title: Take off your genes and let the doctor have a look: why the Mayo and Myriad decisions have invalidated method claims for genetic diagnostic testing.
abstract: Ass'n for Molecular Pathology v. U.S. Patent & Trade Office sent shockwaves through the legal community, when the U.S. District Court for the Southern District of New York rejected a series of patents held by Myriad Genetics, Inc. The court invalidated all of Myriad's compositional patents for human genes and its method patents for diagnosing genetic predispositions to breast cancer. While commentators have discussed the ethical implications of allowing patent rights to human genes in great detail, the Court's ruling on Myriad's method claims went by comparatively unnoticed. The ability to test a patient's genetic profile for predisposition to cancer and other diseases is an incredible achievement in the field of personalized medicine. Whether these tests deserve patent protection is a hotly debated issue that involves weighing the interests of both incentivizing research and making these tests available to the general public. This Comment analyzes the legal framework established by the Supreme Court and U.S. Court of Appeals for the Federal Circuit to decide patent eligibility for genetic diagnostic tests. It concludes that, while the world was spellbound by the ethical quandary of compositional claims on human genes, the recent Supreme Court and Federal Circuit decisions have surreptitiously eliminated genetic diagnostic tests as patentable subject matter under § 101 of the United States Patent Act.
authors.forename: Christopher
authors.initials: C
authors.lastname: Bergin
mesh_terms: D035843:Biomedical Research / Q000331:legislation & jurisprudence; D020022:Genetic Predisposition to Disease / Q000235:genetics*; D005820:Genetic Testing / Q000331:legislation & jurisprudence* / Q000379:methods*; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D010330:Patents as Topic / Q000331:legislation & jurisprudence*; D057285:Precision Medicine / Q000379:methods; D035521:Supreme Court Decisions; D014481:United States