Life Sciences at the ITC: Predictions and Considerations for Biosimilar Litigation

AuthorHassen A. Sayeed, Patrick Nack-Lehman
Published in Landslide® magazine, Volume 13, Number 2, a publication of the ABA Section of Intellectual Property Law (ABA-IPL), ©2020 by the American Bar Association. Reproduced with permission. All rights reserved.
This information or any portion thereof may not be copied or disseminated in any form or by any means or stored in an electronic database or retrieval system without the express written consent of the American Bar Association.
34 LANDSLIDE n November/December 2020
Life Sciences at the ITC
Predictions and Considerations
for Biosimilar Litigation
By Hassen A. Sayeed and Patrick Nack-Lehman
Non-life-sciences products have historically accounted
for most disputes heard at the International Trade
Commission (ITC).1 The increasing frequency of
biologics litigation in the U.S., however, raises the
possibility of an inection point: the ITC may soon
become a more popular alternative forum for life sci-
ences. This article briey explores some of the benets and
risks associated with litigating biologics cases in the ITC in
comparison to district court. The article also reviews the uti-
lization of the ITC as an alternative forum for traditional
pharmaceutical (Hatch-Waxman) and trade secret litigation.
Litigating Biologics Cases in the ITC
Biological medical products (biologics) are the fast-
est-growing class of therapeutic products in the U.S.2
Biologics are medicines approved by the U.S. Food and Drug
Administration (FDA) produced by biotechnology in a liv-
ing system, such as microorganisms or cells.3 Biologics are
typically much larger and more complex than conventional
drugs. A “biosimilar” drug is a biological product that is
highly similar to the FDA-approved reference product and
has no clinically meaningful differences from that product.4
As of July 7, 2020, the FDA has approved 28 biosimilars,
and approvals are becoming more frequent, with 10 approv-
als in 2019 alone.5 As the number and frequency of biosimilar
approvals increase, biologics companies may turn to new
forums such as the ITC to enforce their rights.
Image: Molekuul/Science Photo Library, GettyImages

To continue reading

Request your trial

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT