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Can a Supplementary Protection Certificate (SPC) be obtained for a previously marketed active ingredient?

Date: 3 May 2012

Opinion of Advocate General of 3rd May 2012 Case C-130/11 Neurim Pharmaceuticals


Neurim Pharmaceuticals (Neurim) discovered that certain formulations of melatonin, a natural hormone, can be used as a medicine against insomnia. Neurim was granted a patent and applied for a marketing authorisation for a product for human use. The medicinal product is currently sold under the name "Circadin". However, by the time the marketing authorisation was granted, the patent had less than five years to run and Neurim filed an application for a Supplementary Protection Certificate.


The UKIPO rejected the application. According to the UKIPO, Neurim's marketing authorisation was not the first marketing authorisation within the meaning of Article 3(d) of Regulation 1768/92 because there was an earlier marketing authorisation, which was for melatonin for use in sheep. The veterinary medicinal product was sold under the name "Regulin".


Neurim first brought an action against the IPO decision before the national court, which confirmed the IPO's decision, then appealed to the Court of Appeal who asked the CJEU the following question: when a marketing authorisation has been granted for a medicinal product comprising an active ingredient, can an SPC be granted based on a later marketing authorisation for a different medicinal product comprising the same active ingredient? Advocate Trstenjak's opinion is "yes".


She explains that a purely literal interpretation of Article 3(d) of Regulation 1768/92 would mean that no SPC can be granted for the medicinal product for human use, because of the first marketing authorisation for the veterinary product. However, she recognises that increasingly pharmaceutical research involves new formulations of old active substances and that such a literal interpretation is not compatible with the objectives of the SPC Regulation. Also, the insertion of Article 54(5) in EPC 2000 expressly recognises the patentability of "second and further medical uses" of known substances and the health and economic importance of such uses.


In her view, in order to achieve a balance of interests and considering the requirements of Article 3(c) (prohibiting the grant of more than one certificate for each basic patent), she proposes that "The fact that the same product has previously been authorised as a medicinal product for human use or a veterinary medicinal product in the Member State for which the application is made does not preclude the grant of a supplementary protection certificate based on a later authorisation to place that product on the market as a new medicinal product, provided the first-authorised medicinal product is not within the scope of protection conferred by the patent designated by the patent designated by the applicant as the basic patent".


We believe that this Opinion, that we hope the CJEU will share, is good news for medicinal patentees.