Sandostatin (Octreotide) LAR is used for treating acromegaly, carcinoid tumors, and neuroendocrine tumors, among other conditions.
Novartis owned EP 2377519, which expired on November 18, 2023. This patent covered specific processes for preparing octreotide acetate microparticles.
In EU-5 countries, Teva and Pharmathen have approvals for generic versions of Sandostatin LAR, but only Teva has launched its product. Pharmathen Global BV, a Dutch holding company, leads the Pharmathen group, with its Greek subsidiary, Pharmathen SA, manufacturing generic octreotide in Greece and selling it to Teva.
Key Legal Developments:
Initial Infringement Case (2019): A Greek court ruled that Pharmathen’s Greek subsidiary did not infringe EP ‘519. Novartis then pursued legal action in the Netherlands, targeting Pharmathen Global BV.
July 2022, The Hague: The District Court ruled that Pharmathen was inducing infringement by its Greek subsidiary and ordered Pharmathen to cease such activities, subject to a €100,000 daily penalty.
November 2022, The Hague: The Court of Appeal confirmed that Pharmathen had infringed EP ‘519 by controlling the subsidiary’s actions and upheld the cease and desist order.
December 2022, Amsterdam: The PI court ruled that Pharmathen breached the injunction by sending infringing products to Guatemala and failing to update their Global Products Catalogue. Pharmathen was ordered to pay €7.5 million in penalties.
March 2024, Amsterdam: The Court of Appeal confirmed the penalty. The court interpreted ‘offering’ broadly, determining that the presence of the Octreotide LAR product in the 2021 catalog on the CPHI website constituted an infringement. The court rejected Pharmathen’s arguments that (1) it was unable to remove the catalog from the CPHI website because its account at CPHI had been transferred to Pharmathen’s Greek entity, and (2) the catalog contained a disclaimer that the generic octreotide product cannot be ordered and delivered as long as there is patent protection. Pharmathen’s arguments regarding sales to Guatemala were also rejected due to insufficient evidence.
May 17, 2024, Supreme Court of the Netherlands: Pharmathen’s appeal was rejected, affirming the pan-European preliminary injunction.
Key Takeaways from the Supreme Court Decision:
- Supreme Court upheld previous decisions, barring Pharmathen Global BV from commercializing generic octreotide across Europe.
- Pharmathen must pay €7.5 million penalty to Novartis for non-compliance with the 2022 injunction.
- Sets precedent for Dutch-based parent companies facing pan-European injunctions.
- Pharmathen may seek compensation if it wins main proceedings proving ’519 patent invalid or not infringed. However, €7.5 million penalty remains regardless.
