Over the last decade it has become apparent that interpretation of European Regulation 469/2009/EC (the SPC Regulation) is far from straightforward. To seek further clarification, the UK High Court referred two further questions to the Court of Justice of the European Union (CJEU). Interestingly, these two latest referrals mirror questions previously considered by the CJEU, highlighting the ongoing difficulties surrounding interpretation of this Regulation.

The first referral concerns what is required for a product to be considered “protected by a basic patent in force” under Article 3(a) of the SPC Regulation. This referral relates to Gilead Sciences Inc’s SPC for their HIV combination treatment Truvada®. Although the marketing authorisation for Truvada® requires the active ingredients Tenofovir disoproxil and Emtricitabine, the basic patent relied upon merely claims a pharmaceutical composition comprising Tenofovir disoproxil, optionally in combination with other therapeutic ingredients. The patent does not describe the specific combination of Tenofovir disoproxil and Emtricitabine. Mr Justice Arnold considered that it was unclear whether Truvada® should be considered “protected by a basic patent in force” under Article 3(a) and referred the following question to the CJEU:

“What are the criteria for deciding whether ‘the product is protected by a basic patent in force’ in Article 3(a) of the SPC Regulation?”

The interpretation of Article 3(a), as it relates to combination products, was first considered by the CJEU in the landmark Medeva and Georgetown cases (C-322/10 and C-422/10). There, the CJEU decided that an SPC could be granted for a combination of active ingredients only if those ingredients were “specified in the wording of the claims”. Following this, the exact question above was initially referred to the CJEU by the UK High Court in 2013 (Actavis Group PTC ehf v Sanofi; C-443/12; http://www.boult.com/bulletins/big-day-for-spcs/). On that occasion the CJEU decided that Sanofi’s SPC was invalid on other grounds and did not discuss Article 3(a). Since then this point has been brought before the CJEU on multiple occasions and it has been determined that in order to comply with Article 3(a) the product must be protected “as such” (Actavis Group PTC ehf v Boehringer Ingelheim Pharma GmbH & Co KG; C-577/13) and that the claims of the basic patent must “relate, implicitly, but necessarily and specifically, to the active ingredient in question” (Eli Lilly & Co Ltd v Human Genome Sciences Inc; C-493/12; http://www.boult.com/bulletins/big-day-for-spcs/). However, it is generally accepted that the interpretation of Article 3(a) remains unclear.

The second referral relates to whether SPCs can be granted for new formulations of known products or whether Article 3(d) of the SPC Regulation precludes this. In this case, Abraxis Bioscience LLC appealed against refusal of an SPC application for Abraxane®, which contains paclitaxel formulated as albumin bound nanoparticles for the treatment of cancer, on the basis that paclitaxel had previously been approved for the treatment of cancer.

It had previously been confirmed that “a substance which does not have any therapeutic effect of its own and which is used to obtain a pharmaceutical form of the medicinal product” cannot form the basis of an SPC (Massachusetts Institute of Technology; C-431/04) and that “the term ‘active ingredient’ does not cover substances forming part of a medicinal product which do not have an effect of their own on the human or animal body” (Forsgren v Österreichisches Patentamt; C-631/13; http://www.boult.com/news-item/cjeu-confirmsthat-mere-carrier-proteins-are-not-active-ingredients-in-the-context-of-spcs/). It is therefore considered clear that an SPC cannot be granted merely for a new formulation of a known product with a standard excipient. However, it has also been determined that “the mere existence of an earlier MA [Marketing Authorisation] obtained for a veterinary medicinal product does not preclude the grant of an SPC for a different application of the same product” (Neurim Pharmaceuticals (1991) Ltd v Comptroller-General of Patents; C-130/11; http://www.boult.com/bulletins/spcs-for-second-medical-uses/), indicating that a new therapeutic use of a known product could form the basis of an SPC. In some cases it appears that the line between a new formulation and a new therapeutic use is blurred, and Mr Justice Arnold considered that a further referral to the CJEU was warranted. The question referred was:

Is Article 3(d) of the SPC Regulation to be interpreted as permitting the grant of an SPC where the marketing authorisation referred to in Article 3(b) is the first authorisation within the scope of the basic patent to place the product on the market as a medicinal product and where the product is a new formulation of an old active ingredient?”

This question amalgamates issues previously considered by the CJEU, namely whether a new formulation should be considered a new product (Massachusetts Institute of Technology; C-431/04 & Forsgren v Österreichisches Patentamt; C-631/13) and whether a previous authorisation for a different medical use should preclude the grant of an SPC (Neurim Pharmaceuticals (1991) Ltd v Comptroller-General of Patents; C-130/11). It is hoped that this latest referral will clarify when a new formulation is considered a new therapeutic use.

This latest round of referrals to the CJEU may bring some much needed clarity to the SPC Regulation. However, the repeated referrals over the last decade have taught us that it is difficult for the CJEU to issue guidance on the issues underpinning this Regulation which is specific whilst covering a wide variety of situations.