SPC for medicinal products

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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
(previously Regulation No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products)

1 pending referral

Referral C-149/22 (Merck Sharp & Dohme, 2 Mar 2022)

41 preliminary rulings

Judgment of 9 Jul 2020, C-673/18 (Santen)

Article 3(d) 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 marketing authorisation cannot be considered to be the first marketing authorisation, for the purpose of that provision, where it covers a new therapeutic application of an active ingredient, or of a combination of active ingredients, and that active ingredient or combination has already been the subject of a marketing authorisation for a different therapeutic application.

Judgment of 30 Apr 2020, C-650/17 (Royalty Pharma Collection Trust)

L’article 3, sous a), du règlement (CE) no 469/2009 du Parlement européen et du Conseil, du 6 mai 2009, concernant le certificat complémentaire de protection pour les médicaments, doit être interprété en ce sens qu’un produit est protégé par un brevet de base en vigueur, au sens de cette disposition, lorsqu’il répond à une définition fonctionnelle générale employée par l’une des revendications du brevet de base et relève nécessairement de l’invention couverte par ce brevet, sans pour autant être individualisé en tant que mode concret de réalisation à tirer de l’enseignement dudit brevet, dès lors qu’il est spécifiquement identifiable, à la lumière de l’ensemble des éléments divulgués par le même brevet, par l’homme du métier, sur la base de ses connaissances générales dans le domaine considéré à la date de dépôt ou de priorité du brevet de base et de l’état de la technique à cette même date.

L’article 3, sous a), du règlement no 469/2009 doit être interprété en ce sens qu’un produit n’est pas protégé par un brevet de base en vigueur, au sens de cette disposition, lorsque, bien que relevant de la définition fonctionnelle donnée dans les revendications de ce brevet, il a été développé après la date de dépôt de la demande du brevet de base, au terme d’une activité inventive autonome.

Judgment of 21 Mar 2019, C-443/17 (Abraxis Bioscience)

Article 3(d) 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, read in conjunction with Article 1(b) of that regulation, must be interpreted as meaning that the marketing authorisation referred to in Article 3(b) of that regulation, relied on in support of an application for a supplementary protection certificate concerning a new formulation of an old active ingredient, cannot be regarded as being the first marketing authorisation for the product concerned as a medicinal product in the case where that active ingredient has already been the subject of a marketing authorisation as an active ingredient.

Judgment of 25 Oct 2018, C-527/17 (LN)

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.

Judgment of 25 Jul 2018, C-121/17 (Teva UK and Others)

Article 3(a) of Regulation 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 product composed of several active ingredients with a combined effect is â€˜protected by a basic patent in forceâ€™ within the meaning of that provision where, even if the combination of active ingredients of which that product is composed is not expressly mentioned in the claims of the basic patent, those claims relate necessarily and specifically to that combination. For that purpose, from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent:

â€“ the combination of those active ingredients must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent, and

â€“ each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent.

Judgment of 21 Jun 2018, C-681/16 (Pfizer Ireland Pharmaceuticals, Operations Support Group)

The Specific Mechanisms laid down in Chapter 2 of Annex IV to the Act concerning the conditions of accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic and the adjustments to the Treaties on which the European Union is founded, in Chapter 1 of Annex V to the Act concerning the conditions of accession of the Republic of Bulgaria and Romania and the adjustments to the Treaties on which the European Union is founded, and in Chapter 1 of Annex IV to the Act concerning the conditions of accession of the Republic of Croatia and the adjustments to the Treaty on European Union, the Treaty on the Functioning of the European Union and the Treaty establishing the European Atomic Energy Community, must be interpreted as authorising the holder of a supplementary protection certificate issued in a Member State other than the new Member States referred to in those Acts of Accession to oppose the parallel importation of a medicinal product from those new Member States in a situation where the legal systems of those States provided for the possibility of obtaining equivalent protection at the time when the application for the basic patent was published and/or the application for a supplementary protection certificate in the importing Member State was filed, but did not yet provide for such a possibility at the time when the application for a basic patent was filed, with the result that it was impossible for the patent holder to obtain an equivalent patent and a supplementary protection certificate in the exporting States.

