Kerisha A. Bowen
Dentons US LLC, USA
Title: Janssen Biotech V. Celltrion: The Balance Between the BPCIA and Litigation
Biography
Biography: Kerisha A. Bowen
Abstract
On March 6, 2013, Janssen Biotech, Inc. and New York University filed suit against Celltrion Healthcare Co., LTD, Celltrion, Inc,., and Hospira in the Federal District of Massachusetts. Janssen filed the suit as an attempt to assert its intellectual property rights for the drug Remicade® (Infliximab). The patents in dispute are U.S. Patent No. 6,284,471, which covers the infliximab cA2 monoclonal antibody; U.S. Patent No. 7,223, 396, which covers novel uses of infliximab to treat disease; and U.S. Patent No. 5,807,715, which covers methods of producing functional antibodies that are capable of specifically binding antigens. Celltrion submitted a Biologic License Application in August of 2014, which the FDA accepted for review in October of 2014. However, Celltrion indicated that they would begin commercial marketing of their proposed biosimilar product as early as August 5, 2015. The question at hand is was Celltrion's notice of commercial marketing premature, and how does a biosimilar company properly serve notice of commercial marketing?
Speaker Presentations
Speaker PPTs Click Here