DCT
1:23-cv-01319
Exact Sciences Corp v. Geneoscopy Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Exact Sciences Corp (Delaware)
- Defendant: Geneoscopy, Inc. (Delaware)
- Plaintiff’s Counsel: Quinn Emanuel Urquhart & Sullivan, LLP; Morris, Nichols, Arsht & Tunnell LLP
- Case Identification: 1:23-cv-01319, D. Del., 06/03/2024
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because the Defendant is a Delaware corporation and therefore resides in the district.
- Core Dispute: Plaintiff alleges that Defendant’s ColoSense at-home colorectal cancer screening test infringes a patent related to methods for processing fecal samples for subsequent laboratory analysis of both blood and nucleic acid biomarkers.
- Technical Context: The technology relates to non-invasive, at-home colorectal cancer screening kits designed to improve patient compliance by simplifying sample collection and preservation for multi-target laboratory analysis.
- Key Procedural History: The complaint notes that on May 22, 2023, Defendant Geneoscopy filed an ex parte reexamination request against the patent-in-suit. The USPTO ultimately rejected the request, issuing a Notice of Intent to Issue a Reexamination Certificate on October 18, 2023, and an Ex Parte Reexamination Certificate on December 4, 2023, confirming the patentability of all original claims.
Case Timeline
| Date | Event |
|---|---|
| 2009-02-03 | ’781 Patent Priority Date |
| 2015 | Geneoscopy, Inc. founded |
| 2023-04-25 | U.S. Patent No. 11,634,781 Issues |
| 2023-05-22 | Geneoscopy files ex parte reexamination request for ’781 Patent |
| 2023-10-18 | USPTO confirms patentability of all claims in ’781 Patent |
| 2023-12-04 | USPTO issues Ex Parte Reexamination Certificate for ’781 Patent |
| 2024-05-03 | FDA grants Premarket Approval (PMA) for ColoSense |
| 2024-06-03 | Plaintiff files Second Amended and Supplemental Complaint |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,634,781 - "Fecal Sample Processing and Analysis Comprising Detection of Blood"
- Issued: April 25, 2023
The Invention Explained
- Problem Addressed: The patent’s background section describes the challenge that prior at-home stool tests for colorectal cancer (CRC) were often limited to detecting only blood. While methods for analyzing nucleic acid markers (like DNA) existed, they were difficult to combine with blood protein analysis in an at-home setting because the different biomarkers require different preservation techniques, and preserving nucleic acids often required freezing the sample—a step considered impractical for patients to perform reliably at home (Compl. ¶64; ’781 Patent, col. 3:42-54).
- The Patented Solution: The invention provides a method for processing a single, freshly collected fecal sample to allow for both blood protein and nucleic acid analysis without requiring the patient to freeze the sample. The method involves the patient collecting a sample at home, separating it into two portions in two different sealed containers, and combining each portion with a distinct buffer: one buffer specifically designed to prevent the degradation of blood proteins, and a separate "stabilizing buffer" for the other portion, preserving it for subsequent nucleic acid analysis in a laboratory (’781 Patent, col. 18:1-20, Claim 1; Compl. ¶¶59, 61).
- Technical Importance: This two-buffer, two-container approach enabled the development of more sophisticated, multi-target, at-home screening tests that could analyze for multiple types of cancer biomarkers from a single patient collection event, thereby facilitating "mass screening of asymptomatic patients" (’781 Patent, col. 1:51-55; Compl. ¶61).
Key Claims at a Glance
- The complaint asserts independent claims 1 and 3 (Compl. ¶¶59, 60).
- Independent Claim 1 recites a method of processing a sample, with key elements including:
- Collecting a fecal sample at home by defecation directly into a sealable collection vessel
- Removing a portion of the sample to a separate sealable container
- Combining the removed portion with a "buffer that prevents denaturation or degradation of blood proteins" and sealing the container
- Combining the remaining portion in the original vessel with a "stabilizing buffer" and sealing the vessel
- Independent Claim 3 recites a method of processing a sample, with key elements including:
- Obtaining a pair of sample portions prepared according to the method of claim 1
- Testing the portion from the separate container for an amount of a blood protein
- Extracting nucleic acid from the remaining portion
- Testing the nucleic acid for an amount of a human nucleic acid
- The complaint also asserts dependent claims 2, 4, and 12-19 (Compl. ¶¶128, 141).
