Patent holder is not required to give notification of his intention to oppose a proposed importation

PATENT LAW – SPC

The holder of a patent or SPC is not required to give notification of his intention to oppose a proposed importation before invoking his rights under the first paragraph of the mechanism from the 2003 Act of Accession to the European Union

"33 In the light of the foregoing, the answer to Questions 1 and 2 is that the second paragraph of the Specific Mechanism must be interpreted as not requiring the holder, or beneficiary, of a patent of SPC to give notification of his intention to oppose a proposed importation before invoking his rights under the first paragraph of that mechanism."

The second paragraph of the mechanism prevents that the holder the possibility of relying on his rights with regard to any importation and marketing of the pharmaceutical product carried out before such an intention was indicated.

"33 However, if such a holder or beneficiary does not indicate such an intention during the one-month waiting period laid down in the second paragraph of the mechanism, the person proposing to import the pharmaceutical product in question may legitimately apply to the competent authorities for authorisation to import the product and, where appropriate, import and market it. The specific mechanism thus denies that holder or his beneficiary the possibility of relying on his rights under the first paragraph of the mechanism with regard to any importation and marketing of the pharmaceutical product carried out before such an intention was indicated."

IPPT20150212, CJEU, Merck v SIGMA

C-539/13 - ECLI:EU:C:2015:87