欧州での合剤の特許権の延長(C-322/10とC-422/10)
合剤についてのECJの判決がついに出ました。侵害テストと保護テストについて、一応の決着を見ました。
今回はJETROのリリースに、やや分かりにくさがあるように思います。
C-322/10
1. Article 3(a) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as precluding the competent industrial property office of a Member State from granting a supplementary protection certificate relating to active ingredients which are not specified in the wording of the claims of the basic patent relied on in support of the application for such a certificate.
2. Article 3(b) of Regulation No 469/2009 must be interpreted as meaning that, provided the other requirements laid down in Article 3 are also met, that provision does not preclude the competent industrial property office of a Member State from granting a supplementary protection certificate for a combination of two active ingredients, corresponding to that specified in the wording of the claims of the basic patent relied on, where the medicinal product for which the marketing authorisation is submitted in support of the application for a special protection certificate contains not only that combination of the two active ingredients but also other active ingredients.
C-422/10
Article 3(b) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that, provided the other requirements laid down in Article 3 are also met, that provision does not preclude the competent industrial property office of a Member State from granting a supplementary protection certificate for an active ingredient specified in the wording of the claims of the basic patent relied on, where the medicinal product for which the marketing authorisation is submitted in support of the supplementary protection certificate application contains not only that active ingredient but also other active ingredients.
<JETROのプレスリリースにおける関連条文の仮訳>
医薬品の補充的保護証明書に関する規則(2009/469)
第3条 証明書取得のための条件
第7条に記載する申請が行われた加盟国において,かつ,その申請日に,次の場合,証明書を付与する:
(a) 製品が効力を有する基本特許によって保護され;
(b) 必要に応じ,指令2001/83/ECまたは指令2001/82/ECに従い,当該製品を医薬製品として市場に出す有効な認可が付与され;
(c) 当該製品が既に証明書の対象とされておらず;
(d) (b)に記載される認可が,当該製品を医薬品として市場に出す最初の認可であること。
今回はJETROのリリースに、やや分かりにくさがあるように思います。
C-322/10
1. Article 3(a) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as precluding the competent industrial property office of a Member State from granting a supplementary protection certificate relating to active ingredients which are not specified in the wording of the claims of the basic patent relied on in support of the application for such a certificate.
2. Article 3(b) of Regulation No 469/2009 must be interpreted as meaning that, provided the other requirements laid down in Article 3 are also met, that provision does not preclude the competent industrial property office of a Member State from granting a supplementary protection certificate for a combination of two active ingredients, corresponding to that specified in the wording of the claims of the basic patent relied on, where the medicinal product for which the marketing authorisation is submitted in support of the application for a special protection certificate contains not only that combination of the two active ingredients but also other active ingredients.
C-422/10
Article 3(b) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that, provided the other requirements laid down in Article 3 are also met, that provision does not preclude the competent industrial property office of a Member State from granting a supplementary protection certificate for an active ingredient specified in the wording of the claims of the basic patent relied on, where the medicinal product for which the marketing authorisation is submitted in support of the supplementary protection certificate application contains not only that active ingredient but also other active ingredients.
<JETROのプレスリリースにおける関連条文の仮訳>
医薬品の補充的保護証明書に関する規則(2009/469)
第3条 証明書取得のための条件
第7条に記載する申請が行われた加盟国において,かつ,その申請日に,次の場合,証明書を付与する:
(a) 製品が効力を有する基本特許によって保護され;
(b) 必要に応じ,指令2001/83/ECまたは指令2001/82/ECに従い,当該製品を医薬製品として市場に出す有効な認可が付与され;
(c) 当該製品が既に証明書の対象とされておらず;
(d) (b)に記載される認可が,当該製品を医薬品として市場に出す最初の認可であること。