Santen ends Neurim-style SPCs

The wording of Article 3(d) of the SPC Regulation requires that the SPC application must rely on “the first authorisation to place the product on the market as a medicinal product”. This suggests that a marketing authorisation granted for a new indication of a previously approved active cannot be relied upon as the basis of an SPC for the patent directed to the new medical use.

However, based on a purposive construction of the Regulation, the CJEU decision in Neurim in 2012 opened the door to just that possibility.

Unusually, the CJEU has now reversed its own decision in the Santen decision C673/18 issued on 9 July 2020. A later MA to a different indication cannot be used as the “first MA” supporting an SPC on a new medical use of the same active:

“Article 3(d) of [the SPC Regulation] 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.”

Neurim was always the problem child, out of step with earlier CJEU decisions, and national patent offices struggled to know how to apply it. In Santen, the CJEU expressly now disapproves of the Neurim logic (see paragraph 53 of the decision).

In reaching its decision, the CJEU (sitting with 13 judges) first concluded that the definition of an active ingredient under Article 1(b) of the SPC regulation does not import any use-limitation:

“…..the fact that an active ingredient, or a combination of active ingredients, is used for the purposes of a new therapeutic application does not confer on it the status of a distinct product where the same active ingredient, or the same combination of active ingredients, has been used for the purposes of a different, already known, therapeutic application”.

As a result, Article 3(d) of the Regulation must then refer to the first MA for any use:

“In addition, in the light of the strict definition of the term ‘product’ within the meaning of Article1(b) of Regulation No469/2009, .. the analysis of the wording of Article3(d) of that regulation presupposes that the first MA for the product as a medicinal product for the purpose of that provision means the first MA for a medicinal product incorporating the active ingredient or the combination of active ingredients at issue (see, to that effect, judgment of 21March 2019,Abraxis Bioscience, C‑443/17, EU:C:2019:238, paragraph34), irrespective of the therapeutic application of that active ingredient, or of that combination of active ingredients, in respect of which that MA was obtained.”

So, the Neurim logic appears to be dead.

Crucially, any products protected by SPCs based on second or further medical use patents, and relying on a second, or later, MA for that active may now be vulnerable to immediate generic competition.