On May 9, 2019, Ha Kung Wong was quoted in Center for Biosimilars regarding the federal circuit affirming a lower court's decision in a patent dispute. According to the article, the case was an appeal of two decisions by the United States District Court for the Northern District of California in Biologics Price Competition and Innovation Act (BPCIA) patent infringement actions brought by Amgen against Sandoz. The lower court granted a summary judgment of noninfringement of patents covering filgrastim and pegfilgrastim. The patents are related to purification of proteins and methods of treatment.
Wong said that the decision largely maintains the status quo in demonstrating the difficulty of proving infringement under the doctrine of equivalents.
Additionally, said Wong, the court did discuss determination of infringement of biosimilars while abbreviated Biologics License Applications (aBLAs) are pending FDA review. "The approval process may impact the exact characteristics of the approved biosimilar product (i.e., it may change the product so that it will result in a different analysis of infringement)," he wrote.
"In the Hatch-Waxman context, it's been relatively settled that a court has [a] 'broad mandate to render a just, speedy, and inexpensive decision based upon the evidence of record' and not have to wait for the final approved product to determine infringement." Such an understanding, wrote Wong, appears to be extended to the aBLA context in this decision, as the court concluded that "the district court was not obligated to postpone summary judgment [of noninfringement] until Sandoz submitted its amended…aBLA." Instead, the federal circuit affirmed the noninfringement determination made by the lower court based on the evidence in record.