The Plot Thickens -- Or Does It? PTAB Initiates Review of '086
So yesterday the Patent and Trademark Appeal Board agreed to take a look at Dartmouth/ChromaDex's '086 patent (8,383,086), after last week denying review of the similar '807 patent (8,197,807). You can read the PTAB's reasoning here:
It is the same panel of examiners who ruled on both IPR requests. In order to make sense of this, we are going to have to look at the similarities and differences between the two patents, and try to understand the panel's arguments.
But we are going to also have to look at this in the context of the larger business dispute, so we can understand the implications and possible outcomes.
Before we get going, though, a WHOLE bunch of disclaimers:
First, Patent Litigation is a highly technical, complex, and fast-changing area of the law. Even experts would have a devil of a time predicting outcomes.
Second, I am not an expert in patent law, so my own comments are worth that much lessagain, and anybody who wants to stop reading right here and just conclude, "No one really knows what it means or what might happen," would be well within reason to do so.
Third, the entire IPR process is itself currently being reviewed by the SCOTUS for constitutionality. Although I think the odds are very low that IPR will actually be invalidated, no one knows, and there may be some new procedural safeguards in our future. [One justice at oral argument mentioned the need to allow the PTAB to fix its own errors, but the risk, of course, is that they create new ones.]
Adverse decisions by the PTAB can be appealed to the US Court of Appeals for the Federal Circuit.
With that said, let's try to make some sense of this, starting out on firm ground with things that we DO know:
The '807 Patent is not currently being challenged, so to the extent that Elysium's Basis were infringing '807, getting '086 invalidated won't help much.
The '086 Patent has not been invalidated by the PTAB. Yesterday's decision BEGINS a review process, it does not end one.
Not every claim in the '086 Patent is being reviewed -- only claims 1, 3, 4, & 5. Claim 2 is not being reviewed, so there is NO chance that the '086 patent will be entirely invalidated. Worst case scenario is that four of the five claims are invalidated.
Now all of that sounds pretty good for ChromaDex -- Nothing bad happened yet, it might not ever happen, anything bad could be appealed, and only a part of one patent is at issue anyway.
This is all true, but in an abundance of caution, we are also going to look for worst-case scenarios, too, and there is one scenario that is nagging at me.
But before we get to the law, let's look at the business context.
What Does Elysium Want
I honestly have no idea why Elysium is seeking to invalidate these patents, and I have never heard anybody suggest a plausible motivation.
It would SEEM that what Elysium REALLY wants is either (1) to have ownership of these patents transferred to them (perhaps via some "nefariously conceived plan...to steal ChromaDex's" IP), or (2) to secure some favorable licensing terms that would give Elysium an exclusive or superior rights to market NR.
It would NOT seem that what Elysium wants is to invalidate the patents, because that essentially throws the intellectual property into the public domain -- the invention is disclosed, but not protected. Elysium would not benefit from the complete liberation of the IP around Nicotinamide Riboside because then ANYBODY could make and sell it, including big wholesalers.
Elysium is neither a low-price retailer nor a low-cost producer, so they are not likely to win in a market free-for-all.
In fact, ChromaDex is doing all it can to keep the price of NR high, which is just what Elysium wants and needs, to support its premium marketing style.
So it isn't obviously in Elysium's interest to torpedo the IP. Elysium not only needs the IP to be solid, but they also need it to be managed exactly the way ChromaDex is managing it, with a limited number of distributors and a premium price.
The only thing MISSING for Elysium is that they don't get to be one of the distributors.
So I have always believed that all of this frenzy of litigation really has as its single goal to regain access to NR, presumably through a favorable settlement of the litigation, if Elysium can manage to get itself into a strong enough position.
If that is the correct business context, then this IPR challenge is like a Doomsday Bomb in the hands of a suicide bomber: "Unless you give us what we want, we will destroy the entire market, and both of us with it -- not bluffing!" That is how I have understood this IPR challenge, because I can't think of any other way in which it makes sense.
So next, we need to look at the two patents and the two PTAB rulings, to see whether the PTAB's analysis actually makes sense or whether they are more likely to backtrack or be reversed. And then we'll look at the worst-case scenario for ChromaDex, which is the invalidation of four of the five claims in the '086 patent, and see if that buys Elysium anything they might want.
Back to the '807 Patent for a Moment
You will recall that last week the PTAB upheld the '807 patent on the grounds that NR was not "isolated" in milk, because the amount of NR was less than 25%. I thought that was the weirdest, most arbitrary interpretation in the world, but it shows up again in the '086 analysis, and may turn out to be important in the real world, so let's see how it got there.
The '807 Patent discloses:
Nicotinamide riboside kinase compositions and methods for using the same
A composition comprising isolated nicotinamide riboside
...formulated for oral administration and increases
NAD+ biosynthesis upon oral administration.
Elysium argued that "a significant concentration of nicotinamide riboside is naturally present in skim milk," so that's not a new invention.
The PTAB disagreed, and said, "the broadest reasonable interpretation of the term 'isolated' requires that the nicotinamide riboside is separated or substantially free from at least some of the other components associated with the source of the molecule such that it constitutes at least 25% (w/w) of the composition."
In other words, it doesn't have to be 99.44% pure, but if the substance is less than 25% NR, then it's not isolated -- it's all mixed up with other stuff.
