Supplementary Protection Certificates (SPCs) are 5-year maximum extensions to a 20-year patent for medicinal and plant protection products. The SPC was instituted to offset, at least in part, the period intervening while awaiting the issuance of a Marketing Authorisation (M.A.) for the medicinal or plant-protection product, i.e., between the filing of the patent application and the granting of an M.A. Article 3 of Regulation EC/469/2009 specifies the conditions for obtaining this I.P. tool which is based on the two legal pillars: patent law and regulatory law. Under patent law, application for an SPC may be filed for a product that is an active ingredient or combination of active ingredients, if that product is protected by a basic patent currently in force. The product must be an embodiment of the invention protected by the basic patent and must be specifically identified in the claims of the same basic patent by way of its structural characterisation (Medeva C-322/10) or its functional characterisation (HGS vs Eli Lilly C-493/12). In the case of combinations of active ingredients, the combination must be part of the invention covered by the patent, and each of the active ingredients must be specifically identifiable in the light of the information disclosed in that patent. Under regulatory law, the active ingredient or combination of active ingredients for which an SPC is sought must be contained in a medicinal product with an M.A. pursuant to Directive 2001/83/EC. The medicinal product must contain all the active ingredients mentioned in the SPC application, as confirmed by decisions Georgetown C-422/10, Medeva C-322/10. The medicinal product in question may, however, also comprise other active ingredients. No product that has been granted an SPC may obtain a second SPC. However, the same patent may generate other SPCs for different products, provided that each product is protected by that same patent and is an ingredient of the Marketing-Authorised medicinal product. In the special case of a new combination of ingredients consisting of a first active ingredient protected by a basic patent and already the subject matter of an SPC, along with a second active ingredient known in the prior art, a new SPC may be obtained only if the combination is specified in the wording of the claims of the basic patent and is identified as an embodiment of the invention. However, if the specific combination is not an embodiment of the invention, no new SPC may be allowed (Sanofi C-443/12). The question of SPC protection of combinations of active ingredients is the subject of open debate in Europe and important decisions of the CJEU on the issue are expected in the very near future. SPCs may be granted only on the basis of the first M.A. for a medicinal product. A second SPC may not be granted on the basis of a new M.A. for a second therapeutic use or for a new formulation of a product that has already been granted a first M.A. (see Decision C-673/18 - Santen vs INPI and Decision C-443/17-Abraxis Biosciences vs Comptroller). Regulation EC/469/2009 was recently amended by Regulation EU/2019/933 to include the granting a waiver within the SPC framework to allow the manufacture and storing of generic and biosimilar forms of original active ingredients, yet without affecting the finality of the protection of intellectual property rights that remain one of the cornerstones of innovation, competitiveness and growth in the internal market. (Recital no.7). In practical terms, the waiver system allows a medicinal containing a product SPC-protected, as well as any connected act strictly necessary for the realization to be manufactured no earlier than six months prior to the expiry of the SPC for the purpose of export to third countries where there is no protection or, for the purpose of temporarily storing product in a EU member state before release onto the market that is allowed the day after SPC expiry.

PATENT EXTENSION FOR MEDICINAL PRODUCTS IN EUROPE: SUPPLEMENTARY PROTECTION CERTIFICATES, SPECIFIC CASE LAW AND THE EXPORT WAIVER

Sara Bertoli;Chiara Triunfo;Federica Bigucci;Patrizia Rampinelli
2023

Abstract

Supplementary Protection Certificates (SPCs) are 5-year maximum extensions to a 20-year patent for medicinal and plant protection products. The SPC was instituted to offset, at least in part, the period intervening while awaiting the issuance of a Marketing Authorisation (M.A.) for the medicinal or plant-protection product, i.e., between the filing of the patent application and the granting of an M.A. Article 3 of Regulation EC/469/2009 specifies the conditions for obtaining this I.P. tool which is based on the two legal pillars: patent law and regulatory law. Under patent law, application for an SPC may be filed for a product that is an active ingredient or combination of active ingredients, if that product is protected by a basic patent currently in force. The product must be an embodiment of the invention protected by the basic patent and must be specifically identified in the claims of the same basic patent by way of its structural characterisation (Medeva C-322/10) or its functional characterisation (HGS vs Eli Lilly C-493/12). In the case of combinations of active ingredients, the combination must be part of the invention covered by the patent, and each of the active ingredients must be specifically identifiable in the light of the information disclosed in that patent. Under regulatory law, the active ingredient or combination of active ingredients for which an SPC is sought must be contained in a medicinal product with an M.A. pursuant to Directive 2001/83/EC. The medicinal product must contain all the active ingredients mentioned in the SPC application, as confirmed by decisions Georgetown C-422/10, Medeva C-322/10. The medicinal product in question may, however, also comprise other active ingredients. No product that has been granted an SPC may obtain a second SPC. However, the same patent may generate other SPCs for different products, provided that each product is protected by that same patent and is an ingredient of the Marketing-Authorised medicinal product. In the special case of a new combination of ingredients consisting of a first active ingredient protected by a basic patent and already the subject matter of an SPC, along with a second active ingredient known in the prior art, a new SPC may be obtained only if the combination is specified in the wording of the claims of the basic patent and is identified as an embodiment of the invention. However, if the specific combination is not an embodiment of the invention, no new SPC may be allowed (Sanofi C-443/12). The question of SPC protection of combinations of active ingredients is the subject of open debate in Europe and important decisions of the CJEU on the issue are expected in the very near future. SPCs may be granted only on the basis of the first M.A. for a medicinal product. A second SPC may not be granted on the basis of a new M.A. for a second therapeutic use or for a new formulation of a product that has already been granted a first M.A. (see Decision C-673/18 - Santen vs INPI and Decision C-443/17-Abraxis Biosciences vs Comptroller). Regulation EC/469/2009 was recently amended by Regulation EU/2019/933 to include the granting a waiver within the SPC framework to allow the manufacture and storing of generic and biosimilar forms of original active ingredients, yet without affecting the finality of the protection of intellectual property rights that remain one of the cornerstones of innovation, competitiveness and growth in the internal market. (Recital no.7). In practical terms, the waiver system allows a medicinal containing a product SPC-protected, as well as any connected act strictly necessary for the realization to be manufactured no earlier than six months prior to the expiry of the SPC for the purpose of export to third countries where there is no protection or, for the purpose of temporarily storing product in a EU member state before release onto the market that is allowed the day after SPC expiry.
2023
62° Simposio AFI - La filiera della Salute: motore di sviluppo per il Paese
154
154
Claudio Germinario, Paolo di Giovine, Sara Bertoli, Chiara Triunfo, Antonella Chiara Di Palo, Federica Bigucci, Patrizia Rampinelli
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11585/964611
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