SPC Waiver: no MA? UK says ok

On 24 November 2025, the Patents Court delivered its decision in Regeneron& Bayer v Alvotech & Fisher, addressing a key question under the SPC manufacturing waiver: must a manufacturer include marketing authorisation (MA) numbers for export countries in its initial notification, or can these follow later?

The Decision

Mr Justice Meade held that a notification is valid even if MA numbers for export countries are not available at the time of filing. The SPC Regulation requires these details to be provided “as soon as publicly available” but does not make them a precondition for starting the three-month notice period. In other words, the clock starts ticking from the initial notification, not from the later update with MA numbers.

This interpretation aligns with recent rulings from Dutch and Belgian courts and diverges from the restrictive approach adopted by the Munich court in 2023. The judge emphasised that legislative purpose and recitals carry greater weight than legislative drafting history, which he found of “no real assistance” in this case. The travaux préparatoires - background legislative materials - were scrutinised but ultimately did not alter the clear meaning of the text.

Why It Matters

Although unsurprising given the European trend, this is one of the first UK decisions on the SPC manufacturing waiver and provides welcome clarity for businesses operating in the UK post-Brexit. It confirms that UK law remains materially consistent with EU law on this point, ensuring predictability for companies planning cross-border strategies.

The ruling also underscores the policy objective behind the waiver: to level the playing field between EU/UK-based manufacturers and competitors in third countries, enabling timely entry into export markets or day-1 entry in the UK/EU without undermining the essence of SPC rights.

Implications

• For Manufacturers: You can notify early without waiting for overseas MAs, reducing delays and supporting competitive entry into overseas markets. Ensure updates are made promptly when MA numbers become publicly available.‍
• For SPC Holders: Notifications may arrive before overseas MAs are granted. Monitoring and proactive engagement remain essential to assess compliance and manage risk. While the court highlighted that the legislation avoids requiring disclosure of export destinations upfront to protect commercially sensitive information, SPC holders can still request further information and enforce safeguards against premature entry into protected markets.‍
• Strategic Planning: Businesses should review their waiver strategies now. Timely notifications, accurate documentation, and clear internal processes are critical to avoid disputes and maintain compliance.

Looking Ahead

This decision reinforces the UK’s alignment with broader European case law and rejects the Munich court’s more restrictive interpretation. For life sciences companies, the message is clear: the SPC manufacturing waiver offers flexibility, but it comes with obligations. Both SPC holders and manufacturers should take note of this judgment when planning UK-based production or enforcement strategies.

Our team is closely monitoring developments in this area and can advise on notification requirements, risk management, and strategic timing under the UK and EU regimes.