III. The Accused Instrumentality
Product Identification
- Defendant Geneoscopy’s ColoSense test, including its related kits, devices, and services (Compl. ¶67).
Functionality and Market Context
- ColoSense is an at-home, non-invasive screening test for CRC that analyzes both RNA biomarkers and blood protein from a patient-collected stool sample (Compl. ¶¶67, 68). The complaint alleges that the ColoSense test protocol instructs patients to collect a stool sample and partition it into two separate portions, which are then combined with different stabilizing buffers and shipped to Geneoscopy’s laboratory for subsequent RNA and hemoglobin analysis (Compl. ¶134). An investor presentation slide included in the complaint shows a projection for the ColoSense product launch in mid-2024, expecting to reach a market of 85 million covered lives by the end of the year (Compl. ¶107, p. 40).
- The complaint alleges Geneoscopy is positioning ColoSense as a direct competitor to Plaintiff’s Cologuard test and has entered a multi-year distribution agreement with Labcorp to facilitate a large-scale commercial launch following its May 3, 2024 FDA approval (Compl. ¶¶14, 70, 79).
IV. Analysis of Infringement Allegations
’781 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 method comprising: | The ColoSense test is designed for at-home collection and shipment to a lab without requiring the patient to freeze the sample. | ¶134 | col. 18:1-2 |
| a) collecting a fecal sample from a human subject, wherein the fecal sample is collected at home by the human subject by defecation directly into a sealable collection vessel; | The ColoSense kit provides users with a collection kit for at-home use. | ¶67, ¶131 | col. 18:3-6 |
| b) removing a portion of the fecal sample to a separate sealable container to produce a removed portion and a remaining portion of the fecal sample; | The ColoSense test instructs patients to collect the stool sample in two portions. | ¶134 | col. 18:7-10 |
| c) combining the removed portion of the fecal sample in the separate sealable container with a buffer that prevents denaturation or degradation of blood proteins found in a fecal sample, and sealing the sealable container; and | One portion of the collected sample is combined with a buffer for subsequent hemoglobin (a blood protein) analysis. | ¶134 | col. 18:11-15 |
| d) combining the remaining portion of the fecal sample in the sealable collection vessel with a stabilizing buffer, and sealing the sealable collection vessel. | The other portion of the sample is combined with a stabilizing buffer for subsequent RNA (nucleic acid) analysis. | ¶134 | col. 18:16-20 |
| Claim Element (from Independent Claim 3) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a) obtaining a pair of portions of a fecal sample collected from a human subject...the pair of portions obtained by the method of claim 1; | Geneoscopy’s laboratory receives the two separate sealed containers prepared by the patient according to the kit's instructions. | ¶134, ¶146 | col. 19:2-10 |
| b) testing the removed portion of the fecal sample for an amount of a blood protein present in the removed portion; | Geneoscopy’s laboratory performs hemoglobin analysis on one of the received portions. | ¶68, ¶134 | col. 19:11-13 |
| c) extracting nucleic acid from the remaining portion of the fecal sample; and | Geneoscopy’s laboratory extracts RNA from the other received portion. | ¶68, ¶146 | col. 19:14-16 |
| d) testing the nucleic acid for an amount of a human nucleic acid. | Geneoscopy’s laboratory performs RNA analysis using its multi-target stool RNA (mt-sRNA) biomarker panel. | ¶67, ¶134 | col. 19:17-18 |
Identified Points of Contention
- Scope Questions: The dispute may center on whether the specific chemical compositions of the two buffers used in the ColoSense kit meet the functional requirements of a "buffer that prevents denaturation or degradation of blood proteins" and a "stabilizing buffer" as those terms are construed in the context of the ’781 Patent. A slide from an April 2024 investor presentation depicts the ColoSense launch as a "[d]e-risked path to launch," which may suggest Defendant's view that its technology is distinct from the patented method (Compl. ¶106, p. 39).
