Use of ITC in Life Sciences

The International Trade Commission remains an active venue for medical devices and other life science patents under 19 U.S.C. § 1337 (“337”). While the ITC is not attractive for ANDA cases where patentees often want to take benefit the 30 month stay of generic approval which is not available in ITC actions, its relatively quick procedures, approximately 16 months from institution to  final decision make it attractive to cases where 35 USC 271(e)(2) are not available. Such cases include medical devices, processes of synthesizing pharmaceuticals including biologics. Of the 11 product categories used by the ITC to categorize technologies, excluding “other”, the pharmaceuticals and medical devices had third the greatest number of petitions instituted at 12 in fiscal year 2022 .   Interest in the ITC as a venue increased markedly beginning in 2012.  The ITC is generally viewed as a pro-patentee forum. Not only patent infringement actions can be brought at the ITC but also trade secret actions. In January 2022 the ITC instituted an investigation for a violation stemming from alleged misuse of AbbVie trade secrets by Alvotech related to its production of a Humira biosimilar. The short pendency of the investigations is attractive for biosimilars to thwart a successful launch of a biosimilar.