Now, on to the '086 Patent
The '086 Patent discloses:
Nicotinamide riboside kinase compositions
and methods for using the same
A pharmaceutical composition comprising
nicotinamide riboside in admixture with a carrier,
wherein said composition is formulated for oral administration
That's Claim 1, which is called an "Independent Claim." Claims 2-5 are "Dependent Claims," which mean they add on some details. Independent claims are the broadest IP protection you hope to secure, but if you lose the big one, you have some fallback positions in the Dependent Claims. Dependent Claims 2-5 are dependent on Claim 1 as follows:
2. AND the NR is isolated
3. AND it is formulated a certain way
4. AND the formulation includes certain things
5. AND which increases NAD+
What the PTAB said about this is, yeah, what we said before about "isolated" is true. There is a 25% rule that we just made up that sounds right -- that's news -- but all that other stuff about "pharmaceutical composition" "comprising nicotinamide riboside" "in admixture with a carrier" and "formulated for oral administration" doesn't sound new to us. We think that MILK is a "pharmaceutical composition comprising nicotinamide riboside in admixure with a carrier and formulated for oral administration." So those bits all got disclosed when we learned about the cool effects of milk a hundred years ago.
In other words, all you did with the Nicotinamide Riboside was isolate it and serve it up, and you get to own "isolate," but you don't get to own "serve-it-up."
Is PTAB Right that Milk Is a Pharmaceutical, Etc.?
Well, Steptoe already addressed these points in Dartmouth/ChromaDex's preliminary response, which we read about here.
So the PTAB has already rejected those arguments. At Trial, Steptoe is likely to return to those arguments and sharpen them.
The PTAB's decision does not offer us anything like deep analysis. Check this out:
Petitioner contends that the term “pharmaceutical composition” embraces foods and that milk, including the skim milk administered in Goldberger et al., is a food...Patent Owner contends that the term “pharmaceutical composition” does not embrace foods, thus, milk is not a pharmaceutical composition...We have construed the term “pharmaceutical composition” to include foods when the composition is formulated for oral consumption.
In other words, Elysium says it includes food, ChromaDex says it does not, we say it does, if you eat it.
I predict that Steptoe is going to bring to bear a significant body of evidence that the word "pharmaceutical" should not be read out of the patent. In fact, there is a whole branch of the SDNY litigation dedicated to the unique standards for pharmaceuticals that are different from food supplements.
A similar kind of reasoning occurs for the phrase in admixture with a carrier.
Petitioner contends that...skim milk is in admixture... [and] that the other components of milk bind to and stabilize the nicotinamide riboside...Patent Owner contends that Petitioner has not shown which of the many components in milk act as a carrier...We find that the skim milk in Goldberger et al. comprises nicotinamide riboside in an admixture with a carrier...carriers include sugars, such as lactose ...milk contains a combination of nicotinamide riboside and other components including lactose....Thus...the milk in Goldberger et al. contains nicotinamide riboside in an admixture with a carrier."
Steptoe's argument that the PTAB rejected goes like this:
There is no discussion of admixtures, carriers, pharmaceuticals, or pharmaceutically acceptable carriers in Goldberger and Tanner. A person of ordinary skill in the art would understand how to prepare the claimed compositions using the teachings of the ’086 patent, including selection of a pharmaceutically acceptable carrier. See ’086 patent, at 28:49-60. A person of ordinary skill in the art would also readily understand that the buttermilk disclosed in Goldberger and Tanner was not prepared as an admixture of nicotinamide riboside and a carrier.
My sense is that the PTAB has too much ignored phrases like "admixture," "pharmaceutical," and "carrier," and Steptoe will be able to make strong arguments that these phrases mean things in other patents, so they should not be written out here.
However, I haven't done that research, so we'll just have to wait to see what arguments emerge, and we can evaluate them then.
I would only add that the terms at issue here have a common-sense aspect to them that invites judicial review. I mean, really...buttermilk is a pharmaceutical grade carrier? Not if words mean anything.
Worst Case Scenarios
Elysium is already living the nightmare, because Basis almost certainly infringes on both patents' non-contested claims for "isolated" NR. So their hope to free themselves from patent restrictions -- if that indeed was their hope -- is already foiled, but they STILL have to incur all the litigation costs of prosecuting their IPR trial on the '086 patent, even though their BEST case scenario doesn't appear to vindicate the current formulation of Basis.
Can Elysium continue to fund high power litigation for another year? We don't know anything about Elysium's finances, but it's a BIG bite to keep chewing. Especially if Elysium faces the very real prospect of having to disgorge their profits if ChromaDex ever asserts a patent infringement claim based on the portions of the patents for which IPR was denied.
ChromaDex's worst case scenario is that it its IP protection in these two patents is eventually limited to just isolated NR. Whether that's a very bad thing or a no-big-deal thing depends on (1) The strength of their OTHER patents that aren't at issue in this IPR proceeding, and (2) Whether Elysium or others exploit the PTAB's construction by selling BIG, 4x-size pills of Not-Isolated-NR that contain just 24% nicotinamide riboside, with 76% filler, so you take eight of them per day instead of two per day. That is a kind of outrageous example, which I think illustrates one problem with the PTAB's reasoning, but I suppose it is possible.
How lucky to be a legal blogger in an age when the litigation never ends.