SPC manufacturing waiver ruling offers legal clarity, say experts

Charlotte Weekes and Stefan van Kolfschooten of Pinsent Masons were commenting after the Brussels Enterprises Court confirmed that Samsung Bioepis had met legal requirements for relying on the SPC manufacturing waiver to manufacture its denosumab ‘biosimilar’, with a view to exporting it from the EU, dismissing claims brought by Amgen. The Brussels court is the first across the EU to issue a judgment on the merits of a dispute relating to the SPC manufacturing waiver.

SPCs are available to obtain in the EU and UK. They enable pharmaceutical patent holders to effectively extend the period for which they can exercise monopoly rights over the sale of medicinal products they have invested time and money into developing. SPCs are only available for ‘products’ that fall within the scope of SPC law and meet eligibility criteria set out in the legislation.

Amgen holds an SPC for denosumab, a medicinal product used to strengthen the bones of patients undergoing certain cancer treatments. That SPC is due to expire later this year. In anticipation of that, Samsung Bioepis is exploring the development of its own rival biosimilar to denosumab – biosimilars are medicines that are highly similar, but not identical, to originator biologic products on which they are based. In March 2024, it wrote to the Belgian Intellectual Property Office (BIPO) to notify its intention to manufacture products containing denosumab in Belgium, and carry out related acts in the Netherlands, and to export them to third countries on the basis of an SPC manufacturing waiver. However, Amgen claimed that Samsung Bioepis could not rely on the SPC manufacturing waiver for its endeavours.

Since 1 July 2019, SPC waivers have applied under EU law permitting manufacturing and related activities in the EU that would otherwise require consent of an SPC holder where they are undertaken for the purpose of exporting the goods to territories outside of the EU. The waiver also allows producers of generics or biosimilars to store new products in the EU ready for release on the EU market upon the expiry of an SPC during the last six months that the SPC is valid. Generic and biosimilar manufacturers must conform to a series of notification and labelling requirements to be eligible for the waiver.

Before the Brussels court, Amgen argued that the letter Samsung Bioepis sent to BIPO did not adhere to the notification requirements provided for in the EU SPC manufacturing waiver regulation, citing the fact it did not mention the reference number of the marketing authorisation in the countries to which Samsung Bioepis wants to export nor the names of the third countries for export. Amgen further claimed that, in the export countries likely to be targeted by Samsung Bioepis, its patent rights would apply, and it also argued that Samsung Bioepis’ notification constituted an unfair trade practice.

The Brussels Enterprises Court dismissed Amgen’s claims.

The court agreed with Samsung Bioepis’ interpretation of notification requirements under Article 5 of the SPC manufacturing waiver regulation, by confirming that the notification does not need to include a marketing authorisation number or list of countries where the product will be exported.

The court further rejected Amgen’s argument that countries receiving exported products must be patent-free to rely on the SPC manufacturing waiver in Europe. The court stated that such a requirement would be contrary to the regulation’s objective of creating a level playing field between EU and non-EU manufacturers.

The court also rejected Amgen’s argument that stockpiling under the SPC manufacturing waiver is only permitted if strictly necessary for immediate export. Instead, the court noted that the waiver allows stockpiling for a period that reflects the normal course of business.

The notification requirements under the SPC manufacturing waiver regulation had been considered by two other courts in Europe previously in the context of preliminary injunction proceedings – by the Munich Regional Court in Germany and the Hague District Court in the Netherlands, respectively. The Munich court had assessed that the reference number of the market authorisation needs to be included in the notification for the waiver eligibility criteria to be met, while the Hague court considered it was legitimate for the identity of the third countries to which products were to be exported to be omitted from notification on commercial sensitivity grounds.

In its ruling, the Brussels court said the Hague court’s interpretation of the notification requirements took account of the context and the objectives of the regulation, as well as its genesis, finding the Munich court’s interpretation to be too strict.

The Brussels court also dismissed Amgen’s claim that Samsung Bioepis’ notification constituted an unfair trade practice, as Amgen failed to prove there was a serious risk of infringement.

Weekes said: "The Belgian court's judgment offers guidance as to how a manufacturing waiver can and should be achieved, thereby enabling more medicines manufacturing in Europe. The court noted more than once that EU-based manufacturers should not be put at a disadvantage compared to competitors based outside of the EU which are not subject to manufacturing restrictions."

Van Kolfschooten added: "The clarifications on the interpretation of the SPC manufacturing waiver regulation provide much-needed legal certainty. Additionally, the court's flexible approach, aligning more closely with the Netherlands rather than Germany's stricter stance, is a notable development. This judgment not only solidifies the legal landscape but also paves the way for more consistent applications of the regulation across Europe."