Welcome to the second issue of the Morgan Lewis Pharma Review, which summarizes key recent cases from the Federal Circuit and district courts that impact the pharma space, including: • Federal Circuit and district court decisions in Hatch-Waxman litigations • Federal Circuit reviews of IPR challenges to Orange book–listed patents • Appellate and district court decisions in pharma-related antitrust litigations We hope Pharma Review can serve as a one-stop source for your patent and antitrust pharma-related legal developments.
PATENTS/PATENT-ELIGIBLE SUBJECT MATTER
Michael J. Abernathy, Maria E. Doukas, and Michael T. Sikora Federal Circuit Clarifies PTO Guidance Regarding Subject Matter Eligibility The Federal Circuit found that controlling case law supersedes any US Patent and Trademark Office (PTO) guidance on subject matter eligibility and rejected Example 29 of a May 4, 2016, PTO guidance as inconsistent with prior Federal Circuit law. Cleveland Clinic Foundation v. True Health Diagnostics, LLC, No. 2018-1218 (Fed. Cir. 2019) (Cleveland Clinic II). In a prior case, the Federal Circuit addressed a Cleveland Clinic patent that was “directed to the ineligible natural law that blood MPO [myeloperoxidase] levels correlate with atherosclerotic CVD.” Cleveland Clinic II involved method claims issuing from continuations of that same patent. The Federal Circuit acknowledged a difference between these claims: the continuation claims