The Advocate General has now presented his conclusions on C-66/09 to the Court of Justice and these can be summarized as follows:
- the SPC Regulation took effect in Lithuania on the accession date (1 May 04)
- the EMEA marketing authorization for Aranesp (granted in 2001) also took effect in Lithuania on the accession date [NB: Kirin did not seek a separate MA in Lithuania]
- the 'effective' MA date in Lithuania cannot be equated to the date on which the product was first placed on the market within the meaning of article 3(b) of the Regulation
- Kirin cannot therefore be granted a SPC because they had not obtained a Lithuanian MA for Aranesp before the accession date.
Unfortunately, the Opinion isn't available in English yet, but in French or in German, or if you're up for a challenge this weekend you can read it in Lithuanian here.
Thanks to Marc Nevant (Cabinet Beau de Loménie) for providing an English summary of the conclusions.
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