On 13 January 2017, Arnold J made two references to the European Court of Justice in relation to the Supplementary Protection Certificate Regulation, one concerning SPCs for combination products, the other new formulations of old active ingredients. In both cases, the reason for the referral was Arnold J's trenchant criticism of the CJEU's inconsistent and unclear reasoning in key cases interpreting the Regulation.
It usually takes around 18 months to two years for the CJEU to deal with a reference and so the making of referrals in these cases raises interesting considerations around the timing of Brexit, and how SPCs will be treated in the UK post-Brexit. It also comes at a time when the SPC regime in the EU is under review, with Commission recently issuing a document analysing a number of potential reforms, including an SPC manufacturing waiver.
Combination products: will a 'clear answer' be forthcoming from the CJEU?
The first reference was in Teva v Gilead. Various generic pharmaceutical companies have challenged the validity of Gilead's SPC/GB05/041 for a product described in the SPC as "Composition containing both Tenofovir disoproxil, optionally in the form of a pharmaceutically acceptable salt, hydrate, tautomer or solvate, together with Emtricitabine". Gilead markets the product, an anti-viral medication used in the treatment of HIV, as Truvada. The SPC is based on EP (UK) 0 915 894 ('the Patent').
The Patent does not mention or refer to emtricitabine. Instead, claim 27 states: "A pharmaceutical composition comprising a compound according to any one of claims 1-25 together with a pharmaceutically acceptable carrier and optionally other therapeutic ingredients". In interpreting claim 27, Arnold J determined that it did not reflect any further 'inventive advance' (or technical contribution) over that in claims 1-25, i.e., it was not independently valid.
This is not the first time that the validity of Gilead's SPC has been challenged. In 2008, Kitchin J (as he then was) decided that the product comprising the combination of tenofovir and emtricitabine was protected by claim 27. However, since that date, a number of significant CJEU decisions ("Medeva and its progeny") have impacted on this issue – indeed, in Novartis v MedImmune, Arnold J noted it was difficult to see how the CJEU's Medeva test would apply in relation to Gilead's SPC.
Arnold J concluded that the test to determine whether a product is protected by a basic patent remains unclear and that therefore a further reference was necessary, expressing hope that the CJEU will provide further and better guidance than it has done to date. The question referred is identical to one he made in 2012 in Actavis v Sanofii (where the CJEU did not take up his invitation to re-consider the Medeva test as it was not necessary to do so):
"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?"
As he did in Actavis v Sanofi, Arnold J offered the CJEU his own answer: the product must infringe because it contains an active ingredient, or a combination of active ingredients, which embodies the inventive advance (or technical contribution) of the basic patent. Where the product is a combination of active ingredients, the combination must embody the inventive advance. In Arnold J's view, this interpretation would accord with the object of the Regulation, to encourage invention in the field of medicinal products by compensating inventors for delay in exploitation due to the need to obtain regulatory approval, but not to confer unjustified monopolies.
It might be wondered whether the CJEU will provide further clarification, given its earlier decisions in Medeva and Lilly. Arnold J was however "encouraged" by statements the CJEU had made in Actavis v Sanofi and Actavis v Boehringer. In the former, the CJEU (in the context of Article 3(c)) drew a contrast between "the core inventive advance" of the basic patent and "other active ingredients, not protected as such by the basic patent but simply referred to in the wording of the claims of the patent in general terms". Arnold J suggested that the apparent message that what matters is whether the product constitutes "the subject matter of the invention covered by the basic patent", meant there was "a realistic prospect" of better guidance.
New formulations of old active ingredients
On the same day, Arnold J also made a reference in Abraxis v Comptroller concerning whether an SPC can be granted where a product is a new formulation of an active ingredient (as opposed to a new therapeutic use of an active ingredient). The issue is whether this complies with Article 3(d), which requires the authorisation relied upon to be the first to place the product on the market as a medicinal product. SPCs have been granted for nab-paclitaxel in nine EU member states, but refused in two other member states (applications are pending in other member states). Abraxis argued that this lent support to its submission that questions should be referred to the CJEU.
The UKIPO had refused Abraxis's SPC application (GB/09/046) for a product described as "paclitaxel formulated as albumin bound nanoparticles" (called nab-paclitaxel by Abraxis, and marketed under the trade mark Abraxane), because it did not comply with Article 3(d). Abraxane is indicated for treatment of metastatic breast cancer, metastatic adenocarcinoma of the pancreas and non-small cell lung cancer, used alone or together with other anti-cancer treatments. Before the marketing authorisation for Abraxane had been obtained, paclitaxel had been marketed by other parties under the marks Paxene and Taxol under earlier MAs. The Hearing Officer decided that as the active ingredient of the medicinal product authorised by the MA was paclitaxel, and not nab-paclitaxel, the Abraxane MA was not the first authorisation. The Hearing Officer also rejected the alternative argument that nab-paclitaxel was a new and inventive formulation of an old active ingredient (paclitaxel) and that Article 3(d) should permit the grant of an SPC for a product which consists of a new and inventive formulation of an old active ingredient.
In its Neurim decision, the CJEU had endorsed SPC protection for new applications for existing 'old' active ingredients. Applying a teleological approach to the Regulation and focusing on its objectives, the CJEU decided that the existence of an earlier MA for a medicinal product would not preclude the grant of an SPC for a different application of the same product. Arnold J has criticised Neurim in previous cases and he returned to this line of attack here, referring the following question to the CJEU:
"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 active ingredient?"
Again, Arnold J offered his own suggested answer, namely that SPCs should not be available for new formulations of old active ingredients (as opposed to new applications i.e., new therapeutic uses). Whilst he recognised the primary purpose of the SPC Regulation was to reward innovative research and compensate patentees for delays in obtaining marketing authorisations, he stressed that it was also intended to provide a simple and predictable system that could be operated by national patent offices in a uniform manner, and which balanced the interests of patentees with other stakeholders. As such, it was necessary to have 'bright-line rules', even if they might sometimes deprive meritorious inventions of extended protection.