DCT
1:18-cv-01434
ChromaDex Inc v. Elysium Health Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: ChromaDex, Inc. (California) and Trustees of Dartmouth College (New Hampshire)
- Defendant: Elysium Health, Inc. (Delaware)
- Plaintiff’s Counsel: Young Conaway Stargatt & Taylor, LLP; Covington & Burling LLP; Haley Guiliano LLP
- Case Identification: 1:18-cv-01434, D. Del., 09/17/2018
- Venue Allegations: Venue is alleged to be proper as Defendant Elysium Health, Inc. is a corporation organized under the laws of the State of Delaware and therefore resides in the district.
- Core Dispute: Plaintiffs allege that Defendant’s BASIS® dietary supplement infringes two patents related to compositions containing isolated nicotinamide riboside (NR) for increasing cellular NAD+ levels.
- Technical Context: The technology involves using NR, a form of vitamin B3, as a dietary supplement to boost levels of nicotinamide adenine dinucleotide (NAD+), a critical coenzyme for cellular metabolism whose decline is associated with aging.
- Key Procedural History: The complaint alleges a prior business relationship where ChromaDex supplied Elysium with NR for its BASIS® product under a Supply Agreement and licensed the patents-in-suit. The complaint also notes that Elysium previously challenged the patents-in-suit in Inter Partes Review (IPR) proceedings before the Patent Trial and Appeal Board (PTAB). According to the complaint, the PTAB declined to institute trial on any claims of the ’807 patent, while it did institute trial on some claims of the ’086 patent.
Case Timeline
| Date | Event |
|---|---|
| 2004-02-10 | Priority Date for ’807 and ’086 Patents |
| 2012-06-12 | Issue Date for U.S. Patent No. 8,197,807 |
| 2013-02-26 | Issue Date for U.S. Patent No. 8,383,086 |
| 2014-02-01 | ChromaDex and Elysium enter Supply and License Agreements (approx. date) |
| 2015-11-01 | ChromaDex receives first FDA NDI acknowledgement for NIAGEN® (approx. date) |
| 2016-08-01 | FDA issues GRAS No Objection Letter for NIAGEN® (approx. date) |
| 2017-02-02 | ChromaDex terminates Supply Agreement with Elysium |
| 2017-07-01 | Elysium allegedly begins selling BASIS® with NR from alternative sources (no later than) |
| 2018-01-18 | PTAB issues Final Written Decision declining to institute IPR on ’807 patent |
| 2018-01-29 | PTAB issues decision to institute IPR on certain claims of ’086 patent |
| 2018-03-01 | ChromaDex receives second FDA NDI acknowledgement for NIAGEN® (approx. date) |
| 2018-04-27 | PTAB modifies institution decision for IPR on ’086 patent |
| 2018-09-17 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,197,807 - "Nicotinamide Riboside Kinase Compositions and Methods for Using the Same," Issued June 12, 2012
The Invention Explained
- Problem Addressed: The patent describes that cellular levels of the vital co-enzyme NAD+ decline with age and physiological stress, and that existing methods for supplementation using other forms of vitamin B3 (niacin) can produce undesirable side effects such as flushing (’807 Patent, col. 2:2-24, col. 9:1-8).
- The Patented Solution: The invention is based on the discovery that nicotinamide riboside (NR) is a precursor to NAD+ in a previously unknown but conserved eukaryotic biosynthetic pathway (’807 Patent, col. 3:2-13). The patent describes using compositions of isolated NR, formulated for oral administration, to increase NAD+ levels in the body, which can prevent or treat conditions associated with decreased NAD+ biosynthesis (’807 Patent, Abstract; col. 5:23-34).
- Technical Importance: The invention provided a novel nutritional and therapeutic strategy for boosting NAD+ levels by identifying NR as an effective and orally bioavailable precursor. (Compl. ¶25).
Key Claims at a Glance
- The complaint asserts independent claim 1. (Compl. ¶37).
