DCT
1:18-cv-04919
Glycominds Diagnostics 2014 Ltd v. Raybiotech Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Glycominds Diagnostics (2014) Ltd. (Israel)
- Defendant: RayBiotech, Inc. (Georgia)
- Plaintiff’s Counsel: KENT & RISLEY LLC; COTMAN IP LAW GROUP, Group
- Case Identification: 1:18-cv-04919, N.D. Ga., 10/24/2018
- Venue Allegations: Plaintiff alleges venue is proper because Defendant is a Georgia corporation that maintains a regular and established place of business in the district, where infringing acts have allegedly occurred.
- Core Dispute: Plaintiff alleges that Defendant’s "Glycan Array 100" product, a type of diagnostic tool, infringes a patent directed to combinatorial libraries of complex carbohydrates.
- Technical Context: The technology relates to glycomics, specifically the creation of microarrays containing diverse carbohydrate structures (glycans) for use in diagnostics and drug discovery.
- Key Procedural History: The complaint alleges that Plaintiff provided Defendant with pre-suit notice of infringement via a letter dated April 4, 2017, and that Defendant acknowledged receipt of the letter on April 17, 2017. This correspondence may form the basis for the willfulness allegation.
Case Timeline
| Date | Event |
|---|---|
| 1999-02-17 | U.S. Patent No. 6,972,172 Priority Date |
| 2005-12-06 | U.S. Patent No. 6,972,172 Issues |
| 2017-04-04 | Plaintiff sends pre-suit notice letter to Defendant |
| 2017-04-17 | Defendant acknowledges receipt of notice letter |
| 2018-10-24 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 6,972,172 - "Combinatorial Complex Carbohydrate Libraries and Methods for the Manufacture and Uses Thereof"
- Issued: December 6, 2005
The Invention Explained
- Problem Addressed: The patent describes the difficulty and limitations of traditional chemical synthesis for creating diverse libraries of complex carbohydrates for drug discovery and screening ('172 Patent, col. 5:46-6:1). Existing methods struggled to produce the highly branched and structurally complex carbohydrates found in nature, hindering research into their biological roles.
- The Patented Solution: The invention proposes using enzymatic synthesis on a solid support to build complex carbohydrate structures at specific, known locations ('172 Patent, Abstract; col. 9:20-32). By using enzymes, the process can achieve the high stereo- and regioselectivity needed to build complex, branched structures, creating an "addressable" library where the identity and location of each unique carbohydrate is known, facilitating high-throughput screening.
- Technical Importance: This approach provided a method for creating large-scale, diverse arrays of biologically relevant carbohydrates, a critical tool for identifying new drug targets and diagnostic markers associated with various diseases ('172 Patent, col. 1:12-32).
Key Claims at a Glance
- The complaint asserts independent Claim 2.
- The essential elements of Claim 2 are:
- A carbohydrate library comprising a plurality of carbohydrate structures.
- Each structure is attached at a specific and addressable location of an array.
- The plurality of carbohydrate structures are selected from a large, specified Markush group of chemical structures.
- The stereo-specificity of each bond interconnecting the monosaccharide units is defined by the addressable location on the array.
- The complaint does not explicitly reserve the right to assert other claims.
III. The Accused Instrumentality
Product Identification
The accused product is Defendant's "Glycan Array 100" ('172 Patent, Compl. ¶15).
Functionality and Market Context
- The complaint describes the Glycan Array 100 as an "analytical carbohydrate array using a library of distinct carbohydrate structures assigned to specific locations on a two-dimensional grid" (Compl. ¶17). It is designed for use with a chemical marker mixture and a light-based scanner to detect interactions, indicating its function as a tool for biological screening or diagnostics (Compl. ¶17).
