2026: A year of clarity for the SPC Manufacturing Waiver Regulation?

This article is part of our Biotech Review of the Year - Issue 13 publication.

Between 2024 and 2025, there were multiple cases across Europe addressing the scope of the SPC Manufacturing Waiver Regulation. The courts have diverged, with different interpretations across the EU and the UK. Through 2026 and 2027, it is hoped that further judgments and the European Commission’s consultation will help to clarify its scope. 

Introduced in 2019, the SPC Manufacturing Waiver Regulation¹ was provided to remedy a competitive disadvantage that EU-based generic and biosimilar manufacturers (makers) faced, particularly in relation to manufacture for: (i) export to ‘third countries’² during the lifetime of a supplementary protection certification (SPC); and (ii) entry into the EU market on SPC expiry. Typically, during the period an SPC is in force in the EU, any unlicensed manufacturing activities in the EU would be an infringement of that SPC, whereas makers would be free to manufacture and service markets where there is no SPC (or equivalent rights) protecting the relevant product. 

The SPC Manufacturing Waiver Regulation allows makers to manufacture in the EU in circumstances where: 

1. the product will be exported to a third country during the SPC period; or
2. in the final six months of the SPC term, the product will be stockpiled to enable launch in the EU on the day after the expiry of the SPC. 

In order to protect the SPC holder, the SPC Manufacturing Waiver Regulation contains various conditions, including labelling requirements and supply chain due diligence. The maker is also required to notify the competent industrial property office and the SPC holder with prescribed information no later than three months before making or the first related act. 

The SPC Manufacturing Waiver Regulation was adopted and amended by the UK post-Brexit through the Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (certain amendments were necessary, not least because the UK is now itself a third country). The UK version of the waiver permits manufacturing for export to countries outside both the UK and the EU. 

In essence, the disputes across Europe and the UK have related to one piece of prescribed information required by Article 5(5)(e) of the SPC Manufacturing Waiver Regulation: 

“The notification must include the following:

…

5. for medicinal products to be exported to third countries, the reference number of the marketing authorisation, or the equivalent of such authorisation, in each third country of export, as soon as it is publicly available.”

The courts have been asked to decide whether a notification which does not contain the relevant marketing authorisation (MA) number is valid such that it starts the three-month notice period (the interpretation advanced by generic and biosimilar companies), or if the clock for the three-month notice period only starts once the MA number is provided in any subsequent update (the interpretation advanced by SPC holders). 

In addition to this main argument, various sub-arguments have been raised to support one interpretation or another. In particular, courts have heard arguments on whether the SPC Manufacturing Waiver Regulation also protects other rights in the relevant export countries - in other words, can the maker avail itself of the export waiver if the SPC holder also has relevant rights in the export country? 

This is relevant to the main argument, as SPC holders have argued that the MA number must be provided sooner rather than later so that they can confirm the relevant country of export is free of rights. 

Previous cases – a divergence emerges

The first decision relating to the scope of the SPC Manufacturing Waiver Regulation was Janssen v Formycon.³ The Munich Court, having considered evidence from both parties, awarded Janssen (the SPC holder) a preliminary injunction. The court held that Formycon’s notification was not valid as the maker must provide the MA number in at least one country of export or confirm the country of export in its notification.

After the Munich decision was handed down, cases were also heard in the Netherlands⁴ and Belgium,⁵ where similar arguments were raised. However, in these cases the Dutch and Belgian courts held that:

1. a notification which does not include an MA number is valid (and starts the three-month period), but must be updated once the MA number is publicly available;
2. the country of export does not need to be provided to the SPC holder; and
3. the relevant export country does not have to be “rights-free” for the SPC waiver to be used. 

One of the key considerations in the Belgian and Dutch decisions was the protection of maker’s confidential information. This was based on submissions relating to the “travaux préparatoires” and the recitals of the SPC Manufacturing Waiver Regulation. 

As recital 15 states, the information provided to the SPC holder should: “… be limited to what is necessary and appropriate for the certificate holder to assess whether the rights conferred by the certificate are being respected, and should not include confidential or commercially sensitive information” (emphasis added).

