Source: EURLEX
Language: en
Format: md

Case C‑527/17

Proceedings brought by Boston Scientific Ltd

(Request for a preliminary ruling from the Bundespatentgericht)

(Reference for a preliminary ruling — Intellectual and industrial property — Supplementary protection certificate for medicinal products — Regulation (EC) No 469/2009 — Scope — Medical device incorporating as an integral part a substance which, used separately, may be considered to be a medicinal product — Directive 93/42/EEC — Article 1(4) — Concept of ‘administrative authorisation procedure’)

Summary — Judgment of the Court (Ninth Chamber), 25 October 2018

1. Approximation of laws — Medicinal products for human use — Directives 93/42 and 2001/83 — Distinction between medicinal products and medical devices — Criteria — Substance forming an integral part of a medical device and performing on the human body an action ancillary to that of the device — Classification as medicinal product — Precluded

   (Directive 2001/83 of the European Parliament and of the Council, as amended by Directive 2004/27, Article 1(2)(b); Council Directive 93/42, as amended by Directive 2007/47, Article 1(2)(a) and (5)(c))
2. Approximation of laws — Medical devices — Directive 93/42 — Scope — Product with a principal mode of action principal obtained other than by pharmacological, immunological or metabolic means — Included

   (Council Directive 93/42, as amended by Directive 2007/47, Article 1(2)(a))
3. Approximation of laws — Uniform legislation — Industrial and commercial property — Patent right — Supplementary protection certificate for medicinal products — Scope — Products which have been the subject of a marketing authorisation procedure — Concept of marketing authorisation procedure — Prior authorisation procedure of a medical device under Directive 93/42 — Precluded

   (Regulation No 469/2009 of the European Parliament and of the Council, Article 2; Directive 2001/83 of the European Parliament and of the Council, as amended by Directive 2004/27; Council Directive 93/42, as amended by Directive 2007/47, Article1(4), and Annex I, section 7.4)

1. See the text of the decision.

   (see paras 31, 32, 34, 35)
2. See the text of the decision.

   (see para. 33)
3. Article 2 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 a prior authorisation procedure, under Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007, for a device incorporating as an integral part a substance, within the meaning of Article 1(4) of that directive as amended, cannot be treated in the same way, for the purposes of applying that regulation, as a marketing authorisation procedure for that substance under Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004, even if that substance was the subject of the assessment provided for in the first and second paragraphs of section 7.4 of Annex I to Directive 93/42, as amended by Directive 2007/47.

   (see para. 51, operative part)

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