“Neurim”: The European Court of Justice gives green light to supplementary protection certificates in cases there is more than one Authorization for commercialization
The European Court of Justice (ECJ) on its decision of 19th July 2012, C-130/11,”Neurim” has clarified the requirements needed in order to obtain a supplementary protection certificate (SPC) in those cases in which this certificate is applied for a second therapeutic use of a given active ingredient.
In the case at hand, Neurim Pharmaceuticals after some research discovered that appropriate formulations of melatonin could be used as a medicine for insomnia. Aiming at the protection of such an invention, Neurim applied for the corresponding patent that was subsequently granted. After this, Neurim also applied for the authorization to place the medicinal product on the market (MA) that was equally issued on June the 28th 2007. In that date, the patent base for that MA had a useful life remaining of only 5 years, a fact that made Neurim apply for a SPC in order to extend protection for their medicament. Unlike the previous applications, this SPC was denied.
The reason for this was no other than a previous SCP on melatonin had been issued (in this case as a medicine for sheep treatment based on a patent property of a different company). The IPO -the British authority in charge of the granting of the SPC- invoked art 3.d of the Regulation 469/2009 in order to back its decision on the denial, since the wording of this article explicitly states there can only be one MA issued for the given product as a medicine: “the authorization (…) is the first authorization to place the product on the market as a medicinal product.” Following this wording, the IPO said that melatonin was “the product” thus an authorization had already been given when it was approved for prior use in sheeps.
Neurim argued that this previous veterinary use was irrelevant for the granting of the MA they had applied for. The new claimed use for melatonin fell within the scope of a new patent and therefore a new MA and a new SCP should have the chance to be issued.
Accordingly, since each patent is entitled to have its own SPC, the relevant MA on which to base Neurim´s intended SCP is the one based on their own patent and not in the patent owned by a third party (and that had already been granted a SPC).
With this factual background, the Court considers whether the fact there is a previous SCP on a given product prevents the possibility to issue a second SCP on that same product but for a different use. The conclusion is positive: in those cases where a patent protects a new therapeutic use of an active ingredient (being this already known and marketed as a medicine), the market release of a new medicine that commercially exploits this new use, as it is protected by the base patent (the patent protecting the new use), enables its owner to ask for a second SCP. However in this case, the SCP protection will embrace only the new use of the active ingredient and not the active ingredient itself.
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