Judgment of 20 Dec 2017, C-492/16 (Incyte Corporation)

Article 18 du 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, read in the light of Article 17(2) of Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products, must be interpreted as meaning that the date of the first authorisation to place the product on the market, as stated in an application for a supplementary protection certificate, on the basis of which the national authority competent for granting such a certificate calculated the duration of the certificate, is incorrect in a situation, such as that at issue in the main proceedings, where the date led to a method for calculating the duration of the certificate which does not comply with the requirements of Article 13(1) of Regulation No 469/2009, as interpreted by a subsequent judgment of the Court.

Article 18 of Regulation No 469/2009, read in the light of recital 17 and of Article 17(2) of Regulation No 1610/96, must be interpreted as meaning that, in a situation such as that set out in point 1 of this operative part, the holder of a supplementary protection certificate may, under Article 18 of Regulation No 469/2009, bring an appeal for rectification of the duration stated in the certificate, provided that that certificate has not expired.

Judgment of 7 Dec 2017, C-567/16 (Merck Sharp)

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 is to be interpreted as meaning that an end of procedure notice issued by the reference Member State in accordance with Article 28(4) of 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, as regards pharmacovigilance, by Directive 2010/84/EU of the European Parliament and the Council of 15 December 2010, before the expiry of the basic patent, as defined in Article 1(c) of Regulation No 469/2009, may not be treated as equivalent to a marketing authorisation within the meaning of Article 3(b) of that regulation, with the result that a supplementary protection certificate may not be obtained on the basis of such a notice.

Article 10(3) of Regulation No 469/2009 is to be interpreted as meaning that the fact that no marketing authorisation has been granted by the Member State concerned at the time the supplementary protection certificate application is lodged in that Member State does not constitute an irregularity that can be cured under that provision. Toader Prechal Jarašiūnas

Judgment of 5 Oct 2016, C-572/15 (F. Hoffmann-La Roche)

The Court of Justice of the European Union does not have jurisdiction to rule on the validity of Article 21(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, as amended by the Act concerning the conditions of accession of the Republic of Croatia and the adjustments to the Treaty on European Union, the Treaty on the Functioning of the European Union and the Treaty establishing the European Atomic Energy Community.

Article 21(2) of Regulation No 469/2009, as amended, must be interpreted as meaning that it applies to a supplementary protection certificate, relating to a given medicinal product, granted by a Member State prior to its accession to the European Union. To the extent that that medicinal product was the subject, within the European Economic Area, of a marketing authorisation before that granted in that Member State, and, as the case may be, before its accession to the European Union, only the first marketing authorisation must be taken into account for the purposes of determining the duration of validity of the supplementary protection certificate.

Judgment of 6 Oct 2015, C-471/14 (Seattle Genetics)

Article 13(1) 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 the ‘date of the first authorisation to place the product on the market in the [European Union]’ is determined by EU law.

Article 13(1) of Regulation No 469/2009 is to be interpreted as meaning that the ‘date of the first authorisation to place the product on the market in the [European Union]’ within the meaning of that provision is the date on which notification of the decision granting marketing authorisation was given to the addressee of the decision.

Judgment of 12 Mar 2015, C-577/13 (Actavis Group)

Article 3(a) and (c) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 16 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that, where a basic patent includes a claim to a product comprising an active ingredient which constitutes the sole subject-matter of the invention, for which the holder of that patent has already obtained a supplementary protection certificate, as well as a subsequent claim to a product comprising a combination of that active ingredient and another substance, that provision precludes the holder from obtaining a second supplementary protection certificate for that combination.

