Georgetown University v Octrooicentrum Nederland (CJEU, C-484/12, 2013)

Dhenne Avocats · 11 October 2026

Our analysis

Summary

On a reference from The Hague District Court, the Court held that the proprietor of a patent protecting a combination of active ingredients, who already holds an SPC for that combination, may also obtain, on the basis of the same patent, an SPC for one of those active ingredients where it is protected as such by that patent. Article 3(c) does not require a single certificate per patent where the patent protects several products. Delivered on the same day as Actavis (C-443/12), from which it is expressly distinguished, the judgment sets out when a single patent may support several certificates.

Facts and procedure

Georgetown University held European patent EP 0 647 140, applied for on 24 June 1993, granted on 12 December 2007 and expired on 23 June 2013, for a human papillomavirus (HPV) vaccine. On 14 December 2007 it filed eight SPC applications in the Netherlands, relying on the MAs for Gardasil (HPV-6, -11, -16 and -18) and Cervarix (HPV-16 and -18). On 15 January 2008 the Netherlands Patent Office granted an SPC for the combination of the four HPV types and another for the HPV-16 and HPV-18 combination. On 19 May 2010 it refused the application for HPV-16 alone, first under Article 3(b) and then arguing that Article 3(c) bars a second certificate on the same basic patent. Georgetown offered to surrender the two certificates granted and withdraw its other applications if an SPC could be obtained for HPV-16. The Rechtbank ‘s-Gravenhage referred five questions by decision of 12 October 2012.

The applicable law

The case concerns Articles 1(b), 3(c), 4, 5, 13 and 14 of Regulation 469/2009. The Court recalled that where a product is protected by several basic patents, each may give rise to a certificate, but only one certificate may be granted for each basic patent (paras 27 and 28, referring to Biogen and AHP Manufacturing).

Question

Does Article 3(c) preclude the proprietor of a patent protecting several products from obtaining an SPC for each of them, in particular for a single active ingredient where it already holds a certificate for a combination containing it?

Decision

A patent protecting several different products may in principle support several certificates, provided that each product is protected as such by the basic patent and is contained in a medicinal product with an MA (paras 29 and 30). Neither Article 1(b) nor Article 3(c) rules this out, and the aim of encouraging pharmaceutical research supports it, since the proprietor might otherwise be driven to file a separate basic patent for each product (para 31). The case differs from Actavis, where the patent protected a single active ingredient and the second certificate sought covered a combination of it with an unprotected active ingredient (paras 33 and 34). As Georgetown’s patent protected both the four-ingredient combination and HPV-16 alone, Article 3(c) did not in principle preclude two certificates based on the Gardasil MA, which would expire on the same date (para 35). Once the certificates expire, third parties are free to market any medicinal product containing the single ingredient or the combination (paras 39 and 40). The remaining questions, including those on surrender of certificates, did not need answering (paras 42 and 43).

Key points for practice

• A single patent may support several SPCs if it protects several products, each as such, and each is contained in an authorised medicinal product (para 30).
• The holder of an SPC for a combination may obtain a separate SPC for a component of that combination protected on its own by the patent (para 41 and operative part).
• The distinction from Actavis lies in whether each active ingredient concerned is protected as such by the basic patent (paras 33 to 35).
• Practical point: where the basic patent protects both a combination and its components, separate certificates may be sought on the same MA; as they expire on the same date, they protect each product without extending the term.

Provisions applied

Regulation (EC) No 469/2009

Arts 1, 3, 4, 5, 13 and 14

National law

Rijksoctrooiwet 1995, Arts 63 and 75 (set out in the order for reference)

Case law cited

Biogen (C-181/95); AHP Manufacturing (C-482/07); Medeva (C-322/10); Georgetown University and Others (C-422/10); Actavis Group PTC and Actavis UK (C-443/12); Neurim Pharmaceuticals (C-130/11); Hogan Lovells International (C-229/09); Daiichi Sankyo (C-6/11, order); University of Queensland and CSL (C-630/10, order)

Related decisions

• Actavis v Sanofi, CJEU, 12 December 2013, delivered the same day, cited and distinguished (paras 30 and 33 to 34).
• Medeva, CJEU, 24 November 2011, cited.
• Neurim, CJEU, 19 July 2012, 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.