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ARTICLE · 02 JANUARY 2025

CJEU Clarifies SPC Eligibility For Combination Products

Potter Clarkson LLP
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The Court of Justice of the European Union (CJEU) has issued its long-awaited judgement on the interpretation of Articles 3(a) and (c) of the SPC Regulation in the joined cases C-119/22 and C-149/22.

European UnionIntellectual Property
Molly Lightowler
Molly Lightowler
Hannah Kite
Hannah Kite
Michael Pears
Michael Pears
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The Court of Justice of the European Union (CJEU) has issued its long-awaited judgement on the interpretation of Articles 3(a) and (c) of the SPC Regulation in the joined cases C-119/22 and C-149/22.

These cases relate to SPCs for combination products where one active ingredient is the subject of its own claims in the patent and the other active ingredient was already known yet is also expressly referenced in the claims. The CJEU confirms that:

  • Grant of SPC for Combination Products: Article 3(c) does not prevent the grant of an SPC for a product consisting of two active ingredients, even if one of those ingredients has already been the subject of an earlier SPC and is the only one disclosed by the basic patent, while the other active ingredient was known at the filing or priority date of the patent.

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