{"id":23000607,"date":"2026-02-04T16:19:03","date_gmt":"2026-02-04T15:19:03","guid":{"rendered":"https:\/\/www.karoip.com\/unkategorisiert\/2026\/02\/the-latest-judicial-interpretation-of-first-marketing-authorisation-under-the-spc-regulation\/"},"modified":"2026-05-22T15:31:26","modified_gmt":"2026-05-22T13:31:26","slug":"first-marketing-authorisation","status":"publish","type":"post","link":"https:\/\/www.karoip.com\/en\/blog-en\/patent-en\/2026\/02\/first-marketing-authorisation\/","title":{"rendered":"The Latest Judicial Interpretation of \u201cFirst Marketing Authorisation\u201d under the SPC Regulation"},"content":{"rendered":"

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In recent years, the interpretation of the term \u201cfirst marketing authorisation<\/em>\u201d in Article 3(d) of the EU Supplementary Protection Certificate Regulation (Regulation (EC) No 469\/2009, hereinafter the SPC Regulation) has given rise to significant divergence in European judicial practice and has triggered ongoing legal controversy.<\/p>\n

Under Article 3(d) of the SPC Regulation, one of the prerequisites for the grant of an SPC is that the relevant \u201cproduct\u201d (i.e. the active ingredient or combination of active ingredients) must not previously have obtained a marketing authorisation as a medicinal product in the European Union. Once any earlier marketing authorisation exists for the same product, a subsequent authorisation will, in principle, no longer qualify as a \u201cfirst marketing authorisation\u201d. A series of recent cases has centred precisely on the interpretation of this provision.<\/p>\n

I. Factual Background of the Boehringer Case<\/strong><\/p>\n

Boehringer Ingelheim has recently attracted considerable attention in the pharmaceutical and patent community as a result of two parallel decisions relating to its SPC application activities.<\/p>\n

The essential facts of the case may be summarised as follows:<\/p>\n

Boehringer Ingelheim Vetmedica GmbH applied for an SPC for its product Aservo\u00ae EquiHaler\u00ae, on the basis of its European patent EP 2 934 479 (entitled \u201cCiclesonide for the Treatment of Respiratory Diseases in Horses\u201d) and a veterinary medicinal product marketing authorisation (MA) granted by the European Medicines Agency (EMA) in 2020. This marketing authorisation was issued pursuant to Directive 2001\/82\/EC (the Veterinary Medicinal Products Directive).<\/p>\n

It is noteworthy that this was the first veterinary marketing authorisation in the EU for a medicinal product containing ciclesonide as the active ingredient. During the marketing authorisation procedure, the EMA classified ciclesonide as a \u201cnew active substance\u201d within the meaning of Article 3(2)(a) of Regulation (EC) No 726\/2004, and on that basis required the applicant to submit a full set of clinical data.<\/p>\n

II. The Decision of the District Court of The Hague: Strict \u201cProduct-Centred Formalism\u201d<\/strong><\/p>\n

As anticipated, the SPC application met with differing outcomes in different Member States. The decision of the District Court of The Hague is particularly noteworthy.<\/p>\n

The Hague court refused to grant an SPC based on the above-mentioned veterinary MA, on the ground that:<\/p>\n

prior to that veterinary MA, a human medicinal product marketing authorisation based on the same active ingredient, ciclesonide, already existed.<\/p>\n

The core reasoning of the court may be summarised as follows:<\/p>\n

    \n
  1. The definition of \u201cproduct\u201d in Article 1(b) of the SPC Regulation refers exclusively to the active ingredient as such, and does not encompass the intended use, therapeutic indication, or regulatory classification (human or veterinary).<\/li>\n
  2. Once an active ingredient has previously been the subject of a marketing authorisation, irrespective of whether that authorisation concerns a human or a veterinary medicinal product, the requirement of a \u201cfirst marketing authorisation\u201d under Article 3(d) is no longer fulfilled.<\/li>\n
  3. The assessment of whether an authorisation constitutes a \u201cfirst marketing authorisation\u201d is a normative issue of patent law, falling within the competence of patent authorities and courts, and not within the remit of medicinal product regulatory authorities.<\/li>\n<\/ol>\n

    This decision reflects a highly formalistic approach that relies exclusively on the concept of the \u201cproduct\u201d as the sole decisive criterion.<\/p>\n

