DCT
1:17-cv-04514
Boston Heart Diagnostics Corp v. Medical Diagnostic Laboratories LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Boston Heart Diagnostics Corporation (Massachusetts)
- Defendant: Medical Diagnostic Laboratories, L.L.C. (New Jersey)
- Plaintiff’s Counsel: Brown Rudnick LLP
- Case Identification: 1:17-cv-04514, E.D.N.Y., 08/01/2017
- Venue Allegations: Plaintiff alleges venue is proper because Defendant conducts business in the district that infringes the patent-in-suit and has a regular and established place of business, specifically by sponsoring and conducting an ongoing clinical study in the district.
- Core Dispute: Plaintiff alleges that Defendant’s genetic testing service for identifying patient risk for statin-induced myopathy infringes a patent related to diagnostic methods for detecting such susceptibility.
- Technical Context: The technology concerns pharmacogenomics, specifically using genetic markers to predict an individual's adverse reaction to statins, a widely prescribed class of cholesterol-lowering drugs.
- Key Procedural History: The patent-in-suit, U.S. Patent No. 8,455,194, underwent an ex parte reexamination requested in 2013. In 2015, the U.S. Patent and Trademark Office issued a reexamination certificate that confirmed the patentability of claims 1-7 in an amended form and added new claims 15-25. The infringement allegations are therefore based on the post-reexamination, amended claims. The Plaintiff, Boston Heart Diagnostics, is an exclusive licensee of the patent.
Case Timeline
| Date | Event |
|---|---|
| 2008-02-29 | U.S. Patent No. 8,455,194 Priority Date |
| 2011-11-01 | Exclusive license granted to Plaintiff BHDX |
| 2013-06-04 | U.S. Patent No. 8,455,194 Issue Date |
| 2013-11-22 | Request for reexamination of the ’194 Patent filed |
| 2015-01-06 | PTO issued Ex Parte Reexamination Certificate |
| 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's background describes that while statins are effective at lowering cholesterol, they can, in rare cases, cause severe muscle pain or weakness (myopathy), a risk that increases with higher doses. (’194 Patent, col. 6:29-45). The precise mechanisms and any genetic predisposition for this side effect were not well understood, and prior small-scale studies had provided inconclusive evidence for any genetic associations. (’194 Patent, col. 6:35-59).
- The Patented Solution: The invention provides a method for determining an individual's susceptibility to statin-induced myopathy by testing a biological sample for specific genetic variations (polymorphisms) in the SLCO1B1 gene. (’194 Patent, Abstract). This gene is involved in the transport of statins into the liver; certain variations, such as the C allele of the rs4149056 single nucleotide polymorphism (SNP), are identified as being associated with an increased risk of myopathy, allowing for risk stratification. (’194 Patent, col. 7:35-46).
- Technical Importance: This genetic testing method enables a personalized approach to medicine, allowing clinicians to adjust statin dosage or select alternative treatments based on a patient's genetic risk profile, thereby minimizing the potential for a serious adverse drug reaction. (’194 Patent, col. 7:56-65).
Key Claims at a Glance
- The complaint alleges infringement of the "patented method," which corresponds to the structure of the independent method claims. The lead independent claim, as amended by the reexamination certificate, is Claim 1.
- Amended Independent Claim 1:
- (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.
III. The Accused Instrumentality
Product Identification
The "MDL SLCO1B1 Test," a genetic testing service. (Compl. ¶18).
Functionality and Market Context
The service is marketed as a genetic test 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 MDL offers and sells this test to patients and healthcare providers, providing specimen collection kits and test requisition forms. (Compl. ¶¶ 19, 22). After performing the assay, MDL is alleged to provide "clinical guidance to physicians for medication dosing" through its electronic results systems. (Compl. ¶24).
IV. Analysis of Infringement Allegations
The complaint alleges that MDL directly infringes the ’194 Patent, with the infringement theory appearing to rely on a combination of actions by MDL and by physicians acting under MDL's alleged direction. (Compl. ¶¶ 21, 25). The complaint provides a copy of MDL’s Pharmacogenetics Test Requisition Form, which is used for collecting a DNA sample and requesting a genetic variation panel of SLCO1B1. (Compl. ¶22, Ex. C).
