Up until now, the Danish Patent Office (Patent- og Varemærkestyrelsen) has allowed SPC applications for medicines based on a different medical use than the already approved use of a medicinal product, considering the marketing approval of the further medical use as the "first authorisation to place the product on the market" for the purposes of Article 3(d) of the SPC Regulation (EC 469/2009).
In view of the Santen decision from the CJEU (C-673/18), the Danish Patent Office has now decided to discontinue this practice and not approve SPC applications based on a further medical use of an already approved medicinal product (since it would in fact not comply with Article 3(d)).
The new practice applies to future SPC applications as well as pending applications. However, already granted SPCs that would have been refused based on the new practice will not be examined ex officio by the Danish Patent Office. Any third party interested in having an incorrectly granted SPC re-examined by the Danish Patent Office can instigate this by filing a request for re-examination.
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