SPC制造豁免立场文件

EFPIAPosition Paper Date:16June2026Version:FINAL Supplementary Protection Certificates and the Manufacturing Waiver Intellectual property (IP) rights, and their effective enforcement, are fundamental to ensurecontinuedinvestment in pharmaceutical innovation and the development of innovativemedicines. Supplementary protection certificates (SPCs) are a key component ofthis incentivestructure by providing a limited period of additional patent term to innovative medicinal products The SPC Manufacturing Waiver (Waiver), introduced by Amending Regulation (EU) 2019/933(Amending Regulation), was created as a carefully limited exception to this important IP right.The Waiver was intended to support generic and biosimilar manufacturers established in theEuropean Union by allowing manufacturing activities during the SPC term for two narrowly-defined purposes: (i) export to third countries where IP protection does not exist or has expired CJEU Referral for Preliminary Ruling The Danish Maritime and Commercial High Court has requested a preliminary ruling from theCourt of Justice of the European Union (CJEU) regarding theExportExemption under the Waiver.This referral represents the first time that the CJEU has been asked to interpret thescopeof the Case C-371/26, brought by a group of Johnson & Johnson companies (J&J) against SamsungBioepis NL B.V. (Samsung) and AGC Biologics A/S (AGC),concernsthe manufacture andexport ofa biosimilar product to the UK while a SPC held by one of the J&J companies was still in force. Samsung and AGC manufactured the product in Denmark and stored it in the EU. At the time ofmanufacture, Samsung could not export to or sell the products in the UK due to,inter alia, J&J's According to well-established case law of the CJEU, all exceptions to or derogations from legalproperty rights must be interpreted narrowly and strictly. This principle should equally apply to Importantly, the Waiver establishes two distinct exemptions: one relating to export and anotherrelating to stockpiling. TheExportExemptiononly applies to manufacture for actual andimminentexportanddoes not extend to general or strategic stockpiling. If a given generic orbiosimilar manufacturer cannot carry out the intendedexportdirectlyafter the manufacturinghas been completed,a sudden pivot to general stockpiling is not contemplated under thestrictures of the Waiver. This would go against the very purpose of theExportExemption, which was created to facilitate the export of finished and stocked products to qualifying third countriesand wouldfurtherundermine the careful balance of rights established by the SPC system,effectively broadening theExportExemption beyond the limits intended by the EU legislature.Critically, if theExportExemption,which is not limited in time,isinterpreted to permitgeneralor strategicstockpilingthroughout the SPC term, it would grant broader storage rights than the As the Export Exemption currently stands, generic and biosimilar manufacturers are required toserve a notification to the SPC holder, which permits manufacture for export three months afterthe notification. Under the terms of the Waiver, the notificationshould include the marketingauthorization (MA) number of the generic product in the intended export country as soon as it ispublicly available, presupposing that the MA has indeed been granted at the time of thenotification-even if the MA number is published later. This obligation reflects a carefullyconsidered legislative compromise to enable the SPC holder to verify-before manufacture and As mentioned, the Export Exemption should only apply to exports to third countries where IPprotection does not exist or has expired, and where markets are open to competition at the timeof manufacture. The Commission's intention from the outset was to permit manufactureexclusively for export to rights-free markets. The Amending Regulation expressly placesresponsibilityon the EU-based manufacturer to verify that protection does not exist or hasexpired in the country of export.Permitting manufacture for export to countries where IP rights While this referred matter represents the first CJEUreferral, various national courts have alreadyinterpreted notification under the Waiver with diverging results. This legal fragmentation createsuncertainty for both SPC holders and genericand biosimilarmanufacturers.Importantly, theseries of national court decisions on theExportExemption provide no alternative explanation asto how the intended verification by the SPC holder can effectively take place without a grantedand disclosed MA number for use in a given geography. It is therefore essential that theCJEU In this context, EFPIA urges the CJEU to hold to the legislative intent of the Waiver and find that:(1) theExportExemption does not cover general or strategic stockpiling, and that manufacturemust be for actual and imminent export; (2) a valid marketing authorization must have beengranted at the time of notificati