DCT
1:24-cv-00583
Exact Sciences Corp v. Geneoscopy Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Exact Sciences Corporation (Delaware)
- Defendant: Geneoscopy, Inc. (Delaware)
- Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP; Quinn Emanuel Urquhart & Sullivan, LLP
- Case Identification: 1:24-cv-00583, D. Del., 05/15/2024
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because the Defendant, Geneoscopy, Inc., is a Delaware corporation and therefore resides in the district.
- Core Dispute: Plaintiff alleges that Defendant’s ColoSense at-home colorectal cancer (CRC) screening test will imminently infringe a patent covering methods for processing a single fecal sample for both nucleic acid and blood protein analysis.
- Technical Context: The lawsuit concerns the market for at-home, non-invasive CRC screening tests, which provide a more convenient alternative to traditional colonoscopies and aim to increase patient participation in early cancer detection.
- Key Procedural History: The asserted patent is a continuation of a parent patent (’781 Patent) which was the subject of prior litigation between the parties. Defendant Geneoscopy previously challenged the parent patent through an ex parte reexamination and an inter partes review (IPR) petition at the USPTO. The complaint notes that the USPTO reaffirmed the patentability of the parent patent's claims in the reexamination, and that the examiner for the asserted patent considered these challenges during prosecution before allowing the claims.
Case Timeline
| Date | Event |
|---|---|
| 2009-02-03 | ’746 Patent Priority Date |
| 2015-01-01 | Geneoscopy, Inc. Founded |
| 2021-04-01 | Geneoscopy Initiates CRC-PREVENT Clinical Trial |
| 2023-01-24 | Geneoscopy Submits PMA Application for ColoSense to FDA |
| 2023-03-07 | ’746 Patent Application Filed |
| 2023-09-29 | AMA Releases PLA Code for ColoSense |
| 2023-11-14 | Geneoscopy Announces Distribution Agreement with Labcorp |
| 2023-11-17 | Prior Litigation Filed by Exact Sciences on Parent Patent |
| 2024-04-10 | USPTO Issues Issue Notification for ’746 Patent |
| 2024-04-30 | ’746 Patent Issued |
| 2024-05-03 | FDA Approves Geneoscopy’s ColoSense Test |
| 2024-05-15 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,970,746 - Fecal Sample Processing and Analysis Comprising Detection of Blood
- Patent Identification: U.S. Patent No. 11,970,746, "Fecal Sample Processing and Analysis Comprising Detection of Blood," issued April 30, 2024 (Compl. ¶47; ’746 Patent, front page).
The Invention Explained
- Problem Addressed: The patent addresses the low patient adherence to traditional, invasive colorectal cancer (CRC) screening methods like colonoscopy (Compl. ¶31). While at-home tests existed, they faced a technical hurdle: effectively testing a single, unfrozen stool sample for two different types of biomarkers—nucleic acids (like DNA) and blood proteins (like hemoglobin)—which require different preservation methods to maintain their integrity for analysis (’746 Patent, col. 5:35-51; Compl. ¶59).
- The Patented Solution: The invention is a method for processing a fecal sample that allows for the dual analysis of both nucleic acids and blood proteins from a single at-home collection without freezing. The method involves the patient collecting a fecal sample and partitioning it into two separate portions, each placed in its own sealed container with a distinct preservative: a "stabilizing buffer" for the nucleic acid portion and a "solution that prevents denaturation or degradation of blood proteins" for the blood protein portion (’746 Patent, Abstract; col. 17:15-35; Compl. ¶54).
- Technical Importance: This patented method enabled the development of a more comprehensive and convenient at-home CRC screening test, removing logistical barriers and combining multiple analytical targets to improve diagnostic accuracy (Compl. ¶¶ 9, 57).
Key Claims at a Glance
- The complaint asserts independent claims 1 and 3 (Compl. ¶¶ 121, 132).
- Independent Claim 1: A method of processing a freshly-collected fecal sample without freezing, comprising the steps of:
- Collecting a fecal sample at home.
- Combining a first portion of the sample in a sealable vessel with a "stabilizing buffer."
- Combining a second portion of the sample in a separate sealable container with a "solution that prevents denaturation or degradation of blood proteins."
- Independent Claim 3: A method of processing a fecal sample comprising:
- Obtaining a pair of sample portions prepared by the method of claim 1.
- Extracting and testing nucleic acid from the first portion.
- Testing the second portion for a blood protein.
- The complaint reserves the right to assert additional dependent claims (Compl. ¶132).
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is Geneoscopy’s "ColoSense" test, including all associated products, kits, devices, and services (Compl. ¶62).
Functionality and Market Context
- ColoSense is described as an at-home, non-invasive screening test for CRC that analyzes both a panel of RNA biomarkers (a type of nucleic acid) and hemoglobin (a blood protein) from a patient-collected stool sample (Compl. ¶¶ 63, 82, 125). The complaint alleges that the user instructions for ColoSense will direct patients to partition a stool sample into two portions, each combined with a different buffer for shipment and subsequent analysis (Compl. ¶125).
