Royalty Pharma Collection Trust v Deutsches Patent- und Markenamt (CJEU, C-650/17, 2020)

Dhenne Avocats · 11 October 2026

Our analysis

Summary

On a reference from the Federal Patent Court (Bundespatentgericht), the Court applied the Teva test to products falling within a functional definition. A product corresponding to a general functional definition in a claim is protected by the basic patent within the meaning of Article 3(a) of Regulation 469/2009, even though it is not individualised as a specific embodiment, provided that it necessarily falls under the invention and is specifically identifiable by the skilled person in light of all the information disclosed by the patent, on the basis of common general knowledge and the prior art at the filing or priority date (para 43). By contrast, a product developed after the filing date following an independent inventive step is not protected, even if it falls within the functional definition (para 50). The Court made clear that the « core inventive advance » criterion is not relevant (paras 31 and 32).

Facts and procedure

Royalty Pharma holds European patent EP 1 084 705, filed on 24 April 1997, which discloses lowering blood glucose in mammals by administering dipeptidyl peptidase IV (DP IV) inhibitors. Sitagliptin, a DP IV inhibitor, was developed after the filing date by a licensee of the patent, which obtained a new patent on that molecule, itself used as the basic patent for an SPC. On 17 December 2014 Royalty Pharma applied to the German Patent and Trade Mark Office (DPMA) for an SPC for sitagliptin, based on EP 1 084 705 and the Januvia authorisation of 21 March 2007. The DPMA refused it on 12 April 2017: sitagliptin meets the functional definition in the claims, but the patent does not specifically disclose it. On appeal, the Bundespatentgericht referred three questions by decision of 17 October 2017 and maintained its request after Teva. The Court rejected a request to reopen the oral procedure (paras 24 to 29).

The applicable law

The Court recalled the central role of the claims under Article 3(a) (para 34), and Article 69 EPC and its Protocol on Interpretation, which require fair protection for the proprietor and a reasonable degree of legal certainty for third parties (para 35). It restated the two cumulative conditions laid down in Teva for a product not expressly mentioned in the claims (para 37).

Question

Is a product falling within a general functional definition, without being individualised as an embodiment, protected by the basic patent and, if so, is it still protected where it was developed after the filing date following an independent inventive step?

Decision

In Teva the Court did not adopt the « core inventive advance » criterion relied on by the referring court and based itself on the claims, so that the criterion is irrelevant under Article 3(a) (paras 31 and 32). Subject to verification, sitagliptin, as a DP IV inhibitor, necessarily falls under the invention, which meets the first condition (para 38). On the second, the referring court must determine whether the skilled person could derive directly and unambiguously from the patent as filed that the product falls within its protection (paras 40 and 42); the absence of individualisation does not in principle rule out a certificate (para 41). Protection is assessed at the filing or priority date, and taking later research into account would allow the certificate to protect results unknown at that date (para 45), beyond the invention covered by the patent (para 46). A product developed after that date following an independent inventive step is therefore not specifically identifiable from the patent and is not protected, even if it falls within the functional definition (paras 47 to 50).

Key points for practice

• The « core inventive advance » criterion plays no part under Article 3(a) (para 32).
• A functional definition may suffice without individualisation, if the skilled person could specifically identify the product at the filing or priority date (paras 41 to 43).
• A product resulting from an independent inventive step after the filing date falls outside the protection of the basic patent, even if within the functional definition (para 50).
• Practical point: a patent with a functional claim cannot support an SPC for a molecule developed later through an independent inventive step, such as the one developed here by a licensee (paras 47 to 50).

Provisions applied

Regulation (EC) No 469/2009

Art. 3(a)

European Patent Convention

Art. 69 and Protocol on the Interpretation of Article 69

Case law cited

Teva UK and Others (C-121/17); Merck Sharp & Dohme (C-125/10); Abraxis Bioscience (C-443/17)

Related decisions

• Teva v Gilead, CJEU, 25 July 2018, whose test the Court clarified and applied (paras 31 to 37).
• Abraxis, CJEU, 21 March 2019, among the case law cited.
• Merck Sharp & Dohme, CJEU, 8 December 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.