Teva UK and others v Gilead Sciences (EWCA, [2019] EWCA Civ 2272, 2019)

Dhenne Avocats · 11 October 2026

Our analysis

Summary

Applying the two-limb test laid down by the Court of Justice in the same case (C-121/17), the Court of Appeal upheld the invalidity of Gilead’s SPC for the combination of tenofovir disoproxil (TD) and emtricitabine (Truvada). A claim to a composition of TD « and optionally other therapeutic ingredients » does not necessarily relate to the combination, as the second active ingredient is optional. Along the way the Court of Appeal rejected the technical contribution test applied by Arnold J and left open the meaning of the second limb.

Facts and procedure

SPC/GB05/041 describes a product combining TD, as its fumarate salt, and emtricitabine, used against HIV (para 2). Gilead relied on European Patent (UK) No 0 915 894, claim 27 of which is to a composition comprising a compound of claims 1 to 25, which include TD, « and optionally other therapeutic ingredients »; emtricitabine is not mentioned in the patent (paras 3, 7 and 8). Teva, Accord, Lupin and Mylan challenged the SPC’s validity. Arnold J made a reference to the Court of Justice on 13 January 2017; following the Grand Chamber’s judgment of 25 July 2018, he declared the SPC invalid on 18 September 2018 (paras 5 and 6).

The applicable law

Under Article 3(a) of Regulation 469/2009, the product must be protected by a basic patent in force (paras 3 and 14). Extent of protection is governed by Article 69 EPC and its Protocol, implemented by section 125 of the Patents Act 1977 (paras 16 and 17). The Court of Justice held that a product composed of several active ingredients is protected if the claims relate necessarily and specifically to the combination: the combination must necessarily fall under the invention covered by the patent, and each active ingredient must be specifically identifiable, on the basis of the prior art at the filing or priority date (para 53).

Question

Does a claim to a composition of TD and, optionally, other therapeutic ingredients satisfy the first limb of the Court of Justice’s test for the combination of TD and emtricitabine?

Decision

Floyd LJ held that the phrase « fall under the invention covered by the patent » does not refer to the inventive advance or technical contribution of the patent: the Court of Justice has set its face against such a test, which must now be regarded as wrong (para 74). The first limb elaborates the requirement, laid down in Eli Lilly, that the claim relate « necessarily » to the active ingredient: a claim to a formulation comprising A does not protect a combination of A and B, and the claim must require the presence of both compounds (para 75). This is not a simple extent of protection test (para 76). Claim 27, however, expressly makes other therapeutic ingredients optional, which is no different in principle from a claim « comprising » TD (para 77). Claim drafting is decisive (paras 78 and 79). The skilled person, even knowing that other antivirals would be useful against HIV, would not assume that the claim required them (paras 81 and 82). As the first limb was not met, the Court did not decide the second, while declining to endorse a requirement that emtricitabine be known at the priority date to be effective in humans (para 84). The appeal was dismissed (paras 85 to 88).

Key points for practice

• The first limb of the C-121/17 test does not reintroduce an inventive advance criterion (para 74).
• To support a combination SPC, the claim must require the presence of each active ingredient; an optional mention is not enough (paras 75 and 77).
• The content of the second limb (a mere temporal cut-off or a qualitative requirement of common general knowledge) remains open (para 84).
• Practical point: an SPC strategy for a combination starts with drafting the basic patent, through claims that expressly require the combination.

Relevance before the UPC

As the UPC has jurisdiction over actions concerning SPCs based on a European patent, this reading of the first limb of the Court of Justice’s test may be relied on before it.

Provisions applied

Regulation (EC) No 469/2009

Arts 1, 3(a), 4 and 5

European Patent Convention

Art. 69 and Protocol on its interpretation

National law

Patents Act 1977, section 125

Case law cited

CJEU, Teva UK and Others (C-121/17); CJEU, Farmitalia (C-392/97); CJEU, Medeva (C-322/10); CJEU, Eli Lilly (C-493/12); CJEU, Actavis Group PTC and Actavis UK (C-577/13); Sandoz v G.D. Searle [2018] EWCA Civ 49; Opinion of Advocate General Hogan in Cases C-650/17 and C-114/18

Related decisions

• Teva UK and Others v Gilead Sciences, CJEU, 25 July 2018, preliminary ruling in the same case (paras 33 to 54).
• Eli Lilly v Human Genome Sciences, CJEU, 12 December 2013, cited on the necessary and specific link (paras 23, 24 and 75).
• Medeva, CJEU, 24 November 2011, cited on active ingredients not specified in the claims (para 21).
• Actavis Group PTC v Sanofi, CJEU, 12 December 2013, cited through C-577/13 (para 40).

Prepared by Dhenne Avocats from the text of the decision (National Archives, Find Case Law), consulted on 11 October 2026. Only the official text is authoritative.