    III. Referral of the German Case: The Question Returns to the Court of Justice<\/strong><\/p>\n

    Boehringer also filed a corresponding SPC application in Germany. In 2023, the application was initially rejected by the German Patent and Trademark Office (GPTO) on the ground of non-compliance with Article 3(d) of the SPC Regulation, for the same reason, namely that:<\/p>\n

    another company had already obtained a marketing authorisation in 2005 for a human medicinal product containing ciclesonide (for the treatment of asthma).<\/p>\n

    The applicant appealed against this decision. By decision of 12 December 2025, the 14th Senate of the German Federal Patent Court (Bundespatentgericht) stayed the national proceedings and referred the following question to the Court of Justice of the European Union (CJEU) for a preliminary ruling:<\/p>\n

    Is Article 3(d) of the SPC Regulation to be interpreted as meaning that a marketing authorisation for a veterinary medicinal product granted under Directive 2001\/82\/EC constitutes the first marketing authorisation of that product as a medicinal product, even if the same active ingredient of that product has previously been authorised as a human medicinal product under Directive 2001\/83\/EC?<\/p>\n

    IV. The Shadow of the Neurim<\/em> and Santen<\/em> Case Law<\/strong><\/p>\n

    Readers familiar with SPC case law will readily recall the landmark judgment of the CJEU in Neurim (C-130\/11, 2012).<\/p>\n

    The factual sequence in Neurim was the reverse of the present case:<\/p>\n

    Neurim concerned a veterinary MA followed by a human MA (melatonin for the treatment of human sleep disorders), whereas the Boehringer case involves a human MA followed by a veterinary MA. Substantively, however, the two situations are highly comparable, in that:<\/p>\n

    a known active ingredient was classified by the EMA as a \u201cnew active substance\u201d under a different regulatory pathway and requires submission of full clinical data.<\/p>\n

    In Neurim, the CJEU held that, for the purposes of Article 3(d), it is necessary to examine whether the earlier marketing authorisation covered the same therapeutic use as that protected by the basic patent. On that basis, the Court allowed the grant of an SPC based on a second medical use human MA.<\/p>\n

    However, this \u201cscope-of-protection-oriented\u201d approach was expressly abandoned by the CJEU in Santen (C-673\/18, 2020). In Santen, the Court reverted to a strict product-centred interpretation, rejecting the possibility of granting SPCs based solely on new therapeutic indications.<\/p>\n

    Importantly, the Santen judgment did not address the following specific scenario:<\/p>\n

    namely, how Article 3(d) should be applied where a known active ingredient is nevertheless classified by the regulatory authority as a \u201cnew active substance\u201d, thereby triggering a full, stand-alone marketing authorisation procedure.<\/p>\n

    V. The Position of the German Court and Systemic Considerations<\/strong><\/p>\n

    In its referral decision, the German Federal Patent Court clearly tends to regard the veterinary MA at issue as a \u201cfirst marketing authorisation\u201d within the meaning of Article 3(d), despite the existence of an earlier human MA.<\/p>\n

    This position is primarily based on the legislative purpose of the SPC system, in particular:<\/p>\n

      \n
    • clinical data generated under Directive 2001\/83\/EC (human medicinal products) generally cannot be directly relied upon to accelerate authorisation procedures under Directive 2001\/82\/EC (veterinary medicinal products), and vice versa;<\/li>\n
    • denying SPC protection solely because of the existence of an earlier human or veterinary MA may, in practice, lead to genuine gaps in protection;<\/li>\n
    • such an interpretation may also undermine incentives for pharmaceutical companies to invest in research and development in cross-sector areas (human\/veterinary).<\/li>\n<\/ul>\n

      VI. Conclusion: Awaiting Further Clarification from the Court of Justice<\/strong><\/p>\n

      The referral by the German court provides the CJEU with an important opportunity to further systematise and clarify its case law between the Neurim and Santen lines of authority.<\/p>\n

      Regardless of the eventual outcome, the decision is likely to have implications far beyond the individual case and will significantly influence future SPC applications across the EU in situations involving the interaction between human and veterinary medicinal products.<\/p>\n

      [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"

