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

For the purposes of Article 3(d) of the Council Regulation 1768/92/EEC, the relevant authorisation is the first authorisation to place the active ingredient on the market as any medicinal product. The intended use, target species and therapeutic indication do not alter that rule. A later patent, including one for a second medical use, does not make a later authorisation the first authorisation for the product. The Regulation’s teleological objectives cannot override the clear principles established by the Court of Justice.

Neurim appealed from the hearing officer’s refusal of its application for a supplementary protection certificate for melatonin under the Council Regulation 1768/92/EEC. The application relied on a 2007 human medicinal-product authorisation for Circadin, used to treat insomnia in older patients. Melatonin had previously been authorised in a veterinary medicinal product, Regulin, for sheep.

The parties agreed that the products did not fall within each other’s patent claims. The central issue was whether the earlier veterinary authorisation prevented the Circadin authorisation from being the first authorisation to place melatonin on the market as a medicinal product under Article 3(d).

1. The appeal was dismissed. The hearing officer had correctly concluded that the Circadin authorisation was not the first authorisation to place melatonin on the market as a medicinal product.

2. Article 3(d) had to be interpreted in accordance with the overall scheme and objectives of the Regulation, as stated in AHP Manufacturing BV v Bureau voor de Industriële Eigendom Case C-482/07. Those objectives included encouraging pharmaceutical research, securing a uniform Community solution, protecting public health and taking account of third-party interests.

3. Those objectives did not displace the established interpretation of the Regulation. The Court of Justice had held in Pharmacia Italia SpA Case C-31/03 that the intended use of the product was not decisive and that the protection extended to medicinal use without distinction between human and veterinary use. Massachusetts Institute of Technology Case C-431/04 and Yissum Research and Development Company of the Hebrew University of Jerusalem v Comptroller-General of Patents Case C-202/05 confirmed that the product meant the active ingredient, not its therapeutic use.

4. A later patent or second medical-use authorisation did not alter the identity of the product or the date of its first authorisation. The fact that the present case involved both a different indication and a different species did not distinguish the Court of Justice authorities. If neither difference was individually material, their combination could not be material.

5. The interpretation was acte clair. A reference to the Court of Justice was therefore unnecessary.

• High Court (Patents Court): dismissed the appeal from the hearing officer’s decision dated 15 December 2009, BL O/384/09.