Although the Biologics Price Competition and Innovation Act (BPCIA) was enacted several years ago, activity under the BPCIA was sparse, and limited primarily to U.S. Food and Drug Administration (FDA) draft guidance. This inactivity led to speculation as to how the FDA, reference product sponsors, and biosimilar applicants would implement the BPCIA regulatory and prelitigation provisions. Well, the speculation is over. There has been a plethora of activity over the past several months concerning the BPCIA. Please join our panelists as they discuss issues relating to:
- Recent FDA approval of biosimilars and what lessons can be learned
- Case law update: Use, or lack thereof, of the BPCIA “patent dance” procedures
- Ethical considerations concerning disclosure and use of a biosimilar application
- The impact of Inter Partes Review (IPR)/Post-Grant Review (PGR) on patents covering biologics
- Strategic use of European Patent Office (EPO) proceedings to assist with U.S. litigation
RSVP: Space is limited. To attend, please register by May 4, 2015.
Date:
Thursday, May 7, 2015
Time:
9:15 a.m. - 9:45 a.m. – Registration and Breakfast
9:45 a.m. - 12:00 p.m. – Workshop
12:00 p.m. - 12:30 p.m. – Working Lunch
12:30 p.m. - 3:00 p.m. – Workshop
Location:
Finnegan
Two Seaport Lane
Boston, MA 02210
