DCT
1:17-cv-11412
Boston Heart Diagnostics Corp v. Genealign LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Boston Heart Diagnostics Corporation (Massachusetts)
- Defendant: GeneAlign, LLC (Texas)
- Plaintiff’s Counsel: Brown Rudnick LLP
- Case Identification: 1:17-cv-11412, D. Mass., 08/01/2017
- Venue Allegations: Plaintiff alleges venue is proper in the District of Massachusetts because Defendant conducts business in the state, infringes in the state, and has a regular and established place of business in the Commonwealth, including through a partnership for an ongoing clinical study.
- Core Dispute: Plaintiff alleges that Defendant’s genetic testing services for identifying patient risk for statin-induced myopathy infringe a patent covering diagnostic methods for the same purpose.
- Technical Context: The technology relates to pharmacogenetics, specifically using genetic markers in the SLCO1B1 gene to predict an individual's adverse reaction to widely prescribed cholesterol-lowering drugs known as statins.
- Key Procedural History: Plaintiff is the exclusive licensee of the patent-in-suit, with the right to enforce it. The patent, U.S. Patent No. 8,455,194, survived an ex parte reexamination proceeding, with a Reexamination Certificate issuing on January 6, 2015. The reexamination amended claims 1-7 and added new claims, which may strengthen the patent's presumption of validity against the prior art considered by the U.S. Patent and Trademark Office.
Case Timeline
| Date | Event |
|---|---|
| 2008-02-29 | ’194 Patent Priority Date |
| 2013-06-04 | ’194 Patent Issue Date |
| 2013-11-22 | Request for Reexamination of '194 Patent filed |
| 2015-01-06 | ’194 Patent Reexamination Certificate Issued |
| 2017-08-01 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,455,194 - "DIAGNOSTIC METHODS"
Issued June 4, 2013 (as amended by Ex Parte Reexamination Certificate issued January 6, 2015).
The Invention Explained
- Problem Addressed: The patent's background section describes that while statin drugs are effective at lowering cholesterol, they can cause a serious side effect known as myopathy (muscle pain and weakness), and this risk increases with higher doses. The mechanisms causing myopathy were not well understood, making it difficult to predict which patients were most at risk ('194 Patent, col. 1:33-49).
- The Patented Solution: The invention is a method for identifying an individual's susceptibility to statin-induced myopathy by analyzing their genetic makeup. Specifically, the inventors identified that a single nucleotide polymorphism (SNP), rs4149056, in the SLCO1B1 gene is strongly associated with myopathy risk ('194 Patent, col. 16:15-22). The SLCO1B1 gene encodes a protein that helps transport statins into the liver ('194 Patent, col. 2:14-18). By testing for a specific variant (the "C allele") at this location, clinicians can identify high-risk patients and adjust their treatment, for example, by administering a lower or "standard" dose of a statin instead of a higher one ('194 Patent, col. 4:35-46).
- Technical Importance: The invention provided a specific and highly predictive genetic marker that accounts for a substantial number of statin-induced myopathy cases, thereby enabling a practical pharmacogenetic test to personalize statin therapy and improve patient safety ('194 Patent, col. 16:36-41).
Key Claims at a Glance
- The complaint alleges infringement of a three-step method, mapping to the independent method claim, Claim 1, as amended by the Reexamination Certificate.
- The essential elements of amended Claim 1 are:
- (a) assaying for the presence of a C or T allele at single nucleotide polymorphism rs4149056 in the SLCO1B1 gene in a biological sample from a patient;
- (b) determining a dosage for a chosen statin type based upon the presence of the C or T allele, where the C allele correlates with an increased risk of myopathy; and
- (c) administering said dosage to the patient.
III. The Accused Instrumentality
Product Identification
The accused instrumentality is Defendant GeneAlign’s "GA SLCO1B1 Test" and associated services (Compl. ¶18).
Functionality and Market Context
The service is a genetic test intended to identify patients at a higher risk of developing statin-induced myopathy due to a variation in their SLCO1B1 gene (Compl. ¶18). The complaint alleges that GeneAlign provides collection kits and a lab requisition form for ordering the test (Compl. ¶22). After performing the assay, GeneAlign provides "clinical guidance for medication dosing" through its "Clinician Decision Support ('GeneAlign's Reporting Tool')" (Compl. ¶24). The complaint provides a "GeneAlign Lab Requisition Form for Pharmacogenetic ('PGx') Testing" as Exhibit C, which shows a request for a complete genetic variation panel of SLCO1B1 (Compl. ¶22).
