On March 27, The American Lawyer recognized San Francisco partner Rachel Krevans and New York partner Grant Esposito as its Litigators of the Week. They received the honor for leading, along with Palo Alto partner Erik Olson, the MoFo trial team that secured a major victory for Sandoz that will likely influence the future of health care in the United States.
“Our strategy is one that is designed to win at the trial court and the appellate level,” Krevans told The American Lawyer.
Last week, in a “first-of-its-kind case,” a federal district court issued a decision interpreting the Biologics Price Competition and Innovation Act (BPCIA) that became law under the Affordable Care Act. Amgen filed a suit in October 2014 seeking to delay Sandoz’s launch of the biosimilar filgrastim Zarxio®, which can help fight infections in cancer patients. Biosimilars are less-expensive copies of brand name biologics that have been found equally safe and effective. The case was the first to decide two key issues concerning how patent disputes between a biosimilar applicant and reference product sponsor are resolved under the BPCIA.
On March 19, the federal district court ruled in Sandoz’s favor on all issues before the court, fully adopting Sandoz’s interpretation of the BPCIA. At the same time, the court denied Amgen’s motions urging a contrary interpretation and seeking a preliminary injunction.
As a result of the ruling, Sandoz is one step closer to launching the first biosimilar product in the United States, which FDA approved in early March.