On June 2, 2015, Boston Heart Diagnostics Corporation (BHDX) sued Harmonyx Diagnostics in the Eastern District of Texas for infringement of US patent number 8,455,194. The patent is assigned to Isys Innovation Limited, a wholly owned subsidiary of the University of Oxford and the assignee of the diagnostic patents at issue in two other cases recently discussed in this blog, Arioso Diagnostics and Athena Diagnostics. BHDX represents that it is the exclusive licensee. The patent is basically directed towards testing for the presence of a single nucleotide polymorphism (SNP) correlated with risk of statin -induced myopathy, and using that information to establish and administer the appropriate statin type and dosage to the patient. The patent recently emerged successfully from a reexamination that resulted in the amendment of some claims in the addition of some new claims. Here is a representative claim:
1. A method, comprising: (a) assaying for the presence or absence of a C or T allele for single nucleotide polymorphism rs4149056 in the SLCO1B1 gene in a biological sample obtained from a patient in need of treatment with a statin; (b) correlating the identity of the allele of said polymorphism with risk of statin-induced myopathy; (c) establishing a statin type and dosage based on said patient's statin-induced myopathy risk; and (d) administering said statin type and dosage to said patient.The patent raises interesting enforcement issues, since there appears to be no single party that directly performs all of the steps recited in the claims. In its recent Akamai v.Limelight decision, the Federal Circuit held that infringement of a method claim requires a single party to perform all of the steps of the method, either directly or through an agent or some other party contractually obligated to perform the steps. In Akamai, a divided panel of the Federal Circuit rejected “calls to expand the scope of direct infringement to include a wider allowance for joint-tortfeasors when parties collectively practice all of the elements of a claimed invention.” This decision, combined with the Supreme Court’s earlier decision in Limelight v.Akamai which held that liability for induced infringement requires some party to directly infringe, creates difficulties for owners of diagnostic patents such as BHDX attempting to enforce the patents against competitors.
In particular, note that the representative claim includes steps of “assaying” for presence of an allele and “administering” a particular statin type and dosage to a patient based on the results of the assay. The problem is, there appears to be no single party that is directly performing both the “assaying” and “administering” steps.
In its complaint, BHDX attempts to address this issue by alleging that Harmonyx directly infringes because it directly performs the “assaying” and “determining” steps, and that “Harmonyx acts in concert with performances and physicians, as a partner or joint venture, and this jointly performs the “administering” step of the patent method.” BHDX also alleges that “Harmonyx enters into written agreements with pharmacies pursuant to which the pharmacies offer the Harmonyx Test for Statins to customers, as an agent and under the direction and control of Harmonyx.” Clearly, BHDX is attempting to establish the contractual-agency relationship between Harmonyx and pharmacists necessary under Akamai to attribute the “administering” step two Harmonyx.
BHDX also alleges induced infringement in its complaint, but under Limelight the patent owner needs to establish that someone directly infringement forming all the steps. In particular, Harmonyx alleges that pharmacists and physicians directly infringe the patent, and that Harmonyx induces this infringement. BHDX attempts to address the divided infringement problem by alleging that Harmonyx performs the “assaying” steps of the patented method “under the control and direction of the pharmacists and physicians, pursuant to written agreements.”
This is a perfect example of the “caught between a rock and a hard place” problem facing diagnostic innovators as a consequence of recent developments in patent eligibility and divided infringement, as discussed in an earlier blog post and in this short article. Basically, the recent restrictive interpretation of patent eligibility seems to require the inclusion in diagnostic method claims of a step applying information derived from the diagnostic test, i.e., the administering step in BHDX’s claims, but the inclusion of such a step renders the claim vulnerable to circumvention when no single party performs all the steps, e.g., a diagnostic testing company performs the assaying and correlation steps but does not directly administer drug to a patient.
This would appear to be another interesting diagnostic method case to follow in light of the ongoing developments in patent eligibility and divided infringement.