In the UK, the first decision on the SPC Manufacturing Waiver Regulation was handed down on 24 November 2025.⁶ Consistent with the Belgian and Dutch decisions, the Patents Court confirmed that the requirement to provide the MA number in the notification “as soon as it is publicly available” means that a notification which does not contain an MA number can still be valid and, therefore, three months after that notification, the maker may begin manufacturing. However, the UK judgment differed from the Dutch and Belgian decisions as the court concluded that rights in third countries might be relevant and that, to police compliance with the waiver conditions, the SPC holder is entitled to request information from the maker, which may include confidential information.

Therefore, by the end of 2025, across Europe and the UK three divergent approaches to the SPC Manufacturing Waiver Regulation notifications have emerged. For a notification to be valid:

1. the MA number (or country of export) must be provided (the German approach);
2. the MA number does not need to be provided, but third-country rights might be relevant and the SPC holder can request further information from the maker even if it is confidential information (the UK approach); or
3. the MA number does not need to be provided, and confidential information such as the country of export need not be disclosed to SPC holder (the Belgian and Dutch approach).

2026/2027

Janssen has appealed the Dutch Court of Appeal’s decision to the Dutch Supreme Court. Therefore, it is anticipated that in 2026 there will be a decision in Europe from a final appeal court, which may help to clarify the requirements and scope of the SPC Manufacturing Waiver Regulation, although the Dutch Supreme Court decision will not bind other courts in Europe. Elsewhere, an appeal remains possible against one of the first instance decisions in Belgium⁷. In the UK, the deadline to appeal the first instance decision has now passed and there has been no indication that the decision has been appealed to the Court of Appeal. As the parties to the German case settled following the court’s ruling, this first instance decision will not be reviewed by a higher court either. However, considering the divergence in different courts’ approaches, a possible reference to CJEU is also anticipated in 2026. We expect that there will also be fresh litigation on this issue in the coming years.

In addition to further litigation and judgments, the European Commission announced a public consultation calling for evidence for its initiative evaluating the SPC Manufacturing Waiver Regulation and assessing whether its objectives have been achieved. The date at which the consultation is due to open has not yet been confirmed, but the amending measures are due to be implemented in the fourth quarter of 2027, so the public consultation is expected to open soon.

Conclusion

On its face, the SPC Manufacturing Waiver Regulation appeared to be a win-win for SPC holders and generic/biosimilar manufacturers. It gives makers more options to manufacture in the EU/UK in jurisdictions they may be more familiar with. Practically, due to the global nature of manufacturing and supply chains, without the SPC Manufacturing Waiver Regulation, makers were able to manufacture or utilise contract manufacturing organisations in jurisdictions without SPCs (or equivalent rights) and therefore SPC holders had no visibility over the actions of generics/biosimilars. In exchange for allowing makers the ability to manufacture in the EU/UK during the SPC term, SPC holders are given more visibility over makers’ activities. 

However, the current murky picture regarding the SPC Manufacturing Waiver Regulation’s interpretation is leading to litigation and increased costs for both SPC holders and makers. This could mean that fewer generics/biosimilars utilise the waiver, leaving SPC holders in the dark as manufacture occurs outside the EU/UK. It is hoped that the scope and requirements of the SPC Manufacturing Waiver Regulation will be clarified and settled in 2026/2027 so that both SPC holders and generics/biosimilars will be able to rely fully on the mutual benefits. 

Footnotes

[1] Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products

[2] Countries outside the European Union

[3] Janssen v Formycon Munich District Court (case no. 21 O 12030/23)

[4] Janssen v Samsung Bioepis, District Court of The Hague (case no. C/09/657817),
               upheld by the Dutch Court of Appeal in Janssen v Samsung Bioepis (case no.
               200.337.844/01)

[5] Amgen v Samsung Bioepis, Court of Appeal of Brussels (case no. 2024/QR/44), Amgen v Samsung Bioepis, Dutch-speaking Brussels Enterprise Court (case no. A/24/02113) and Regeneron v Sandoz, French-speaking Brussels Enterprise Court (case no. A/24/02427)

[6] Regeneron & Bayer v Alvotech & Fisher [2025] EWHC 3050 (Pat)

[7] Regeneron v Sandoz (case no. A/24/02427)