Teva UK Limited and Others v Gilead Sciences Inc, High Court of England and Wales (Arnold J), London, UK, 13 January 2017, Neutral Citation Number: [2017] EWHC 13 (Pat)

Arnold J has again referred a question to the CJEU concerning the interpretation of Article 3(a) of Regulation 469/2009 (the “SPC Regulation”) namely: what are the criteria for deciding whether a product (active ingredient or combination of active ingredients) is “protected” by a basic patent in force?

The Claimants (Teva, Accord, Lupin and Mylan) sought to challenge the validity of Gilead’s SPC (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 fumarate salt of tenofovir disoproxil in combination with emtricitabine as a single, fixed dose tablet. This is sold under the brand name Truvada® as a treatment for HIV.

Gilead’s SPC relies on the marketing authorisation for Truvada and EP 0 915 894 (“the Patent”), claim 27 of which reads as follows: “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”.

Tenofovir disoproxil is “a compound according to… claims 1-25” but it was common ground that emtricitabine is not mentioned or referred to in the Patent.

The SPC application was initially rejected by the UKIPO in January 2008 but this decision was overturned by Kitchin J (as he then was) in July 2008 ([2008] EWHC 1902 (Pat)). However, as Arnold J pointed out, there has been a significant number of judgments from the CJEU concerning the interpretation of Article 3(a) since Kitchin J’s decision and Kitchin J did not have the benefit of the Claimants’ arguments before him. As such, Arnold J considered the matter afresh.

Arnold J approached the issue from first principles and identified two sets of rules which could be of relevance when determining whether a product is “protected”, namely: • The “Extent of Protection Rules”, consisting of national laws implementing Article 69 of the EPC, which states that the extent of protection conferred by a European Patent shall be determined by the claims, interpreted with reference to the description and drawings; and • The “Infringing Act Rules”, consisting of national laws implementing Articles 25 and 26 of the Community Patent Convention, which define the acts which amount to an infringement of a patent.

Arnold J then went on to review the CJEU case law in which the interpretation of Article 3(a) has arisen, namely Farmitalia (C-392/97), Medeva (C-322/10) and what Arnold J refers to as its progeny (Yeda (C-518/10), Queensland (C-630/10), and Daiichi (C-6/11)), Actavis v Sanofi (C-443/12), Eli Lilly v HGS (C-493/12), and finally Actavis v Boehringer (C-577/13).

Notwithstanding the plethora of CJEU jurisprudence on the issue, Arnold J held that the test to be applied in determining whether a product is “protected” within the meaning of Article 3(a) remains unclear. It was however possible to derive certain points of principle: • it is not sufficient that a product falls within the claims by virtue of the Infringing Act Rules; • it is necessary that the product falls within the claims by virtue of the Extent of Protection Rules; and • falling within the claims by virtue of the Extent of Protection Rules is not sufficient; something more is required.

However, Arnold J held that what constitutes “something more” is not clear. Consequently, the national patent offices have been applying Article 3(a) differently, including in relation to the SPC in suit, and in his view, a further reference to the CJEU was required.

As he did previously in Actavis v Sanofi [2012] EWHC 2545 (Pat), Arnold J proffered his own solution to the question, proposing that “the product must infringe because it contains an active ingredient or 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, as distinct from one of them, must embody the inventive advance of the basic patent” [emphasis added].

Having held that the technical contribution of the Patent lay in the disclosure of the new compounds (i.e. including tenofovir disoproxil but not emtricitabine), and that claim 27 did not reflect any further technical contribution per se, Arnold J went on to suggest that, if the CJEU agrees with his analysis, Gilead should not be entitled to an SPC.

A copy of the entire decision (in English) can be found here.