The EU’s upcoming “Pharma Package”—the biggest reforms of medicines rules in 20+ years—will push biotech and pharma to rethink IP earlier and more holistically. With more strategic (and potentially conditional) exclusivity, earlier generic/biosimilar readiness via a clearer Bolar exemption, and a new transferable exclusivity voucher, IP, regulatory and market access teams will need tighter alignment.

Read the full story by Alexander Johann Bjørnå and Mattias Salling Dahllöf here.