DCT
1:20-cv-01098
W R Grace & Co Conn v. Elysium Health Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: W. R. Grace & Co.-Conn. (Connecticut)
- Defendant: Elysium Health, Inc. (Delaware)
- Plaintiff’s Counsel: Venable LLP
- Case Identification: 1:20-cv-01098, D. Del., 08/21/2020
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because the Defendant is a corporation organized under the laws of Delaware and therefore resides in the district.
- Core Dispute: Plaintiff alleges that Defendant’s dietary supplement, BASIS®, infringes three patents related to specific crystalline forms of nicotinamide riboside chloride (NRCl).
- Technical Context: The technology concerns chemical polymorphs—distinct crystalline structures of the same compound—which can possess different properties of stability, purity, and bioavailability, making them significant in the pharmaceutical and nutraceutical industries.
- Key Procedural History: The complaint alleges Defendant had pre-suit knowledge of the patents-in-suit based on a March 2019 deposition of its CEO in separate litigation, where he testified to being aware of a Grace patent application for a "crystalline structure patent." The complaint also alleges actual notice of the corresponding patent publications prior to their issuance, forming the basis for claims of provisional rights.
Case Timeline
| Date | Event |
|---|---|
| 2014-07-24 | Earliest Priority Date ('207 & '058 Patents) |
| 2015-03-09 | Earliest Priority Date ('872 Patent) |
| 2017-07-27 | Publication of U.S. App. No. 2017/0210774 (related to '058 Patent) |
| 2018-02-01 | Publication of U.S. App. No. 2018/0030079 (related to '872 Patent) |
| 2018-03-29 | Publication of U.S. App. No. 2018/0086783 (related to '207 Patent) |
| 2019-01-29 | Issue Date: U.S. Patent No. 10,189,872 |
| 2019-03-19 | Issue Date: U.S. Patent No. 10,233,207 |
| 2019-03-27 | Deposition of Elysium's CEO in prior litigation |
| 2019-06-18 | Issue Date: U.S. Patent No. 10,323,058 |
| 2020-08-21 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 10,233,207 - "Crystalline Form of Nicotinamide Riboside"
The Invention Explained
- Problem Addressed: The patent's background section notes that amorphous (non-crystalline) forms of molecules can have disadvantages for commercial use, whereas crystalline forms are often easier to process, more stable during storage, and more amenable to purification (’207 Patent, col. 1:25-34).
- The Patented Solution: The invention is a specific crystalline polymorph of nicotinamide riboside chloride, designated "Form I." This form is not defined by its chemical composition alone, but by its unique three-dimensional lattice structure, which is identified and claimed through its characteristic powder X-ray diffraction (XRPD) pattern (’207 Patent, Abstract; col. 5:19-25). The patent asserts this novel form provides formulation scientists with a material having improved properties, such as enhanced stability (’207 Patent, col. 3:45-56).
- Technical Importance: Identifying and isolating a stable, pure crystalline form of a biologically active compound is a critical step in developing consistent and reliable pharmaceutical or nutraceutical products (’207 Patent, col. 1:34-42).
Key Claims at a Glance
- The complaint asserts independent claims 1 (a composition of matter), 20 (a method of increasing NAD concentration), and 23 (a method for supplementing a diet) (Compl. ¶¶ 24-26, 83).
- Independent Claim 1:
- A crystalline Form I of nicotinamide riboside chloride according to formula I
- that is characterized by a powder X-ray diffraction pattern having peaks at 5.1, 15.7, and 21.7 degrees two theta ±0.2 degrees two theta.
- Independent Claim 20:
- A method for increasing nicotinamide adenine dinucleotide (NAD) concentration in a subject in need thereof
- comprising administering to the subject a pharmaceutically acceptable amount of the crystalline Form I according to claim 1.
- Independent Claim 23:
- A method for supplementing the diet of a subject
- comprising administering to the subject a pharmaceutically acceptable amount of the crystalline Form I according to claim 1.
- The complaint also asserts infringement of dependent claims, including claims 2 and 3, which add further characterizing XRPD peaks (Compl. ¶ 28).
U.S. Patent No. 10,323,058 - "Crystalline Form of Nicotinamide Riboside"
The Invention Explained
- Problem Addressed: As with the '207 Patent, the '058 Patent addresses the need for crystalline forms of nicotinamide riboside that offer advantageous properties, such as stability and purity, compared to the amorphous form (’058 Patent, col. 1:25-34).
