(265b) Understanding What Is Still Patentable in the Life Science Industry

Authors: 
Roscetti, J., Finnegan

The Supreme Court’s recent decisions invalidating patents under section 101 of the Patent Act as patent-ineligible subject matter have affected patent portfolios across all life sciences industries, from biotechnology patents and the development of personalized medicine.  These recent decisions have made it essential to reassess your company’s patent strategy to ensure protection of your inventions and enable future partnering and marketing success.  In Mayo, the Court held unpatentable claims to optimizing treatment of an immune-related disorder by determining the level of drug metabolite in a patient's blood based on knowledge of effective levels. According to the Court, the claims recited an unpatentable natural law—the relationship between metabolite levels and the drug effectiveness—applied via well-understood and conventional steps, thus impermissibly preempting all use of that law. Next, in Myriad, the Court struck down claims to isolated DNA molecules as directed to unpatentable products of nature, distinguishing between patent-ineligible gene sequences found in nature and patent-eligible genetic sequences, such as complementary DNAs (cDNAs), created by scientists in the lab.  In March of this year, the United States Patent and Trademark Office (USPTO) issued its long awaited Guidance for Determining Subject Matter Eligibility of Claims Reciting or Involving Laws of nature, Natural Phenomena, & Natural Products. These decisions and subsequent guidelines significantly affect a company's patent portfolio strategy. During this session, we will address how natural product and diagnostic method claims will be examined by the USPTO.