Judgments leave uncertainty over value of SPCs

• Published in: Managing Intellectual Property 2013-02
• Main Authors: Sternfeld, Diana, Jadeja, Nicole
• Format: Magazinearticle
• Language: English
• Subjects: Comptrollers; Court decisions; Ingredients; International; Marketing; Pediatrics; Regulation
• ISSN: 0960-5002

Supplementary protection certificates were introduced in the EU to compensate for patent term lost while applying for marketing authorisation and to compete with Japan and the US. But IP offices have made inconsistent decisions in granting them, and the SPC Regulation has been difficult to apply. Since 1992, there have been more than 25 references to the CJEU, with 12 decisions in the past 18 months alone. These have provided clarity on a number of issues, but others - such as whether one SPC can be granted per product (rather than per patent) - remain uncertain. Another problematic question is what a "product protected by a basic patent in force" means, after the Court ruled (in Medeva) that the active ingredient must be specified in the wording of the claims of the basic patent. This raises particular problems for antibody claims, Markush claims and combination products, which have led to calls for further clarification. [PUBLICATION ABSTRACT]