O
n January 15, the Court of Justice of the European Union (CJEU) handed down its judgment in Forsgren
(C-631/13). T e judgment provides further guidance on the eligibility for supplementary protection certifi cates (SPCs) under articles 1(b) and 3(a), and 3(b) of regulation number 469/200—the SPC regulation. T e basic patent, EP0594610 (registered to Arne Forsgren), relates to protein D, which binds immunoglobulin D and is conserved in Haemophilus infl uenzae. Protein D is present in Synfl orix, a pneumococcal vaccine for which GlaxoSmithKline Biologicals received a European marketing authorisation (MA) in 2009. Synfl orix is a vaccine composed of ten pneumococcal polysaccharide serotypes conjugated to a carrier protein, protein D, and absorbed by aluminium phosphate. T e MA states that the vaccine is for use in active immunisation against diseases caused by Streptococcus pneumoniae. T e Österreichische Patentamt (Austrian Patent
Offi ce) rejected Forsgren’s application for an SPC for protein D based on EP0594610. In a subsequent appeal to the Oberster Patent- und Markensenat (the Austrian supreme patent and trademark adjudication tribunal), the tribunal concluded that it was necessary to refer questions to the CJEU in order to determine Forsgren’s appeal.
T e fi rst question referred to the CJEU concerned the interpretation of article 1(b) of the SPC regulation, which defi nes the term “product” and therefore delineates what may be the subject of an SPC. Under article 1(b), a product is “the active ingredient or combination of active ingredients of a medicinal product”. T e referring tribunal asked whether an SPC may be granted when, as in the present case, the active ingredient is covalently bound to other active ingredients. Citing its judgment in Massachusetts Institute of Technology (C-431/04), the CJEU noted that a substance is considered an active ingredient when it has a pharmacological, immunological or metabolic eff ect on its own. Whether the active ingredient is bound to another active ingredient is in itself immaterial to this test; the test simply requires the active ingredient to have an independent pharmacological, immunological or metabolic eff ect.
Accordingly, the CJEU found that the SPC regulation does not preclude the grant of an SPC where the active ingredient is covalently bound to other active ingredients.
T e referring tribunal’s second question related to the scope of article 3(b) of the SPC regulation. Article 3(b) requires that, in order to be protected by an SPC, a MA must have been granted for the product.
the
Further
By the fi rst part of its question, the referring tribunal asked the CJEU to determine whether article 3(b) precludes the grant of an SPC where the therapeutic eff ect of the active ingredient does not fall within the indications specifi ed in the MA. Forsgren noted that protein D is known to promote an immune response against Haemophilus infl uenzae (but not against Streptococcus pneumoniae, the indication covered by the Synfl orix MA).
Forsgren submitted that the SPC regulation does not expressly require that a MA identifi es the therapeutic eff ect of the product. Forsgren also argued that because a MA can be amended, this approach would be diffi cult to administer. T e European Commission noted that Forsgren’s proposed approach would itself cause
administrative diffi culties, as the patent offi ce examining the SPC application would need to verify the product’s therapeutic characteristics by reference to sources other than the MA. T e commission also submitted that granting an SPC for therapeutic properties not covered by the MA would be contrary to the purpose of the SPC regulation. SPCs are intended to compensate a patentee for the delay in commercialising its product, caused by the rigorous, protracted process of conducting clinical trials and applying for regulatory approval. Granting an SPC for a product whose therapeutic eff ects do not fall within the MA would not serve this purpose. T e CJEU held that article 3(b) of the SPC regulation precludes the grant of an SPC for an active ingredient whose eff ect does not fall within
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