This CLE course will guide patent counsel on overcoming the challenges of obviousness in biologics patent claims in the U.S., Europe, and China. The panel will examine the similarities and differences between claim types that have the best chance of success. The group will also discuss recent case law and critical issues that arise.
Several of the top-selling drugs are biologics. Unsurprisingly, patents relating to new biologics products are often challenged in patent offices and courts around the world, as well as the PTAB. When global litigation is the norm, it is vital to understand and coordinate strategies around the world.
There is an abundance of decisions on written description in the U.S., but relatively few Federal Circuit cases address the obviousness of inventions related to biologics. Hundreds of IPR petitions have been filed at the PTAB alleging biologic claims are not patentable under Section 103.
In Europe, it is particularly challenging to establish an inventive step for new antibody products, with strict tests for when a new product is considered inventive, and what scope of patent claim might be obtained. Also, China has seen rapid growth as a destination for biologics patents.
Listen as our authoritative panel of patent attorneys provides an in-depth analysis of biologic IPR petitions. The panel will review the similarities and differences between biologic claim types that have the best chance of success in the U.S., China, and Europe and the obviousness issues that may arise. The panel will also review current EPO and China practice, discuss recent case law, and outline key issues that arise. The panel will offer guidance addressing obviousness issues in biologics inventions.
