Protecting Intellectual Property in View of the Myriad/Mayo Patent Eligibility Guidelines

Price: $224 OnDemand


Sign up today for an entire year of unlimited access to relevant, timely professional learning courses, including webinars, eLearning courses and OnDemand offerings, and keep your professional credits up to date. All for just $399.

Learn more about the subscription!



The past two years have seen dramatic changes in U.S. life science and biotechnology patent law. Particularly notable are the Supreme Court decisions in Mayo Collaborative Servs. v. Prometheus Labs., Inc. and Association for Molecular Pathology v. Myriad Genetics, Inc., in which the Court explained more clearly what should be considered patent eligible under 35 U.S.C. § 101.

In Prometheus, the Court essentially found that correlations between naturally occurring phenomena, even if newly discovered, are not patentable as long as the remaining claim limitations cover only conventional activities routinely conducted in the art. In Myriad, the Court found that genomic DNA, even if isolated, is not patentable subject matter because it is a product of nature.

The Court left open how its rulings in Prometheus and Myriad apply to technologies other than diagnostics and technologies specifically discussed in those cases. On March 4, 2014, the United States Patent and Trademark Office (USPTO) issued guidelines attempting to clarify how its examiners should determine subject matter eligibility with respect to other technologies. The significance of the guidelines cannot be overstated since they expand the holdings of Prometheus and Myriad to any claim involving laws of nature, natural phenomena and natural products. As a result, for example, newly discovered purified proteins or stem cells may no longer be considered patent eligible. Similarly, homeopathic mixtures of natural compounds may not pass muster, unless a synergistic effect can be shown.

It remains to be seen how the guidelines will hold up against future challenges. For the time being, however, they represent a dramatic change of which patent practitioners and their clients must be aware. The aforesaid changes are even more significant in view of the patent laws in other foreign jurisdictions, such as Europe and Japan, where isolated DNA and proteins are still patentable.

Educational Objectives:
•Learn about the changes in U.S. patent practice and the significance of these changes for patent practitioners and stakeholders.
•Hear analysis and practice points regarding the development of international patent portfolios in view of the dramatic differences between subject matter patent eligibility in the U.S. and abroad.
•Understand issues concerning what impact the guidelines may have on litigation.

Who would benefit most from attending this program?
Intellectual property practitioners



Patrice Jean is a partner at Kenyon & Kenyon. She has more than a decade of experience counseling leading and start-up pharmaceutical, chemical, and biotechnology companies in areas of patent law. In particular, Dr. Jean is adept at asserting and defending the patent rights underlying the core technologies and innovations of leading hi-tech and pharmaceutical companies to protect and/or improve their access to multi-billion dollar markets.


Dr. Jean earned a J.D. from Columbia University, an M.A. and a Ph.D. in Molecular Biology from Princeton University, and a B.S. in Biochemistry from Xavier University. She is admitted to practice in the District of Columbia and New York as well as before the U.S. District Courts for the Eastern and Southern Districts of New York, the U.S. Court of Appeals for the Federal Circuit, and the U.S. Patent and Trademark Office.



Paul Richter is a partner at Kenyon & Kenyon LLP, where he has been practicing all aspects of intellectual property law for more than twenty years. He primarily focuses on litigation and has extensive experience litigating patent cases in the biotechnology, medical device and chemical industries. Mr. Richter also regularly handles complex inter partes matters before the United States Patent and Trademark Office.

Mr. Richter earned a J.D. from George Washington University Law School and a B.S. in Chemical Engineering from Tufts University. He is admitted to practice in New York, Massachusetts, and the District of Columbia.


Carmella Stephens is counsel at Kenyon & Kenyon LLP. She has substantial experience in a wide variety of intellectual property matters, with a particular emphasis in the biotechnology and pharmaceutical industries. Dr. Stephens has prepared and prosecuted many applications involving gene therapy, RNA based therapeutics, bioassays, immunobiology, signal transduction and genomics, among others. She has also counseled clients on legal issues relating to biotechnology and pharmaceutical patents, including patent enforcement, validity and infringement, licensing, and business development.

Dr. Stephens earned a J.D. from Fordham University School of Law, a Ph.D. in Microbiology from Cold Spring Harbor Laboratory, and a B.S. in Biology from Adelphi University. She is admitted to practice in New York as well as before the U.S. District Court for the Southern District of New York and the U.S. Patent and Trademark Office.