Article: January 2013 European Litigation Update

The European Court of Justice (ECJ) on European Supplementary Protection Certificate (SPC) for Further Medical Uses: With a remarkable ruling from July 2012 (Neurim Pharmaceuticals, C-130/11), the European Court of Justice (ECJ) substantiated its interpretation of the granting conditions for the European Supplementary Protection Certificate (SPC) for medicinal products by extending the scope of protection to usage patents. This judgment further liberalizes the SPC system and subsequently will stimulate investments of pharmaceutical or biotech companies researching on new medical uses of earlier marketed products.

General Background on the SPC: Subject to European regulations complemented by national legislation, e.g. by section 16a of the German Patent Act, the SPC generally allows for supplementary protection of patents for products depending on regulatory licensing. The SPC provides a maximum of an additional five years of protection to compensate the patent owner for the loss of time for effective use due to the period that elapses between the filing of an application for a patent for a new product and the authorization to place the product on the market. Within European legislation, the lack of effective protection has been considered to penalize research, potentially leading to a relocation of research centers situated in the Member States to countries that offer greater protection. In view of the purpose of promoting protection for research, the SPC so far has been introduced by European regulations for medicinal products and for plant protection products such as herbicides and insecticides. By virtue of the direct effect of European regulations, the granting conditions are thereby governed by European Law, being subject to the jurisdiction of the European Court of Justice (ECJ).

The Neurim Case: In the recent decision Neurim Pharmaceuticals, the ECJ inter alia had to substantiate its interpretation of Regulation (EC) No 469/2009 concerning the SPC for medicinal products. The referring UK court first and foremost was seeking clarification on the requirement pursuant to Article 3(d) of the Regulation that the marketing authorization referred to in the SPC application has to be the first authorization to market as a medicinal product.

The case concerned Neurim’s discovery that appropriate formulations of the natural hormone melatonin could be used as a medicine for insomnia. Based on a patent protecting a medical product for human use called “Circadin”, Neurim applied for a grant of an SPC. This application was rejected by the UK Intellectual Property Office as being contrary to Article 3(d) of the Regulation, since an earlier marketing authorization already had been granted for a medical use of melatonin with respect to regulating the seasonal breeding activity of sheep under the mark “Regulin”.

ECJ Ruling: The Court followed the opinion of the Advocate General and decided that the mere existence of an earlier marketing authorization obtained for a veterinary medicinal product does not preclude the grant of a SPC for a different application of the same product for which marketing authorization 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 SPC. Furthermore, Article 13 (1), defining the duration of the SPC, equally must be interpreted as meaning that it refers to the marketing authorization of a product that comes within the limits of the protection conferred by the basic patent relied upon for the purposes of the SPC application.

The reasoning is formal and logical, as it is not only based on the wording and context of the Regulation, but also on its protective purpose, as the introduction of SPC was meant to foster research within the Member States, by preventing a relocation of research centers due to a lack of adequate protection. In these premises, the decision rightly broadens the application range of SPCs by including usage patents for new medical developments of earlier known medicinal products in the scope of supplementary protection.