Developers for biosimilars face not only stiff technical and manufacturing challenges, but also legal uncertainty regarding the enabling legal framework, the Biologics Price Competition and Innovation Act (BPCIA) of 2010. Two of those questions — regarding the availability of a federal injunction to compel information disclosure and the timing of the biosimilar maker’s notice of marketing — were answered in last month’s U.S. Supreme Court opinion on two cases between Amgen and Sandoz.
But much remains uncertain. Our panel of top drug industry litigators will give their views on what lies ahead regarding such questions as:
- Will the “patent dance” be essentially mandatory under state law? Will availability of an injunction vary by state, perhaps triggering important venue issues?
- When would a biosimilar maker choose the patent dance even if it is not mandatory?
- How soon can a biosimilar manufacturer give notice of commercial marketing? Can it be done before filing for FDA approval?
Speakers:
- Elaine Blais, Goodwin Procter LLP
- Brian Slater, Kramer Levin Naftalis & Frankel LLP
- Bruce Wexler, Paul Hastings LLP