- The Patented Solution: The patent discloses the same "Form I" crystalline polymorph of nicotinamide riboside chloride. The claims, specification, and figures are substantially similar to those in the related '207 Patent, describing the invention in terms of its unique physical structure as identifiable by XRPD analysis (’058 Patent, Abstract; col. 5:3-9).
- Technical Importance: The invention provides the market with a specific, stable, and characterizable form of a vitamin B3 precursor, enabling more reliable manufacturing and formulation of dietary supplements (’058 Patent, col. 1:34-42).
Key Claims at a Glance
- The complaint asserts independent claims 1 (a composition of matter), 20 (a method of increasing NAD concentration), and 23 (a method of supplementing a diet) (Compl. ¶¶ 42-44, 116).
- Independent Claim 1:
- A crystalline Form I of nicotinamide riboside chloride according to formula I.
- Independent Claim 20:
- A method for increasing nicotinamide adenine dinucleotide (NAD) concentration in a subject in need thereof
- comprising administering to the subject a pharmaceutically acceptable amount of the crystalline Form I according to claim 1.
- Independent Claim 23:
- A method for supplementing the diet of a subject
- comprising administering to the subject a pharmaceutically acceptable amount of the crystalline Form I according to claim 1.
- The complaint also asserts infringement of dependent claims, including claims 2 and 3, which further define the crystalline form by reference to its XRPD pattern (Compl. ¶ 46).
U.S. Patent No. 10,189,872 - "Crystalline Form of Nicotinamide Riboside"
- Patent Identification: U.S. Patent No. 10,189,872, "Crystalline Form of Nicotinamide Riboside," issued January 29, 2019 (Compl. ¶17).
- Technology Synopsis: The patent addresses the general need for improved physical forms of nicotinamide riboside chloride for use in nutritional supplements (’872 Patent, col. 2:11-16). The invention provides a different crystalline polymorph, designated "Form II," which is distinguished from other forms by its own unique and defining powder X-ray diffraction (XRPD) pattern and other physical properties (’872 Patent, Abstract; col. 4:35-51).
- Asserted Claims: Independent claims 1 (composition), 15 (pharmaceutical composition), 16 (method of production), and 17 (method of administration) (Compl. ¶¶ 60-63).
- Accused Features: The complaint alleges that the BASIS® supplement contains the claimed crystalline Form II NRCl and is sold with pharmaceutically acceptable excipients, thereby infringing the composition claims. It further alleges that the use of BASIS® by consumers infringes the method of administration claims (Compl. ¶¶ 67, 71, 81).
III. The Accused Instrumentality
Product Identification
The accused instrumentality is Defendant's dietary supplement, BASIS® (Compl. ¶1).
Functionality and Market Context
BASIS® is a capsule sold as a daily supplement that contains crystalline nicotinamide riboside (Compl. ¶23). It is marketed to consumers for "promot[ing] a healthy cellular aging process" by increasing the body's levels of NAD+ (Compl. ¶23). The complaint alleges that Elysium represents to the public that BASIS® is "clinically proven to increase NAD+ levels by an average of 40%" (Compl. ¶23). The product is sold with other ingredients, such as microcrystalline cellulose and silica, which the complaint alleges are "pharmaceutically acceptable excipients" (Compl. ¶32). The complaint includes a chemical structure diagram for the active ingredient, nicotinamide riboside chloride (Compl. ¶24, p.6).
IV. Analysis of Infringement Allegations
'207 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A crystalline Form I of nicotinamide riboside chloride according to formula I | The complaint alleges, on information and belief, that BASIS® comprises crystalline Form I of nicotinamide riboside chloride (NRCl). | ¶30 | col. 5:19-21 |
| that is characterized by a powder X-ray diffraction pattern having peaks at 5.1, 15.7, and 21.7 degrees two theta ±0.2 degrees two theta. | The complaint alleges, on information and belief, that the crystalline Form I NRCl contained in BASIS® is characterized by this specific X-ray diffraction pattern. | ¶35 | col. 5:21-25 |
'058 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A crystalline Form I of nicotinamide riboside chloride according to formula I | The complaint alleges, on information and belief, that the BASIS® supplement comprises crystalline Form I of NRCl, as depicted in the chemical structure diagram provided in the complaint. | ¶48, ¶53 | col. 5:3-5 |
Identified Points of Contention
- Evidentiary Questions: The complaint's allegations of infringement are made "on information and belief" and do not include empirical data (e.g., XRPD test results) for the accused product. The central factual dispute will be whether the NRCl in BASIS® is, in fact, the specific "Form I" or "Form II" crystalline structure as defined in the patents. This raises the question of what evidence Plaintiff will produce during discovery to substantiate its claims.
