Biosimilars Global Congress 2014 Europe
Hilton London Kensington
W11 4UL, United Kingdom
179-199 Holland Park Ave
Preparing for U.S. Market Entry: Strategy Considerations in view of BPCIA and AIA. Partner, Renita Rathinam, lectured on the complexities and strategic navigation of the patent information exchange and litigation framework articulated under the Biologics Price Competition & Innovation Act (“Act”), as well as on tools for obtaining patent certainty outside of the Act, including potential for early adjudication of rights via declaratory judgment (subject of pivotal actions testing the same brought by sponsors of the first two 351(k) applications filed in the U.S. for biosimilar products (filgrastim and infliximab)) and inter partes proceedings before the United States Patent & Trademark Office.