- The complaint alleges Geneoscopy is preparing for an imminent, large-scale commercial launch, positioning ColoSense as a direct competitor to Plaintiff's Cologuard test (Compl. ¶¶ 65, 91). An April 2024 investor presentation slide, reproduced in the complaint, depicts a graph showing a projected product launch in mid-2024 with the goal of reaching a market of 85 million covered lives within the first year (Compl. ¶94).
IV. Analysis of Infringement Allegations
The complaint references, but does not include, a preliminary claim chart as Exhibit W (Compl. ¶126). The following chart summarizes the infringement allegations for claim 1 based on the narrative provided in the complaint.
'746 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of processing a freshly-collected fecal sample without freezing... | The ColoSense test is an at-home test designed to be used with an unfrozen stool sample that is shipped via standard mail for laboratory analysis. | ¶¶ 59, 125 | col. 17:56-62 |
| a) collecting a fecal sample from a human subject, wherein the fecal sample is collected at home by the human subject; | The ColoSense test is described as an "at-home CRC screening test" where the patient collects the stool sample in the privacy of their home. | ¶125 | col. 17:15-19 |
| b) in a sealable vessel, combining a first portion of the fecal sample with a stabilizing buffer, and sealing the sealable vessel; and | The ColoSense test allegedly instructs patients to collect the sample in two portions, with one portion being combined with a buffer for subsequent RNA (nucleic acid) analysis. | ¶125 | col. 18:41-44 |
| c) in a sealable container, combining a second portion of the fecal sample with a solution that prevents denaturation or degradation of blood proteins..., and sealing the sealable container. | The second portion of the collected sample is allegedly combined with a different buffer designed for subsequent hemoglobin (blood protein) analysis. | ¶125 | col. 17:20-24 |
Identified Points of Contention
- Scope Questions: A potential dispute may arise over whether the specific buffer used in the ColoSense kit to preserve RNA qualifies as the "stabilizing buffer" recited in the patent, which was prosecuted with a focus on preserving DNA. A similar question may be raised regarding whether the buffer for the hemoglobin test meets the functional definition of a "solution that prevents denaturation or degradation of blood proteins."
- Technical Questions: As infringement is alleged to be "imminent," the allegations rely on pre-launch materials like clinical study protocols and investor presentations (Compl. ¶¶ 124, 126). A central question for the court will be whether the final commercial version of the ColoSense kit and its user instructions direct users to perform the method exactly as described in these documents and as required by the claims.
V. Key Claim Terms for Construction
The Term
- "stabilizing buffer" (Claim 1)
Context and Importance
- This term defines the preservative for the first sample portion, which is tested for nucleic acids. Its construction is critical because the accused product tests for RNA, while the patent specification frequently discusses the buffer in the context of preserving DNA. Practitioners may focus on this term to determine if the claim scope is limited to DNA-based tests or is broad enough to cover RNA-based tests.
Intrinsic Evidence for Interpretation
- Evidence for a Broader Interpretation: The patent does not provide a specific chemical formula for the buffer, instead referring to "suitable buffers for maintaining DNA integrity" (’746 Patent, col. 18:41-42). This general functional language may support a construction that covers any buffer achieving the goal of preserving nucleic acids, including RNA.
- Evidence for a Narrower Interpretation: The specification repeatedly frames the purpose of this buffer in relation to DNA, such as for detecting "aberrantly methylated DNA" or retaining "DNA integrity" (’746 Patent, col. 6:5-10, col. 10:63-65). A party could argue the term is implicitly limited to buffers designed for and known to work with DNA at the time of the invention.
VI. Other Allegations
Indirect Infringement
- The complaint alleges that Geneoscopy will induce infringement by providing user instructions with its ColoSense kits that direct patients to perform the patented method (Compl. ¶127). It also alleges contributory infringement, asserting the kits are especially designed for this infringing use and have no substantial non-infringing purpose (Compl. ¶147).
Willful Infringement
- The complaint alleges willfulness based on Geneoscopy's alleged knowledge of the asserted patent and its parent patent. The allegations cite a pre-suit notice letter regarding the parent patent sent in May 2023, Geneoscopy’s subsequent challenges to that patent at the USPTO, and its continued preparations for commercial launch after the asserted patent issued on April 30, 2024 (Compl. ¶¶ 101, 112, 114, 151).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can the term "stabilizing buffer," which is described in the patent’s specification primarily in the context of preserving DNA, be construed to cover the buffer used to preserve RNA in the accused ColoSense test? The resolution of this question will likely determine whether the patent's protection extends beyond DNA-based diagnostics to the RNA-based technology of the accused product.
- A key evidentiary question will be one of commercial reality versus pre-launch projection: does the final, commercially launched ColoSense kit and its associated user manual direct the performance of the exact steps of the patented method? The plaintiff's case for imminent infringement relies heavily on clinical trial protocols and marketing presentations, and the court will need to compare these with the actual product upon launch.
- A third central question will concern willfulness and intent: given the detailed history of correspondence, litigation over the parent patent, and USPTO challenges preceding this lawsuit, the court will have to determine whether Geneoscopy’s decision to launch ColoSense was based on an objectively reasonable belief that it did not infringe a valid patent, or if its actions rise to the level of willful infringement.