Burden Of Section 101 Following Myriad

The Supreme Court's decision in Association for Molecular Pathology v. Myriad Genetics Inc., 2013 DJDAR 7484 (2013), held that Myriad's claims directed to "a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated." In addition, the court held that "cDNA is patent eligible because it is not naturally occurring."

Left largely unaddressed by this decision was who bears the initial burden during the patent examination process of showing that a claimed invention is in fact naturally occurring as well as what evidence is needed to meet that burden.

Shortly after Myriad, the U.S. Patent and Trademark Office (USPTO) issued a memorandum on June 13 instructing patent examiners to reject composition claims drawn solely to naturally occurring nucleic acids or fragments thereof. Unfortunately, the memorandum failed to address which party (patent applicant or patent examiner) bears the initial burden of demonstrating