Extension to the European Market Sample Clauses

Extension to the European Market. The 180-day exclusivity is explicit in the US but not in the EU. Nonetheless, in the EU there are other barriers to entry, such as delays in market autho- rization by the medical agencies that create de facto duopoly periods for the first successful generic challenger, making it perhaps similar to the American case. These delays which are sometimes caused by too many applications being filed with the EMA may be strategic and were noted in the Pharmaceutical Sector Inquiry by DG Comp (EC, 2009). The outcomes in that respect should be similar to the ones shown in the main document for the American case. An alternative however is to model the European case as when all the remaining generics enter the market as soon as one generic invalidates the patent. In that case, the European case would mimic the No Exclusivity option modeled above and for which results are shown in the main text.