This case concerns infringement by Glenmark on Novartis' SPC 300451 for eltrombopag (marketed as Revolade®). Novartis sought urgent relief after Glenmark included its generic "Eltrombopag Glenmark" product in the Dutch "G-Standaard" (the Dutch pharmaceutical database showing medicines (soon to be) available on the Dutch market), which was listed on 1 September 2025 while Novartis' SPC expired on 14 September 2025. Glenmark contended that such preparatory steps were necessary for Day one entry and should be permitted, referencing the balancing of interest made in the SPC Regulation, the EU SPC manufacturing waiver, and the proposed Bolar-exception expansions.
These arguments did not hold. The Court reaffirmed that G-Standaard listing qualifies as an "offering" and thus infringes the SPC if done before expiry. The judge rejected Glenmark's argument that preparatory acts for Day one entry justify early listing, noting that the SPC Regulation's waivers referred to by Glenmark in this respect do not extend to market offers or listings and that Glenmark had not even applied for such waivers. The Court, citing UPC Court of Appeal Boehringer v Zentiva, also dismissed reliance on the draft EU Pharma Package, emphasizing that legislative proposals do not alter current law, and that even under the draft, commercial offers would remain excluded from the exception. Lastly, the Court held that any administrative inflexibility in the G-Standaard system is not a justification for infringement.
The Court therefore concluded that early G-Standaard listing
causes immediate commercial harm to the SPC holder, including price
erosion and loss of exclusivity. The injunction was granted,
including orders for removal and rectification, with significant
penalties for non-compliance.
District Court of the Hague, 27 August 2025, C/09/690339, Novartis
AG v Glenmark Arzneimittel GMBH
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