Case C-414/11

Daiichi Sankyo Co. Ltd and Sanofi-Aventis Deutschland GmbH

v

DEMO Anonimos Viomikhaniki kai Emporiki Etairia Farmakon

(Request for a preliminary ruling from the Polimeles Protodikio Athinon)

‛Common commercial policy — Article 207 TFEU — Commercial aspects of intellectual property — Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) — Article 27 — Patentable subject-matter — Article 70 — Protection of existing subject-matter’

Summary — Judgment of the Court (Grand Chamber), 18 July 2013

  1. Questions referred for a preliminary ruling — Admissibility — Conditions — Questions relating to the actual facts or purpose of the dispute — Request providing the Court with sufficient information on the factual and legal context

    (Art. 267 TFEU)

  2. Common commercial policy — Scope — Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) — Commercial aspects of intellectual property — Included

    (Arts 113 EC and 133 EC; Arts 3(1)(e) TFEU and 207(1) TFEU; TRIPs Agreement, Art. 27)

  3. International agreements — Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) — Commercial aspects of intellectual property — Patentability of the invention of a pharmaceutical product — Included

    (TRIPs Agreement, Art. 27)

  4. Approximation of laws — Uniform legislation — Industrial and commercial property — Patent right — Supplementary protection certificate for medicinal products — Scope — Application for a patent for the process of manufacture and for the pharmaceutical product — Patent granted solely for the process of manufacture — Coverage extending to the pharmaceutical product by reason of the application of the rules in Articles 27 and 70 of the TRIPs Agreement — Excluded

    (TRIPs Agreement, Arts 27, 65(1) and 70(2); Council Regulation No 1768/92, Arts 4 and 5)

  1.  See the text of the decision.

    (see paras 35-39)

  2.  Article 27 of the Agreement on Trade-Related Aspects of Intellectual Property Rights, which constitutes Annex 1 C to the Agreement establishing the World Trade Organisation, approved by Decision 94/800 concerning the conclusion on behalf of the European Community, as regards matters within its competence, of the agreements reached in the Uruguay Round multilateral negotiations, falls within the field of the common commercial policy.

    Article 207(1) TFEU differs noticeably from the provisions it essentially replaced, so that the question of the distribution of the competences of the European Union and the Member States must be examined on the basis of the Treaty now in force.

    First, in accordance with Article 207(1) TFEU, the common commercial policy falls within the exclusive competence of the European Union, and relates inter alia to the commercial aspects of intellectual property. In that context, the mere fact that an act of the European Union, such as an agreement concluded by it, is liable to have implications for international trade is not enough for it to be concluded that the act must be classified as falling within the common commercial policy, but, on the other hand, it does fall within that policy if it relates specifically to international trade in that it is essentially intended to promote, facilitate or govern trade and has direct and immediate effects on trade. It follows that, of the rules adopted by the European Union in the field of intellectual property, only those with a specific link to international trade are capable of falling within the concept of commercial aspects of intellectual property in Article 207(1) TFEU and hence the field of the common commercial policy.

    Secondly, to regard the rules on patentable subject-matter in Article 27 of the TRIPs Agreement as falling within the field of the common commercial policy rather than the field of the internal market correctly reflects the fact that the context of those rules is the liberalisation of international trade, not the harmonisation of the laws of the Member States of the European Union.

    (see paras 46, 48, 49, 51, 52, 60, 61, operative part 1)

  3.  Article 27 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) must be interpreted as meaning that the invention of a pharmaceutical product such as the active chemical compound of a medicinal product is, in the absence of a derogation in accordance with Article 27(2) or (3), capable of being the subject-matter of a patent, under the conditions set out in Article 27(1).

    That interpretation follows from the actual wording of the TRIPs Agreement. Pharmacology is regarded by the contracting parties to the agreement as a field of technology within the meaning of Article 27(1). That also follows from Article 70(8) of the agreement, which is a transitional provision and provides that Article 27 of the TRIPs Agreement includes the obligation to make inventions of pharmaceutical products patentable. Similarly, the derogations provided for by Article 27(2) and (3) of the TRIPs Agreement cannot be interpreted as laying down a general exclusion for inventions of pharmaceutical products.

    (see paras 64, 66-68, operative part 2)

  4.  A patent obtained following an application claiming the invention both of the process of manufacture of a pharmaceutical product and of the pharmaceutical product as such, but granted solely in relation to the process of manufacture, does not, by reason of the rules set out in Articles 27 and 70 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs), have to be regarded from the entry into force of that agreement as covering the invention of that pharmaceutical product.

    It cannot be considered that the protection of existing subject-matter referred to in Article 70 of the TRIPs Agreement can consist in attributing to a patent effects which it does not have and never has had. To classify the invention of a pharmaceutical product as protected on the date of application of the TRIPs Agreement, when that invention was precisely not protected under the rules which governed that patent until then, would thus be possible only if that agreement were interpreted as requiring the members of the World Trade Organisation (WTO) to convert claimed inventions to protected inventions, on the occasion and solely because of the entry into force of the agreement. Such an obligation cannot, however, be derived from the TRIPs agreement, and would go beyond the ordinary meaning of the words ‘existing subject-matter’ deriving from Article 65(1) read in conjunction with Article 70(2) of the TRIPs Agreement. While Article 27 of the TRIPs Agreement obliges members of the WTO to make it possible to obtain patents for inventions of pharmaceutical products, that obligation cannot, however, be understood as meaning that members of the WTO which, in a period anterior to the date of that agreement’s entry into force, excluded protection of inventions of pharmaceutical products claimed in patents granted for inventions of processes of manufacture of those products must, from that date, regard those patents as covering those inventions of pharmaceutical products.