      In recent years, the interpretation of the term \u201cfirst marketing authorisation\u201d in Article 3(d) of the EU Supplementary Protection Certificate Regulation (Regulation (EC) No 469\/2009, hereinafter the SPC Regulation) has given rise to significant divergence in European judicial practice and has triggered ongoing legal controversy. Under Article 3(d) of the SPC Regulation, one of the […]<\/p>\n","protected":false},"author":10,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"In recent years, the interpretation of the term \u201cfirst marketing authorisation<\/em>\u201d in Article 3(d) of the EU Supplementary Protection Certificate Regulation (Regulation (EC) No 469\/2009, hereinafter the SPC Regulation) has given rise to significant divergence in European judicial practice and has triggered ongoing legal controversy. \r\n\r\nUnder Article 3(d) of the SPC Regulation, one of the prerequisites for the grant of an SPC is that the relevant \u201cproduct\u201d (i.e. the active ingredient or combination of active ingredients) must not previously have obtained a marketing authorisation as a medicinal product in the European Union. Once any earlier marketing authorisation exists for the same product, a subsequent authorisation will, in principle, no longer qualify as a \u201cfirst marketing authorisation\u201d. A series of recent cases has centred precisely on the interpretation of this provision. \r\n\r\nI. Factual Background of the Boehringer Case<\/strong>\r\n\r\nBoehringer Ingelheim has recently attracted considerable attention in the pharmaceutical and patent community as a result of two parallel decisions relating to its SPC application activities.\r\n\r\nThe essential facts of the case may be summarised as follows:\r\n\r\nBoehringer Ingelheim Vetmedica GmbH applied for an SPC for its product Aservo\u00ae EquiHaler\u00ae, on the basis of its European patent EP 2 934 479 (entitled \u201cCiclesonide for the Treatment of Respiratory Diseases in Horses\u201d) and a veterinary medicinal product marketing authorisation (MA) granted by the European Medicines Agency (EMA) in 2020. This marketing authorisation was issued pursuant to Directive 2001\/82\/EC (the Veterinary Medicinal Products Directive). \r\n\r\nIt is noteworthy that this was the first veterinary marketing authorisation in the EU for a medicinal product containing ciclesonide as the active ingredient. During the marketing authorisation procedure, the EMA classified ciclesonide as a \u201cnew active substance\u201d within the meaning of Article 3(2)(a) of Regulation (EC) No 726\/2004, and on that basis required the applicant to submit a full set of clinical data. \r\n\r\nII. The Decision of the District Court of The Hague: Strict \u201cProduct-Centred Formalism\u201d<\/strong>\r\n\r\nAs anticipated, the SPC application met with differing outcomes in different Member States. The decision of the District Court of The Hague is particularly noteworthy. \r\n\r\nThe Hague court refused to grant an SPC based on the above-mentioned veterinary MA, on the ground that:\r\n\r\nprior to that veterinary MA, a human medicinal product marketing authorisation based on the same active ingredient, ciclesonide, already existed.\r\n\r\nThe core reasoning of the court may be summarised as follows:\r\n

