Pharmacyclics LLC v. Alvogen, Inc. (Fed. Cir. 2022)

By Kevin E. Noonan — On November 15th, the Federal Circuit handed down its opinion affirming all aspects of the District Court’s decision in Pharmacyclics LLC v. Alvogen, Inc. The case illustrates once more the importance of the substantial evidence standard in support of factual aspects of a district court’s decision, even regarding ultimate questions of law, such as enablement and obviousness that are based on factual considerations. The case arose as ANDA litigation between Pharmacyclics LLC and Janssen Biotech, Inc., whose patents for the compound ibrutinib (an inhibitor of Burton’s tyrosine kinase (BTK) and the basis for their Imbruvica…