    (see paras 79, 81-83, operative part 3)


Case C-414/11

Daiichi Sankyo Co. Ltd and Sanofi-Aventis Deutschland GmbH

v

DEMO Anonimos Viomikhaniki kai Emporiki Etairia Farmakon

(Request for a preliminary ruling from the Polimeles Protodikio Athinon)

‛Common commercial policy — Article 207 TFEU — Commercial aspects of intellectual property — Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) — Article 27 — Patentable subject-matter — Article 70 — Protection of existing subject-matter’

Summary — Judgment of the Court (Grand Chamber), 18 July 2013

  1. Questions referred for a preliminary ruling — Admissibility — Conditions — Questions relating to the actual facts or purpose of the dispute — Request providing the Court with sufficient information on the factual and legal context

    (Art. 267 TFEU)

  2. Common commercial policy — Scope — Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) — Commercial aspects of intellectual property — Included

    (Arts 113 EC and 133 EC; Arts 3(1)(e) TFEU and 207(1) TFEU; TRIPs Agreement, Art. 27)

  3. International agreements — Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) — Commercial aspects of intellectual property — Patentability of the invention of a pharmaceutical product — Included

    (TRIPs Agreement, Art. 27)

  4. Approximation of laws — Uniform legislation — Industrial and commercial property — Patent right — Supplementary protection certificate for medicinal products — Scope — Application for a patent for the process of manufacture and for the pharmaceutical product — Patent granted solely for the process of manufacture — Coverage extending to the pharmaceutical product by reason of the application of the rules in Articles 27 and 70 of the TRIPs Agreement — Excluded

    (TRIPs Agreement, Arts 27, 65(1) and 70(2); Council Regulation No 1768/92, Arts 4 and 5)

  1.  See the text of the decision.

    (see paras 35-39)

  2.  Article 27 of the Agreement on Trade-Related Aspects of Intellectual Property Rights, which constitutes Annex 1 C to the Agreement establishing the World Trade Organisation, approved by Decision 94/800 concerning the conclusion on behalf of the European Community, as regards matters within its competence, of the agreements reached in the Uruguay Round multilateral negotiations, falls within the field of the common commercial policy.

    Article 207(1) TFEU differs noticeably from the provisions it essentially replaced, so that the question of the distribution of the competences of the European Union and the Member States must be examined on the basis of the Treaty now in force.

    First, in accordance with Article 207(1) TFEU, the common commercial policy falls within the exclusive competence of the European Union, and relates inter alia to the commercial aspects of intellectual property. In that context, the mere fact that an act of the European Union, such as an agreement concluded by it, is liable to have implications for international trade is not enough for it to be concluded that the act must be classified as falling within the common commercial policy, but, on the other hand, it does fall within that policy if it relates specifically to international trade in that it is essentially intended to promote, facilitate or govern trade and has direct and immediate effects on trade. It follows that, of the rules adopted by the European Union in the field of intellectual property, only those with a specific link to international trade are capable of falling within the concept of commercial aspects of intellectual property in Article 207(1) TFEU and hence the field of the common commercial policy.

    Secondly, to regard the rules on patentable subject-matter in Article 27 of the TRIPs Agreement as falling within the field of the common commercial policy rather than the field of the internal market correctly reflects the fact that the context of those rules is the liberalisation of international trade, not the harmonisation of the laws of the Member States of the European Union.

    (see paras 46, 48, 49, 51, 52, 60, 61, operative part 1)

  3.  Article 27 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) must be interpreted as meaning that the invention of a pharmaceutical product such as the active chemical compound of a medicinal product is, in the absence of a derogation in accordance with Article 27(2) or (3), capable of being the subject-matter of a patent, under the conditions set out in Article 27(1).

    That interpretation follows from the actual wording of the TRIPs Agreement. Pharmacology is regarded by the contracting parties to the agreement as a field of technology within the meaning of Article 27(1). That also follows from Article 70(8) of the agreement, which is a transitional provision and provides that Article 27 of the TRIPs Agreement includes the obligation to make inventions of pharmaceutical products patentable. Similarly, the derogations provided for by Article 27(2) and (3) of the TRIPs Agreement cannot be interpreted as laying down a general exclusion for inventions of pharmaceutical products.

    (see paras 64, 66-68, operative part 2)

  4.  A patent obtained following an application claiming the invention both of the process of manufacture of a pharmaceutical product and of the pharmaceutical product as such, but granted solely in relation to the process of manufacture, does not, by reason of the rules set out in Articles 27 and 70 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs), have to be regarded from the entry into force of that agreement as covering the invention of that pharmaceutical product.

    It cannot be considered that the protection of existing subject-matter referred to in Article 70 of the TRIPs Agreement can consist in attributing to a patent effects which it does not have and never has had. To classify the invention of a pharmaceutical product as protected on the date of application of the TRIPs Agreement, when that invention was precisely not protected under the rules which governed that patent until then, would thus be possible only if that agreement were interpreted as requiring the members of the World Trade Organisation (WTO) to convert claimed inventions to protected inventions, on the occasion and solely because of the entry into force of the agreement. Such an obligation cannot, however, be derived from the TRIPs agreement, and would go beyond the ordinary meaning of the words ‘existing subject-matter’ deriving from Article 65(1) read in conjunction with Article 70(2) of the TRIPs Agreement. While Article 27 of the TRIPs Agreement obliges members of the WTO to make it possible to obtain patents for inventions of pharmaceutical products, that obligation cannot, however, be understood as meaning that members of the WTO which, in a period anterior to the date of that agreement’s entry into force, excluded protection of inventions of pharmaceutical products claimed in patents granted for inventions of processes of manufacture of those products must, from that date, regard those patents as covering those inventions of pharmaceutical products.

    (see paras 79, 81-83, operative part 3)