Professor Lietzan recently filed an amicus brief in the United States Supreme Court, in a closely-watched case involving patent litigation under the Biologics Price Competition and Innovation Act (BPCIA).
The appellate court concluded that biosimilar applicants may elect not to comply with the information exchange provisions laid out in the statute, effectively opting out of the statutory premarket patent litigation scheme enacted in 2010.
Professor Lietzan practiced for 18 years before joining the law school faculty and has deep expertise in issues relating to regulation and approval of biological medicines. She was also deeply immersed for more than a decade in the development of the BPCIA, from initial thinking as early as 2002 through negotiation of the primary legislative language in 2006 and 2007, passage in 2009 and enactment in 2010.
Professor Lietzan drafted a brief on behalf of herself and ten other professors, pointing out that meaningful patent protection for biologics is essential to ensuring that the United States retains its place at the forefront of innovation. This brief explains how the mandatory information exchange process in the statute ensures that patent owners have a meaningful opportunity to enforce their patent rights. Finally, it explains that the multi-year legislative process afforded biosimilar manufacturers many opportunities over many years to address the scope, contours and design of the patent information exchange and litigation provisions. Congress considered and rejected the “optional” participation approach now advanced by the cross-respondent, and in fact the company complained publicly after enactment that participating in the scheme was mandatory.
Professor Lietzan’s comprehensive history of the statute, published in the Food and Drug Law Journal in 2010, has been cited in many of the briefs filed in the pending case.