Posted: July 17th, 2020
Santen – Clear Judgment by the Court of Justice of the European Union, by Tobias Wuttke Dr. Tobias Popp, Meissner Bolte
The recently published judgement of the Court of Justice of the European Union (“CJEU”) dated 9 July 2020 (C-673/18 – Santen) does not merely concern supplementary protection certificates (“SPCs”), which can extend the term of patent protection by up to five years. The judgment affects pharmaceutical industry and research as well as public health within the European Union.
The CJEU decided that Article 3(d) of Regulation (EC) No 469/2009 (“the regulation”) of the European Parliament and of the Council of 6 May 2009 concerning SPCs for medicinal products must be interpreted as meaning that a marketing authorization (“MA”) cannot be considered to be the first MA, 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 MA for a different therapeutic application.
The entire article can be read here.
The judgment (available in various languages) can be read here.
It is now clear that a SPC will not be available for a second or further medical use of a know product.
It will be interesting to see whether the new situation will impact filings for second or further medical uses.
I do not think so, but I could be wrong!