The Legal 500

Supplementary Protection Certificates with regard to second marketing authorization of medical compounds (decision of July 19, 2012 – Case C-130/11 –Neurim Pharmaceuticals vs. Comptroller General of Patents)

Neurim Pharmaceuticals (Neurim) had discovered that melatonin, which was not patented as such, could be used as a medicine for insomnia. The European Commission issued Neurim a Marketing Authorisation (MA) on June 28, 2007 for its medicinal product called "Circadin". Neurim applied for an SPC for its medicinal product, basing its application on the Circadin MA which it had just obtained.

The U.K. Intellectual Property Office (UKIPO) refused to grant the request. In its reasoning, the UKIPO stated that the MA for "Regulin", dating from 2001, and issued for the regulation of seasonal breeding activity of sheep, was the first MA. Thus, according to the opinion of the UKIPO, the Circadin MA was not the "first MA" relating to melatonin in the sense of Article 3 (d) of the SPC Regulation 469/2009. That refusal was challenged by Neurim before the High Court of Justice (Chancery Division). In essence, Neurim argued, that the relevant MA for the application of Article 3 (d) of the SPC Regulation is the MA which concerns the product for which the application for the SPC is sought. Although the High Court considered Neurim's arguments well founded, it none the less decided to stay the proceedings in order to refer the questions to the ECJ for a preliminary ruling.

In essence, the High Court asked, whether the provisions of article 3 and 4 of the SPC Regulation are to be interpreted as meaning that the existence of an earlier MA for a veterinary medicinal product is sufficient to preclude the grant of an SPC for the product application which obtained the other MA. As the Commission pointed out that these questions are essentially aimed at establishing whether there is a link between, on the one hand, the MA referred to in Article 3 (b) and (d) of the SPC Regulation, and on the other hand, the basic patent referred to in Article 3 (a) of the Regulation.

The ECJ decided that in such a situation only the MA of the first medicinal product, comprising the product and being authorised for a therapeutic use corresponding to the one protected by the patent underlying the application for the SPC, may be considered to be the "first MA" of "that product", as a medicinal product exploiting a new use within the meaning of Article 3(d) of the SPC Regulation.

Remarks

This decision improves the situation of research and development in the pharmaceutical industry since it supports the development of new medicinal indications for a well-known drug. However, this is only possible in cases in which the scope of the basic patent is very small. The decision confirms the situation for SPC applicants, according to which the narrower the scope of a basic patent (and the related SPC) is, the better the chances are to obtain an SPC. 

© 2012 BARDEHLE PAGENBERG Partnerschaft.
First published in BARDEHLE PAGENBERG IP Report 2012/III

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