The Court of Justice of the European Union (CJEU) rendered judgment relating to a preliminary reference from the English Court of Appeal, holding that the existence of an earlier marketing authorization (MA) of a pharmaceutical product does not preclude the grant of a Supplementary Protection Certificate (SPC) for a different application of the same product. Neurim Pharmaceuticals (1991) Ltd v Comptroller-General of Patents (CJEU, C-130/11, July 19, 2012).
The SPC system exists to provide protection to pharmaceutical products past the expiry of their related patents, generally for a maximum period of five years. This is designed to compensate drug developers for delays between innovation and commercial exploitation caused by the complexity of obtaining the necessary authorizations. A SPC confers the same rights as a patent limited to the product authorized by the relevant MA.
The Supplementary Protection Certificate Regulation provides that in order to obtain a SPC, the MA must be the first authorization to place the product on the market as a medicinal product. The SPC Regulation defines “medicinal product” as any substance or combination of substances for treating or preventing disease and defines a “product” as the active ingredient or combination of active ingredients of a medicinal product.
Neurim discovered that certain formulations of melatonin could be used as a treatment for insomnia. Neurim applied for, and was granted, a patent for such formulations, but it took Neurim more than 15 years from filing its patent to being granted a MA. Neurim accordingly applied for a SPC to obtain additional protection beyond the life of the patent based on its June 2007 MA.
The UK Intellectual Property Office (IPO) refused to grant the SPC on the basis that Neurim’s MA was not the first MA for melatonin. The IPO identified an earlier MA for a different melatonin treatment sold under the trademark REGULIN. REGULIN was used in sheep to regulate seasonal breeding activity and was the subject of a different patent from Neurim’s insomnia treatment. Neurim referred the matter to the English courts, but the IPO’s refusal was upheld. Neurim appealed to the Court of Appeal, which decided to make a reference to the CJEU concerning the interpretation of the SPC Regulation.
Central to the CJEU’s reasoning was a recognition that a fundamental objective of the SPC Regulation was to ensure sufficient protection to cover the investment put into product development to encourage pharmaceutical research. The CJEU ruled that the mere existence of an earlier MA obtained for a medicinal product (for veterinary or human use) did not preclude the grant of a SPC for a different application of the same product for which a MA has been granted, provided that the application was within the limits of the protection conferred by the patent relied upon for the purposes of the application for the SPC. Only the first MA of the medicinal product, comprising the product and authorized for a therapeutic use corresponding to that protected by the patent relied upon for the SPC, should be considered to be the first MA of that product as a medicinal product exploiting that new use within the meaning of the SPC Regulation.
Practice Note: This decision continues the teleological, rather than literal, approach to the interpretation of the SPC Regulation adopted by the CJEU in other recent SPC decisions. It is a practical ruling that reduces the barriers to obtaining SPCs for applicants. There is the potential for the same arguments to be applied to obtain SPC protection for other categories of products, such as inventive formulations of known products for known uses. It will be interesting to see the extent to which this decision paves the way for SPC protection beyond secondary medical use products.