IV. Analysis of Infringement Allegations
’194 Patent Infringement Allegations
| Claim Element (from Independent Claim 1, as amended) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| (a) assaying for the presence of a C or T allele at single nucleotide polymorphism rs4149056 in the SLCO1B1 gene in a biological sample obtained from a patient in need of treatment with a statin; | GeneAlign is alleged to directly perform this step by offering and conducting its "GA SLCO1B1 Test," which analyzes a patient's SLCO1B1 gene for variations. | ¶21, ¶22 | col. 4:35-39 |
| (b) determining a dosage for a chosen statin type based upon said presence of a C or T allele, wherein the presence of a C allele correlates with an increased risk of statin-induced myopathy; and | GeneAlign is alleged to perform this step through its "Reporting Tool," which provides "clinical guidance for medication dosing" that is correlated to the assay result. | ¶23, ¶24 | col. 4:39-46 |
| (c) administering said dosage to said patient. | This step is performed by physicians and pharmacists, whom GeneAlign allegedly "directs and controls" by providing "detailed information, recommendations, and instructions." | ¶25 | col. 4:56-59 |
Identified Points of Contention
- Scope Questions: The case may turn on whether GeneAlign’s "clinical guidance for medication dosing" constitutes "determining a dosage" as required by claim 1(b). A court will need to decide if providing guidance, recommendations, and correlations is legally equivalent to the affirmative act of determination.
- Legal Questions: A primary legal question is one of divided infringement. Since GeneAlign does not "administer" the statin itself, Plaintiff's direct infringement claim depends on showing that GeneAlign "directs or controls" the actions of the physicians or pharmacists who do. The complaint’s allegations that GeneAlign provides "detailed information, recommendations, and instructions" and acts as a "partner or joint venturer" will be scrutinized under the legal standard for joint infringement (Compl. ¶¶25, 26).
V. Key Claim Terms for Construction
The Term: "determining a dosage"
- Context and Importance: This term is central to infringement of step (b) and the overall divided infringement theory. Its construction will define the line between merely providing raw data (the genotype) and performing a claimed step of the patented method. Practitioners may focus on this term because if GeneAlign's "clinical guidance" does not rise to the level of "determining a dosage," the infringement allegation for this element may be difficult to sustain.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent links the genotype to a suitable dosage, stating the method involves "determining a suitable dosage for statin treatment by reference to the susceptibility of the individual" (ʼ194 Patent, col. 3:17-19). This could support an interpretation where providing a risk classification that directly implies a dosage adjustment (e.g., "high risk, standard dose recommended") is sufficient.
- Evidence for a Narrower Interpretation: The claim uses the active verb "determining." A defendant could argue this requires specifying a concrete dosage (e.g., "40 mg daily") rather than providing a risk category or a recommendation. The patent distinguishes between classifying the individual and determining the dose, suggesting they are distinct actions (ʼ194 Patent, col. 3:11-19).
The Term: "administering"
- Context and Importance: This term defines the final step of the method, which is performed by a third-party clinician. The viability of the direct infringement claim hinges on whether GeneAlign's conduct makes it legally responsible for the clinician's act of "administering" the drug.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent claims a comprehensive method of "treating an individual" that culminates in administration, and the administration is directly linked to the genotype determined in the earlier steps (ʼ194 Patent, col. 4:45-59). Plaintiff may argue that the entire purpose of GeneAlign's service is to cause this administration, making it an integral part of a single, controlled process.
- Evidence for a Narrower Interpretation: "Administering" is a specific medical act. A defendant may argue that this act remains under the independent professional judgment and sole control of the prescribing clinician, who is free to disregard the test results or recommendations. The patent itself lists "administering" as a distinct step from "determining," which could support the view that they are separate and not necessarily controlled by the same entity (ʼ194 Patent, col. 4:56).
VI. Other Allegations
Indirect Infringement
The complaint includes a count for induced infringement, alleging that GeneAlign knowingly encourages and facilitates infringement by physicians and pharmacists. This is based on GeneAlign marketing its test for the patented use, providing instructions, and recommending specific statin dosages through its Reporting Tool (Compl. ¶¶31, 33). This serves as an alternative theory if the direct infringement claim fails on the issue of divided infringement.
Willful Infringement
The complaint alleges willful infringement on the basis that BHDX provided GeneAlign with notice of its patent rights, and GeneAlign continued its allegedly infringing conduct thereafter (Compl. ¶¶40, 41).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of divided infringement: can the Plaintiff establish that the Defendant, a diagnostic testing company, "directs or controls" the subsequent actions of prescribing physicians to such a degree that all steps of the multi-part method claim can be legally attributed to the Defendant for a finding of direct infringement?
- A key question of claim scope will be whether the accused "clinical guidance for medication dosing" provided by the Defendant’s reporting tool satisfies the claim requirement of "determining a dosage," or if it merely provides information that leaves the determinative act entirely within the clinician’s discretion.