Teva UK and Others v Gilead Sciences (CJEU, C-121/17, 2018)

Dhenne Avocats · 11 October 2026

Our analysis

Summary

On a reference from the High Court (Patents Court), the Grand Chamber held that a product composed of several active ingredients with a combined effect is protected by a basic patent in force, within the meaning of Article 3(a) of Regulation 469/2009, where the claims relate necessarily and specifically to that combination, even if it is not expressly mentioned. Two cumulative conditions apply, assessed from the standpoint of the person skilled in the art and on the basis of the prior art at the filing or priority date: the combination must necessarily fall under the invention covered by the patent, in light of the description and drawings, and each active ingredient must be specifically identifiable in light of all the information disclosed by the patent (para 57 and operative part). The judgment sets the framework for combination SPCs based on a general claim.

Facts and procedure

Gilead markets Truvada, an antiretroviral for HIV combining two active ingredients with a combined effect, tenofovir disoproxil and emtricitabine, authorised on 21 November 2005. Its European patent EP 0 915 894, filed on 25 July 1997 with a priority date of 26 July 1996, expired on 24 July 2017. Claim 25 expressly names tenofovir disoproxil; claim 27 covers a pharmaceutical composition comprising a compound of claims 1 to 25, a carrier and « optionally other therapeutic ingredients », words the patent neither defines nor explains. In 2008 Gilead obtained, on the basis of that claim and the authorisation, an SPC for the composition combining both ingredients. Teva UK, Accord Healthcare, Lupin, Lupin (Europe) and Generics (UK), which intend to market generics in the United Kingdom, challenge the validity of the certificate under Article 3(a), since emtricitabine is specified in the claims neither structurally nor functionally; Gilead relies on Eli Lilly. The High Court referred a question by decision of 23 February 2017.

The applicable law

In the absence of harmonised patent law, the extent of protection is determined by the non-EU rules governing the patent (para 31): Article 69 EPC and its Protocol on Interpretation, together with section 125 of the Patents Act 1977, to the exclusion of the rules on infringement such as section 60 (paras 32 and 33). The Court also relied on recitals 4 and 10 of the Regulation (paras 39 and 41) and on Articles 4 and 5 (paras 44 and 45).

Question

What criteria determine whether « the product is protected by a basic patent in force » within the meaning of Article 3(a) of Regulation 469/2009?

Decision

A product is protected only if it is expressly mentioned in the claims or if the claims relate to it necessarily and specifically (para 37), the description and drawings being taken into account (para 38). The certificate cannot extend protection beyond the invention covered by the patent without upsetting the balance between the interests of the pharmaceutical industry and those of public health (paras 40 to 43). The question is whether the skilled person would understand without any doubt, on the basis of common general knowledge and the description and drawings, that the claimed product is a specification required for the solution of the technical problem disclosed (para 48). Only the prior art at the filing or priority date counts, to the exclusion of the results of later research (paras 49 and 50). The test applies to products consisting of several active ingredients (para 53). As regards claim 27, it is for the referring court to determine whether the general wording meets those requirements; the Court observed, however, that the description says nothing of a combined effect of the two ingredients, so that it seems unlikely the skilled person would understand the combination as necessarily falling under the invention (paras 54 to 56).

Key points for practice

• Article 3(a) is assessed under the rules on the extent of protection (Article 69 EPC and its Protocol), not the rules on infringement (paras 32 and 33).
• The test has two cumulative limbs: the combination must necessarily fall under the invention, and each active ingredient must be specifically identifiable (para 57).
• The assessment is made at the filing or priority date, without regard to later research (paras 49 and 50).
• Practical point: general wording such as « optionally other therapeutic ingredients » is not enough on its own; the description must enable the skilled person to understand that the combination falls under the invention (paras 54 to 56).

Provisions applied

Regulation (EC) No 469/2009

Arts 1, 3(a), 4 and 5

European Patent Convention

Art. 69 and Protocol on the Interpretation of Article 69

National law

Patents Act 1977 (United Kingdom), sections 60 and 125

Case law cited

Medeva (C-322/10); Georgetown University and Others (C-422/10); Actavis Group PTC and Actavis UK (C-443/12); Eli Lilly and Company (C-493/12); Actavis Group PTC and Actavis UK (C-577/13)

Related decisions

• Teva UK v Gilead Sciences, Court of Appeal (England and Wales), 19 December 2019, the same case before the English courts.
• Eli Lilly, CJEU, 12 December 2013, cited on functionally defined active ingredients (paras 31 and 36).
• Actavis v Sanofi, CJEU, 12 December 2013, cited by the referring court and by the Court.
• Medeva, CJEU, 24 November 2011, among the case law cited.

Prepared by Dhenne Avocats from the text of the decision (EUR-Lex, English version), consulted on 11 October 2026. Only the official text is authoritative.