Joint Claim Construction Brief Deciphered
Just kidding. It's way beyond me to make sense of this forest of claim construction arguments. But maybe we can get a high-level sense of what's going on in this hundred page document, which is worth reading if only because it likely cost hundreds of thousands of dollars to produce.
Just to get ourselves grounded, two of the most important parts of a patent are the Claims and the Specification.
The Claims are the essence of the patent -- what you are claiming as a protected invention. The language matters immensely, every word has meaning, and the purpose of the "Markman Hearing" or the "Claims Construction Hearing" is to allow the court to determine the meaning of any ambiguous words or phrases. Our Markman Hearing is about a month away: Thursday, December 17, 2020.
The Specification contains background information and a description of the invention. The specification helps the court understand the meaning of the words in the claims.
So imagine that an inventor had a patent that claimed "blue jeans." There might be ambiguity about what constitutes "blue" and what constitutes "jeans." Maybe "blue" means one specific shade of blue, or maybe it means anything that most people recognize as blue, or maybe it means anything that's not yellow. Based on what we see in the specification, we might get a better sense of what was intended.
A competitor challenging the blue jeans patent might advocate for a very narrow definition of "blue" so that the competitor's competing pants, which are blue-green, are determined to be non-infringing.
Conversely, and competitor may advocate for a very broad definition of "blue" in order to establish that the patent was anticipated by prior art, because black jeans were already well-known, and therefore the patent was invalid.
If we could see ChromaDex's infringement contentions and Elysium's invalidity contentions, then we might better understand the implications of the parties' competing definitions. But in the meantime we can make some reasonable guesses.
So an example of claim language from the Dartmouth patent might be:
"A composition comprising isolated nicotinamide riboside in combination with one or more of tryptophan, nicotinic acid, or nicotinamide,...wherein said composition is formulated for oral administration and increases NAD+ biosynthesis upon oral administration [and] the nicotinamide riboside is isolated from a natural or synthetic source."
The parties have asked the court to clarify disputes about what some of these terms might mean.
We can't reliably guess what claim constructions the Court will settle on, but we can at least get a sense of what the parties are arguing about, and maybe the relative strength of some of the arguments.
The Court is going to construe six words or phrases. Depending on what definitions the court chooses, it will be more or less likely that Elysium's product is infringing or that the Dartmouth patents are valid. Normally patent infringement cases settle after the Markman hearing, because the writing is usually on the wall about how things will go at trial. Our case, of course, seems unlikely to settle EVEN IF the writing is on the wall. But we would nonetheless welcome a sense of how things are likely to go at trial.
Although the technical claims are quite dense, the attorneys do a good job of explaining the context in which the technical questions arise. Here is what ChromaDex says:
The Asserted Patents are directed to compositions containing nicotinamide riboside (“NR”), a unique form of vitamin B3 that increases cellular metabolism, mitochondrial function, and energy production. The inventor, Dr. Charles Brenner, while a faculty member at Dartmouth, discovered that isolated NR provides an independent and previously unknown route to the production in humans of “NAD+,” a coenzyme vital to cellular function. Although other forms of vitamin B3 were known, Dr. Brenner discovered that isolated NR could be formulated and administered orally in a way that enhances NAD+ biosynthesis more effectively than those other forms of vitamin B3, while also avoiding undesirable side effects. Dr. Brenner’s discoveries resulted in the Asserted Patents, which are assigned to Dartmouth.
ChromaDex was the third company to license the Asserted Patents, but the first to successfully commercialize NR. After spending millions of dollars ensuring that NR is both safe and efficacious for human consumption, ChromaDex began selling commercial batches of NR in 2014 to companies that market direct-to-consumer products. One of those companies was a start-up, Elysium.
Elysium bought NR from ChromaDex for inclusion in its consumer product called “BASIS®,” the same product now accused of infringing the Asserted Patents. Notably, during the time Elysium was purchasing NR from ChromaDex, it was aware of the Asserted Patents and marked them on the label of its BASIS product. Elysium, however, wanted the NR market all to itself, and not long after its commercial relationship with ChromaDex began, it set upon a course to “destroy” ChromaDex and “take control of everything.” D.I. 63-1, Ex. A at 232, 249. Using the financial chaos that Elysium itself caused by ordering large amounts of NR from ChromaDex that it never intended to pay for, Elysium approached Dartmouth and tried to steal away ChromaDex’s exclusive license to the Asserted Patents. The private text messages made public in the California Action make this crystal clear, with Elysium’s principals discussing their “game changing” patent strategy and exclaiming “We need those patents!” Id. at 250; Ex. 1 at 133.
