The so-called “manufacturing waiver” was introduced in 2022 in an amendment to the SPC Regulation. The manufacturing waiver provides a limited exception to SPC protection in certain circumstances. It allows the manufacture of a generic or biosimilar version of a product protected by an SPC provided that:
- the manufacturing is done for export to third countries (at any point during the SPC term), or
- the manufacturing is done within the last 6 months of the SPC’s term, for the purpose of stockpiling for day-one entry onto the EU market.
The manufacturing waiver also allows for ancillary acts that are strictly necessary for the manufacturing, export or stockpiling to be carried out.
The manufacturing waiver was introduced to offset a perceived disadvantage suffered by EU-based generic and biosimilar manufacturers compared to manufacturers based in countries where SPC protection is not available. To rely on the waiver, generic and biosimilar manufacturers need to comply with certain formal requirements, including notifying the SPC holder and the national patent office of the intention to use the waiver, and providing the reference number of the relevant marketing authorization(s) for the generic/biosimilar product as soon as it is publicly available.
The Belgian decision relates to denosumab, which is the active ingredient in Amgen’s Prolia® and Xgeva® products marketed for the treatment of osteoporosis and bone cancer, respectively. In Europe, Amgen holds SPCs directed to denosumab, which expire later in 2025. Amgen also holds corresponding patents in third countries protecting denosumab, including in the US and South Korea. Samsung Bioepis notified the Belgian Patent Office that it intends to manufacture a biosimilar version of denosumab in Belgium during the SPC’s term, with a view to exporting it to third countries. In the notification, Bioepis indicated that the marketing authorisation reference would be provided as soon as it became publicly available. Bioepis also did not provide a list of countries to which it intended to export the drug.
Amgen challenged the validity of Bioepis’s notification, arguing that the reference number of the marketing authorisation or the countries of export must be provided for the waiver to be valid. It also claimed that a waiver could not be granted because denosumab was protected in third countries (i.e., the US and South Korea), where rights could potentially be infringed if Bioepis were to manufacture and export denosumab from Belgium. In this respect, Amgen referred to the recitals to the SPC Waiver Regulation, which imply that third countries to which export is intended should be patent-free for the SPC manufacturing waiver to apply. Amgen further argued that long-term storage of denosumab was not an ancillary act that is strictly necessary for the actual export, meaning that such storage is not covered by the waiver.
In its decision, issued in December 2024, the Brussels Enterprise Court dismissed Amgen’s claims, confirming that Bioepis’s waiver notification complied with the requirements set out in the amended SPC Regulation.
In particular, the Court clarified that a marketing authorisation number is not required for a valid notification, provided that this number is notified as soon as it becomes publicly available. The court also confirmed that it is not necessary to specify the countries of export, allowing manufacturers to keep confidential this potentially sensitive information. Regarding the existence of exclusive rights to the drug in export countries, the court noted that this was not mentioned in the operative part of the Regulation. As the recitals are not legally binding, Amgen’s rights in the US and South Korea had no bearing on whether or not a manufacturing waiver could be granted. Finally, the court rejected Amgen’s claim that the waiver does not cover longterm storage for the purposes of export. The court regarded temporary storage as being permitted under the manufacture-for-export waiver, as long as its duration is one that is customary in the normal course of business.
The Brussels Court’s ruling therefore provides clarification, for both innovators and generic/ biosimilar companies, of the requirements for applying for an SPC manufacturing waiver.
Originally published in the CIPA Journal