Posts Tagged: "biomarker"

Patent-Ineligibility of Medical Diagnostics, Life Sciences Discoveries Arrests U.S. Progress

In a research project funded by the Austrian Science Fund (FWF), evidence emerged that a higher expression of the GIRK1 protein in malignant tissue samples was linked to higher relapse and mortality rates in breast cancer patients who have gone through surgery. The novel use of the GIRK1 protein as a biomarker could have a great impact on breast cancer diagnostics and treatments and further research could yield more discovery on the interdependence of GIRK1 with other important biological pathways critical to cancer management… Unfortunately, discovery of GIRK1 as a biomarker for breast cancer diagnostics would run into 35 U.S.C. § 101, the basic threshold statute for determining patentability of subject matter, under the Supreme Court’s March 2012 ruling in Mayo Collaborative Services v. Prometheus Laboratories, Inc. In that case, the Court held that processes involving correlations between blood test results and patient health is not patent-eligible subject matter because the process incorporates laws of nature. This would seemingly render any processes involving the application of GIRK1 as a biomarker for breast cancer prognoses unpatentable as well as the expression of GIRK1 occurs naturally.