Georgetown's patent claimed a vaccine for the prevention of papillomavirus infection, comprising at least that protein, or fragment thereof, of, among others, HPV‑16, HPV‑18 or HPV‑16 and HPV‑18 together. The patent, granted on 12 December 2007, expired on 23 June 2013.
Two SPC applications were granted but, on 19 May 2010 the SPC application based on the MA granted for Gardasil, which referred to the recombinant L1 protein of the human papillomavirus (HPV) type 16 as the ‘product’ within the meaning of Regulation No 469/2009, was rejected. Said the OCN, the MA which Georgetown relied on related to a medicinal product containing other active ingredients in addition to the recombinant protein of HPV-16. Georgetown appealed against the OCN’s decision to the Rechtbank’s-Gravenhage. That court observed that a rule to the effect that only one SPC may be granted per basic patent could be easily circumvented by the holders of patents protecting several products: it would be sufficient for such holders to separate their patents in such a way that each basic patent protected only one product, thus enabling them to obtain an SPC for each individual product. Said Georgetown, it would be prepared to surrender the two SPCs already granted and to withdraw its other pending SPC applications if that enabled it to obtain, in accordance with the Court’s interpretation of Regulation 469/2009, an SPC in respect of HPV‑16. The Rechtbank’s-Gravenhage was however uncertain whether the surrender of the two SPCs already granted might have retroactive effect. In any event, that court decided to stay the proceedings and to refer the following questions to the Court for a preliminary ruling:
‘(1) Does Regulation No 469/2009 …, more particularly Article 3(c) thereof, preclude, in a situation where there is a basic patent in force which protects several products, the holder of the basic patent from being granted a certificate for each of the protected products?This morning the CJEU ruled as follows:
(2) If the first question must be answered in the affirmative, how should Article 3(c) of Regulation No 469/2009 be interpreted in the situation where there is one basic patent in force which protects several products and where, at the date of the application for a certificate in respect of one of the products (A) protected by the basic patent, no certificates had yet been granted in respect of other products (B, C) protected by the same basic patent, but where certificates were nevertheless granted in respect of the products (B, C) before a decision was made with regard to the application for a certificate in respect of the first-mentioned product (A)?
(3) Is it significant for the answer to the previous question whether the application in respect of one of the products (A) protected by the basic patent was submitted on the same date as the applications in respect of other products (B, C) protected by the same patent?
(4) If the first question must be answered in the affirmative, may a certificate be granted for a product protected by a basic patent which is in force if a certificate has already been granted for another product protected by the same basic patent, but where the applicant surrenders the latter certificate with a view to obtaining a new certificate on the basis of the same basic patent?
(5) If the issue of whether the surrender has retroactive effect is relevant for the purpose of answering the previous question, is the question of whether surrender has retroactive effect governed by Article 14(b) of Regulation No 469/2009 or by national law? If the question of whether surrender has retroactive effect is governed Article 14(b) of Regulation No 469/2009, should that provision be interpreted to mean that surrender does have retroactive effect?’
"In circumstances such as those in the main proceedings, where, on the basis of a basic patent and a marketing authorisation for a medicinal product consisting of a combination of several active ingredients, the patent holder has already obtained a supplementary protection certificate for that combination of active ingredients, protected by that patent within the meaning of Article 3(a).. , Article 3(c) of that regulation must be interpreted as not precluding the proprietor from also obtaining a supplementary protection certificate for one of those active ingredients which, individually, is also protected as such by that patent".At [29] to [31] the CJEU observed:
"29 ... the main proceedings concern a ... situation ... in which the same basic patent may be regarded as protecting a number of products within the meaning of Article 3(a) ..., thus raising a different question, namely whether such a patent may permit its holder to obtain several SPCs.
30 In that regard, it is possible, in principle, on the basis of a patent which protects several different ‘products’, to obtain several SPCs in relation to each of those different products, provided, inter alia, that each of those products is ‘protected’ as such by that ‘basic patent’ within the meaning of Article 3(a) ..., and is contained in a medicinal product with an MA.
31 Indeed, the wording of Article 1(b) and Article 3(c) ... does not preclude such an interpretation. That interpretation is also borne out by the objective pursued by that regulation, which, as is apparent from paragraph 11 of the Explanatory Memorandum to the Proposal for a Council Regulation (EEC) of 11 April 1990 concerning the creation of a supplementary protection certificate for medicinal products (COM(90) 101 final), is to encourage research in the pharmaceutical sector by granting one SPC per product, a product being understood to mean an active substance in the strict sense. Any other interpretation might, moreover, give rise to circumvention tactics, entailing additional costs which may discourage innovation, in the sense that those concerned would be minded to apply for a separate basic patent for each of their ‘products’".
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