6. What are the exceptions to the protection conferred by a CCP?

The absence, in règlement (CE) n° 469/2009 , of any exception to the protection conferred by the certificate meant that manufacturers of generics and biosimilars established in the European Union were prevented from manufacturing generics and biosimilars in the Union, even for export to third-country markets (countries outside the Union) where protection did not exist or had expired. Similarly, manufacturers were prevented from producing generics and biosimilars for stockpiling purposes before the certificate expired.

These circumstances made it more difficult for these manufacturers to enter the EU market immediately after the expiry of the certificate, unlike manufacturers located in third countries (where protection...