The case concerned the scope of the UK's SPC manufacturing waiver for export, which permits the making of products protected by a supplementary protection certificate ("SPC") in the UK for export outside the UK during the SPC term. The defendants, Alvotech and Fisher, planned to manufacture in the UK a biosimilar version of aflibercept, for export to Japan. The relevant SPC protected EYLEA, whose active ingredient is the fusion protein aflibercept, a widely used therapy for "wet" macular degeneration. The defendants did not challenge the SPC's validity or infringement; the dispute turned solely on compliance with the waiver's notification regime.

Under the SPC Regulation, the defendants notified the claimants, Regeneron and Bayer, of their intended activities. However, at the time of notification, the Japanese marketing authorisation ("MA") numbers were not yet publicly available and were therefore not included. The claimants contended that the notifications were invalid and sought to restrain any UK manufacturing prior to expiry of the SPC.

The issue at trial

The central question was whether a valid notification under Article 5(5)(e) of the SPC Regulation can be given before a MA in the export country has been granted or, at least, before its reference number is available, provided that the reference number is supplied once it becomes public. Article 5(5)(e) requires, for products to be exported outside the United Kingdom, disclosure of "the reference number of the marketing authorisation...in each country of export, as soon as it is publicly available."

The claimants argued that no notification can be valid unless and until the export-country MA has been granted and the reference number can be given. The defendants maintained that a notification can validly be given earlier, with the reference number to follow when it becomes publicly available.

The judgment

The Court held that the defendants' notifications were not invalid for omitting the Japanese MA numbers at the time they were served, and it declined to grant an injunction restraining the manufacturing.

Characterising the matter as a short point of legislative interpretation, the Judge concluded that the answer lies in the text, structure, recitals, and purpose of the SPC Regulation. On the ordinary meaning of Article 5(5), the Court found that the requirement to provide the export-country marketing authorisation reference number is expressly contingent: it must be provided "as soon as it is publicly available." Accordingly, the absence of a number at the time of the initial notification does not render the notification invalid, provided the number is supplied once public.

Turning to legislative purpose, the Court emphasised that a contrary interpretation would distort the intended "level playing field." It would allow non-UK manufacturers to commence manufacture before obtaining an export-country MA, while UK manufacturers operating under the waiver could not notify and start manufacturing until the MA issued. That asymmetry would undermine the waiver's pro-competitive objective.

The Court also considered decisions from Germany, the Netherlands, and Belgium addressing the same provision. While noting a first‑instance German decision favourable to the claimants' position, the Court observed that Dutch and Belgian courts had reached the opposite conclusion, including at appellate level. The Judge held that foreign decisions were not determinative but, having examined their reasoning, found them to support the ordinary-meaning and purpose-based approach adopted. In particular, the Court noted consensus that the text of Article 5 does not support the claimants' reading, and that the German court's analysis relied on a materially mistaken understanding of the amending legislation's history and intent.

In sum, the Court concluded that the defendants' notifications were valid notwithstanding the initial absence of the Japanese MA numbers and that those numbers need only be provided when they become publicly available. 

Take‑home message

The judgment confirms that a notification under Article 5(5)(e) is valid even if it does not initially include the export‑country MA number, provided the number is supplied as soon as it becomes public. UK manufacturers can therefore commence notified manufacturing for export without waiting for the foreign MA to issue, but must update promptly when the number is available. This approach aligns with Benelux authority and the waiver's level‑playing‑field purpose, reducing the risk of injunctive relief where timely updates are given.

Regeneron Pharmaceuticals, Inc. & Anor v Alvotech HF & Anor [2025] EWHC 3050 (Pat)