Artist Bjørn Bjørnholt

The European SPC system has been liberalized- Judgment of the CJEU in Case C-130/11 ‘Neurim

Pharmaceuticals’

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Background

- Recently the Court of Justice of the European Union (CJEU) passed judgment in case C-130/11 'Neurim Pharmaceuticals'. This was a judgment eagerly awaited by SPC practitioners since it would clarify whether in some cases an SPC can be granted based on a new marketing authorization even though the product (i.e. the Active Product Ingredient(s)) had been prior approved in an earlier marketing authorization.

- Earlier case law has made it quite clear that an SPC could not be obtained based on an already approved product, even if the earlier product was for use in the treatment of a different disease, or if the dose or formulation was different, etc. In essence, a 'second medical use' as defined in the EPC could not form the basis for an SPC if the product/API had prior approval.

 

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The decision and implications

- In the Neurim case the product (melatonin) had an earlier veterinary approval for use in regulating breeding activity in sheep, but had since been approved in Europe for use in the treatment of insomnia in humans. Neurim, who had developed and patented the insomina medicine, applied for an SPC, which was rejected based on the above-mentioned case law, and eventually referred to the CJEU.

- The decision of the CJEU was that Neurim Pharmaceuticals should be granted an SPC based on the approval for human use. Further, the wording of judgment clearly indicates that the decision is not limited to situations where the earlier approval is veterinary, and the new approval is for human use. It is stated in the judgment that at least second medical uses in the form of “new therapeutic indications” may in the future form the basis for an SPC.

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Concluding remark

- In conclusion, be aware that there are now even more cases where it is worth checking whether your medical or agrochemical products may be eligible for an SPC.