Home > Insights > boult.bites Biotech – Winter 2013
13 November, 2013

SPC uncertainties remain
Supplementary Protection Certificates (SPCs) have been the hot topic in the pharmaceutical patent sector in recent years.  On 12 September 2013 the Court of Justice of the European Union (CJEU) heard a number of cases relevant to the issue of whether a product is protected by a basic patent, as required for SPC Protection.

The three referrals heard (Actavis Group and Actavis; Georgetown University; Eli Lilly and Company) request clarification of the CJEU’s ruling in the Medeva and Georgetown decisions of 2011 that an active ingredient must be “specified in the wording of the claims”. Specifically these referrals seek to clarify the level of generality permitted in a claim which is to be used as the basis for an SPC. Although the questions have arisen primarily in relation to combination products, where a secondary active ingredient is often claimed only in general terms, these decisions are expected to be more widely applicable to any basic patent claiming an active ingredient in a generalised form.


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