An unborn baby’s DNA (“fetal DNA”) can be used to determine the sex of the baby as well as to test for conditions such as Down’s syndrome.  In the past, procedures to get samples of fetal DNA for testing involved sticking a large needle through the abdominal wall and into the uterus of the mother to obtain amniotic fluid, but such procedures are invasive and can be life threatening in some cases.  Sequenom Inc. devised and patented less invasive options and licensed them to Illumina, Inc.  Ariosa Diagnostics, Inc. and others, however, challenged the patent eligibility of those options when accused of patent infringement.

Specifically, the various lawsuits have repeatedly brought into question whether the patent claims for these new prenatal tests and related methods are patent eligible under 35 U.S.C. §101 or if they are merely directed to ineligible natural phenomena.  In fact, in 2015, the Federal Circuit found Sequenom and Illumina’s patents (the “Original Patents”) were invalid as unpatentable because they were directed to a natural phenomenon.  This ruling raised many concerns in the industry as to which, if any, inventions of this type could be protected.
Continue Reading Federal Circuit: Sequenom’s Fetal DNA Claims Are Patent Eligible

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.
Continue Reading FEDERAL CIRCUIT CHIPS AWAY AT PATENTABLE SUBJECT MATTER