SPC Export Waiver: High Court Clarifies Notification Requirements

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