Validity of SPC is no longer than 15 years from the first MA in the European Union

PATENT LAW – LITIGATION

Tribunal Arbitral necessário must be considered to be a court or tribunal for the purposes of article 267 TFEU.

"25.Taking all of those considerations into account, it must be held that, in circumstances such as those of the main proceedings, the Tribunal Arbitral necessário fulfils all of the conditions laid down by the case-law of the Court, as set out in paragraphs 16 to 19 of the present order, and must be considered to be a court or tribunal for the purposes of Article 267 TFEU."

Validity of SPC is no longer than 15 years from the first MA in the European Union.

"34. In the light of the foregoing considerations, the answer to the question referred is that Article 13 of Regulation No 469/2009, when read in conjunction with recital 9 thereto, must be interpreted as meaning that it precludes the holder of both a patent and a certificate from relying on the entire period of validity of the certificate, calculated in accordance with Article 13, in a situation where, pursuant to such a period, it would enjoy a period of exclusivity as regards an active ingredient, of more than 15 years from the first MA, in the European Union, of a medicinal product consisting of that active ingredient, or containing it."

IPPT20140213, CJEU, Merck Canada

C‑555/13 - ECLI:EU:C:2014:92