The issue of whether or not the proprietor of a Patent can obtain more than one SPC, when the Patent protects more than one product, is still unclear. In case C322/10 (Medeva), comments made by the CJEU indicate that the interpretation of Article 3(c) of the SPC Regulation (469/2009) should be such that only one SPC may be granted per “basic patent”. However, the practice in some Patent Offices has been to grant more than one SPC per Patent. Two referrals pending before the CJEU, C-443/12 and C484/12 (Georgetown), seek to clarify this important issue.
Case C484/12, has arisen from a refusal by the Dutch Patent Office to grant an SPC for the human papillomavirus protein “HPV16”, the reason being that Georgetown had already obtained two SPCs covering combinations of HPV proteins protected by the same basic patent. Following the Medeva decision, the Dutch Court were unsure how to proceed, and referred five questions to the CJEU, the first of which asks:
Does Article 3(c) of the Regulation 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?
Advocate General Jääskinen has now issued a preliminary Opinion, but interestingly, his comments are confined to addressing the answers to questions 2-5, which request clarification of the situation in the event that the CJEU decides that there can only be one granted SPC per Patent. It is understood that the CJEU did not consider it necessary for the AG to address the main issue of “one SPC per Patent” in his Opinion. This may suggest that the CJEU is minded to follow the earlier comments made in Medeva; however, this will only become clear once the final decision is received.
In the meantime, we summarise the two main issues addressed by the AG, which relate to the following: In the event that the question above is decided in the affirmative, (i) what will be the situation where several SPC applications based on the same “basic patent” are pending at the same time; and (ii) will the holder of a granted SPC be able to surrender their SPC with retroactive effect such that the product is deemed never to have been the subject of an SPC.
In relation to the first issue, the AG has concluded that, where an applicant has filed several SPC applications for separate products covered by the same Patent, it will be up to him to decide which application is a priority. It is suggested that in situations such as this, the competent authorities (e.g. the UK IPO) should request the Patent holder to make a choice about which active ingredient or combination of active ingredients it wishes to protect via an SPC.
With regard to the surrender of an SPC, the AG has concluded that surrender of a certificate is governed by Article 14(b) of the SPC Regulation, and does not have retroactive effect, but is effective only for the future.
It follows from the above, that while multiple SPC applications are pending for different products protected by the same basic patent, the proprietor should have the opportunity to decide which SPC proceeds to grant. However, once an SPC has been granted, the proprietor of the basic Patent will not be able to substitute this SPC for an SPC covering a different product protected by the Patent.