside is at least 25% of the total weight of the nicotinamide riboside and any other components associated with the source of the molecule in said composition."
Elysium says: "the nicotinamide riboside is obtained from a natural source such as milk or a synthetic source such as a chemical library and is not chemically synthesized."
Analysis: Elysium would love it if this phrase "isolated from a synthetic source" did not include synthesizing it in the first place, because then the patent would only apply to NR that was located, and not made. That seems nonsensical to me. Someone has to synthesize the synthetic source; I don't see why the patent would exclude the possibility that the patent holder would synthesize it, and then isolate it and instead require that separate parties engage in the two acts. Not only does the patent not seem to say that, but I can't think of any reason why it would.
In combination with one or more of tryptophan, nicotinic acid, or nicotinamide
ChromaDex says: "both isolated nicotinamide riboside and one or more of tryptophan, nicotinic acid, or nicotinamide are found in the composition"
Elysium says: "...and is formulated using a process of combining 1) the isolated nicotinamide riboside with 2) tryptophan, nicotinic acid, or nicotinamide"
Analysis: This was for me the most interesting term to be construed, because I have never understood why the in-combination language was in the patent. I still do not understand what is going on here, but it seems that ChromaDex wants the related components to merely be present in the combination, whereas Elysium wants for the related components to be specifically combined in the formulation.
Increases NAD+ biosynthesis upon oral administration
ChromaDex says: "This term should be construed according to its plain and ordinary meaning, but if construction is necessary, it should be construed as, "increases NAD+ biosynthesis upon oral administration relative to the level of NAD+ biosynthesis if the composition were not administered."
Elysium says: "increases NAD+ biosynthesis in an animal upon oral administration as compared to oral administration of a composition comprising isolated nicotinamide riboside not in combination with tryptophan, nicotinic acid, or nicotinamide."
Analysis: Elysium seems to want this construed so that it is not the NR that increases the biosynthesis, but the presence of the additional components. Pretty wild.
What alleged infringers do is they propose interpretations of the patent that, if accepted, would mean they were not infringing or that the patent could be invalidated on some other ground. That seems to be Elysium's intent here. I'm not a patent lawyer, but my intuition is that Elysium's proposed constructions are a stretch, or even a big stretch.
Maybe we'll get briefing before the Markman hearing that will help us better understand the arguments. And maybe we'll learn from Judge Connolly in December that patents don't say what they seem to say, but instead say what alleged infringers wished they said. But for now, my sense is that Elysium continues to pepper the end-zone with Hail Mary passes.