When Elysium was unable to obtain a license to the Asserted Patents, it filed two IPRs trying to invalidate them. Elysium challenged the ’807 Patent in the -1796 IPR, but the PTAB denied institution because it found that Elysium had “not established a reasonable likelihood of prevailing” on any of its challenges. Ex. 2 at 12. Elysium challenged the ’086 patent in the -1795 IPR, but was again unsuccessful, with the Board concluding in its Final Written Decision that Elysium had “not shown by a preponderance of the evidence that claim 2 is” invalid. Ex. 3 at 42.
Elysium knew that its BASIS product infringed the Asserted Patents and that it could avoid liability only by obtaining a license to the Asserted Patents from Dartmouth or by invalidating them. It achieved neither. Now, in a renewed attempt to avoid liability for its willful infringement, Elysium offers unreasonable and implausible claim-construction arguments that are completely inconsistent with years of Elysium’s own conduct and understanding of what the Asserted Patents cover. The Court should not countenance Elysium’s tactics. In response to this reasonable and measured account, Elysium immediately hit Bullshit Mode: Plaintiffs devote nearly all their space to unproven allegations and personal attacks having nothing to do with claim construction. Plaintiffs’ statement is rife with misstatements, claiming, for example, that Dr. Brenner discovered that NR enhances NAD+ biosynthesis “more effectively than ... other forms of vitamin B3” while “avoiding... side effects.” This is palpably untrue, as evidenced by the specification. It lacks disclosure of any testing (comparative or otherwise) of the effects of NR in any species of animal. Also false is Plaintiffs’ assertion that Elysium’s IPR proceedings were “unsuccessful.” The PTAB invalidated more than half the claims Plaintiffs asserted in their complaint...
Dr. Brenner did discover the vitamin function of NR, regardless of whether that was documented in the specification, and if Elysium's IPR had been "successful" then Elysium would not now be having to defend against patent claims that survived the IPR. This seems like common sense. And Elysium's worry about "personal attacks having nothing to do with claim construction" is itself a personal attack having nothing to do with claim construction.
ChromaDex has no patience for Elysium's approach:
Continuing its years-long attempt to avoid the consequences of its willful infringement, Elysium proposes claim constructions that lack any basis in the meaning of the claim terms or the intrinsic evidence, and that are instead baldly aimed at avoiding infringement. For example, relying on assertions by its expert Dr. Adams, Elysium attempts to redefine the term “nicotinamide riboside” to include NR esters that do not include the defined structure of NR and that have different properties than NR. For the “isolated” terms, Elysium takes the nonsensical position that NR isolated from the products of a chemical synthesis is not NR isolated from a “synthetic source,” even though a chemically synthesized product mixture that includes NR is, by definition, a “synthetic source” of NR—indeed, it is hard to imagine what a synthetic source for NR could be, aside from the products of a chemical synthesis.
Six semantic battles lie before us, but two of them may be more important than the others. First, what constitutes "isolated" NR? We already marinated in this question during the prior proceedings. Second, what is the meaning of the patent claim language requiring that the NR be "in combination with" tryptophan, nicotinic acid, or nicotinamide? This is new ground for us.
Here are the SIX disputed terms that the court is being asked to construe. We will look at each of the six in turn. These terms are:
1. nicotinamide riboside
2. isolated nicotinamide riboside
3. 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
1. Nicotinamide Riboside
The essence of the dispute here is that ChromaDex wants NR to mean NR, and Elysium says it should mean NR or a derivative of NR.
The specification states that NR can be a derived from esters, but Elysium makes a big leap, I think, when they say that therefore NR includes esters, and that ChromaDex has so defined NR in the patent. Here's what ChromaDex says:
Elysium proposes to construe “nicotinamide riboside” to include “derivative[s] (e.g., L-valine or L-phenylalanine esters) of nicotinamide riboside.” But Elysium’s expert conceded that, unlike NR salts, the recited NR esters are unstable (unless made into a salt) and do not contain the defined structure of NR, which “[m]akes the molecule very different” from NR in a way that has “an enormous impact” on its properties. Ex. 28, 91:19-92:1, 97:5-99:1. Moreover, the specification does not define NR to include esters, but rather treats them as distinct. Elysium’s proposed construction should therefore be rejected.
In other words, (1) they're different, and (2) the specification says they're different. Therefore, Elysium cannot assert a definition of NR that includes both. Next comes some complex chemistry, but you'd think that this argument ought to hold.
