In brief:
- It is not an infringement of a Supplementary Protection Certificate (SPC) to make a protected product for export, provided the maker gives the SPC holder advance notice of its intentions, including information prescribed by Article 5(5) of the SPC Regulation.
- Such notifications do not have to include reference numbers of marketing authorisations in intended countries of export if they are not publicly available when the notification is given.
- Accordingly, there is no need to wait for such reference numbers before giving the minimum three months' notice before commencing activities under the waiver.
Background
It can take years after a patent has been granted for the patentee to secure regulatory approval that permits commercialisation of a medicinal product in the EU and UK. In the meantime, the monopoly period under the patent passes. An SPC extends the term of a patent monopoly, insofar as it covers a medicinal product, as part compensation for this lost time. However, SPCs that prohibit local companies from manufacturing a medicinal product hand an advantage to companies based in countries where there is no equivalent SPC. They can manufacture without infringement, and accordingly gear up to enter the EU and UK with large volumes of relevant products on day 1 after expiry. The SPC Regulation was amended in 2019, by Regulation (EC) No 2019/933 of 20 May 2019 (the Amendment Regulation), to level the playing field by allowing local manufacturers in countries where an SPC has been granted to make the medicinal product for export or stockpiling, notwithstanding the SPC. The SPC Regulation continues to apply in the UK, notwithstanding Brexit, as "assimilated law" under the Retained EU Law (Revocation and Reform) Act 2023.
Article 5(2)(a) of the SPC Regulation, as amended, provides that making a product for export will not involve infringement of an SPC provided that the maker provides certain information to the SPC holder at least three months before they commence the relevant activities.
Article 5(5) lists the requisite information. It includes: the name and address of the maker; an indication of whether the products will be made for export, stockpiling or both; the SPC number and (if the products will be made for export):
" … the reference number of the marketing authorisation, or the equivalent of such authorisation in each country of export, as soon as it is publicly available."
In Regeneron v Alvotech, the court had to decide whether a notification is invalid, and therefore offers no protection against an infringement claim, if it does not include the reference number for the intended country of export (here, Japan) because it was not publicly available when the notice was given. In other words, does the maker have to wait until the export country's reference number is publicly available before giving notice, and then wait another three months before commencing the relevant activities, or can they supplement the notice by supplying the number when it becomes publicly available? Alternatively, if the maker has been provided with the reference number by the foreign regulatory authority on a confidential basis, must they disclose it in the notification?
The same question has been considered by courts in Germany, the Netherlands and Belgium. The German court (the District Court in Munich) decided that the notification was invalid if it did not include the reference numbers for the intended countries of export. The case settled before any appeal.
The Dutch and Belgian courts (including at the appeal level) reached the opposite conclusion. A notification was not invalid if it did not include the reference numbers. These could be supplied later, when they became publicly available.
The Patents Court decision
In his decision, Meade J reached the same conclusion as the Dutch and Belgian courts. He considered that, purely as a matter of interpretation of the SPC Regulation, including its recitals and overall purpose, the answer was clear. The notification did not have to include reference numbers if they were not available or were confidential.
Meade J nevertheless went on to consider the parties' various arguments and the decisions of the German, Dutch and Belgian courts carefully. He considered that the reasoning of the Dutch and Belgian courts gave him additional confidence in his conclusion and that the German Court had made a material mistake about the legislative history and purpose of the Amendment Regulation, which undermined the validity of its whole chain of reasoning. Accordingly, its decision provided no basis on which to question his conclusion.