Deconstructing MDx Patents

Three upcoming court cases could render many molecular diagnostic patent claims moot, while narrowing the scope of claims inventors may seek in the future. While some MDx players and academic institutions worry that investors will shy away from the space if that happens, others suggest the result could be incentives to continuously improve diagnostic processes and services and a more competitive landscape.

Math-based method patents have been under attack for decades, but until recently, similar types of correlation-based medical process patents had been largely immune. Those days are clearly over as litigation partially rooted in abstract mathematical processes threaten to shake up the personalized medicine industry.

The biggest challenge to existing biotech patents comes from Bilski v. Kappos, which is focused on a claim for hedging risk in the field of commodities. The U.S. Court of Appeals for the Federal Circuit (CAFC) ruled en banc last year that such a process must be tied to a machine or perform a transformative step in order to be eligible for patenting.

If the U.S. Supreme Court, which is hearing the case on Nov. 9, upholds this "machine-or-transformation" test requirement for process patents, then claims covering only the use of biomarkers to predict disease and form the basis of treatment would be worthless, according to some constituents of the personalized medicine industry.

The PTO is already using the Bilski test to guide decisions on patent-eligible subject matter under Section 101 of the Patent Act. Biotech patent specialists contacted by BioCentury said the test narrows the scope of molecular diagnostics claims and increases the cost to pursue a patent application.

The second case, Prometheus Laboratories Inc. v. Mayo Collaborative Services, is more directly related to personalized medicine because the patents in question cover a method for determining dosage of a drug based on metabolite levels. A district court ruled the Prometheus patents invalid largely using case law that has limited algorithm-based claims - the same logic that was used in the CAFC's decision in Bilski.

The CAFC heard oral arguments in Prometheus' appeal on Aug. 5, but possibly won't decide on the case until after the Supreme Court rules on Bilski some time next year. Prometheus will likely turn on whether the courts believe that associations between biomarkers and diagnoses, prognoses or response to treatments are "natural phenomena" and thus not eligible for patents, or are concrete physical processes, which are patentable.

The third case, Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al. seeks to eliminate patents held by Myriad Genetics Inc. covering the breast cancer 1 early onset (BRCA1) and BRCA2 genes and the method of using those genes to identify a patient's risk of breast or ovarian cancer.

Patent specialists contacted by BioCentury said the company's method claims could be susceptible to the same "natural phenomena" argument as in Prometheus. A hearing on the defendants' motion to dismiss is Sept. 30.

If these three cases end up restricting method

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