Judgment of 12 Feb 2015, C-539/13 (Merck Canada)

The second paragraph of the Specific Mechanism provided for in Chapter 2 of Annex IV to the Act concerning the conditions of accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic and the adjustments to the Treaties on which the European Union is founded must be interpreted as not requiring the holder, or beneficiary, of a patent or supplementary protection certificate to give notification of his intention to oppose a proposed importation before invoking his rights under the first paragraph of that mechanism. However, if such a holder or beneficiary does not indicate such an intention during the one-month waiting period laid down in the second paragraph of the mechanism, the person proposing to import the pharmaceutical product in question may legitimately apply to the competent authorities for authorisation to import the product and, where appropriate, import and market it. The Specific Mechanism thus denies that holder or his beneficiary the possibility of relying on his rights under the first paragraph of the mechanism with regard to any importation and marketing of the pharmaceutical product carried out before such an intention was indicated.

The second paragraph of the Specific Mechanism must be interpreted as meaning that the notification must be given to the holder, or beneficiary, of the patent or the supplementary protection certificate, the latter term designating any person enjoying the rights conferred by law on the holder of the patent or the supplementary protection certificate.

The second paragraph of the Specific Mechanism is to be interpreted as not requiring the person intending to import or market the pharmaceutical product in question to give notification himself, provided that it is possible from the notification to identify that person clearly.

Judgment of 15 Jan 2015, C-631/13 (Forsgren)

Articles 1(b) and 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 not precluding, in principle, the possibility that an active ingredient can give rise to the grant of a supplementary protection certificate where the active ingredient is covalently bound to other active ingredients which are part of a medicinal product.

Article 3(b) of Regulation No 469/2009 must be interpreted as precluding the grant of a supplementary protection certificate for an active ingredient whose effect does not fall within the therapeutic indications covered by the wording of the marketing authorisation.Article 1(b) of Regulation No 469/2009 must be interpreted as meaning that a carrier protein conjugated with a polysaccharide antigen by means of a covalent binding may be categorised as an ‘active ingredient’ within the meaning of that provision only if it is established that it produces a pharmacological, immunological or metabolic action of its own which is covered by the therapeutic indications of the marketing authorisation, a matter which it is for the referring court to determine, in the light of all the facts of the dispute in the main proceedings.

Order of 13 Feb 2014, C-555/13 (Merck Canada)

Article 13 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, read in conjunction with recital 9 to the same regulation, must be interpreted as meaning that it precludes the holder of both a patent and a supplementary protection certificate from relying on the entire period of validity of such a certificate, calculated in accordance with Article 13, in a situation where, pursuant to such a period, it would enjoy a period of exclusivity as regards an active ingredient, of more than 15 years from the first authorisation to be placed on the market, in the European Union, of a medicinal product consisting of that active ingredient, or containing it.

Judgment of 12 Dec 2013, C-493/12 (Eli Lilly)

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 meaning that, in order for an active ingredient to be regarded as ‘protected by a basic patent in force’ within the meaning of that provision, it is not necessary for the active ingredient to be identified in the claims of the patent by a structural formula. Where the active ingredient is covered by a functional formula in the claims of a patent issued by the European Patents Office, Article 3(a) of that regulation does not, in principle, preclude the grant of a supplementary protection certificate for that active ingredient, on condition that it is possible to reach the conclusion on the basis of those claims, interpreted inter alia in the light of the description of the invention, as required by Article 69 of the Convention on the Grant of European Patents and the Protocol on the interpretation of that provision, that the claims relate, implicitly but necessarily and specifically, to the active ingredient in question, which is a matter to be determined by the referring court.

Judgment of 12 Dec 2013, C-484/12 (Georgetown University)

In circumstances such as those in the main proceedings, where, on the basis of a basic patent and a marketing authorisation for a medicinal product consisting of a combination of several active ingredients, the patent holder has already obtained a supplementary protection certificate for that combination of active ingredients, protected by that patent within the meaning of 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, Article 3(c) of that regulation must be interpreted as not precluding the proprietor from also obtaining a supplementary protection certificate for one of those active ingredients which, individually, is also protected as such by that patent.