2. Isolated Nicotinamide Riboside
We have been through this before, so I don't want to revisit at length, but here is how ChromaDex frames the dispute:
There are two disputes relating to the “isolated nicotinamide riboside” term. First, does the isolated NR need to be separated or substantially free from at least some of “the other components associated with the source of the molecule” (ChromaDex’s position) or from at least some of “the other molecules commonly associated with it” (Elysium’s position)? Second, does isolated NR need to be at least 25% pure (ChromaDex’s position), or can NR be considered “isolated” even when nearly all of the other components associated with the source material remain in the composition, such that NR comprises an insignificant percentage of the total amount of source material in the composition (Elysium’s position)? As discussed below, the Court should adopt ChromaDex’s proposed construction because it is supported by the intrinsic (and extrinsic) evidence and is consistent with the construction adopted by the PTAB...The PTAB correctly found that Elysium’s position “would render the term[s] unreasonably broad”...Notably, the Board applied the “broadest reasonable construction” standard. Since Elysium’s proposed construction is “unreasonably broad” even under the broadest reasonable construction, it is even more unreasonable under the narrower claim construction standard articulated in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc), and applied by this Court. (citations omitted)
3. The Nicotinamide Riboside Is Isolated
From a Natural or Synthetic Source
This is also water under the bridge of the prior proceedings. You will recall that Elysium suggested that separating the milk from the cow was enough to isolate the NR in the milk, and that was the argument that got the federal appeals court laughing.
But Judge Connolly does not have to agree with the PTAB, so we drag through it again, including new arguments about whether Dartmouth allegedly disclaimed the meaning that ChromaDex wants. Apparently Dartmouth said during the IPR proceedings that "[c]laim 2 is narrower than claim 1 because it further specifies that the nicotinamide riboside ‘is isolated from a natural or synthetic source,’ to the exclusion of chemically synthesizing the compound,” and Elysium is asserting a kind of "gotcha" argument that this statement means the patent doesn't reach synthesized NR. ChromaDex points out that the statement would not limit the patent under established disclaimer doctrines in any case, but Elysium says the Court is still free to latch onto the statement as furiously as Elysium itself has.
ChromaDex tries to clear up the matter:
Elysium’s fundamental error is its assumption that “[t]he specification describes three distinct sources of NR: (1) natural sources, such as cow’s milk; (2) synthetic sources, such as commercially available chemical libraries; and (3) chemically-synthesized NR.” The specification, however, does not state or otherwise suggest that these categories cannot overlap (e.g., if the NR molecule were both from a “synthetic source” and “chemically synthesized”). As demonstrated below, that position would make no sense.
One of the disclosed sources of NR is a natural source such as milk. ’807 patent, 27:42-45. In other words, milk is a broth that contains NR along with other components, such as proteins and fats. If NR is isolated from these other components of the broth, then that NR is “isolated from a natural source.”
Another disclosed source of NR is a synthetic source. One synthetic source of NR is a broth containing NR that is created by chemical synthetic reactions (i.e., created by a chemical synthesis). This broth that contains NR (along with other products of the synthetic reactions) is, by definition, a “synthetic source” of NR. And if NR is isolated from the other components of that broth, then that NR is “isolated from a synthetic source.” But it is also “chemically synthesized,” since it was created, along with the other components of the broth, by chemical synthesis...
Contrary to Elysium’s mischaracterizations, Dartmouth did not disclaim NR that is isolated from a chemically synthesized broth, since such NR would be both “isolated from a synthetic source” and “chemically synthesized.” Instead, Dartmouth’s statement is more naturally read to mean that claim 2 excludes NR that is chemically synthesized but not “isolated from a natural or synthetic source.” Elysium, therefore, has not come close to showing a “clear and unmistakable” disclaimer of NR that is isolated from a chemically synthesized broth.
4. In Combination with One or More of Tryptophan, Nicotinic Acid, or Nicotinamide
Elysium’s proposed construction impermissibly seeks to import a process limitation into claim 1, in an attempt to avoid infringement. Specifically, Elysium attempts to limit the recited “composition” to only those compositions that are “formulated using a process of combining 1) the isolated nicotinamide riboside with 2) tryptophan, nicotinic acid, or nicotinamide,” without any support whatsoever in the intrinsic evidence. This is improper...
Elysium’s proposed construction is also improper because the specification discloses that tryptophan, nicotinic acid, or nicotinamide can be present in the inventive compositions without being affirmatively combined with the isolated NR...Contrary to Elysium’s position that tryptophan, nicotinic acid, or nicotinamide must be affirmatively combined with the isolated NR, [the patent specification] shows that the invention includes compositions in which tryptophan, nicotinic acid, or nicotinamide were already present in the composition, as a result of the chemical synthesis that created the NR or otherwise. We have wondered, though, why the patent is limited to NR in combination with other precursors? Elysium says,
"The meaning of this claim language is at issue because Plaintiffs contend that small amounts of nicotinamide inherently present in any NR composition, either as degradation products or impurities, satisfy this claim limitation, even in the absence of any actual combining of isolated NR with nicotinamide...As Dr. Adams explains, nicotinamide is a degradation product of NR. Any NR composition will contain nicotinamide due to the breakdown of a bond in NR's chemical structure by atmospheric humidity, through a process called hydrolysis...In addition, the chemical reaction by which NR is synthesized uses nicotinamide as a starting material, which cannot be fully removed from the synthesis product..."
