One of the features that render the European Union’s Supplementary Protection Certificate (SPC) unique in comparison to similar legal instruments in other jurisdictions, including the United States and Japan, is that there is no legal provision expressly calling for any specific relationship or agreement between the patent proprietor (and SPC applicant) on the one hand,…

In the field of supplementary protection certificates (SPCs) in the European Union, the majority of all CJEU referrals resolved to date have dealt with the interpretation of the – presumably simple – condition that an SPC can only be granted for an active ingredient (or a combination of active ingredients) that is “protected” by the…

The eagerly-awaited judgment of the Court of Justice of the European Union (CJEU) in the SPC referral Abraxis Bioscience (C-443/17) has been handed down today. In the case underlying this referral, the UK IPO had refused an SPC application filed by Abraxis Bioscience for the product “paclitaxel formulated as albumin-bound nanoparticles” (nab-paclitaxel; marketed as Abraxane®)…

Regardless of whether someone intends to enforce their own supplementary protection certificate (SPC) or finds themself at the receiving end of an SPC infringement action, the question which grounds of invalidity justify the revocation of an SPC may become highly relevant. This question is all the more intriguing in light of the CJEU’s corresponding case…

In light of the Teva/Gilead-judgment handed down on 25 July 2018 by the CJEU (C-121/17) as well as the latest referral from the German Federal Patent Court dated 17 October 2017 in re Sitagliptin III (14 W (pat) 12/17), which is pending as C-650/17, Prof. Meier-Beck, the presiding Judge of the German Federal Supreme Court,…

A quarter-century after supplementary protection certificates (SPCs) were introduced in the European Union, there are still a number of unresolved questions as to which types of products are, in principle, eligible for SPC protection. One further important piece in this puzzle will be provided by the CJEU’s forthcoming decision in the pending referral Abraxis Bioscience…

Practitioners dealing with supplementary protection certificates (SPCs) have been holding their breath at the unfolding of the “Truvada saga” around Gilead’s SPCs for the HIV medicament Truvada, which contains the active ingredients tenofovir disoproxil and emtricitabine. The lawsuits involving the Truvada SPCs in various European countries have already given rise to such noteworthy decisions as…

The SPC system was introduced in the European Union in 1992 to compensate for the heavy penalties imposed on pharmaceutical research due to the curtailment in effective patent term resulting from time-consuming and costly regulatory review. As expressly noted in the Explanatory Memorandum to the original SPC Regulation (COM(90) 101 final-SYN 255), the legislative intent…