Judgment of 12 Dec 2013, C-443/12 (Actavis)

In circumstances such as those in the main proceedings, where, on the basis of a patent protecting an innovative active ingredient and a marketing authorisation for a medicinal product containing that ingredient as the single active ingredient, the holder of that patent has already obtained a supplementary protection certificate for that active ingredient entitling him to oppose the use of that active ingredient, either alone or in combination with other active ingredients, Article 3(c) 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 that patent holder from obtaining – on the basis of that same patent but a subsequent marketing authorisation for a different medicinal product containing that active ingredient in conjunction with another active ingredient which is not protected as such by the patent – a second supplementary protection certificate relating to that combination of active ingredients.

Order of 14 Nov 2013, C-617/12 (Astrazeneca)

In the context of the European Economic Area (EEA), Article 13(1) 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 an administrative authorisation issued for a medicinal product by the Swiss Institute for Medicinal Products (SwissMedic), which is automatically recognised in Liechtenstein, must be regarded as the first authorisation to place that medicinal product on the market within the meaning of that provision in the European Economic Area where that authorisation predates marketing authorisations issued for the same medicinal product, either by the European Medicines Agency (EMA), or by the competent authorities of European Union Member States in accordance with the requirements laid down in 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, and the authorities of the Republic of Iceland and the Kingdom of Norway. The fact that, on the basis of similar clinical data, the European Medicines Agency, unlike the Swiss authority, refused to grant a marketing authorisation for that medicinal product at the conclusion of its examination of those data, or the fact that the Swiss authorisation to place the product on the market was suspended by the Swiss Institute for Medicinal Products and subsequently reinstated by the latter only when the holder of the authorisation submitted additional data to it are irrelevant.

Order of 14 Nov 2013, C-210/13 (Glaxosmithkline Biologicals)

Article 1(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, just as an adjuvant does not fall within the definition of

Judgment of 19 Jul 2012, C-130/11 (Neurim Pharmaceuticals)

Articles 3 and 4 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, in a case such as that in the main proceedings, the mere existence of an earlier marketing authorisation obtained for a veterinary medicinal product does not preclude the grant of a supplementary protection certificate for a different application of the same product for which a marketing authorisation has been granted, provided that the application is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the supplementary protection certificate.

Article 13(1) of Regulation (EC) No 469/2009 must be interpreted as meaning that it refers to the marketing authorisation of a product which comes within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the supplementary protection certificate.

The answers to the above questions would not be different if, in a situation such as that in the main proceedings where the same active ingredient is present in two medicinal products having obtained successive marketing authorisations, the second marketing authorisation required a full application in accordance with Article 8(3) of 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, or if the product covered by the first marketing authorisation of the corresponding medicinal product is within the scope of protection of a different patent which belongs to a different registered proprietor from the SPC applicant.

Order of 9 Feb 2012, C-574/11 (Novartis)

Order of 9 Feb 2012, C-442/11 (Novartis)

Articles 4 and 5 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, where a ‘product’ consisting of an active ingredient was protected by a basic patent and the holder of that patent was able to rely on the protection conferred by that patent for that ‘product’ in order to oppose the marketing of a medicinal product containing that active ingredient in combination with one or more other active ingredients, a supplementary protection certificate granted for that ‘product’ enables its holder, after the basic patent has expired, to oppose the marketing by a third party of a medicinal product containing that product for a use of the ‘product’, as a medicinal product, which was authorised before that certificate expired.Articles 4 and 5 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, where a ‘product’ consisting of an active ingredient was protected by a basic patent and the holder of that patent was able to rely on the protection conferred by that patent for that ‘product’ in order to oppose the marketing of a medicinal product containing that active ingredient in combination with one or more other active ingredients, a supplementary protection certificate granted for that ‘product’ enables its holder, after the basic patent has expired, to oppose the marketing by a third party of a medicinal product containing that product for a use of the ‘product’, as a medicinal product, which was authorised before that certificate expired.

Judgment of 8 Dec 2011, C-125/10 (Merck)

Article 13 of Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products, as amended by Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006, read in conjunction with Article 36 of Regulation No 1901/2006, must be interpreted as meaning that medicinal products can be the object of the grant of a supplementary protection certificate where the period that has elapsed between the date of lodging the basic patent application and the first marketing authorisation in the European Union is less than five years. In such a case, the period of the paediatric extension provided for by the latter regulation starts to run from the date determined by deducting from the patent expiry date the difference between five years and the duration of the period which elapsed between the lodging of the patent application and the grant of the first marketing authorisation.

