DCT
3:18-cv-00006
Boston Heart Diagnostics Corp v. MD Labs Inc
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Boston Heart Diagnostics Corporation (Massachusetts)
- Defendant: MD Labs, Inc. (Nevada)
- Plaintiff’s Counsel: Brown Rudnick LLP
- Case Identification: 3:18-cv-00006, D. Conn., 08/01/2017
- Venue Allegations: Plaintiff alleges venue is proper because Defendant conducts business in the District of Connecticut, including through a pharmacogenetics testing program at participating pharmacies, and maintains a regular and established place of business in the district.
- Core Dispute: Plaintiff alleges that Defendant’s genetic testing services for identifying patient risk for statin-induced myopathy infringe a patent related to diagnostic methods.
- Technical Context: The technology relates to pharmacogenetics, specifically using genetic markers in the SLCO1B1 gene to predict a patient's adverse reaction to statins, a widely prescribed class of cholesterol-lowering drugs.
- Key Procedural History: Plaintiff is the exclusive licensee of the patent-in-suit, owned by Isis Innovation Limited (the technology commercialization company for the University of Oxford). Claims 1-7 of the patent underwent ex parte reexamination, resulting in an amended re-issuance on January 6, 2015. The complaint alleges that Plaintiff provided Defendant with notice of its exclusive rights under the patent.
Case Timeline
| Date | Event |
|---|---|
| 2008-02-29 | U.S. Patent No. 8,455,194 Priority Date |
| 2011-11-01 | Exclusive License Agreement granted to Plaintiff |
| 2013-06-04 | U.S. Patent No. 8,455,194 Issued |
| 2013-11-22 | Request for Reexamination of '194 Patent filed with PTO |
| 2014-01-14 | PTO Initiated Ex Parte Reexamination |
| 2015-01-06 | Ex Parte Reexamination Certificate Issued for '194 Patent |
| 2017-08-01 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,455,194 - "Diagnostic Methods"
- Patent Identification: U.S. Patent No. 8,455,194, "Diagnostic Methods", issued June 4, 2013.
The Invention Explained
- Problem Addressed: The patent addresses the problem that statins, while effective at lowering cholesterol, can in rare cases cause myopathy (muscle pain or weakness), a side effect whose risk increases with higher doses or interactions with other drugs. (’194 Patent, col. 1:20-44). The mechanisms causing this side effect were not well understood, and it was unclear whether genetic factors could reliably predict a patient’s risk. (’194 Patent, col. 2:32-56).
- The Patented Solution: The invention provides a method for determining an individual's susceptibility to statin-induced myopathy by detecting the presence of specific single nucleotide polymorphisms (SNPs) in the SLCO1B1 gene. (’194 Patent, Abstract). This gene encodes a protein that affects the uptake of statins by the liver; certain genetic variants are associated with higher statin concentrations in the blood and thus a higher risk of myopathy. (’194 Patent, col. 1:14-20, col. 16:15-23). Based on the patient's genetic profile (e.g., having a C or T allele at the rs4149056 SNP), a suitable statin dosage can be determined to balance efficacy and safety. (’194 Patent, col. 4:35-58).
- Technical Importance: This technology provided a genetic basis for personalizing statin therapy, moving beyond a one-size-fits-all dosage approach to one tailored to an individual’s innate metabolic characteristics. (’194 Patent, col. 16:50-58).
Key Claims at a Glance
- The complaint alleges infringement of the patent as amended by the Ex Parte Reexamination Certificate. (’194 Reexam. Cert., col. 1:15-20; Compl. ¶17). Independent Claim 1, as amended, is the central claim and requires:
- Assaying a biological sample from a patient for the presence of a C or T allele at the rs4149056 SNP in the SLCO1B1 gene.
- Determining a dosage for a chosen statin type based on the presence of the C or T allele, where the C allele correlates with an increased risk of myopathy.
- Administering said dosage to the patient.
- The complaint does not specify other asserted claims but notes claims 1 through 7 were re-issued as amended. (Compl. ¶17).
III. The Accused Instrumentality
Product Identification
- The "MD Labs SLCO1B1 Test," also referred to as the "SLCO1B1 Rxight® PGx Test," and the associated "Personalized Medication Review®" ("PMR") clinical report. (Compl. ¶¶20, 24, 26).
Functionality and Market Context
- Defendant MD Labs offers a genetic testing service to identify patients at higher risk of developing statin-induced myopathy due to a variation in their SLCO1B1 gene. (Compl. ¶20).
