This judgment concerns the information needed to obtain an SPC manufacturing waiver for export under the UK SPC Regulation. The SPC manufacturing waiver scheme permits generic and biosimilar manufacturers to undertake acts of manufacture in the UK (for export outside the UK or EU) prior to expiry of the SPC, provided 3-months’ notice is given together with certain information.
A notification was given in August 2025 which Regeneron (the SPC holder) said was invalid due to the lack of certain information. The action was commenced by Regeneron in September 2025 seeking a final injunction against any acts of manufacture prior to the expiry of the SPC on 22 November 2025.
Rather than seek interim injunctive relief, Regeneron requested a highly expedited trial so that a final answer could be obtained prior to 22 November 2025. Meade J agreed to this significant expedition and the trial was heard on 3-4 November 2025 with a result given immediately at the end of the trial on 4 November 2025. The reasoned judgment was then handed down on 24 November 2025. The Court held that the relevant notification was valid meaning that the acts of manufacture were permitted.
The dispute had arisen over whether the notification must include the published marketing authorisation reference numbers for the country or countries of export. If correct, this meant that notifications could not be made (and the 3-month period could not start to run) until such MA numbers had been published. In the current case, this would have meant that no manufacture could commence prior to SPC expiry.
There is conflicting law on the point under the EU SPC Regulation (from which the UK Regulation derives) with the District Court in Munich having found that MA reference numbers are required and with Courts in the Netherlands and Belgium coming to the contrary conclusion. Meade J held that MA reference numbers for countries of export are not required to make a valid SPC manufacturing waiver notification for export in the UK.