’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... | MDL itself directly performs the "assaying" step of the patented method. | ¶21 | col. 7:1-9 |
| (b) determining a dosage for a chosen statin type based upon said presence of a C or T allele... | MDL "determines" the appropriate dosage of a statin for physicians and provides "clinical guidance to physicians for medication dosing" based on the assay result. | ¶¶23, 24 | col. 7:35-43 |
| (c) administering said dosage to said patient. | MDL "directs and controls physicians and pharmacists to perform the 'administering' step" through the information, recommendations, and instructions it provides. | ¶25 | col. 7:56-65 |
Identified Points of Contention
- Scope Questions: The case presents a significant question of divided infringement. Since MDL performs the "assaying" and allegedly the "determining" steps, while physicians perform the "administering" step, the court will have to determine whether MDL's actions constitute sufficient "direction or control" over the physicians to attribute their actions to MDL for the purpose of direct infringement under 35 U.S.C. § 271(a). The complaint's assertion that MDL acts "as a partner or joint venturer" with physicians suggests an attempt to meet this high legal standard. (Compl. ¶25).
- Technical Questions: A factual and legal dispute may arise over the "determining a dosage" step. What evidence will show that MDL’s "clinical guidance" (Compl. ¶24) rises to the level of "determining" a dosage as required by the claim, versus merely providing information that a physician may use in their own independent medical judgment?
V. Key Claim Terms for Construction
"determining a dosage for a chosen statin type"
Context and Importance
This term is critical because the complaint alleges MDL performs this step by providing "clinical guidance." (Compl. ¶24). The defendant may argue that providing guidance is not the same as "determining" the dosage, asserting that the physician retains ultimate decision-making authority. The construction of this term will be central to whether MDL can be found to perform this step.
Intrinsic Evidence for Interpretation
- Evidence for a Broader Interpretation: The claim language does not specify how the determination must be made or by whom, only that it is "based upon said presence of a C or T allele." This could support an argument that providing a definitive recommendation that is typically followed constitutes "determining."
- Evidence for a Narrower Interpretation: The specification describes a specific outcome of the determination: "a standard dose of a statin is suitable for an individual with a high-risk genotype and a higher dose is suitable for an individual with a low-risk genotype." (’194 Patent, col. 7:40-43). A party could argue this implies a more concrete action than just providing "guidance."
"administering said dosage to said patient"
Context and Importance
Practitioners may focus on this term because it is the element performed by a third party (the physician), making it the lynchpin of the divided infringement analysis. Whether MDL can be held liable for direct infringement hinges on whether it can be said to have performed this step through its "direction or control" of physicians.
Intrinsic Evidence for Interpretation
- Evidence for a Broader Interpretation: The patent does not limit who must perform the administration, focusing on the sequence of diagnostic and therapeutic actions rather than the identity of the actor for each.
- Evidence for a Narrower Interpretation: A defendant may argue that the claim, read as a whole, describes a unified method of treatment that implies either a single actor or a principal-agent relationship, which may not be met by the typical doctor-lab relationship.
VI. Other Allegations
- Indirect Infringement: The complaint includes a separate count for inducing infringement, alleging that MDL knowingly encourages physicians to infringe the ’194 Patent. (Compl. ¶30). This is based on allegations that MDL markets its test specifically for the patented purpose, provides instructions and clinical reports recommending statin dosages, and employs sales representatives to encourage use of the test. (Compl. ¶¶ 31-34). This provides an alternative path to liability if the direct infringement claim fails on the divided infringement issue.
- Willful Infringement: Willfulness is alleged based on MDL’s continuing to offer the accused test after BHDX provided MDL with notice of its exclusive rights under the patent. (Compl. ¶¶ 40-41).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of legal liability for divided infringement: Can the plaintiff prove that the defendant's provision of test results, "clinical guidance," and "recommendations" to physicians establishes the "direction or control" necessary to attribute the physicians' act of "administering" a statin to the defendant for a finding of direct infringement?
- A key question of claim scope and fact will be whether the defendant’s alleged "clinical guidance" functionally meets the claim requirement of "determining a dosage," or if the final, legally operative determination remains the independent medical judgment of the prescribing physician, thereby breaking the chain of infringement required by the method claim.
- The viability of the induced infringement claim will be a central alternative focus, turning on whether the plaintiff can demonstrate that the defendant acted with the specific intent to cause physicians to perform the patented method, regardless of whether the "direction or control" standard for direct infringement is met.