The Hague District Court grants injunction against Glenmark for G-Standaard listing of eltrombopag 14 days prior to SPC expiry Novartis

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