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

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.

Effects of supplementary protection certificates

A supplementary protection certificate shall confer the same rights as conferred by the patent and shall be subject to the same limitations and the same obligations.

Article 83 Transitional regime

During a transitional period of seven years after the date of entry into force of this Agreement, an action for infringement or for revocation of a European patent or an action for infringement or for declaration of invalidity of a supplementary protection certificate issued for a product protected by a European patent may still be brought before national courts or other competent national authorities.

Supplementary protection certificate

In Art 2(h) UPCA, a ‘supplementary protection certificate’ (SPC) is defined as a supplementary protection certificate granted under Regulation (EC) No 469/2009 or under Regulation (EC) No 1610/96. For the purposes of simplification, the comments made hereafter refer solely to the first-mentioned Regulation (here: ‘the Regulation’).

The SPC manufacturing waiver: Good for patients, good for jobs, good for Europe

The European Commission is currently considering an important legislative proposal which is supported by the generic pharmaceutical industry. Following the introduction of supplementary protection certificates in the 1990s, an unintended consequence has been felt by European generic manufacturers, whom are very often the last group to be able to commence commercial production, due to earlier expiry of rights in other parts of the world. This puts European pharmaceutical manufacturers at a competitive disadvantage, seeing as they are not able to manufacture product for export to countries in which no patent rights exist, or in readiness for day 1 launches in Europe. The supplementary protection certificate manufacturing waiver has been independently assessed to represent €7.3–9.5b of revenue to European industry by 2025, to generate 20,000–25,000 jobs, to lead to €1.6–3.1b in healthcare cost-savings and to improve patient access to healthcare. However, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and other innovator pharmaceutical groups have been lobbying against the proposal. In this paper, I examine the arguments against the supplementary protection certificate manufacturing waiver, particularly those set out in EFPIA’s White Paper that was published in 2017. The conclusions of the White Paper are found to be unsupported. It is hoped that the supplementary protection certificate manufacturing waiver will be implemented, and provide a valuable stimulus for the manufacture of pharmaceuticals in Europe.