When I read that, I think, "Sucks to be Elysium, because that means your own expert has conceded without even needing to look at it that Elysium's NR will exist in combination with nicotinamide." But Elysium thinks that the patent must not cover that situation, because then Elysium might be liable for infringement. So that's why Elysium proposes that "in combination with" REALLY means "when combined with." It would be seriously great news for Elysium if "in combination with" meant something other than what it a normal person usually thinks it means.
Elysium then claims that the original patent examiner insisted that the in-combination language be added to avoid obviousness, but if the combination is always present, then the in-combination words wouldn't mean anything.
In response, ChromaDex reiterates that Elysium can't add a process limitation to the language, and responds that Elysium's expert did not say that NR could not be pure. But even if that were true, says ChromaDex, that trace amounts of nicotinamide were inevitably present in NR, that would still be a red herring because [REDACTED]. And in any case, if the other forms of vitamin B are incidentally present, then the formulation can be achieved by choosing not to remove them, rather than by affirmatively combining them. Therefore, you simply cannot require affirmative combination as a process in practicing the art of this patent.
It's difficult to assess this argument, because it's partially redacted, but ChromaDex does seem to be on the case.
5. Increases NAD+ Biosynthesis Upon Oral Administration
ChromaDex explains what is at stake here:
Determining whether this claim limitation is satisfied is straightforward: does oral administration of the claimed composition increase NAD+ biosynthesis, or not? Elysium’s proposed construction—which requires comparing the result of administering the claimed composition to the result of administering a composition found nowhere in the claim—finds no support in the claim language or the specification. It should therefore be rejected. Elysium's position that ChromaDex wants rejected is that an NR composition comprising NR in combination with tryptophan, nicotinamide, and/or nicotinic acid must raise NAD compared to an NR composition NOT in combination with tryptophan, nicotinamide, and/or nicotinic acid.
That strikes me as asinine and sophistic, and the reason people hate lawyers, and the reason that litigation as a civil dispute mechanism is such a failure. Maybe it strikes you different.
But it also exemplifies the general tenor of the discussion -- Elysium's proposed claim constructions seem to me to be based on whatever it takes for Elysium to not be an infringer. I can understand the attraction of the approach, but I can't respect it, and I certainly hope that the court system will not dignify it.
This was not the hardest part of the brief for ChromaDex's attorneys to write, however. ChromaDex points out that the common meaning would be that the "composition" increases NAD+ biosynthesis, and Elysium's proposed construction contorts the term so that it incorporates a comparison with no basis in the extrinsic evidence. The PTAB, ChromaDex points out, also found that the "composition" had to increase NAD+ biosynthesis, not any particular component of the composition.
6. Pharmaceutical Composition
The dispute here is that Elysium wants to limit the patented uses to "pharmaceutical" uses -- preventing or treating a disease or condition. ChromaDex says that's not what "pharmaceutical," means, and that other purposes are also included in the specification, such as prolonging health and well-being, and taking the form of a dietary supplement. The specification also discloses that NR can be used to increase NAD independent of treating or preventing a particular disease or condition.
Elysium says pharmaceutical must mean something more than suitable for ingestion, since the phrase "oral administration" occurs elsewhere in the claims, and the specification specifically discloses treating or preventing a disease or condition. So why not mean to prevent or treat a disease or condition?
ChromaDex says, Because that's not what "pharmaceutical composition" means, and any language like that in the specification is not limiting. Notably, the specification also discloses that "the present invention is a dietary supplement composition." End of story. Or if it weren't the end of the story, another reason would be because "pharmaceutical" relates to safety levels, not uses.
Well, that was loads of fun. It's always a daring thing to try to guess what a court will do, and it would be beyond daring -- indeed, foolhardy -- for me to predict how a technical area like patent claim construction is likely to be resolved.
Nonetheless, I would venture this much. When I first saw the proposed claim constructions some months ago, I thought where there might be close calls, ChromaDex had the stronger argument, and that some of the items weren't even going to be close calls.
Now, having read through the details of the arguments, I still think that ChromaDex is the patient adult in the room, and Elysium is the white-around-the-gills infringer. We will see if the Court agrees.