- The essential elements of claim 1 are:
- A composition comprising isolated nicotinamide riboside;
- in combination with one or more of tryptophan, nicotinic acid, or nicotinamide;
- wherein the combination is in admixture with a carrier from a specified list (including sugar, starch, cellulose, etc.);
- wherein the composition is formulated for oral administration; and
- the composition increases NAD+ biosynthesis upon oral administration.
U.S. Patent No. 8,383,086 - "Nicotinamide Riboside Kinase Compositions and Methods for Using the Same," Issued February 26, 2013
The Invention Explained
- Problem Addressed: The technical problem is identical to that of the ’807 patent: the need for effective ways to supplement NAD+ to counteract age-related decline and other deficiencies (’086 Patent, col. 2:2-24).
- The Patented Solution: This patent claims a "pharmaceutical composition" that comprises NR in admixture with a carrier, where the composition is formulated for oral administration and the NR is isolated from a natural or synthetic source (’086 Patent, cl. 1-2). The invention distinguishes this isolated, bioavailable form of NR from forms found in nature (e.g., in milk) which are bound to other molecules and whose ability to boost NAD+ is unknown (Compl. ¶29, ¶32).
- Technical Importance: This patent, like the parent ’807 patent, established a basis for using isolated NR as a therapeutic or nutritional agent to modulate NAD+ levels. (Compl. ¶25).
Key Claims at a Glance
- The complaint asserts dependent claim 2. (Compl. ¶52).
- The essential elements of claim 2 are:
- A pharmaceutical composition comprising nicotinamide riboside in admixture with a carrier;
- wherein the composition is formulated for oral administration; and
- wherein the nicotinamide riboside is isolated from a natural or synthetic source.
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is Defendant Elysium’s dietary supplement product, BASIS® (Compl. ¶12).
Functionality and Market Context
- BASIS® is a composition sold in capsule form for oral administration (Compl. ¶38, ¶53). The complaint alleges the product comprises "isolated NR" and is promoted and marketed based on the benefits of increasing NAD+ biosynthesis upon oral administration (Compl. ¶12, ¶30). The complaint states that Elysium represents to the public that BASIS® capsules contain microcrystalline cellulose, hypromellose, vegetable magnesium stearate, and silica as carriers (Compl. ¶40, ¶56).
- The complaint alleges Elysium sells BASIS® through the internet to customers nationwide and that it continues to promote the product with reference to clinical studies that were conducted using an earlier formulation of BASIS® that contained NR sourced from Plaintiff ChromaDex (Compl. ¶12, ¶23).
No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
’807 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A composition comprising isolated nicotinamide riboside... | Each capsule of BASIS® contains a composition comprising isolated NR. | ¶39 | col. 3:2-13 |
| ...in combination with one or more of tryptophan, nicotinic acid, or nicotinamide... | The NR in BASIS® is in combination with one or more of tryptophan, nicotinic acid, or nicotinamide. | ¶39 | col. 5:35-36 |
| ...wherein said combination is in admixture with a carrier comprising a sugar, starch, cellulose... | Each capsule of BASIS® comprises isolated NR in admixture with a carrier, including microcrystalline cellulose. | ¶40 | col. 30:42-50 |
| ...wherein said composition is formulated for oral administration... | BASIS® is sold in a capsule form and is formulated for oral administration. | ¶38, ¶41 | col. 30:19-24 |
| ...and increases NAD+ biosynthesis upon oral administration. | Elysium represents to the public that BASIS® increases NAD+ biosynthesis in the body upon oral administration. | ¶42 | col. 3:7-13 |
- Identified Points of Contention:
- Factual Question: The complaint alleges in a conclusory manner that BASIS® meets the limitation "in combination with one or more of tryptophan, nicotinic acid, or nicotinamide" (Compl. ¶39). A central point of contention may be whether Plaintiffs can produce factual evidence to support this allegation, as the complaint does not specify which of these ingredients is present or provide an ingredient list for the accused product that includes them.
- Scope Question: The meaning of "in combination with" could become a point of dispute. The claim language suggests a physical mixture within a single composition, but questions could arise if, for example, the components were co-packaged or marketed for concurrent use.
