MBHB partner Dr. Andrew Williams is the featured presenter for a roundtable presentation entitled, “Strategies for Addressing Intellectual Property Barriers to Biosimilar Marketing,” set for March 7, 2017 in Berlin, Germany in conjunction with the 3rd Biologics & Biosimilars Congress.
Details of Dr. Williams’ presentation are as follows:
Strategies for Addressing Intellectual Property Barriers to Biosimilar Marketing
Schedule: 9:00-10:10 a.m. – March 7, 2017
Biosimilar intellectual-property concerns vary between Europe, the United States, and elsewhere. What factors should be considered in these different jurisdictions before deciding to either launch at risk or wait until the expiration of patent protection?
When should the development of a biosimilar drug product be influenced by the patents that protect it, for example with regard to changing the formulation or altering the manufacturing process?
When should a primary or secondary patent be challenged in an opposition proceeding before the European Patent Office (EPO) or an IPR or PGR before the U.S. Patent Trial and Appeal Board (PTAB), and when should the patent challenge be reserved for litigation?
View details here