- The complaint alleges that Plaintiff competes with Defendant in the field of "chemical and/or biological diagnostics," positioning the accused product in a commercial market for research and diagnostic tools (Compl. ¶51).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
- Claim Chart Summary: The complaint does not contain a claim chart exhibit, but its allegations in paragraphs 17-43 can be summarized as follows:
| Claim Element (from Independent Claim 2) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A carbohydrate library comprising a plurality of carbohydrate structures each being attached at a specific and addressable location of an array | The Glycan Array is described as an "analytical carbohydrate array" with a "library of distinct carbohydrate structures assigned to specific locations on a two-dimensional grid." | ¶17 | col. 97:48-52 |
| said plurality of carbohydrate structures are selected from the group consisting of: [Markush group] | The complaint alleges that the Glycan Array includes numerous specific carbohydrate structures that are members of the claimed Markush group, providing over 20 examples at specific array positions. | ¶¶18-41 | col. 97:53-98:40 |
| wherein a stereo-specificity of each bond interconnecting monosaccharide unit of said plurality of carbohydrate structures is defined by said addressable location thereof on said array | The complaint alleges the Glycan Array "relies on the stereo-specificity of bonds forming the embedded carbohydrate structures as a means of including and organizing different detection regions on the array." | ¶42 | col. 98:41-45 |
- Identified Points of Contention:
- Scope Questions: A central factual dispute may concern whether the specific collection of carbohydrates on the Glycan Array 100 falls within the scope of the extensive Markush group recited in Claim 2. While the complaint provides many examples, the defense may challenge the accuracy of this mapping for each and every structure.
- Technical Questions: A key technical question is whether the accused array meets the final limitation, where stereo-specificity is "defined by" the addressable location. The court will have to determine if this requires the synthesis method itself to be location-dependent in a way that dictates stereo-specificity, or if it is sufficient that a specific stereo-isomer is known to be at a specific location. The complaint's evidence on this point will be critical.
V. Key Claim Terms for Construction
The Term: "carbohydrate library"
- Context and Importance: Practitioners may focus on this term because its definition is fundamental to the scope of the patent. The patent's specification heavily emphasizes a specific method of enzymatic synthesis to create these libraries. The defense might argue that this process limitation should be imported into the apparatus claim, potentially excluding products made by different methods.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim itself is an apparatus claim ("A carbohydrate library comprising...") without explicit process steps, which could support an interpretation covering any array with the claimed structures, regardless of how it was made.
- Evidence for a Narrower Interpretation: The specification repeatedly describes the "present invention" in the context of enzymatic synthesis on a solid support, which could be used to argue that a "carbohydrate library" as patented is necessarily a product of that process ('172 Patent, col. 9:15-32).
The Term: "defined by said addressable location"
- Context and Importance: This term is critical because it links the physical structure of the carbohydrate (its stereo-specificity) to its position on the array. The infringement analysis may turn on whether the accused product's architecture satisfies this "defined by" relationship.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party could argue "defined by" simply means that the stereo-specific structure is predetermined for and fixed at each location, allowing a user to identify the structure by its address.
- Evidence for a Narrower Interpretation: The specification's focus on sequential, location-specific enzymatic synthesis could support an interpretation that "defined by" implies the location itself is an integral part of the process that determines the stereo-specificity during manufacture, not just a label for the final product ('172 Patent, col. 23:25-40).
VI. Other Allegations
- Willful Infringement: The complaint alleges willful infringement based on Defendant's alleged actual knowledge of the '172 Patent prior to the lawsuit. This allegation is supported by reference to a notice letter sent by Plaintiff on April 4, 2017, and Defendant's subsequent confirmation of its receipt (Compl. ¶¶47-49).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of claim construction and scope: does the term "carbohydrate library" in Claim 2 carry an implicit process limitation based on the specification's extensive focus on enzymatic synthesis, and does the phrase "defined by said addressable location" require a specific causal link between position and structure that is present in the accused product?
- A key evidentiary question will be one of factual correspondence: can Plaintiff provide sufficient evidence to prove that the structures on Defendant's Glycan Array 100 are, in fact, the specific and complex structures recited in the patent's extensive Markush group?