Does a pharmaceutical company have to report the exporting countries when applying for a manufacturing waiver?

A ruling by the Dutch-speaking business court in Brussels brings clarity to the information obligation for producers of biosimilar medicines who want to make use of the so-called "manufacturing waiver. The court ruled that a manufacturer does not yet have to specify the export countries in its initial notification to benefit from the waiver, which is an important victory for biosimilar producers.

The facts and legal context

The case revolved around a dispute between pharmaceutical giant Amgen and biosimilar manufacturer Samsung Bioepis (SB). Amgen holds a supplementary protection certificate (SPC) for "denosumab," the active ingredient in its drugs Prolia® and Xgeva®. This certificate grants extended patent protection until the end of November 2025.

SB, for its part, plans to produce a biosimilar version of denosumab in Belgium with the intention of exporting it to countries outside the European Union. To do so, the company invoked the SPC manufacturing waiver, an exception in the European SPC Regulation (Regulation (EC) No. 469/2009, amended by Regulation 2019/933). This exemption allows producers of generic and biosimilar drugs to produce for export to third countries with no or expired patent protection during the term of an SPC.

On March 13, 2024, SB informed the Belgian Intellectual Property Office (DIE) and notified Amgen of its intention. However, Amgen believed that this notification was incomplete and therefore invalid. According to Amgen, SB should have listed the specific export countries and the reference numbers of the marketing authorizations (MA) in those countries. Because this information was missing, Amgen considered the production to be an infringement of its ABC and an unfair market practice. Amgen went to the president of the enterprise court and sought an injunction order.

The court's decision

In a judgment of 23 December 2024, the president of the Dutch-speaking enterprise court in Brussels rejected Amgen's claims and ruled in favor of SB. The court ruled that SB's notification did meet the legal requirements.

At the heart of the discussion was the interpretation of Article 5(5)(e) of the SPC Regulation. This article provides that the notification must include the following:

"the reference number of the marketing authorisation, or the equivalent of such authorisation, in each third country of export , as soon as this is publicly available“.

The court followed SB's reasoning and ruled that:

• The text of the law does not require that the exporting countries already be listed in the initial notification.
• The law only requires the producer to communicate the reference number of the license "as soon as this is publicly available," implying that it may be at a later date.
• The requirement to list exporting countries was deliberately removed during the legislative process in order to protect commercially sensitive information and not harm the competitiveness of European producers.

The president also rejected Amgen's argument that production would only be allowed for export to countries where patent rights no longer apply. The judge stated that this condition is not in the legal text and such an interpretation would undermine the purpose of the regulation - to promote the competitiveness of EU manufacturers.

Finally, the claim based on unfair market practices was declared inadmissible because Amgen could not show that there was an actual or serious threat of exporting to countries (such as the US or South Korea) where its patents were still valid.

Legal analysis and interpretation

This ruling is an important precedent in Belgium on the application of the SPC manufacturing waiver. The court opts for a pragmatic and textual interpretation of the SPC Regulation, in line with the goals of the European legislature.

The court's reasoning relies on classic methods of interpretation of EU law: it looks at the wording of the law, the context, the objectives of the regulation and its genesis (the preparatory works). The court emphasizes that the recitals of a regulation, although they clarify the objectives, have no binding legal force and cannot be used to deviate from the clear legal text.

The ruling juxtaposes a similar ruling of the Hague District Court, but goes against an earlier, stricter decision from a Munich court. This shows that there is still debate within the EU about the exact scope of information obligations. However, the Brussels ruling strengthens the position of generic and biosimilar producers based in the EU. It confirms that they can start production for export without immediately exposing their entire commercial strategy to the patent holder.

What this specifically means

• For manufacturers of biosimilar/generic drugs: You can submit a valid notification for the manufacturing waiver without having to immediately identify the specific exporting countries. However, you must indicate your intention to export and commit to communicate license numbers as soon as they become publicly available. This gives you the flexibility you need to plan your production while keeping your commercial strategy confidential.
• For holders of a SPC (originators): You are still given three months' notice of the start of production, as required by law. However, you cannot require the producer to disclose all its export markets during that first phase. Your ability to bring a prohibitory injunction claim on the basis of incomplete notice is limited by this ruling. The focus shifts to monitoring final exports and enforcing your foreign patent rights in the relevant countries.

FAQ (frequently asked questions)

What is an SPC manufacturing waiver?
The SPC manufacturing waiver is an exception to the protection of a Supplementary Protection Certificate (SPC). It allows EU producers to produce for storage (stockpiling) during the last six months of SPC protection or to produce for export to countries outside the EU at any time during SPC protection.

What information am I required to report for the export exemption?
According to Article 5(5) of the SPC Regulation, you must report at least your name and address, the Member State of production, and the number of the relevant SPC. You must also indicate that the production is for export and undertake to provide the reference numbers of the trade licenses in the exporting countries as soon as they become public.

When does the three-month period begin to run?
The three-month period, which gives the SPC holder time to prepare, begins to run from the time of the notification, provided it contains the legally required information. According to this ruling, a notification without the specific export countries or MA numbers is valid to start this period.

Conclusion

The Brussels enterprise court's ruling provides much-needed clarity and flexibility for biosimilar and generic manufacturers in Belgium. By ruling that export countries need not be disclosed immediately, the court respects the balance the European legislator sought between the rights of the SPC holder and the need to safeguard the competitiveness of the European pharmaceutical industry.