SPC manufacturing waiver – where are we now?

Since its entry into force on 1 July 2019, the Supplementary Protection Certificate (SPC) manufacturing waiver has continued to shape the regulatory and commercial landscape for generics and biosimilars in the European Union (EU). Introduced via Regulation (EU) 2019/933, the waiver carves out limited exemptions to the otherwise exclusive rights conferred by SPCs under Regulation (EC) 469/2009.

EU Regulation 2019/933 was adopted into UK law prior to its departure from the EU so the same provisions apply equally in the UK with respect to UK SPC rights. However, interpretation of the law in the UK will now be subject to the UK courts going forward.
 
The aim of Regulation EU 2019/933? To improve competitiveness of EU-based generics and biosimilar manufacturers, while still respecting the incentive framework underpinning SPCs. As with any legal reform that walks the line between innovation and competition, practical implementation has given rise to questions, some of which are now being tested before national courts.
 

What does the SPC manufacturing waiver allow?

The waiver provides two key exemptions from SPC protection:
 

1. Manufacturing for export: EU-based manufacturers of generics and biosimilars can make medicines inside the EU when those medicines are intended for export to non-EU markets during the life of the SPC.
    

2. Stockpiling for day-one launch: In the final six months before SPC expiry, manufacturing and storage in the EU to prepare for EU market entry are permitted, giving companies a head start to launch as soon as exclusivity ends.
    

This represents a significant shift for EU-based manufacturers of generics and biosimilars who prior to introduction of this waiver would have infringed a relevant SPC if they conducted either of the above activities.

But the carve-out comes with caveats; to benefit from the waiver, a manufacturer must:

• Provide the following information to both the national patent office that granted the SPC and the SPC proprietor 3 months prior to manufacture or the first related act:
   

  • The name and address of the manufacturer
     

  • Whether manufacture for export and/or stockpiling is intended
     

  • The EU member state where the export and/or stockpiling will take place
     

  • The SPC number
     

  • For exported medicinal products, the number of the marketing authorisation (or equivalent) in each country outside the EU to which the product shall be exported
     

  • Any changes to the above before they take effect

• For export to countries outside the EU, a new “EU export” logo must be applied to the outer packaging of the medicinal product or active ingredient.
   

Where are we now?

Over 6 years after its entry into force, several recent decisions before the national courts have now shed light on how the waiver is being interpreted and where its boundaries may lie.
 

Janssen Biotech v Formycon – Munich Regional Court

In this preliminary injunction decision, the court sided with SPC holder Janssen, issuing an injunction to prevent Formycon from manufacturing its ustekinumab biosimilar.
 
The dispute concerned a German SPC which protects drug Stelara®. Formycon developed FYB202, a biosimilar of Stelara®. Formycon intended to produce FYB202 in Germany in order to export it to third countries and enter the EU market immediately following the SPC’s expiry. Formycon notified SPC holder Janssen, as required by the EU Regulation.
 
Janssen’s position was that Formycon had not provided a valid marketing authorisation (MA) for the intended country of export, interpreting the manufacturing waiver as requiring a valid MA for at least one third country in which the SPC does not apply in order to produce the biosimilar for export.
 
Formycon argued that the MA number could be communicated once available, and that delay is often unavoidable, particularly in the biosimilar space. However, the Munich court ruled in favour of the claimant and issued a preliminary injunction, prohibiting Formycon from producing FYB202 in Germany for export.
 

Amgen v Samsung Bioepis – Brussels Enterprise Court

Amgen challenged Samsung Bioepis’s manufacturing waiver notification for a denosumab biosimilar. Denosumab is the active ingredient in Amgen’s Prolia® and Xgeva® products marketed for the treatment of osteoporosis and bone cancer, respectively.
 
Amgen challenged the validity of Samsung Bioepis’s notification arguing that the notification lacked key details, specifically, named countries of export and MA reference numbers.
 
Amgen also pointed to its exclusive rights on the active substance in several third countries, including the US and South Korea, suggesting that export to those territories could infringe local patents.
 
The Brussels court rejected these arguments and confirmed that neither the MA reference number nor the exact export destinations need be included at the time of notification. The MA reference number can be supplemented “as soon as it is publicly available”, and the export destinations could remain confidential, regarding them as potentially sensitive information.
 
Importantly, the court also found that the Regulation does not require the destination market to be patent-free, although infringement in those countries remains a separate issue under their national laws.
 
As such, the Belgian court dismissed Amgen’s claims and arguments, and found that Samsung Bioepis’s SPC manufacturing waiver notification complied with the Regulation.¹
 
Interestingly, in Amgen v Samsung Bioepis, the Belgian court even considered and rejected the stricter interpretation put forward by the Munich regional court in Janssen v Formycon (discussed above).
 

Looking ahead

The Regulation mandates that the European Commission review the waiver’s effect by 1 July 2024, with subsequent reviews every five years. That first review deadline has now passed, and we may see clarifications or legislative amendments in due course, particularly in light of the contrasting conclusions across European courts on the critical issue of the implementation of the notification provisions.
 
For now, though, manufacturers seeking to benefit from the waiver must ensure careful compliance with the notification process and remain alert to variations in how national courts are interpreting the provisions (noting the more lenient approach in the Belgian and Hague courts versus the German courts). Equally, SPC holders should continue to monitor waiver notifications closely and be prepared to act quickly where the boundaries of the Regulation are being tested.
 
Our team has considerable experience advising clients on SPCs, please get in touch with Beth Ormrod, Nick Bassil, or your usual Kilburn & Strode advisor if you have any related queries.