German and Dutch courts have their say on the derogation to the protection conferred by an SPC for the purpose of export to third countries
Béatrice HOLTZ
French and European Patent Attorney
Background
Supplementary Protection Certificates (SPCs) are intellectual property rights that serve as an extension to patent rights that protect medicinal (or phytopharmaceutical) products that have been authorised by regulatory authorities. Regulation (EC) No 469/2009 (hereafter the “Regulation”) governs the supplementary protection certificates for medicinal products.
As provided in article 5(1) of the Regulation, the SPC confers the same rights as conferred by the basic patent.
A derogation to this protection entitles EU-based companies to manufacture a generic or biosimilar version of an SPC-protected medicine during the term of the certificate, if done either for the purpose of export to a non-EU market or the purpose of stockpiling during the final 6 months of an SPC’s life ahead of entry into the EU market. This derogation, defined in article 5(2), was aimed at removing a major competitive disadvantage of EU-based manufacturers compared to manufacturers based in non-EU countries.
Article 5(2)(a)(i) thereby provides that the certificate shall not confer protection against the making of a product, or a medicinal product containing that product, for the purpose of export to third countries.
This exemption is conditioned by the notification, by the maker, to the industrial property office in the Member State in which that making is to take place, and to the certificate holder, of information relating to the manufacturing, including “the reference number of the marketing authorisation, or the equivalent of such authorisation, in each third country of export, as soon as it is publicly available” (article 5(2)(b) together with article 5(5)(e) of the Regulation). The notification is to be made no later than three months before the start date of the making or before the first related act, prior to that making, that would otherwise be prohibited by the protection conferred by a certificate, whichever is the earlier.
The non-compliance with the requirements of article 5(5)(e) with respect to a third country affects exports to that country, only, and consequently such exports do not qualify for the exception (article 5(7) of the Regulation).
Recent national caselaw on SPC Waiver
Two national Courts recently interpreted the conditions for enjoying the manufacturing exemption for the purpose of export to third countries, in two cases involving the same basic patent/SPCs of Janssen Biotech.
Janssen Biotech holds European Patent N°1 309 692 B1 that protects the monoclonal antibody ustekinumab marketed under the brand name “Stelara”. Janssen obtained SPCs in countries including Germany and Denmark (expiry dates on July 20, 2024), and Italy (expiry date on July 19, 2024).
German case
On October 20, 2023, the Regional Court Munich handed down a preliminary injunction in a first case opposing Formycon and Janssen Biotech.
Formycon had developed FYB202, a biosimilar of Stelara. Formycon informed the German patent office and Janssen Biotech, with a notification dated May 31, 2023, of its intention to manufacture in Germany for the purpose of export it to third countries. Formycon did neither provide a marketing authorisation number, nor did they list the intended third countries of export. No application had been made for marketing authorisation in a third country.
The Court held that “it is not necessary for the marketing authorisation number to be available at the time the information pursuant to Art. 5(2)(b) of the Regulation is transmitted. However, according to the meaning and purpose of the Regulation, the exception in Art. 5 of the Regulation must be interpreted restrictively to the effect that the manufacturer cannot rely on this if he has not communicated the approval number for at least one country and has not declared to which third country an export is to take place” (emphasis added).
To reach this decision, that rely on recitals 3, 4, 8, 18, 29 and 30 of the Regulation, the Court reasoned that the purpose of the Regulation is only to enable exports to third countries without property rights, although article 5 of the Regulation does not distinguish between third countries with or without existing IP rights. According to the Court, the three-month period should also enable the IP right holder to check whether a marketing authorisation has been granted in the intended export third country and whether an export to the designated third country is permissible.
Altogether, the Regional Court Munich held that Formycon cannot claim the manufacturing privilege.
Dutch case
The conditions of application of the SPC waiver for the purpose of export to third countries were also examined by the District Court in The Hague.
In this second case, Samsung Bioepis had developed a biosimilar of Stelara and submitted a notification under Article 5(2)(b) to the Danish and Italian authorities, respectively, on October 24, 2023 – with copy to Janssen – announcing Samsung Bioepis’ intention to manufacture and stock its biosimilar in Denmark and Italy, notably for the purpose of export to third countries, as from January 24, 2024.
Few days later, on October 30, 2023, Samsung Bioepis disclosed the intended countries of export in a notification update and mentioned that the marketing authorisation reference numbers will be provided once they are publicly available.
In its judgment of January 23, 2024, and contrary to the Regional Court Munich, the District Court in The Haguefound that “it does not flow from the Regulation that at the time the manufacturer makes the notification under Article 5(2)(b), it must already have been granted an authorisation in the country to which it intends to export. According to the text of the regulation, the manufacturer is obliged to provide the reference number of the marketing authorisation or of the equivalent of such authorisation in each exporting third country only as soon as it is publicly available. This implies […] that if this number is not yet publicly available, the manufacturer has the possibility to supplement the notification with the reference number of the marketing authorisation as soon as it is publicly available, as is evident from Article 5(5)(e)”.
In the Court’s opinion, “the marketing authorisation need[s] not yet have been granted at the time of notification, this is also […] not necessary in order to be able to establish the properties of the biosimilar in order to be able to determine whether it falls under the scope of protection of a patent/SPC in a third country. After all, these properties are often already known after Phase III clinical trials […]” (emphasis added).
Yet, regarding the particular of the case opposing Samsung Bioepis and Janssen Biotech, the District Court in The Hague observed “it is also important to note that Samsung Bioepis, by providing information about the intended export countries, does enable Janssen to verify whether patent or SPC rights still apply in the country in question and whether it can initiate proceedings in this regard”, which is in contrast with the case that opposed Formycon and Janssen Biotech.
Nevertheless, in the end, the District Court in The Hague dismissed the idea that it was the intention of the European legislator that production under this exemption would only be allowed if no relevant (patent) rights apply in the exporting countries.
The District Court in The Hague thus held that Samsung Bioepis could validly rely on the production exemption for export to third countries.
In view of the foregoing, it appears that it is at issue whether the benefit of the SPC waiver for the purpose of export to third countries can be validly claimed absent any granted marketing authorisation in an export third country.
To be on the safe side, manufacturers should a minima list the intended third countries of export at the time of notification to the relevant industrial property office(s) and to SPC holder.
German and Dutch courts have their say on the derogation to the protection conferred by an SPC for the purpose of export to third countries
Béatrice HOLTZ
French and European Patent Attorney
