New SPC Manufacturing waiver: more power to the generics
EU Regulation N° 2019/933, which entered into force on July 1st, 2019 and amends Regulation 469/2009 (the SPC Regulation), limits the extent of SPC protection with respect to the manufacture of the SPC-protected product provided that certain conditions are met. The new Regulation aims to promote competitiveness among EU generic and biosimilar pharmaceutical companies with respect to their foreign competitors, by allowing EU companies to manufacture protected products in the EU for purposes of export to a non-EU country, or for storage for a defined period prior to entering the EU market upon expiry of the certificate. We herein summarize the main facts, and detail the requirements for Belgium.
The rationale of supplementary protection certificates (SPCs), as set out in Regulation (EC) N° 469/2009 (the SPC Regulation), is to promote pharmaceutical research and innovation by compensating at least partly for the delay caused by obtaining the required marketing authorization (MA) for a medicinal product which reduces the period of useful exclusivity from the normal 20 year patent term. The holder of both a patent and a certificate for a medicinal product should be able to enjoy an overall maximum of 15 years of exclusivity from the time the medicinal product first obtains authorization for placement on the market in the Community. An SPC generally grants the same rights as conferred by the basic patent, with the same limitations and obligations, but its protection only extends to the authorized product. Until July 1st, 2019, the prohibited acts thus include any unauthorized making, using, offering to sell, selling or importing of the SPC protected product. EU Regulation N° 2019/933 now introduces specific exceptions to the extent of protection conferred by an SPC with the aim of promoting competitiveness of EU established pharmaceutical companies producing generics and biosimilars against their non-EU competitors, and to prevent delay of generic entries on the EU market upon SPC expiry.
EU Regulation N° 2019/933
Under EU Regulation N° 2019/933, and provided the conditions are met, an SPC will no longer confer protection against the manufacture of an SPC protected product, or any “related act that is strictly necessary for the manufacture of the product”, for the purpose of:
(i) export to non-EU countries. A specific “EU EXPORT” logo being affixed to the packaging is a requirement of the new waiver. No particular time limit is mentioned.
(ii) storing the product in order to place it on the EU market immediately following SPC expiry (“day-one entry”). If storage commences no earlier than six months prior to the expiry of the SPC, the product would eligible for the waiver.
Any act performed for the purpose of repackaging or re-exporting is explicitly excluded from the SPC manufacturing waiver.
An EU established manufacturer who intends to benefit from the manufacturing waiver has to notify the national patent office of the member state where the manufacturing and related acts will take place, using a standardized form. In addition, he must directly inform the SPC holder, no later than three months prior to the first manufacturing or related act. The national patent office is required to publish the notified information as soon as possible. It may charge a fee for these notifications. The Belgian Patent Office (OPRI) has indicated it will make the standardized forms available on its website. It will publish the notified information on its online patent register, at present without fee, and the duly completed notification form will be made available to the public as well.
The information provided by the manufacturer to the SPC holder and the national patent office includes the name and address of the manufacturer; whether the product manufactured is for export, storing, or both export and storing; the EU member state where the manufacture (or related act) is to take place; the number of the SPC; and, in the case of export to third countries, the reference number of the marketing authorization in each such country. Failure to provide this information may result in the intended manufacturer being unable to benefit from the waiver. The notification requirements, in particular the strict adherence thereto, are thus the main safeguards for SPC holders, and should allow the SPC holders to identify whether a certain activity is covered by the waiver or not.
The provisions introduced by EU Regulation N° 2019/933 apply to all SPCs applied for and granted after July 1st, 2019. A transitional period of three years is foreseen for SPC applications applied for prior to July 1st, 2019 but which will take effect after that date, with the manufacturing waiver only becoming applicable for these cases as from July 2, 2022 onwards.
We remain at your service for the latest up-to-date information or more case-specific questions.
The contributor of this article Hans Goesaert, together with Ann De Clercq are joint authors of the “Belgium” chapter of a new handbook “European SPCs Unravelled: A Practitioner’s Guide to Supplementary Protection Certificates in Europe” (eds. von Uexküll, A. and Ridderbusch O.), published by Wolters Kluwer.