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ARTICLE · 16 OCTOBER 2015

CJEU Decides On Calculation Of SPC Term

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The CJEU has decided on a matter of great importance for applicants of pharmaceutical patents who have already obtained a supplementary protection certificate on the basis of a marketing authorization or who intend to do so.

European UnionIntellectual Property
Christian Fulda
Christian Fulda
Tetiana Kharkovets
Tetiana Kharkovets
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The European Court of Justice ("CJEU") has decided on a matter of great importance for applicants of pharmaceutical patents who have already obtained a supplementary protection certificate ("SPC") on the basis of a marketing authorization ("MA") or who intend to do so. The question answered by the decision in C-471/14 Seattle Genetics Inc. related to the calculation of the SPC term, and it has a direct impact on the duration of the SPC protection.

SPCs provide additional protection for pharmaceutical patents after their expiry and are intended to compensate for the long and costly authorization procedure necessary to bring a product to market. The duration of an SPC is calculated according to Art. 13 of the SPC Regulation as an interval between the patent filing and "the date of the first authorization to place the product on the market in the Community" reduced by five years. The maximum duration allowed is limited to five years. Whereas the filing date of the basic

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