This morning there appeared on the Patent Trial and Appeal Board's website several new documents from Elysium's challenge to Dartmouth's '086 (Pharmaceutical) patent, including Elysium's Reply to the response filed by Dartmouth/ChromaDex/Steptoe, and the transcript of Elysium/Foley's deposition of Dr. Sunny Zhou. You can read them here:
It's profoundly boring stuff...or maybe I just haven't had enough coffee.
Caveats
I will preface my comments with a reminder that this patent trial is something of a side show, because it involves the patent for a pharmaceutical composition, and both Elysium Basis and ChromaDex's Niagen are expressly NOT pharmaceuticals.
ChromaDex at the Q4-2017 earnings call went further, declaring, "we're not a drug company, we're a dietary supplement or nutraceutical company." Neither ChromaDex nor Elysium is currently or imminently marketing a pharmaceutical composition containing nicotinamide riboside.
So although ChromaDex is right to be defending the IP that it has licensed (indeed, it may be contractually obligated to do so), the outcome won't have much or any impact on Elysium's liability for its obvious and apparently uncontested patent infringement via Basis with Mystery NR.
There is another reason why this patent trial is not the serious matter that it seems, and that is because the if Elysium had been successful in invalidating the Dartmouth patents that ChromaDex licensed, it would have done ten times more damage to ChromaDex and Dartmouth than it would have benefitted Elysium.
Elysium sells a premium branded product -- flooding the market with inexpensive, commoditized, generic versions of NR would be nearly as deadly to Elysium's business model as losing access to NR altogether.
So Elysium's continued prosecution of this patent challenge doesn't obviously help Elysium's business, but instead strengthens ChromaDex's argument in New York that "Elysium was founded with the specific goal of wrestling control of NR from ChromaDex through unscrupulous means, rather than to compete honestly or fairly.... Elysium’s pattern of behavior with respect to ChromaDex reflects a nefariously conceived plan to damage and/or steal ChromaDex’s NR."
Elysium's continued prosecution of this patent challenge seems consistent with the alleged pattern of behavior.
Onward!
With those caveats in mind, onward to the legal arguments:
You will recall from the last episode, on June 5, that this is the essence of Dartmouth/ChromaDex's argument:
In light of the discovery that nicotinamide riboside is an effective active agent, the ’086 patent claims oral pharmaceutical compositions containing nicotinamide riboside. Contrary to [Elysium's] arguments, the ’086 patent does not cover any composition that happens to include nicotinamide riboside. Instead the ’086 patent claims cover oral compositions specifically formulated with nicotinamide riboside as the active agent.
One of the frustrating things about litigation is that the substantive issues that a normal person can understand inevitably get buried beneath hyper-technical dispositive legal issues.
The principles of patent law are pretty straight forward. It's in the Constitution. Article 1, Section 8:
To promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries.
The legal system has developed some basic doctrines to explain what constitutes a discovery that is entitled to protection. It has to be (1) new, (2) useful, and (3) non-obvious. Typical citizens can understand that.
And at this level of normal discourse, we can have a sensible discussion of how it could conceivably be the case that feeding non-fat milk to dogs in the 1920's would prevent someone eighty years later from patenting
"A pharmaceutical composition comprising nicotinamide riboside in admixture with a carrier which increases NAD+ biosynthesis upon oral administration."
It couldn't.
A normal person would realize that the researchers in the 1920's could not have disclosed that nicotinamide riboside increased NAD+ biosynthesis because in the 1920's nicotinamide riboside hadn't been discovered.
And in any case milk isn't a pharmaceutical composition -- milk is in the dairy section of the supermarket, not in the pharmacy -- and just to be SUPER-clear, there are no prescription drugs that are delivered via milk. Not even prescription veterinary medications for dogs suffering from blacktongue are delivered via milk.
But lawyers wouldn't get paid what they do if they were confined to obvious fields of play, so much of Elysium's argument comes down to this (aggressively paraphrased):
We all know what you meant, but you didn't say it right, or, even if you did say it right, you said the right thing in the wrong place: Specifically, you can't use words in the specification section of a patent to modify the terms in the claims section of a patent.