- The service involves providing healthcare professionals with a kit to collect a patient's DNA sample. MD Labs then "assays" this sample at its laboratory to identify genetic variants in the SLCO1B1 gene. (Compl. ¶¶24-25).
- Following the assay, MD Labs generates a PMR clinical report, through which it allegedly "determines" an appropriate statin dosage for the healthcare provider. (Compl. ¶26). MD Labs is also alleged to train and instruct healthcare providers on how to interpret the report to create treatment programs for patients. (Compl. ¶27).
- No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint asserts direct infringement, either by MD Labs alone or jointly with healthcare providers. (Compl. ¶¶22, 28). The core allegations are summarized below against the elements of amended Independent Claim 1.
’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... | MD Labs provides a kit for collecting patient DNA samples and "assays" the sample at its genetic testing laboratory to identify clinical genetic variants in each patient's SLCO1B1 gene. | ¶24, ¶25 | col. 3:1-9 |
| (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... | Through its "Personalized Medication Review®" clinical report and other information, MD Labs "determines" the appropriate dosage of a statin for health care providers. | ¶26 | col. 3:15-19 |
| (c) administering said dosage to said patient. | MD Labs "directs and controls physicians and pharmacists to perform the 'administering' step" or "acts in concert with" them, and "thus jointly performs the 'administering' step." | ¶28 | col. 4:51-58 |
- Identified Points of Contention:
- Scope Questions: The primary point of contention appears to be divided infringement. The complaint alleges that MD Labs performs the "assaying" and "determining" steps, but that third-party physicians or pharmacists perform the final "administering" step. The case may turn on whether Plaintiff can prove that MD Labs "directs or controls" the actions of these third parties to such a degree that all steps of the claim can be attributed to MD Labs.
- Technical Questions: What evidence demonstrates that MD Labs' PMR report constitutes "determining a dosage" as required by the claim? A court may need to decide if providing a recommendation or a range of options is legally equivalent to the affirmative act of "determining" a specific dosage. Further, what evidence supports the allegation that MD Labs "directs and controls" the administering physicians, beyond just providing a report and training materials?
V. Key Claim Terms for Construction
- The Term: "administering said dosage to said patient"
- Context and Importance: This term is critical because the complaint alleges it is performed not by the Defendant, but by third-party healthcare providers who are "direct[ed] and control[ed]" by the Defendant. (Compl. ¶28). The viability of the direct infringement claim depends on whether MD Labs' alleged activities (providing reports, training, instructions) can be legally construed as performing the "administering" step itself under the principles of divided infringement.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent repeatedly frames the invention as a comprehensive method of treatment, from testing to application. Language such as "a method of treating an individual" could suggest that the claim steps are part of a single, integrated process, potentially supporting the view that one who controls the essential diagnostic steps effectively controls the whole method. (’194 Patent, col. 4:45-46).
- Evidence for a Narrower Interpretation: The claim uses the active verb "administering," which typically implies direct physical action (e.g., a physician giving a drug to a patient). The patent specification describes the "administering" step as distinct from the "determining" step. (’194 Patent, col. 4:51-58). This could support a narrower reading where merely providing information or instructions to a third party does not constitute "administering."
VI. Other Allegations
- Indirect Infringement: The complaint includes a count for induced infringement. It alleges MD Labs knowingly encourages and induces infringement by marketing its test for identifying at-risk patients, providing clinical reports and training that instruct providers on appropriate dosages, and employing sales representatives who encourage use of the test. (Compl. ¶¶33-37).
- Willful Infringement: Willfulness is alleged based on Defendant's continuation of the accused activities after receiving notice of its infringement from the Plaintiff. (Compl. ¶¶43-45). The complaint characterizes this continued conduct as acting in "reckless disregard of the likelihood" of infringement. (Compl. ¶44).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of divided infringement: Can the plaintiff prove that MD Labs directs or controls the conduct of physicians and pharmacists to the extent required by law to attribute the "administering" step to MD Labs, thereby satisfying all limitations of the asserted method claim?
- A second key question involves claim construction: Does providing a "Personalized Medication Review" report and associated training constitute "determining a dosage" as required by the claim, or is this step solely performed by the independent medical judgment of the prescribing physician?
- An evidentiary question will be the basis for knowledge and intent: For the claims of inducement and willfulness, the court will examine what specific information was conveyed in the alleged pre-suit notice and what actions Defendant took in response, which will be critical for establishing the required mental state.