On 19 July 2012, the Court of Justice of the European Union (CJEU) handed down its ruling in Case C 130/11 Neurim Pharmaceuticals (1991) Ltd v Comptroller-General of Patents regarding whether or not a supplementary protection certificate (SPC) granted to Hoescht in relation to a patent for a melatonin product, Regulin, which assisted in regulating sheep’s breeding activities precluded an SPC being granted to extend the term of a later patent granted to Neurim for another melatonin product, Circadin, used in the treatment of insomnia (in humans).
Neurim’s patent for Circadin was dated 23 April 1992 but Neurim did not obtain its marketing authorisation until June 2007 thus leaving it with less than five years left to run on its patent. This allowed Neurim to apply for an SPC to extend the life of its patent to make up partially for the regulatory delay incurred.
However, the UK Intellectual Property Office (UK IPO) refused to grant the SPC to Neurim on the basis that an SPC had already been granted in relation to a patent for a product using the same active ingredient being the melatonin used in Hoescht’s sheep product, Regulin. Neurim appealed and Arnold J of the High Court of Justice (Chancery Division – Patents Court) dismissed the appeal and saw no need to refer questions to the CJEU regarding the interpretation of the Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (codified version) (SPC Regulation). Arnold J stated that the meaning of the relevant Articles of the SPC Regulation were clear and previous CJEU rulings endorsed the interpretation that the relevant marketing authorisation upon which an SPC is based must be the first marketing authorisation to place the product on the market. As only one SPC can be granted per product, this had already occurred in relation to the sheep melatonin product, Regulin.
Neurim appealed to the Court of Appeal which saw merit in Neurim’s arguments that the marketing authorisation for Regulin was irrelevant in identifying the “first authorisation” for the purposes of Neurim’s application for an SPC because Regulin’s marketing authorisation related to a product protected by a different patent (although that product contained the same active ingredient) and did not relate to the formulation and use which was the subject matter of the claims of Neurim’s basic patent for its human Circadin product. On this basis, the Court of Appeal referred five questions to the CJEU.
In May 2012, Advocate General Trstenjak gave an opinion that supported Neurim’s position stating that the first relevant marketing authorisation in the EU should be interpreted as meaning the first marketing authorisation that falls within the scope of protection conferred by the patent on which the SPC application is based (not any other patented invention which includes the same active ingredient). The CJEU agreed and held that the SPC Regulation “must be interpreted as meaning that … the mere existence of an earlier marketing authorisation obtained for a veterinary medicinal product does not preclude the grant of a supplementary protection certificate for a different application of the same product for which a marketing authorisation has been granted, provided that the application is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the supplementary protection certificate”.
The CJEU looked to the intention of the SPC Regulation which was to compensate patentees of pharmaceutical products for the lengthy regulatory delays incurred in bringing products to market thus diminishing the value of their patents and hence, overall return for their research and development endeavours. It did not mention or seek to distinguish previous case law on this issue in any way. This decision will impact the life sciences industry dramatically as it means that SPCs may now be obtained in relation to patented products even where an SPC has been granted previously for a product with the same active ingredient provided the later product is protected by its own separate patent (and therefore has a separate and distinguishable formulation and use).