Lawyers love that shit. Every lawyer in the planet perks up to debate whether or not the words in one section of a patent can influence the meaning of words in another section of a patent. After all, you could have said it here, but you said it there, so shouldn't that be on you?
Fealty to that kind of hypertechnical reasoning is what allows lawyers to make the big bucks, because it turns lawyers into mandarins with a secret language. The lawyers are the only ones who can say the magic words in the right order to prevent the legal system from betraying the Constitution's promise to inventors who make useful discoveries.
You probably think I'm making this up, but here is an actual quote from Elysium's Reply:
Patent Owner incorrectly asserts that “[t]he ’086 patent consistently and repeatedly emphasizes nicotinamide riboside and its use as an active agent in the claimed pharmaceutical composition.” Even if that were true—and it is not, as explained below—limitations from the specification cannot be read into the claims...This permissive language in one paragraph of the specification does not import limitations into the claims. (emphasis added)
This is the essence of Elysium's argument throughout the reply: The way you said it doesn't expressly exclude buttermilk fed to dogs, so you didn't invent anything new.
How strong an argument is that? Not very strong.
If Elysium were right about the rules governing claim construction -- that claim construction is a kind of sudden-death trial wherein one technical error destroys your rights -- then Elysium might have a leg to stand on, even though it would cause a manifestly unjust outcome.
However, the legal system is not unaware that it is riddled with lawyers who think their job is to game the system, and so Foley's wide-eyed objections aren't anything new under the sun, and the patent system stands ready with vats of boiling oil to pour down upon patent marauders.
The actual governing principles, which Foley somehow forgot to bring to the PTAB's attention, were the ones identified by Steptoe last round:
In an inter partes review, claim terms are interpreted according to their “broadest reasonable construction in light of the specification of the patent in which it appears.” Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2136 (2016); see also id. at 2144-45; 37 C.F.R. § 42.100(b); Office Patent Trial Practice Guide, 77 Fed. Reg. 48756, 48764, 66 (Aug. 14, 2012).2...
As the Federal Circuit has explained: The correct inquiry in giving a claim term its broadest reasonable interpretation in light of the specification is not whether the specification proscribes or precludes some broad reading of the claim term adopted by the examiner. And it is not simply an interpretation that is not inconsistent with the specification. It is an interpretation that corresponds with what and how the inventor describes his invention in the specification, i.e., an interpretation that is “consistent with the specification.” In re Smith Int’l, Inc., No. 2016-2303, 2017 WL 4247407, at *5 (Fed. Cir. 2017)...
Anticipation requires a disclosure of “the patented subject matter with sufficient clarity and detail to establish that the subject matter existed in the prior art and that such existence would be recognized by persons of ordinary skill in the field of the invention.” Crown Operations Int’l, Ltd. v. Solutia Inc., 289 F.3d 1367, 1375 (Fed. Cir. 2002). (Emphasis added)
And Foley also forgot to challenge or rebut these legal principles.
Steptoe's brief from last June was quite powerful, and is worth a re-read if you are following the dispute closely. Steptoe included bits like this:
Petitioner’s proposal would also result in the claims being construed to cover milk. However, milk was explicitly disclosed as a prior art “source” of the active agent nicotinamide riboside. See ’086 patent, at 4:8-20 (describing an embodiment where cow’s milk is a natural source of nicotinamide riboside). This disclosure makes clear that the inventor did not intend the invention to cover milk as it occurs naturally, so adopting Petitioner’s proposal would not be a reasonable construction. See In re Smith, 2017 WL 4247407, at *6 (reversing the Board’s anticipation findings for lack of substantial evidence because giving a disputed term “such a strained breadth in the face of the otherwise different description in the specification was unreasonable”). (emphasis added)
Foley's reply doesn't even attempt to defeat this argument, I suspect because it cannot.
