Dutch Court Blocks Glenmark's Early Generic Eltrombopag Launch, Reinforces SPC Protection
核心洞察
The Hague District Court granted an injunction against Glenmark for listing its generic eltrombopag product in the Dutch pharmaceutical database 14 days before Novartis' patent expiry.
The court ruled that G-Standaard listing constitutes a commercial "offering" that infringes supplementary protection certificates even when done as preparation for market entry.
Glenmark's arguments citing EU manufacturing waivers and proposed regulatory changes were rejected, with the court emphasizing current law takes precedence over draft legislation.
The Hague District Court has granted an injunction against Glenmark Arzneimittel (搜索), blocking the generic manufacturer's attempt to list its eltrombopag product in the Dutch pharmaceutical database before Novartis' patent protection expires. The August 27, 2025 ruling reinforces the boundaries of supplementary protection certificate (SPC) rights and clarifies that preparatory market activities can constitute patent infringement.
Case Background and Timeline
The dispute centers on Glenmark's listing of "Eltrombopag Glenmark (搜索)" in the Dutch G-Standaard database on September 1, 2025, while Novartis' SPC 300451 for eltrombopag (marketed as Revolade®) remained valid until September 14, 2025. The G-Standaard serves as the official Dutch pharmaceutical database displaying medicines available or soon to be available on the Dutch market.
Novartis sought urgent relief, arguing that the early listing constituted patent infringement despite occurring only 14 days before SPC expiry. The case highlights the tension between generic manufacturers' need to prepare for immediate market entry upon patent expiry and originator companies' exclusive rights during the patent term.
Court's Analysis of Market Preparation Activities
The court firmly rejected Glenmark's defense that the G-Standaard listing represented necessary preparatory steps for "Day one entry" that should be permitted under existing regulations. Glenmark had referenced the balancing of interests in the SPC Regulation, the EU SPC manufacturing waiver, and proposed Bolar-exception expansions to justify its early listing.
However, the court reaffirmed that G-Standaard listing qualifies as an "offering" under patent law and therefore infringes the SPC when conducted before expiry. The judge noted that the SPC Regulation's waivers cited by Glenmark do not extend to market offers or listings, and crucially, Glenmark had not even applied for such waivers.
Rejection of Legislative Proposals as Defense
The court dismissed Glenmark's reliance on the draft EU Pharma Package, citing the UPC Court of Appeal decision in Boehringer v Zentiva. The judge emphasized that legislative proposals do not alter current law and that even under the proposed draft regulations, commercial offers would remain excluded from patent exceptions.
This aspect of the ruling establishes an important precedent that companies cannot justify current patent infringement based on anticipated regulatory changes that have not yet been enacted into law.
Commercial Harm and Exclusivity Protection
The court concluded that early G-Standaard listing causes immediate commercial harm to SPC holders, specifically identifying price erosion and loss of exclusivity as key damages. The ruling rejected any argument that administrative inflexibility in the G-Standaard system could justify patent infringement.
The injunction includes orders for removal of the listing and rectification measures, with significant financial penalties established for non-compliance. This comprehensive relief demonstrates the court's commitment to protecting patent holder rights during the full term of protection.
Implications for Generic Market Entry
The decision clarifies that generic manufacturers must carefully time their market preparation activities to avoid patent infringement, even when such activities are intended to enable immediate competition upon patent expiry. The ruling suggests that administrative database listings constitute commercial activities subject to patent protection rather than purely preparatory acts.
The case reinforces that patent holders maintain full exclusivity rights until the moment of SPC expiry, regardless of generic manufacturers' operational needs for market preparation. This interpretation may require generic companies to adjust their launch preparation timelines to ensure compliance with patent protection periods.