DCT
1:17-cv-11416
Boston Heart Diagnostics Corp v. Genelex Corp
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Boston Heart Diagnostics Corporation (Massachusetts)
- Defendant: Genelex Corporation (Washington)
- Plaintiff’s Counsel: Brown Rudnick LLP
- Case Identification: 1:17-cv-11416, D. Mass., 08/01/2017
- Venue Allegations: Venue is alleged to be proper based on Defendant conducting business in Massachusetts, operating a subsidiary, sponsoring a clinical trial, and maintaining a regular and established place of business in the district.
- Core Dispute: Plaintiff, an exclusive licensee, alleges that Defendant’s genetic testing services for predicting cardiovascular disease risk infringe a patent covering diagnostic methods for detecting an individual's susceptibility to statin-induced myopathy.
- Technical Context: The lawsuit operates in the field of pharmacogenomics, where genetic testing is used to predict an individual's response to, or risk from, a particular pharmaceutical treatment, in this case statin drugs.
- Key Procedural History: Plaintiff is the exclusive licensee of the patent-in-suit. The patent, U.S. Patent No. 8,455,194, underwent ex parte reexamination, which concluded on January 6, 2015, with the issuance of a certificate that amended original claims and added new claims. The amended claims from the reexamination are central to the dispute.
Case Timeline
| Date | Event |
|---|---|
| 2008-02-29 | '194 Patent Priority Date |
| 2011-11-01 | Oxford grants exclusive license to BHDX (approx.) |
| 2013-06-04 | '194 Patent Issue Date |
| 2013-11-22 | Reexamination request filed for '194 Patent |
| 2014-01-14 | PTO initiated reexamination of '194 Patent |
| 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
The Invention Explained
- Problem Addressed: The patent addresses the problem that statins—a widely used class of cholesterol-lowering drugs—can cause myopathy (muscle pain and weakness) as a side effect, with the risk increasing at higher doses. Prior to the invention, the mechanisms were not fully understood, making it difficult to predict which patients were at an elevated risk (’194 Patent, col. 1:33-48).
- The Patented Solution: The invention is a diagnostic method based on the discovery of a strong association between certain genetic variations (polymorphisms) in the SLCO1B1 gene and an individual's susceptibility to statin-induced myopathy. The method involves testing a biological sample for the presence of specific polymorphisms (e.g., SNP rs4149056), and then using that genetic information to determine an appropriate statin dosage, thereby reducing the patient's risk of myopathy (’194 Patent, Abstract; col. 4:35-58).
- Technical Importance: The invention provided a specific, evidence-based pharmacogenomic tool to help personalize statin therapy, allowing clinicians to tailor drug dosage to a patient’s genetic risk profile rather than using a standard dosing regimen for all patients (’194 Patent, col. 16:50-59).
Key Claims at a Glance
The complaint alleges infringement of the patented method generally, which consists of three steps (Compl. ¶16). These steps align with reexamined independent Claim 1.
- Independent Claim 1 (as reexamined):
- (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;
- (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
- (c) administering said dosage to said patient.
- The complaint does not explicitly reserve the right to assert dependent claims.
III. The Accused Instrumentality
Product Identification
The accused instrumentalities are Defendant’s genetic testing services, specifically the "Genelex SLCO1B1 Test," which is offered individually and as part of its "Polypharmacy Comprehensive Panel" (Compl. ¶¶ 18, 23).
Functionality and Market Context
The complaint alleges that Genelex provides testing supplies to physicians and pharmacists for obtaining a patient's DNA sample (Compl. ¶22). Genelex then "assays" the sample at its laboratory to identify genetic characteristics related to drug processing (Compl. ¶22). Following the assay, Genelex provides a "Personalized Prescribing Report" via its "YouScript® Precision Prescribing" tool, which contains the patient's drug metabolism type and a "recommended medication or dosage" (Compl. ¶25). An illustration from Genelex's website shows this process enabling selection of the "right drug and dose," with outcomes like "responds to lower dose" or "responds to alternative medication" (Compl. ¶25).
