Supplementary Protection Certificates (SPCs) for medicinal products are highly important for the pharmaceutical industry, and decisions from the Court of Justice of the European Union (CJEU) on this complex legal field are often much debated. The CJEU has recently provided further clarification on the rules for granting an SPC.

The rules for granting an SPC are found in Article 3 of Regulation 469/2009 (the SPC-Regulation) Article 3(a) states that the "product" (the active ingredient or combination of active ingredients) must be "protected by a basic patent in force".

In 2011, the CJEU decided in the cases Medeva (C-322/10) and Georgetown (C422/10) that in order for a product to be "protected by a basic patent" the product must be "specified in the wording of the claims of the patent".

With these decisions, the CJEU clarified that SPCs cannot be granted for products within the scope of protection of the basic patent (the "infringement test"), but must be found within the claims of the patent. However, the CJEU did not offer further guidance as to when a product is "specified in the wording", causing further uncertainty when interpreting article 3(a).

The CJEU also issued an obiter dictum in the decisions from 2011. According to Article 3(c) of the SPC-Regulation, it is a condition for granting a certificate that "the product has not already been the subject of a certificate". The CJEU reasoned that "only one certificate may be granted for that basic patent", referring to a phrase from Biogen (C-181/95). However, in that particular case the product was protected by several patents owned by various parties, and the decision has not prior to Medeva been interpreted as "one SPC per basic patent" if the patent covered several different products.

Medeva and Georgetown spurred a number of requests for preliminary rulings. The CJEU passed three decisions on 12 December 2013, offering further guidance for the future.

Eli Lilly vs HGS

Eli Lilly vs Human Genome Sciences (C-493/12) concerns a patent for an antibody, where the relevant claim of the patent was drafted broadly, disclosing only the binding specificity and not providing a specified primary antibody sequence. Thus the antibody was described functionally and not structurally, in the claim.

Eli Lilly sought a declaration from the court that an SPC for the antibody based on the concerned patent would be invalid. According to Eli Lilly, the antibody would not be specified in the wording of the patent. It was argued that in order to meet the "specified" criteria of Medeva, at the very least structural definition for the antibody was required. The UK court referred several questions to the CJEU, essentially asking what the criteria for deciding when the product being "protected by a basic patent", if the criteria are different for combination products and for antibodies or classes of antibodies, if it is sufficient that the antibody is defined by binding characteristics to a target protein or if a structural definition must be provided.

The CJEU decided to consider all referred questions together. The Court decided that it is not necessary for the active ingredient to be identified in a structural formula in the claims of the patent, as Article 3(a) does not preclude the grant of an SPC for an active ingredient given a functional definition in the claims. However, the condition is that the claims, interpreted inter alia by the description, "relate, implicitly but necessarily and specifically, to the active ingredient in question". Whether such a relationship exists is for the national court to decide.

Actavis vs Sanofi

In Actavis vs Sanofi (C-443/12), the relevant claims of the basic patent stated the formula of an active ingredient (irbesartan), and a separate claim with irbesartan in combination with a diuretic. Sanofi obtained two SPCs based on the same patent; for irbesartan, as well as irbesartan in combination with hydrochlorothiazide, a well-known diuretic.

Actavis alleged that the SPC was invalid on two accounts. Firstly, the combination was not "specified in the wording" of the patent, cf. article 3(a), and secondly, that only one SPC could be granted per basic patent. The national court asked the CJEU what the criteria are for deciding whether the product is protected by the basic patent, and if the Regulation and article 3(c) in particular precludes granting the proprietor of the patent an SPC for each of the products protected.

The CJEU decided to answer the second question first. The Court accepted the principle of obtaining an SPC for each product, provided the products are "protected" as such within the meaning of article 3(a).

However, according to the court, it cannot be accepted that the holder of a basic patent may obtain a new SPC each time he places on the market a medicinal product containing, on one hand, the active ingredient protected as such by the basic patent, and on the other, another active ingredient which is not protected as such by the basic patent. Thus article 3(c) precluded two SPCs on the same basic patent in this case.

In light of the answer to the second question, the CJEU did not find it necessary to answer the first question.

Georgetown II

"One SPC per patent" was also the topic in Georgetown vs OCN (C-484/12). In this case, Georgetown had a patent regarding vaccines for the prevention of papillomavirus infection, which protected four active ingredients individually, as well as a number of various combinations.

Prior to the decisions Medeva and Georgetown in 2011, the applicant filed numerous SPC-applications. Two of the applications for combinations were granted, but one was refused since the application concerned an individual ingredient (HPV-16), while the marketing authorisation (MA) was for a combination product including HPV-16. However, the decisions in Medeva and Georgetown accepted this. The new basis for refusal of the Dutch authorities was the lack of compliance with Article 3(c), since two SPCs had already been granted on that patent. The referring Dutch court asked if it is possible to grant an SPC for each of the protected products in a situation where the patent protects several products. Additional questions were asked if the answer for that question was negative, among them if it is possible to surrender a granted certificate for one product with a view of obtaining a certificate for another product.

CJEU referred to Actavis vs Sanofi, stating that it is possible to obtain several SPCs for each different product where a patent protects several different products, provided each of those products is protected "as such" within the meaning of article 3(a), and is contained in a medicinal product with an MA. Thus the difference from Actavis vs Sanofi was that the CJEU regarded the active ingredient in question protected "as such".

Impact of the Decisions

From a legal point of view, the decisions have removed a certain amount of uncertainty created by previous case law. However, since the CJEU did not clarify further what the criteria are for deciding when a product is "protected by a basic patent" - future references to the CJEU are likely to occur.

The reception from the pharmaceutical industry is likely to be mixed. No doubt relieved that it is possible to obtain several SPCs for various products with basis in the same patent, the industry is less likely to be happy with the results of Actavis vs Sanofi, since the launch of medicinal products combining an innovative ingredient with a well-known ingredient is common practice in many therapeutic areas.

This article was originally published in Expert Guide Biotechnology and Pharmaceutical sector 2014, available at Corporate Livewire.