Biotech threats in the SPC system


Jaap Mannaerts

Biotech threats in the SPC system

In its effort to tackle the threat of ‘evergreening’, the CJEU has caused some uncertainty about supplementary protection certificates, as Jaap Mannaerts explains.

At the time the supplementary protection certificates (SPC) regulation was draft ed, the legislator was well aware of the risk of SPCs becoming an instrument in ‘evergreening’ tactics—the ways in which pharmaceutical patent owners use the law and related regulatory processes to extend their IP rights.

A variety of safeguards were built into the system to assure a fair balance between additional protection for the pharmaceutical companies on one hand, which was necessary to stimulate pharmaceutical research, and the public interest, which required a strict maximum duration of the supplementary protection, on the other.

While the regulation, in principle, appeared fit to accomplish a well-balanced system in the reasonably simple and transparent manner envisaged, rulings by the Court of Justice of the EU (CJEU) in the past few years have made things increasingly complicated.

Biotech, threats, SPC, Medeva, CJEU