IV. Analysis of Infringement Allegations
'194 Patent Infringement Allegations
| Claim Element (from Independent Claim 1, as reexamined) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| (a) assaying for the presence of a C or T allele for single nucleotide polymorphism rs4149056 in the SLCO1B1 gene in a biological sample... | Genelex receives a patient's DNA sample and "assays" it at its genetic testing laboratory to determine drug-processing genetic characteristics. | ¶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... | Through its "YouScript® Precision Prescribing" reporting tool, Genelex provides a "Personalized Prescribing Report" that contains a "recommended medication or dosage" which is correlated to the assay result. The complaint includes a graphic from Genelex's website illustrating how the report enables selection of the "right drug and dose" based on genetic results. | ¶¶24, 25 | col. 4:40-44 |
| (c) administering said dosage to said patient. | The complaint alleges that Genelex "directs and controls physicians and pharmacists to perform the 'administering' step" or "acts in concert" with them by providing detailed information, recommendations, and instructions. This is an allegation of divided infringement, where the actions of the physicians are attributed to Genelex. | ¶26 | col. 4:51-58 |
Identified Points of Contention
- Legal Question (Divided Infringement): The complaint alleges that Genelex performs the "assaying" and "determining" steps, while physicians and pharmacists perform the "administering" step. A central issue will be whether Genelex's actions—providing reports, instructions, and recommendations—are sufficient to constitute "direction or control" over the physicians' actions, which would be necessary to attribute the final claim step to Genelex under 35 U.S.C. § 271(a).
- Scope Question: The analysis may raise the question of whether providing a "recommended medication or dosage" in a report (Compl. ¶25) satisfies the claim requirement of "determining a dosage." The court may need to decide if "determining" requires the final, authoritative decision made by a prescribing clinician or if providing a specific, data-driven recommendation is sufficient.
V. Key Claim Terms for Construction
The Term: "determining a dosage"
- Context and Importance: This term is critical because infringement of the second claim step hinges on whether Genelex's act of generating a "recommended...dosage" in a report constitutes "determining" it. Practitioners may focus on this term because the distinction between a "recommendation" and a "determination" could be dispositive for infringement.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent describes a method to "determin[e] a suitable dosage for statin treatment by reference to the genotype" ('194 Patent, col. 4:40-42). This language could suggest that the analytical process of arriving at the correct dose based on the genetic test is itself the "determination."
- Evidence for a Narrower Interpretation: The claim structure links the "determining" step to the subsequent "administering" step. This could support an interpretation that "determining" implies a final, binding decision that directly leads to administration, a power held only by the prescribing clinician, not the testing lab.
The Term: "administering said dosage"
- Context and Importance: As Genelex does not physically administer drugs, this term is central to the divided infringement dispute. The entire infringement theory depends on attributing the physician's act of administering the drug to Genelex.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent frames the invention as a comprehensive method of treatment, from testing to dosing ('194 Patent, col. 4:45-58). A party might argue that in the context of such a method, providing the essential, guiding information that dictates the administration constitutes constructive performance of that step.
- Evidence for a Narrower Interpretation: The plain meaning of "administering" refers to the physical act of giving a drug to a patient. The patent also discusses a method of "treating an individual" which comprises "administering a suitable dose of a statin" ('194 Patent, col. 5:28-39), language that points to the direct clinical act.
VI. Other Allegations
Indirect Infringement
The complaint alleges that Genelex induces infringement by knowingly providing physicians and pharmacists with the "Genelex Test Supplies, clinical reports, and other information that instructs clinicians and recommends appropriate statin dosages" (Compl. ¶34). It also alleges that Genelex employs sales representatives who "actively instruct and encourage" use of the test for this purpose (Compl. ¶32).
Willful Infringement
Willfulness is alleged based on Genelex’s continued infringing activities "notwithstanding the notice provided by BHDX" of its exclusive patent rights, allegedly constituting reckless disregard (Compl. ¶¶ 41-42).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of divided infringement: Can the "administering" of a statin by a physician be legally attributed to Genelex? The case will likely turn on whether the "Personalized Prescribing Report" and associated instructions constitute sufficient "direction or control" to hold Genelex responsible for the entire claimed method.
- A key question of claim interpretation will be: Does providing a "recommended...dosage" in a test report satisfy the claim element of "determining a dosage," or does this term require the final prescriptive authority that rests with the clinician? The resolution of this question will significantly impact the viability of the infringement claim.