Product, Medicinal Product, Basic Patent: The Relationship of Concepts in Regulation 469/2009 Overlooked by the CJEU

Abstract

The CJEU Santen judgment defined the concept of a product for the purposes of Regulation 469/2009 on the supplementary protection certificate for medicinal products (Regulation (EC) No. 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (Codified version), [2009] OJ L152/1, as last amended by Regulation (EU) 2019/933 of 20 May 2019, [2019] OJ L153/1). Leaving aside the practical implications of this judgment in terms of the possibility of obtaining a supplementary protection certificate for a product protected by a patent for a second or further medical application (“application patent”), it is worth considering the reasoning the Court relies on to arrive at the thesis it formulates. While the Court’s response and the resulting impact will be treated differently depending on whether the actual extension of patent protection in the pharmaceutical industry is assessed as appropriate and desirable or whether the justification for said protection is questioned, the manner in which the provisions of Regulation 469/2009 are proposed to be interpreted raises doubts as to whether the final outcome of the interpretation is correct.