- Technical Questions: A key factual question will be whether the protocol actually performed by users and by Geneoscopy's lab perfectly maps to the steps of the asserted claims. While the complaint alleges a direct correspondence, the defense may present evidence of operational differences intended to design around the patent claims.
V. Key Claim Terms for Construction
The Term: "buffer that prevents denaturation or degradation of blood proteins" (Claim 1)
- Context and Importance: This term's construction is critical for infringement, as it defines the required function of the buffer used for the portion of the sample designated for blood analysis. The outcome will depend on whether the buffer in the ColoSense kit performs this specific function.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent specification states that "Suitable buffers for protein preservation are known in the art and commercially available," which may support an interpretation that the term is not limited to a specific formula but covers any buffer known to achieve the stated purpose (”781 Patent, col. 18:19-22).
- Evidence for a Narrower Interpretation: While the claim language is functional, a defendant might argue that the scope is implicitly limited by the patent's overall context, which focuses on enabling immunochemical tests for hemoglobin (’781 Patent, col. 3:28-41).
The Term: "stabilizing buffer" (Claim 1)
- Context and Importance: This term is central to the infringement analysis for the second portion of the sample intended for nucleic acid testing. Whether the buffer used in the ColoSense RNA sample container qualifies as a "stabilizing buffer" will be a key point of dispute.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent states that "Suitable buffers for maintaining DNA integrity may be added," suggesting the term encompasses various compositions that achieve the goal of preservation for later analysis (’781 Patent, col. 18:26-28).
- Evidence for a Narrower Interpretation: The specification's examples and discussion primarily focus on preserving DNA for methylation analysis. A defendant may argue this context limits the term "stabilizing buffer" to buffers suitable for DNA, potentially creating a non-infringement argument if the accused buffer is optimized exclusively for RNA.
VI. Other Allegations
- Indirect Infringement: The complaint alleges inducement of infringement, asserting that Geneoscopy provides instructions with its ColoSense kits that direct end-users (patients) to perform the patented method steps of Claim 1 (Compl. ¶¶128-129, 131). It also alleges contributory infringement on the basis that the ColoSense kits are especially designed to practice the patented method and are not staple articles of commerce with substantial non-infringing uses (Compl. ¶128).
- Willful Infringement: The complaint alleges that Geneoscopy has had actual knowledge of the ’781 Patent and its infringement since at least May 1, 2023, based on a cease and desist letter from Exact Sciences (Compl. ¶114-115). The complaint further supports its willfulness allegation by pointing to Geneoscopy’s subsequent, unsuccessful ex parte reexamination request at the USPTO, arguing this demonstrates continued infringement despite knowledge of the patent and after its validity was affirmed by the patent office (Compl. ¶¶121, 138).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of claim construction and technical equivalence: Does the two-buffer system in Geneoscopy's ColoSense kit, which preserves samples for RNA and hemoglobin analysis, meet the specific functional definitions of a "stabilizing buffer" and a "buffer that prevents denaturation or degradation of blood proteins" as required by the asserted claims? The case may turn on a detailed technical comparison of the buffers' compositions and preservative functions.
- A second pivotal question will relate to willfulness and intent: Given the pre-suit history alleged—which includes a notice letter, a response from the Defendant, and a failed attempt by the Defendant to invalidate the patent at the USPTO—the court will have to determine whether Geneoscopy's continued and planned commercial activities constitute willful infringement, potentially exposing it to enhanced damages.
- Finally, the case raises a question of functional overlap: The patent claims a method for preserving a sample portion for "nucleic acid" analysis, while the accused product is described as analyzing "RNA." The court may need to address whether the term "stabilizing buffer" for "nucleic acid" in the patent's context can be construed to read on a buffer specifically used for preserving RNA.