25
Jul
Last May 2018, the European Commission proposed to amend Regulation (EC) no. 469/2009 on complementary protection certificates (CPC). If adopted, such amendment will affect European patent rights in the pharmaceutical sector. More specifically, the Commission proposed the introduction of Supplementary Protection Certificates (SPCs) to boost investment in the development and manufacture of biosimilars and generics (“the Proposal”).
Medicinal products can be marketed in Europe after obtaining an authorization from the competent administrative authority (in Italy, AIFA). Since such authorization generally...