- Scope Questions: The patents claim specific polymorphs defined by analytical data. A key legal question will concern the scope of these claims. For instance, does the phrase "having peaks at" in the '207 Patent require the accused product's XRPD pattern to match exactly, or can it cover a product whose pattern includes the claimed peaks amongst others? The answer will likely depend on claim construction.
V. Key Claim Terms for Construction
The Term: "crystalline Form I" (and "crystalline Form II" from the '872 patent)
- Context and Importance: This term is the central subject of the composition claims. Its construction will define the specific physical structure of NRCl that is protected. The entire infringement analysis for the composition claims hinges on whether the accused product's material falls within the court's definition of this term.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent specification does not provide a single, explicit definition. A party could argue that the term should be given its plain and ordinary meaning to one of skill in the art, potentially covering any crystalline form that substantially corresponds to the disclosed properties, not just a perfect match.
- Evidence for a Narrower Interpretation: The specification consistently links "crystalline Form I" to specific, defining analytical data, stating it "may be characterized by a powder X-ray diffraction pattern having peaks substantially as shown in FIG. 1" and as provided in Table 1 (’207 Patent, col. 5:30-35). A party could argue these characterizations are definitional and limit the term's scope to materials that precisely exhibit the disclosed XRPD patterns.
The Term: "characterized by"
- Context and Importance: This phrase connects the claimed crystalline form to its identifying physical properties (the XRPD peaks). Its interpretation is critical because it governs how strictly the accused product's properties must match the claimed properties. Practitioners may focus on this term because it determines whether the list of XRPD peaks is exhaustive or merely illustrative.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: "Characterized by" could be interpreted to mean that the listed peaks are a key feature, but not necessarily the only features. This would support a finding of infringement even if the accused product's XRPD pattern contains additional peaks, so long as the claimed peaks are present.
- Evidence for a Narrower Interpretation: In the context of distinguishing polymorphs, a party could argue "characterized by" means the XRPD pattern is defined by the recited peaks, and that a pattern with different or additional significant peaks represents a different, non-infringing crystalline form or a mixture. The use of "substantially as shown in FIG. 1" in dependent claim 2 of the '207 Patent may suggest that independent claim 1 is not so limited, but it also provides a concrete reference point that could be used to inform the meaning of the term.
VI. Other Allegations
Indirect Infringement
The complaint alleges both induced and contributory infringement.
- Inducement is premised on allegations that Elysium provides instructions and marketing materials (e.g., "suggested use" to "take two (2) capsules every morning") that actively encourage its customers to perform the infringing methods of administration claimed in the patents (Compl. ¶¶ 88, 121, 154).
- Contributory infringement is based on allegations that BASIS® is a material component for practicing the patented methods, that it is especially made for this infringing use, and that it is not a staple article of commerce suitable for substantial non-infringing use (Compl. ¶¶ 100, 133, 169).
Willful Infringement
Willfulness is alleged based on both pre- and post-suit knowledge. The complaint alleges pre-suit knowledge based on deposition testimony from Elysium's CEO in a prior case, where he acknowledged awareness of Grace's patent application activity concerning a "crystalline structure patent" (Compl. ¶¶ 21, 109). The filing of the instant complaint is alleged to establish actual notice for any ongoing infringement (Compl. ¶¶ 22, 109).
VII. Analyst’s Conclusion: Key Questions for the Case
This case presents a classic dispute over chemical polymorph patents. The outcome will likely depend on the answers to two central questions for the court:
- A core evidentiary question will be one of physical identity: Does the nicotinamide riboside chloride within the accused BASIS® product, when subjected to analytical testing like X-ray powder diffraction, actually exhibit the specific crystalline structure of "Form I" or "Form II" as defined by the peak data in the asserted patents?
- A determinative legal question will be one of claim scope: How will the court construe the term "crystalline Form I" and the phrase "characterized by"? The infringement analysis will turn on whether these terms require a near-perfect match to the patent's disclosed analytical data or if they can be interpreted more broadly to read on materials that are substantially similar but not identical.