Neurim Pharmaceuticals (1991) Ltd v The Comptroller-General of Patents

On the Court’s provisional view, the first authorisation under Article 3(d) of the SPC regime should be the first relevant authorisation for a product within the scope of the basic patent. It need not be the earliest authorisation of the same active ingredient for an unrelated human or veterinary use. That interpretation better supports the Regulation’s purpose of encouraging pharmaceutical research, including patentable new formulations and second medical uses. The issue was not acte clair. Questions were therefore referred to the CJEU, and the appeal was not finally determined.

Neurim appealed against Arnold J’s decision, reported at [2010] EWHC 976 (Pat), upholding the Intellectual Property Office’s refusal of a supplementary protection certificate. Neurim’s patent covered controlled-release melatonin formulations for treating insomnia, supported by a 2007 marketing authorisation for Circadin. The Comptroller relied on earlier authorisations for melatonin products used in sheep and mink, although those products and uses fell outside the scope of Neurim’s patent. The central issue was whether Article 3(d) required the earliest authorisation of the active ingredient for any medicinal use, or the first authorisation relevant to the basic patent.

The Court of Appeal did not finally determine the merits of the SPC application. It considered that the issue was not acte clair and referred questions to the CJEU.

1. Statutory issue. The dispute concerned the meaning of the first authorisation under Article 3(d) of the SPC Regulation EEC 1768/92. The Comptroller’s case treated melatonin as the product and the earlier human or veterinary authorisation as decisive, regardless of the use protected by the basic patent.
2. Provisional interpretation. The Court considered Neurim’s competing interpretation tenable and, in its view, correct. The relevant authorisation should be linked to a product and use falling within the scope of the basic patent. An authorisation for an unrelated melatonin product would therefore not necessarily prevent an SPC based on the later patent.
3. Purpose of the Regulation. The Court regarded the encouragement and reward of pharmaceutical research as central. That research includes patentable new formulations of known active substances and new medical uses. A contrary construction could leave substantial areas of such research without effective SPC protection and make the Regulation unfit for purpose.
4. Scope of the reference. The earlier authorisations concerned products and patent rights legally distinct from Neurim’s formulation. The Court’s views on the interpretation were expressed to assist the CJEU; the final legal answer and the appeal’s disposition remained for the subsequent reference.

1. Court of Appeal (Civil Division): Considered the issue not acte clair, referred questions to the CJEU, and expressed a provisional view favouring Neurim’s interpretation.
2. High Court of Justice, Chancery Division (Patents Court): Arnold J upheld the Intellectual Property Office’s refusal of the supplementary protection certificate: [2010] EWHC 976 (Pat).