Until the Medeva and Georgetown cases (C-322/10 and C-422/10), it was widely presumed that the patent holder was entitled to one supplementary protection certificate ("SPC") for every product covered by the basic patent. This presumption and interpretation of article 3(c) of the SPC regulation was challenged by the ECJ in the aforementioned cases as it was stated:
"Where the patent protects a product, in accordance with article 3(c) of Regulation No. 469/2009, only one certificate may be granted for that basic patent".
In the aftermath of the rulings in 2011, it was debated by scholars and others whether or not this statement could indeed be interpreted as a deliberate adjustment of the existing interpretation and principle – meaning that it would only be possible to obtain one SPC per basic patent regardless of the number of products protected by the patent. Thus, preliminary references regarding the interpretation of article 3(c) were later referred to the ECJ, including C-443/12, Actavis Group and Actavis UK, and C-484/12, Georgetown University.
On 14 November 2013, Advocate General Jääskinen released his opinion in the Georgetown University case. To the disappointment of many, Jääskinen did not address the important question on the number of SPC that may be issued on the basis of a basic patent. Instead he left it to the ECJ to decide on the matter. Commentators have been quick interpreting this to mean that the Advocate General supports one or the other interpretation, but – in fact – he does not say.
Surrendering of a SPC
In order to answer the other questions referred to the ECJ, the Advocate General placed a prerequisite for an affirmative answer. He then went on to assess whether it should be possible for the patent holder to surrender a SPC for a product (A) protected by a basic patent as a mean to obtain a new SPC for another product (B) protected by the same basic patent in accordance with article 14 of the SPC regulation.
The Advocate General found article 14 of the SPC regulation applicable and, thus, argued for the preclusion of the application of national law. He stated that the surrender of a SPC should not have retroactive effect. Hence, a patent holder should not be able to surrender a SPC for one product in order to gain a SPC for another product based on the same basic patent.
Priority of SPC applications
Moreover, the Advocate General rendered that in a situation where an applicant has submitted several applications for SPC for various products protected by the same patent, it should be for the applicant to choose which of these applications that should be given priority as long as the applications are still pending. If the applicant has made no choice, it should be for the national authorities to decide which should be given priority in accordance with national law.
The ruling of the ECJ
The pharmaceutical industry anticipates the ECJ ruling on the interpretation of article 3(c) of the SPC regulation. Should the ECJ rule that one may obtain "one certificate per basic patent", arguably SPCs granted on the basic of the principle "one certificate per product per basic patent" may be invalid.