The Court of Justice of the European Union (CJEU) commented in its recent decision C-130/11 on a reference which had been made in the context of a dispute between Neurim Pharmaceuticals Ltd. (Neurim) and the United Kingdom Intellectual Property Office (IPO). On July 19, 2012, the CJEU published its decision wherein it commented on the requirements of the first marketing authorization in the EEA which forms the basis for calculating the term of an SPC.

In the case presented to the CJEU Neurim obtained a marketing authorization for a medicinal product for human use containing melatonin for the treatment of insomnia. Since Neurim owned a patent granted for the new medical use of the known human hormone melatonin, Neurim applied for an SPC on the basis of the marketing authorization. The IPO refused to grant the request, reasoning that this marketing authorization was not the first marketing authorization in the EEA for a medicament containing melatonin. In fact there had been a marketing authorization issued in 2001 for melatonin for use in treating sheep for regulating seasonal breeding activity. Neurim appealed this decision, and the Court of Appeal decided to refer several questions to the CJEU. The court asked whether the grant of an SPC based on a new medicament is precluded by an older marketing authorization for an older medicament containing the same active ingredient used for a different purpose. Further, the court asked whether it makes a difference that a marketing authorization for a medicament for animals does not have the same effect as a marketing authorization for a medicament for human beings.

In C-130/11 the CJEU ruled that the refusal of the SPC to Neurim was not justified. It explained that an SPC can be obtained for a patent covering a new medical use of a known active ingredient, wherein the scope of protection of such an SPC is limited to the new medical use. Further, the CJEU clarified that in such a case the marketing authorization for the medicinal product comprising the ingredient and authorised for the new medical use corresponding to that protected by the basic patent is to be considered the first marketing authorization according to Article 3(d) of the SPC regulation. This would not be different if the marketing authorizations have different application requirements (human vs. veterinary) or if the product covered by the first marketing authorization is within the scope of a different patent not belonging to the SPC applicant. 

Should you have any questions, please feel free to contact lenhard@mueller-bore.de