Order of 25 Nov 2011, C-630/10 (University of Queensland)

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 identified in the wording of the claims of the basic patent relied on in support of the application for such a certificate.

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 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.

In the case of a basic patent relating to a process by which a product is obtained, Article 3(a) of Regulation No 469/2009 precludes a supplementary protection certificate being granted for a product other than that identified in the wording of the claims of that patent as the product deriving from the process in question. Whether it is possible to obtain the product directly as a result of that process is irrelevant in that regard.

Order of 25 Nov 2011, C-518/10 (Yeda Research and Development)

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 where the active ingredient specified in the application, even though identified in the wording of the claims of the basic patent as an active ingredient forming part of a combination in conjunction with another active ingredient, is not the subject of any claim relating to that active ingredient alone.

Order of 25 Nov 2011, C-6/11 (Daiichi Sankyo Company)

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 identified in the wording of the claims of the basic patent relied on in support of the application for such a certificate.

Judgment of 24 Nov 2011, C-422/10 (Georgetown University)

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.

Judgment of 24 Nov 2011, C-322/10 (Medeva)

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.

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 supplementary protection certificate contains not only that combination of the two active ingredients but also other active ingredients.

Judgment of 28 Jul 2011, C-427/09 (Generics)

A product, such as that at issue in the main proceedings, which was placed on the market in the European Community as a medicinal product for human use before obtaining a marketing authorisation in accordance with Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products, as amended by Council Directive 89/341/EEC of 3 May 1989, and, in particular, without undergoing safety and efficacy testing, is not within the scope of Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products, as amended by the Act concerning the conditions of accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden and the adjustments to the Treaties on which the European Union is founded, as that scope is defined in Article 2 of that regulation, as amended, and may not be the subject of a supplementary protection certificate.

Judgment of 28 Jul 2011, C-195/09 (Synthon)

Article 2 of Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products, as amended by the Act concerning the conditions of accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden and the adjustments to the Treaties on which the European Union is founded, must be interpreted as meaning that a product, such as that at issue in the main proceedings, which was placed on the market in the European Community as a medicinal product for human use before obtaining a marketing authorisation in accordance with Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products, as amended by Council Directive 89/341/EEC of 3 May 1989, and, in particular, without undergoing safety and efficacy testing, is not within the scope of Regulation No 1768/92, as amended, and may not, therefore, be the subject of a supplementary protection certificate.

A supplementary protection certificate granted for a product outside the scope of Regulation No 1768/92, as amended, as that scope is defined in Article 2 of that regulation, is invalid.

Judgment of 11 Nov 2010, C-229/09 (Hogan Lovells)

Article 3(1)(b) of Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products must be interpreted as not precluding a supplementary protection certificate from being issued for a plant protection product in respect of which a valid marketing authorisation has been granted pursuant to Article 8(1) of Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market, as amended by Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005.

Judgment of 2 Sep 2010, C-66/09 (Kirin Amgen)

Articles 7 and 19a(e) of Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products, as amended by the Act concerning the conditions of accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic and the adjustments to the Treaties on which the European Union is founded, must be interpreted as not allowing the holder of a valid basic patent in respect of a product to apply to the competent Lithuanian authorities, within six months of the date upon which the Republic of Lithuania acceded to the European Union, for the grant of a supplementary protection certificate where an authorisation to place that product on the market as a medicinal product was obtained more than six months before accession under Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products, but the product did not obtain a marketing authorisation in Lithuania.

Judgment of 3 Sep 2009, C-482/07 (AHP Manufacturing)

Article 3(c) of Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products, considered in the light of the second sentence of Article 3(2) of Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products, must be interpreted as not precluding the grant of a supplementary protection certificate to the holder of a basic patent for a product for which, at the time the certificate application is submitted, one or more certificates have already been granted to one or more holders of one or more other basic patents.