        \r\n \t
      1. The definition of \u201cproduct\u201d in Article 1(b) of the SPC Regulation refers exclusively to the active ingredient as such, and does not encompass the intended use, therapeutic indication, or regulatory classification (human or veterinary).<\/li>\r\n \t
      2. Once an active ingredient has previously been the subject of a marketing authorisation, irrespective of whether that authorisation concerns a human or a veterinary medicinal product, the requirement of a \u201cfirst marketing authorisation\u201d under Article 3(d) is no longer fulfilled.<\/li>\r\n \t
      3. The assessment of whether an authorisation constitutes a \u201cfirst marketing authorisation\u201d is a normative issue of patent law, falling within the competence of patent authorities and courts, and not within the remit of medicinal product regulatory authorities.<\/li>\r\n<\/ol>\r\nThis decision reflects a highly formalistic approach that relies exclusively on the concept of the \u201cproduct\u201d as the sole decisive criterion.\r\n\r\nIII. Referral of the German Case: The Question Returns to the Court of Justice<\/strong>\r\n\r\nBoehringer also filed a corresponding SPC application in Germany. In 2023, the application was initially rejected by the German Patent and Trademark Office (GPTO) on the ground of non-compliance with Article 3(d) of the SPC Regulation, for the same reason, namely that: \r\n\r\nanother company had already obtained a marketing authorisation in 2005 for a human medicinal product containing ciclesonide (for the treatment of asthma).\r\n\r\nThe applicant appealed against this decision. By decision of 12 December 2025, the 14th Senate of the German Federal Patent Court (Bundespatentgericht) stayed the national proceedings and referred the following question to the Court of Justice of the European Union (CJEU) for a preliminary ruling: \r\n\r\nIs Article 3(d) of the SPC Regulation to be interpreted as meaning that a marketing authorisation for a veterinary medicinal product granted under Directive 2001\/82\/EC constitutes the first marketing authorisation of that product as a medicinal product, even if the same active ingredient of that product has previously been authorised as a human medicinal product under Directive 2001\/83\/EC?\r\n\r\nIV. The Shadow of the Neurim<\/em> and Santen<\/em> Case Law<\/strong>\r\n\r\nReaders familiar with SPC case law will readily recall the landmark judgment of the CJEU in Neurim (C-130\/11, 2012).\r\n\r\nThe factual sequence in Neurim was the reverse of the present case:\r\n\r\nNeurim concerned a veterinary MA followed by a human MA (melatonin for the treatment of human sleep disorders), whereas the Boehringer case involves a human MA followed by a veterinary MA. Substantively, however, the two situations are highly comparable, in that: \r\n\r\na known active ingredient was classified by the EMA as a \u201cnew active substance\u201d under a different regulatory pathway and requires submission of full clinical data.\r\n\r\nIn Neurim, the CJEU held that, for the purposes of Article 3(d), it is necessary to examine whether the earlier marketing authorisation covered the same therapeutic use as that protected by the basic patent. On that basis, the Court allowed the grant of an SPC based on a second medical use human MA.\r\n\r\nHowever, this \u201cscope-of-protection-oriented\u201d approach was expressly abandoned by the CJEU in Santen (C-673\/18, 2020). In Santen, the Court reverted to a strict product-centred interpretation, rejecting the possibility of granting SPCs based solely on new therapeutic indications. \r\n\r\nImportantly, the Santen judgment did not address the following specific scenario:\r\n\r\nnamely, how Article 3(d) should be applied where a known active ingredient is nevertheless classified by the regulatory authority as a \u201cnew active substance\u201d, thereby triggering a full, stand-alone marketing authorisation procedure.\r\n\r\nV. The Position of the German Court and Systemic Considerations<\/strong>\r\n\r\nIn its referral decision, the German Federal Patent Court clearly tends to regard the veterinary MA at issue as a \u201cfirst marketing authorisation\u201d within the meaning of Article 3(d), despite the existence of an earlier human MA.\r\n\r\nThis position is primarily based on the legislative purpose of the SPC system, in particular:\r\n
          \r\n \t
        • clinical data generated under Directive 2001\/83\/EC (human medicinal products) generally cannot be directly relied upon to accelerate authorisation procedures under Directive 2001\/82\/EC (veterinary medicinal products), and vice versa;<\/li>\r\n \t
        • denying SPC protection solely because of the existence of an earlier human or veterinary MA may, in practice, lead to genuine gaps in protection;<\/li>\r\n \t
        • such an interpretation may also undermine incentives for pharmaceutical companies to invest in research and development in cross-sector areas (human\/veterinary).<\/li>\r\n<\/ul>\r\nVI. Conclusion: Awaiting Further Clarification from the Court of Justice<\/strong>\r\n\r\nThe referral by the German court provides the CJEU with an important opportunity to further systematise and clarify its case law between the Neurim and Santen lines of authority.\r\n\r\nRegardless of the eventual outcome, the decision is likely to have implications far beyond the individual case and will significantly influence future SPC applications across the EU in situations involving the interaction between human and veterinary medicinal products.","_et_gb_content_width":"","inline_featured_image":false,"footnotes":""},"categories":[151],"tags":[],"class_list":["post-23000607","post","type-post","status-publish","format-standard","hentry","category-patent-en"],"yoast_head":"\nLatest Judicial Interpretation of \u201cFirst Marketing Authorisation\u201d<\/title>\n<meta name=\"description\" content=\"The Latest Judicial Interpretation of \u201cFirst Marketing Authorisation\u201d under the SPC 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