The Myriad Decision: Has The Dust Settled Yet?

Six months ago, the United States Supreme Court shook up the biotechnology industry by ruling that genetic sequences are not patent eligible "simply because they have been isolated." AMP v. Myriad Genetics, 569 U.S. 12-398 (June 13, 2013). While providing little practical guidance, the Court succeeded in raising many new questions at the core of biotechnology patenting. For example, what characteristics are required to make natural nucleic acids patent eligible? What about other natural products, such as stem cells, polypeptides, antibodies, purified enzymes, and hormones?

The U.S. Patent and Trademark Office (USPTO) is still developing comprehensive guidance for applying Myriad. Based on preliminary guidance and current USPTO practice, Myriad is being applied strictly to nucleic acids, but generally not to other natural products. For now, sequence variations (e.g., 95% or greater identity) or point mutations may not be enough to make a natural nucleic acid patent