1. According to Art. 3 of Regulation (EC) 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (hereinafter SPC Regulation), a supplementary protection certificate may be granted if, in the Member State in which the application for a supplementary protection certificate is submitted, at the time of that application
a) the product is protected by a basic patent in force;
b) a valid marketing authorization has been granted for the product as a medicinal product;
c) another protection certificate has not already been issued for the certificate and
d) the marketing authorization referred to in point (b) is the first authorization to place this product on the market as a medicinal product.
As a sui generis right, the certificate grants thus the same rights as the basic patent and is subject to the same restrictions and obligations.
The purpose of introducing the supplementary protection certificate was to promote the research and innovation required for the development of medicinal products by granting an additional period of protection in the Union and to compensate for the time needed to obtain a marketing authorization.
2. Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019 added nine further paragraphs to Article 5 of the SPC Regulation.
The reason for this was that in recent years enormous growth in the manufacture of generics and biosimilars and their substances had been in countries outside the European Union and the rules laid down in the regulation had the unintended side effect that active European generics and biosimilars manufacturers were not even allowed to manufacture their preparations in the Union for export to third countries or for the purpose of storage for a limited period before the protection certificate expired. In this respect, there was a need to strengthen the position of generics manufacturers in competition with competitors outside the EU as far as possible while safeguarding at the same time the rights of certificate holders in relation to the Union market.
According to the new Art. 5 (2) SPC Regulation, the certificate does not protect against acts consisting of the manufacture of a product or a medicinal product containing this product for the purpose of export to third countries or an associated act strictly necessary for the manufacture in the Union or the actual export. Likewise, acts carried out at the earliest 6 months before the expiry of the certificate for the manufacture of a product or medicinal products containing that product in order to store the products/medicinal products in the Member State of manufacture and to place them on the market in the Member States after the expiry of the corresponding certificate cannot be prevented, or acts that are strictly necessary for manufacture in the Union or for actual storage, provided that these associated acts are also carried out noT earlier than 6 months before the expiry of the certificate.
Art. 5 para. 2 b) SPC Regulation stipulates that the manufacturer must provide certain information to the certificate holder and the competent authority of the Member State in which the manufacture will take place, at the latest three months before the date of the start of manufacture in that Member State or the first related act and, if the product/medicinal product is to be placed on the market in the Union after the expiry of the supplementary protection certificate, additionally at the earliest six months before the expiry of the protection certificate. In Germany, the notification must be made to the DPMA; the form to be used is available on the DPMA website.
The information to be notified is listed in Art. 5 para. 5 SPC Regulation and includes the name and address of the manufacturer, whether the manufacture is for the purpose of export, storage or export and storage, the Member State in which the manufacture, storage or any first related act is carried out, the number of the certificate issued in the Member State of manufacture or the number of the certificate issued in the Member State of the first related act and for medicinal products, intended for export to third countries, the number of the marketing authorization or equivalent for each exporting third country, as soon as this is publicly available.
3. Although the regulation has far-reaching implications for holders of supplementary protection certificates as well as for generics and biosimilar manufacturers, relatively few rulings have been handed down in the EU – with sometimes significantly divergent results.
In a judgment of 20/03/2023 (GRUR-RS 2023, 39994), the Regional Court of Munich I found that the exception in Art. 5 SPC Regulation should be interpreted restrictively according to its meaning and purpose to the effect that the manufacturer cannot invoke it if it has not provided the approval number for at least one country and has not declared to which third country an export is to take place. In addition, the manufacturer’s privilege only exists in the case of exports to countries without intellectual property rights. Manufacturers in third countries where protection exists are not allowed to operate in any case, so that there is no risk of manufacturers in the EU being disadvantaged in this respect. The 3-month period of Art. 5 para. 2 b) SPC Regulation should not only enable the IP right holder to check whether the requirements of the Regulation are being complied with and, in particular, whether there is a risk of the products being diverted to the Union market, but also whether a market authorization has been granted in the intended third country of export and whether export to the designated third country is permissible. Otherwise, there is a risk that the manufacturer, without providing any information on the intended export country, will start production after the three months have expired and submit the application in the third country, and then, after receiving the approval, subsequently transmit the approval number and enter the market of the third country directly. The IP right holder would thus only be informed of this immediately before entering the market and would have no opportunity to check whether the market entry in the third country would be opposed by IP rights.
On 23/01/2024, the court in The Hague (Ref.: C/09/657817/KEZA23-1039) ruled, with knowledge of the decision of the Regional Court Munich I, that it is permissible to only name the countries for which the manufacturing privilege is to be claimed in a notification of variation after the actual notification. The wording of Art. 5 of the SPC Regulation does not indicate that a manufacturer may only send the notification after approval has been granted – and may only start production a further three months after approval. This would be contrary to the purpose of the SPC Regulation, which is to create a level playing field between manufacturers from the EU and those in third countries. The opinion of Munich Regional Court I that the SPC Regulation should be interpreted restrictively in the sense that the notification must contain the approval number before production for export can begin is not correct. Also, according to the text of the regulation, the manufacturer’s privilege is not only intended for exports to countries without intellectual property rights. Instead, the question of whether or not the production that falls under the manufacturing privilege is permitted in the third country is irrelevant for the manufacturing privilege. If the placing on the market in a third country is to be regarded as an infringement of an existing protection certificate, the holder of the protection certificate must conduct infringement proceedings in that third country.
On 23/12/2024, the Enterprise Court in Brussels ruled (Ref.: A/24/02113) that a notification pursuant to Art. 5 para. 5 SPC Regulation is also lawful if the approval number is missing in relation to export countries, insofar as this is not yet publicly available. Nothing else can be inferred from the wording of the regulation. The had also European legislator deliberately decided against including further information in the catalog of notification obligations and had given preference to the protection of manufacturers’ business secrets over the interests of the holders of the protection certificates.
In view of the two judgments from The Hague and Brussels, which are to be endorsed (cf. v. Czettritz/Thewes, PharmR 2024, 253 et seq.), the development of case law in Germany can be eagerly awaited.