Order of 17 Apr 2007, C-202/05 (Yissum Research and Development Company)

Article 1(b) of Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products, in the version resulting from the Act concerning the conditions of accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden and the adjustments to the Treaties on which the European Union is founded, is to be interpreted as meaning that in a case where a basic patent protects a second medical use of an active ingredient, that use does not form an integral part of the definition of the product.

Judgment of 4 May 2006, C-431/04 (Massachusetts Institute of Technology)

Article 1(b) of Council Regulation No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products, in the version resulting from the Act concerning the conditions of accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden and the adjustments to the Treaties on which the European Union is founded, must be interpreted so as not to include in the concept of ‘combination of active ingredients of a medicinal product’ a combination of two substances, only one of which has therapeutic effects of its own for a specific indication, the other rendering possible a pharmaceutical form of the medicinal product which is necessary for the therapeutic efficacy of the first substance for that indication.

Judgment of 21 Apr 2005, C-207/03 (Millennium Pharmaceuticals)

In so far as an authorisation to place a medicinal product on the market issued by the Swiss authorities and automatically recognised by the Principality of Liechtenstein under that State’s legislation is the first authorisation to place that product on the market in one of the States of the European Economic Area, it constitutes the first authorisation to place the product on the market within the meaning of Article 13 of Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products, as it is to be read for the purposes of the application of the Agreement on the European Economic Area.

Judgment of 19 Oct 2004, C-31/03 (Pharmacia Italia)

The grant of a supplementary protection certificate in a Member State of the Community on the basis of a medicinal product for human use authorised in that Member State is precluded by an authorisation to place the product on the market as a veterinary medicinal product granted in another Member State of the Community before the date specified in Article 19(1) of Council Regulation No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products.

Judgment of 11 Dec 2003, C-127/00 (Hässle)

Consideration of the second question referred has disclosed no factor capable of affecting the validity of Article 19 of Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products.

So far as concerns medicinal products for human use, the concept of first authorisation to place ... on the market ... in the Community in Article 19(1) of Regulation No 1768/92 refers solely to the first authorisation required under provisions on medicinal products, within the meaning of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products, granted in any of the Member States, and does not therefore refer to authorisations required under legislation on pricing of or reimbursement for medicinal products.

A supplementary protection certificate which, contrary to the requirements of Article 19 of Regulation No 1768/92, has been delivered where the first marketing authorisation in the Community was obtained prior to the relevant date fixed by that provision is invalid pursuant to Article 15 thereof. Skouris Gulmann Cunha Rodrigues Schintgen Macken

Judgment of 16 Sep 1999, C-392/97 (Farmitalia)

On a proper construction of Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products and, in particular, Article 3(b) thereof, where a product in the form referred to in the marketing authorisation is protected by a basic patent in force, the supplementary protection certificate is capable of covering the product, as a medicinal product, in any of the forms enjoying the protection of the basic patent.

In order to determine, in connection with the application of Regulation No 1768/92 and, in particular, Article 3(a) thereof, whether a product is protected by a basic patent, reference must be made to the rules which govern that patent.

Judgment of 12 Jun 1997, C-110/95 (Yamanouchi Pharmaceutical)

The grant of a supplementary protection certificate pursuant to Article 19 of Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products is, in accordance with Article 3(b) of that regulation, conditional on a valid authorization to place the product on the market as a medicinal product having been granted in the Member State in which the application is submitted and at the date of that application.

Judgment of 23 Jan 1997, C-181/95 (Biogen)

Where a medicinal product is covered by several basic patents, Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products does not preclude the grant of a supplementary protection certificate to each holder of a basic patent.

Regulation No 1768/92 does not require the holder of the marketing authorization to provide the patent holder with a copy of that authorization, referred to in Article 8(1)(b) of the Regulation.

Where the basic patent and the authorization to place the product on the market as a medicinal product are held by different persons and the patent holder is unable to provide a copy of that authorization in accordance with Article 8(1)(b) of Regulation No 1768/92, an application for a certificate must not be refused on that ground alone.

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