’086 Patent Infringement Allegations
| Claim Element (from Dependent Claim 2) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A pharmaceutical composition comprising nicotinamide riboside in admixture with a carrier... | Each capsule of BASIS® contains a composition of isolated NR with carriers such as microcrystalline cellulose and hypromellose. | ¶54, ¶56 | col. 29:1-8 |
| ...wherein said composition is formulated for oral administration... | BASIS® is sold in capsule form and is formulated for oral administration. | ¶53, ¶57 | col. 30:19-24 |
| ...wherein the nicotinamide riboside is isolated from a natural or synthetic source. | The NR in each capsule of BASIS® is isolated from a natural or synthetic source. | ¶55 | col. 4:6-14 |
- Identified Points of Contention:
- Scope Question: The primary point of contention for this patent will likely be the claim term "pharmaceutical composition". Elysium markets BASIS® as a "dietary supplement" (Compl. ¶12). The court will have to determine whether this term, in the context of the patent, is broad enough to cover a dietary supplement or if it is limited to products regulated as pharmaceuticals (e.g., FDA-approved drugs).
V. Key Claim Terms for Construction
- The Term: "pharmaceutical composition" (from ’086 Patent, Claim 2)
- Context and Importance: This term is critical to the ’086 patent infringement analysis. If the court construes this term to exclude dietary supplements like BASIS®, the infringement claim may fail. Practitioners may focus on this term because its interpretation directly determines whether the accused product's category falls within the claim's scope.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent specification also uses the term "dietary supplement composition" when describing the invention, suggesting the patentee may have viewed the terms as related or overlapping (’086 Patent, col. 4:14-17). The abstract refers more generally to "compositions and methods" for "treating" conditions, which can be achieved by both pharmaceuticals and supplements.
- Evidence for a Narrower Interpretation: The patent explicitly uses the term "pharmaceutical," which carries a common meaning distinct from "dietary supplement" or "nutraceutical." The specification also discusses the use of the invention in the context of cancer treatment and chemotherapy, which supports a traditional pharmaceutical application rather than a general wellness supplement (’086 Patent, col. 3:14-20). A party could argue that the patentee's choice to use "pharmaceutical composition" in the claim, when other terms like "dietary supplement" were available and used elsewhere in the specification, was a deliberate limitation.
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement for the ’807 and ’086 patents. The inducement allegations are based on Elysium allegedly instructing and encouraging its customers on how to use BASIS® in an infringing manner (i.e., to increase NAD+ biosynthesis) (Compl. ¶44, ¶59). The contributory infringement allegations are based on BASIS® being a material component especially made for an infringing use and not being a staple article of commerce (Compl. ¶45, ¶60).
- Willful Infringement: The complaint alleges willful infringement of both patents based on Elysium's alleged pre-suit knowledge. The complaint asserts that Elysium knew of the patents at least as early as February 2014, when it entered into a Supply Agreement and a Trademark License and Royalty Agreement with ChromaDex that referenced the patents. The complaint further alleges that Elysium marked its own BASIS® product with the patent numbers during this agreement, and that Elysium's subsequent IPR challenges also demonstrate knowledge (Compl. ¶46, ¶61).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue for the ’086 patent will be one of definitional scope: can the term "pharmaceutical composition," as used in the claim, be construed to cover a product that is marketed and sold to consumers as a "dietary supplement"? The case may turn on whether the patent's use of this term creates a hard line between regulated drugs and nutritional products.
- A key evidentiary question for the ’807 patent will be one of factual proof: can Plaintiffs substantiate the allegation that the accused BASIS® product contains one of the specific additional ingredients (tryptophan, nicotinic acid, or nicotinamide) required by claim 1, an assertion made in the complaint without supporting evidence?
- Given the parties' prior licensing relationship and Elysium's alleged patent marking, a central question will be on willfulness: does Elysium's alleged knowledge of the patents from its prior agreements, followed by its decision to source NR from others while continuing to sell a similar product, rise to the level of willful infringement, potentially justifying enhanced damages?