United States: Another Patent Challenge For Personalized Medicine

The U.S. Supreme Court's recent trilogy of patent-eligibility decisions (Prometheus, Myriad and Alice) have called into question the validity of many U.S. patents on diagnostic medical methods. Nevertheless, legal battles ensue and to the benefit of the public, as further jurisprudence will bring more clarity to whether and how diagnostic technologies – critical to personalized medicine – can be patented in the United States.

Health Diagnostic Laboratory, Inc. ("HDL") will be adding to this jurisprudence. The company recently alleged that Boston Heart Diagnostic Corp. ("Boston Heart") is infringing U.S. Patent No. 8,119,358 (the ' 358 Patent) entitled "Diabetes-related Biomarkers and Methods of Use Thereof."

Boston Heart Prediabetes AssessmentTM

Boston Heart offers the Prediabetes Assessment Test" to predict whether an individual may develop diabetes based on a number of statistically significant variables: fasting serum glucose, fasting triglycerides, glycated serum protein, albumin, statin/niacin therapy, BMI, and parental history of diabetes.

According to Boston Heart's website, its test is more accurate than traditional glucose tests and the predication assessment can classify prediabetic patients as having a low, borderline, or high risk of developing diabetes. For those patients falling within borderline or high risk, Boston Heart's test also offers a structured lifestyle program that aims to significantly reduce the risk of developing diabetes.

The '358 Patent

The '358 Patent discloses biomarkers associated with diabetes and claims methods of using the biomarkers to determine the risk that an individual will develop diabetes and other pre-diabetic conditions. HDL's complaint alleges that Boston Heart practices one or more methods claimed in the '358 Patent, including at least claim 2. Claim 2 of the '358 Patent recites:

"2. In a method of treating an individual with a Diabetes-modulating drug, the improvement comprising:

  1. obtaining measurements of biomarkers from at least one biological sample isolated from said individual, wherein said biomarkers comprise

    1. at least three biomarkers, where three of the biomarkers are selected from the RDMARKER sets listed in FIG. 6A; or
    2. at least four biomarkers selected from RDMARKERS; or
    3. at least three biomarkers, where two biomarkers are selected from ADIPOQ; CRP; GLUCOSE; GPT; HBA1C; HSPA1B; IGFBP1; IGFBP2; INS, LEP; and TRIG; and one biomarker is selected from the ALLDBRISKS, CPs, and TLRFs of Table 1, Table 2, and Table 3; or
    4. at least three biomarkers, where at least one biomarker is selected from GLUCOSE and HBAIC; at least one biomarker is selected from ADIPOQ, CRP, GPT, HSPA1B, IGFBP1, IGFBP2, INS, LEP, and TRIG; and at least one biomarker is selected from the ALLDBRISKS, CPs, and TLRFs of Table 1, Table 2, and Table 3; or
    5. at least three biomarkers, where at least two biomarkers are selected from the biomarkers within the group consisting of Core Biomarkers I and Core Biomarkers II and at least a third biomarker is selected from any of the biomarkers listed in Table 4; or
    6. ADIPOQ, GLUCOSE, CRP and one biomarker selected from the group consisting of HBA1C, IGFBP1, IGFBP2, Insulin, LEP and TRIG; and
  2. calculating an index value from the output of a model, wherein the inputs to said model comprise said measurements, and further wherein said model was developed by fitting data from a longitudinal study of a selected population of individuals and said fitted data comprises levels of said biomarkers and an end point in said selected population of individuals, wherein said end point is selected from risk for developing a diabetic condition, the diagnosis of a diabetic condition, response to a Diabetes-modulating drugs, a surrogate diabetes endpoint, glucose class, and a complication of a diabetic condition."

Interestingly, claim 2 requires not only the measurement and analysis of a series of biomarkers, but also the integrated analysis of the markers based on an index value from the output of a model, that, in turn is based data on information acquired from prior studies. Whether the complexity of the test and its interpretation satisfies 35 U.S.C. § 101 will likely will be a hotly litigated issue between the parties.

Meanwhile, Back in Massachusetts

This lawsuit is not the only legal proceeding between the parties. In December of 2013, Boston Heart sued HDL in the U.S. District Court for the District of Massachusetts, alleging that a genetic testing offered by HDL infringes U.S. Patent No. 8,455,194 (the '194 Patent) entitled "Diagnostic Methods" and exclusively licensed to Boston Heart.

The asserted '194 Patent claims a test for detecting the susceptibility of an individual to statin-induced myopathy -muscular pain or weakness caused by cholesterol medications—based on the association between that condition and a mutation at position 521 of the SLCO1B1 gene, similar to the test offered by Boston Heart. Claim 1 of the '194 Patent recites:

"1. A method, comprising:

  1. 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;
  2. correlating the identity of the allele of said polymorphism with risk of statin-induced myopathy;
  3. establishing a statin type and dosage based on said patient's statin-induced myopathy risk; and
  4. administering said statin type and dosage to said patient."

HDL is alleged to be offering an infringing test that also assesses a patient's risk of developing statin-induced myopathy by assaying for genetic variation in the SLCO1B1 gene.

The district court granted HDL's motion to stay the proceeding pending resolution of a pending USPTO reexamination of the '194 Patent requested by HDL.

A Patent Food Fight?

The parties' patent fights will be interesting to follow. How will the parties challenge each other's patent claims while maintaining the validity of their own patents? Stay tuned as we follow these proceedings and the evolving law of patent-eligibility.

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