Richard CHINCEO, Inst. for OneWorld Health

The intellectual property rights for antibodies and biologics differ significantly from small molecules. In addition, the landscape for antibody patents is complicated because in addition to IP directed against targets, there are numerous patents around enabling technologies. Furthermore, current and pending regulations may give certain market exclusivity for antibodies and biologics that go beyond the traditional protection afforded by patents. This presentation will address the patent rights as they apply to antibodies and biologics in the United States, Europe, and other countries. Some of the major blocking patents in the field of antibodies will be discussed. In addition, current and pending regulations that affect intellectual property right in the U.S. and EU will be presented. Also, biosimilar pathways in the U.S., EU, and other countries will be discussed.