Hatch-Waxman and Biosimilars: A Total Immersion Course Encompassing Strategies for Prosecution, FDA Regulation, Post-Grant Challenge, Litigation and Appeal

The Patent Resources Group is hosting their Spring Advanced Courses Program from April 12-18, 2015. During this program, Fish principals Janis Fraser, Terry Mahn, Chad Shear, and Dorothy Whelan will teach a course titled, “Hatch-Waxman and Biosimilars: A Total Immersion Course Encompassing Strategies for Prosecution, FDA Regulation, Post-Grant Challenge, Litigation and Appeal.”

The course starts with a broad survey of the Hatch-Waxman and BPCIA legislation provisions that underpin the strategies to be discussed throughout the course. The course then conveys both fundamentals and advanced legal strategies in three major areas: (1) pharmaceutical and biotech patent prosecution; (2) litigation and appeal; and (3) post-grant challenges such as inter-partes review and post-grant review.

Topics covered by the course include ideas for addressing the new challenge of patenting compositions derived from nature, for ensuring that your claims will survive validity challenges, and for obtaining patents on inventions (such as side effects) discovered after the product is on the market. The lecturers will explain what to expect in a Hatch-Waxman litigation or in the "patent dance" required by the BPCIA, considerations to take into account when settling such a litigation, and strategies for successfully challenging a patent (or surviving a challenge) under the various types of post-grant procedures. The increasing importance of the pharmaceutical label as a way to extend the life cycle of an approved drug is explored and specific strategies proposed.