Regeneron Pharmaceuticals, Inc. & Anor v Alvotech HF & Anor

A notification under the SPC manufacturing waiver is not invalid merely because the marketing-authorisation reference number for the export country is unavailable when the notification is made. Article 5(5)(e) requires the number to be provided once it becomes publicly available. It does not postpone validity of the notification or commencement of the three-month notice period.

The waiver provisions must be interpreted in light of their purpose, including creating a level playing field for UK and EU manufacturers. The notification regime enables the SPC holder to make a meaningful provisional assessment of compliance with the UK SPC. It does not require certainty, or enable enforcement of rights in the export country.

Regeneron Pharmaceuticals, Inc. and Bayer Plc claimed that Alvotech HF and Fisher Clinical Services UK Ltd would infringe SPC/GB13/028 by manufacturing a biosimilar of aflibercept in the United Kingdom before the SPC expired.

The defendants relied on the export and storage waivers in the assimilated SPC Regulation. The claimants argued that two notifications were invalid because they did not contain Japanese marketing-authorisation reference numbers. The court also identified a maker issue, timing issues and a relief issue, but the parties agreed that only the Export Issue needed to be decided for the purposes of pre-expiry injunctive relief.

1. Claim dismissed on the Export Issue. The First and Second Notifications were not invalid merely because Japanese marketing-authorisation reference numbers were unavailable when they were made. The claim for an injunction was refused.
2. Article 5(5) of the assimilated SPC Regulation makes specified information mandatory. Article 5(5)(e), however, requires the export-country marketing-authorisation reference number only as soon as it is publicly available. Article 5 does not state that a notification is invalid until that information is supplied, nor that the three-month period under Article 5(2)(b) starts only then.
3. Recital (17) confirms that a notification may be updated when the reference number becomes available. The wording of Article 5(5)(e) cannot be expanded to require an already-granted marketing authorisation. Such a requirement would undermine the legislative objective of putting UK and EU manufacturers on a level footing with manufacturers outside the UK and EU.
4. The notification provisions serve to give the SPC holder sufficient information to begin a meaningful assessment of whether the UK SPC may be infringed. They do not require enough information to establish certainty, and they are not directed to determining whether an SPC or other right is infringed in the export country.
5. The foreign decisions were not decisive. The court agreed with the Dutch and Belgian decisions and disagreed with the Munich decision’s reasoning insofar as it treated removal of the requirement to identify export countries as a simplification rather than a response to commercial confidentiality concerns. The Munich decision’s error materially affected its reasoning.
6. The court would have proceeded to the Relief Issue if necessary, but no injunction or interim relief pending appeal was sought. The Maker Issue and timing points were left capable of revival in any later claim for damages.

First-instance decision. No prior appellate stage is stated in the judgment.