compositions and methods

The Federal Circuit Court of Appeals has applied the Supreme Court’s test for unpatentable abstract ideas to patents covering methods to determine a person’s likelihood of getting certain types of cancer.

In University of Utah Research Foundation v. Ambry Genetics Corp., 2014 U.S. App. LEXIS 23692, decided by the Federal Circuit on December 17, 2014, the court addressed the patentability of two types of claims:  compositions and methods.  The composition claims were directed to single strands of DNA called “primers” that correspond to the double-stranded DNA of a gene.  The method claims were directed to diagnostic methods used to determine whether a patient carries a particular gene mutation that carries an increased risk of breast and ovarian cancer.

The plaintiffs were Myriad Genetics, University of Utah, and others.  They discovered the BRCA1 and BRCA2 genes that, when mutated, cause breast and ovarian cancer.  Myriad developed diagnostic test kits to detect the presence of the mutations.  Myriad patented the natural gene sequences, synthetic primers, and medical test kits.

In 2013, the U.S. Supreme Court held that Myriad’s claims to the natural gene sequences were invalid.  Association for Molecular Pathology v. Myriad, 133 S. Ct. 2107 (2013).  The Court found that the gene sequences were not patent-eligible subject matter, but were instead ineligible natural phenomena.
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