is a litigation Associate with Fenwick & West. Her practice focuses on litigating patent matters for companies in the life sciences, biotechnology, pharmaceutical and chemistry arenas. Ewa’s experience includes resolving disputes in the federal district courts and the Court of Appeals for the Federal Circuit, in addition to her growing inter partes review (IPR) practice. Ewa was selected as a Washington “Rising Star” in the area of Intellectual Property Litigation in 2016 and 2015, and was awarded the Outstanding Volunteer in Public Service by The Bar Association of San Francisco for her pro bono work in 2014. She served as a managing editor of the Washington Law Review while in law school. At MIT, she worked in the laboratory of Dr. H. Robert Horvitz, winner of the 2002 Nobel Prize in Physiology or Medicine. Ewa was awarded several academic distinctions while an undergraduate at Princeton University.
The Supreme Court is currently considering whether to review Amgen Inc. v. Sandoz Inc., the Federal Circuit’s first decision regarding the Biologics Price Competition and Innovation Act (BPCIA). Although the Federal Circuit does not technically have any input into the Supreme Court’s grant or denial of certiorari, it nonetheless took the opportunity last week to bolster one of the challenged holdings: that a biosimilar applicant cannot provide its biologic competitor with 180 days’ notice of intent to commercially market a biosimilar product until that product is licensed. Specifically, in the course of ruling in Amgen Inc. v. Apotex Inc. that a biosimilar applicant must provide such notice even if it participated in the BPCIA’s so-called “patent dance,” the Federal Circuit addressed a primary criticism of its earlier decision, namely, that permitting only post-licensure notice effectively extends by 180 days the twelve-year exclusivity term of the biologic product. The solution suggested by the panel, however, is far from a legal certainty.