Neurim v Comptroller-General of Patents (CJEU, C-130/11, 2012)

Dhenne Avocats · 11 October 2026

Our analysis

Summary

On a reference from the Court of Appeal (England and Wales), the Court held that an earlier marketing authorisation (MA) for a veterinary medicinal product containing the same active ingredient does not preclude an SPC for a different application of that product covered by its own MA, provided that the application falls within the protection conferred by the basic patent. The first MA under Article 3(d) and the Union MA under Article 13(1) are those of a product within the limits of that protection. Sitting as a Grand Chamber, the Court departed from this reading in Santen of 9 July 2020 (C-673/18), in the light of which the judgment must now be read.

Facts and procedure

Melatonin, a natural hormone, is not patented as such. Neurim holds a patent, applied for on 23 April 1992, for a melatonin formulation for treating insomnia, marketed as Circadin, for which the Commission granted an MA on 28 June 2007. The UK Intellectual Property Office refused its SPC application on 15 December 2009 because of a veterinary MA granted in 2001 for a melatonin product for sheep (Regulin). The High Court dismissed Neurim’s appeal; the Court of Appeal, considering its arguments well founded, stayed the proceedings and referred five questions by decision of 11 March 2011.

The applicable law

The case concerns Articles 2, 3, 4 and 13(1) of Regulation 469/2009 and Article 8(3) of Directive 2001/83. The Court recalled that the fundamental objective of the Regulation is to ensure sufficient protection to encourage pharmaceutical research, since the period of effective protection under the patent is insufficient to recoup the investment (paras 22 and 23). It relied on the 1990 explanatory memorandum, according to which a patent protecting a new application of a new or known product may support an SPC (para 24).

Question

Does an earlier MA for a veterinary medicinal product containing the same active ingredient bar an SPC based on a later MA for a different application protected by the basic patent?

Decision

Where a patent protects a therapeutic application of a known active ingredient already marketed as a veterinary or human medicinal product for other indications, the marketing of a new medicinal product exploiting that application may support an SPC whose scope covers only the new use, not the active ingredient (para 25). Only the MA of the first medicinal product comprising the product and authorised for a therapeutic use corresponding to that protected by the patent may then be regarded as the first MA of that product under Article 3(d) (para 26). Articles 3 and 4 therefore do not preclude the grant of the certificate in a case such as this one (para 27). The Union MA referred to in Article 13(1), which determines the duration of the certificate, is a further condition rather than a substitute for the national MA under Article 3(b); there is no reason to assess it by different criteria, so it too refers to the MA of a product within the limits of the protection conferred by the basic patent (paras 29 to 31). The answers would be the same if the second MA had required a full application under Article 8(3) of Directive 2001/83, or if the product covered by the first MA fell within a different patent belonging to a different proprietor (paras 32 to 35 and operative part).

Key points for practice

• The judgment ties the concept of first MA to the scope of the protection conferred by the basic patent rather than to the active ingredient alone (paras 26 and 30).
• An SPC obtained on this basis covers only the new use of the product, not the active ingredient as such (para 25).
• The duration of the certificate runs from the first Union MA within the protection of the patent relied on (para 31).
• Practical point: since Santen of 9 July 2020 (C-673/18), an MA for a new therapeutic application of an active ingredient already authorised for a different application can no longer be regarded as the first MA; Neurim can no longer support an SPC application.

Provisions applied

Regulation (EC) No 469/2009

Arts 1, 2, 3, 4 and 13

Directive 2001/83/EC

Art. 8(3)

Case law cited

Synthon (C-195/09); Medeva (C-322/10); Georgetown University and Others (C-422/10); University of Queensland and CSL (C-630/10, order); Hässle (C-127/00)

Related decisions

• Medeva, CJEU, 24 November 2011, cited on the purpose of the Regulation and on new-application patents (paras 22 to 24).

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.