Taft Pharmaceutical and Life Sciences Litigation attorneys Steve Auten and Luke Shannon contributed a chapter to the ABA publication “Biosimilars Litigation and Client Counseling.” Auten and Shannon authored Chapter 5 – “Notable Differences between Hatch-Waxman and BPCIA Litigation: What Can We Learn?” In this section, Taft partners provide overviews of the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act (BPCIA) and explore pre-suit considerations and key litigation considerations, including applicable local rules and practices, experts, trends, and more. Shannon served as an associate editor.

The book serves as a guide to the field of biologic products and biosimilars, focusing on the laws that govern them, particularly the Biologics Price Competition and Innovation Act (BPCIA).

For more information or to order the book, click here.

Auten is chair of Taft’s Pharmaceutical and Life Sciences Litigation group. He is widely known in Hatch-Waxman and biosimilar matters, including related patent litigation, and is followed by key industry leaders (brand and generic alike), law firms, analysts, educators, and others on his LinkedIn blog, “Hatch Waxman ANDA Litigation Forum,” which has more than 14,000 members worldwide. Auten represents clients primarily in the areas of Paragraph IV design strategies, Hatch-Waxman litigation, and biosimilar market opportunities.

Shannon focuses on patent infringement suits arising under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act, and other disputes involving pharmaceutical and life sciences and other intellectual property issues. He also advises clients regarding post-grant procedures, including inter partes review proceedings, and has experience preparing Paragraph IV notice letters, as well as non-infringement and invalidity opinions.