Instead, Foley spends a lot of time arguing that the milk in the 1920's experiments MUST have had NR as an active ingredient, despite the lack of actual evidence, because, well, it has to have, and no one has disproved it. And it's certainly possible. But that's not the legal standard. The legal standard is that Elysium must prove that the invention was fully disclosed; it's not everyone else's job to prove that it wasn't fully disclosed.
Expert Testimony
I enjoyed reading Foley's excuses for why Elysium's own expert testified in support of ChromaDex's theory of recovery:
While counsel for Patent Owner slipped the phrase “active agent” into a few questions to develop misleading testimony about Dr. Baur’s opinions, counsel never sought to directly challenge Dr. Baur’s opinion that claim 1 merely requires the composition to contain nicotinamide riboside.
Of course: Dr. Baur directly challenged that himself.
I did not get from the excerpts of Dr. Zhou's deposition that Foley had any comparable success with their cross-examination.
There are a couple times when Foley presents Zhou's testimony as if they were revealing an Aha! moment -- but I cannot figure out what good thing happened for Elysium at that moment.
In the excerpt below, Zhou responds to Foley's questioning attorney by suggesting that the attorney is getting confused. That may in fact be an Aha! moment, but not the kind I'd be copying into my client's brief:
[ELYSIUM'S BRIEF:] ...Two of the quoted excerpts (bullet points 1 and 3) refer to an “effective amount” of “a nicotinamide riboside composition” or “nicotinamide riboside.” However, Patent Owner’s own proposed claim construction does not refer an “effective amount.” And for good reason: the claims say nothing about the presence of an “effective amount” of nicotinamide riboside. Indeed, Patent Owner’s expert, Dr. Zhaohui Sunny Zhou, testified that the claims do not include an “effective amount” limitation:
Q. . . . . Is that your understanding of Claim 1, that it requires that there be an amount that can be deemed an effective amount, meaning that it causes a certain effect with respect to a disease state?
MR. ABRAMIC: Objection. Scope.
A. When you ask me that question, I think that’s not part of Claim 1 at all. Sorry, I said this very bluntly. I think maybe you confused the concept of the patent claim and the ultimate drug. That’s maybe where the confusion comes from.
(Ex. 1026, Zhou Tr. at 28:15-29:3 (emphasis added).)
CONCLUSION
I'm not going to predict how this comes out. My dad -- also a lawyer -- when pressed to predict a legal outcome used to say, "I'm a lawyer, not a fortune teller."
I don't think the PTAB should have initiated review in the first place, and I don't think that their somewhat-arbitrary construction of "isolated" makes much sense, either. Nor do I deeply understand how these very technical arguments fit into the larger developing mosaic of patent law as it relates to pharmaceuticals.
However, what I can say is that Steptoe's Response document is way more convincing, and way more closely tied to mandatory authority, than is Foley's reply.
I don't think Foley has made the kind of outlandish, kitchen-sink claims that we have seen from Skadden.
But Elysium is swinging for the fences and trying to achieve a highly counterintuitive outcome -- that a non-pharmaceutical composition containing an unknown molecule can somehow preempt a patent for a pharmaceutical composition containing a known molecule.
You would need a really convincing argument to achieve that result, and Elysium just doesn't have it. It's not enough for Elysium to say, "You didn't use the exact words "active ingredient" in your claim specification, when it's pretty obvious that pharmaceuticals by definition contain active ingredients and NR is specified in the claims -- even Elysium's own expert conceded that.
And it's hard to see how milk is disqualifying prior art when milk is disclosed in the patent application itself.
And I can't say any more artfully than Steptoe did that the fact that a pharmaceutical composition can take the form of food does not mean that all foods are pharmaceutical compositions.
So what comes next?
I think the only dates that got moved in the various scheduling orders were dates 1 & 2, and I think that Dartmouth/ChromaDex has not moved to amend the Patent.
So if I have that right, then we are now at Date 4 in the operative scheduling order and in the coming weeks we'll see evidentiary motions and a request for oral argument. I'll keep you posted.