One of the most controversial topics in the SPC field is whether the development of a known drug for a new therapeutic use justifies the grant of an SPC.
Several years ago, the CJEU in the so-called “Neurim” case (C-130/11) adopted a rather liberal approach, holding that the mere existence of an earlier marketing authorization obtained for a veterinary medicinal product does not preclude the grant of an SPC for a different application of the same product for which a marketing authorization has been granted, as long as this application is within the scope of the basic patent. However, this liberal approach was now explicitly given up in the recent “Santen” decision (C 673/18).
The CJEU found that in the case at issue the requirement of Article 3d of Regulation No 469/2009 according to which the SPC application must refer to “the first authorisation to place the product on the market as a medicinal product” are not met, as:
“Article 3(d) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that a marketing authorisation cannot be considered to be the first marketing authorisation, for the purpose of that provision, where it covers a new therapeutic application of an active ingredient, or of a combination of active ingredients, and that active ingredient or combination has already been the subject of a marketing authorisation for a different therapeutic application.”
In reaching this decision the CJEU adopted a narrow definition of the term “product” in Article 1(b) of Regulation (EC) No 469/2009 by reference to an active ingredient or combination of active ingredients and not by reference to the therapeutic application of an active ingredient protected by the basic patent or a combination of active ingredients protected by the basic patent.
The present decision will probably have a huge impact on generic and biosimilar competition, as it does no longer allow originator companies to extend protection of their product by filing SPCs based on new therapeutic uses of their product. Existing granted SPCs based on new therapeutic uses may also be vulnerable to validity attacks. It is therefore recommended to re-evaluate the SPC situation for a given product in light of this decision.