Even though microbiome research is identifying new avenues for research, diagnosis, therapy and product development, IP challenges to commercialization still exist. Securing patent protection has become more difficult and complicated as a result of recent US Supreme Court, Federal Circuit decisions (Mayo, Myriad, and Alice; Sequenom) and Patent Office guidelines that create vague exceptions to the definition of patent-eligible subject matter. Microbiomic inventions, which often utilize microbes, microbial components, and/or microbial products, big data and medical correlations will be susceptible to challenges. The regulatory environment introduces further complexity as governments and companies grapple with appropriate labeling and regulation of probiotics and other practical applications of microbiome research. In this session, experts will discuss recent developments in the study of the human microbiome and how intellectual property rights can be protected. Further, attendees will hear how careful, thoughtful and creative patent drafting, trademark rights and contractual provisions can be used to protect innovations in this area.

Session ID: 22015