Dutch court halts sale of Pharmathen cancer drug Okrodin in Europe

The District Court of The Hague has issued a preliminary injunction after a previous failed attempt by originator Novartis to claim infringement in the Greek courts. The decision, which caused the Swiss-American multinational company to pursue Pharmathen in the Netherlands (case ID: C/09/625801 / KG ZA 22-201), has resulted in a cross-border injunction against the latter company.

Now Pharmathen, which is domiciled in Greece, and its subsidiaries are prohibited from selling the drug Okrodin. The court has also imposed an immediately-payable penalty of €100,000 for each full or partial violation of the prohibitions. It also ordered Pharmathen to pay the costs of the proceedings, so far estimated at €80,676.

Novartis has enforced the patent in the Netherlands, Austria, Belgium, France, Germany, Greece, Italy, Liechtenstein, Portugal, Spain, Switzerland, Turkey and the UK.

Pharmathen starts in Greece

The dispute revolves around EP 23 77 519 B1, which pertains to a slow-release hormonal treatment used by medical professionals to treat cancer patients. The patent expires in November 2023. Since the production of the drugs is notably difficult, and given its prevalence as a cancer treatment, the drug is likely worth hundreds of millions of euros to either party in Europe.

Otto Swens

The dispute began in 2019, when pharmaceutical generics company Pharmathen SA took Novartis to court in Athens in a proceedings on the merits. It sought a declaration of non-infringement of EP 519.

Subsequently, Novartis applied for a preliminary injunction in October 2019, whereby the Greek judge found that Pharmathen did not infringe EP 519 and dismissed the claims. In the proceedings on the merits, Novartis requested that the Greek court revoke the PI judge’s dismissal of its application claim.

However, in November 2021, the merits court rejected both companies’ claims on procedural grounds. In Greece, parties are unable to appeal against a preliminary injunction decision.

Marketing authorisation given

Then, in 2021, Pharmathen SA then obtained market authorisations in the Czech Republic and Germany to market its injectable octreotide LAR products under the brand name Okrodin.

Following this, Novartis sent a cease-and-desist letter to Pharmathen, although according to the judgment, the company did not respond. Since Pharmathen also has an entity in the Netherlands, Novartis did not challenge the company at the Greek courts. Instead, it was able to turn to the Dutch courts to seek a cross-border injunction.

Novartis returns the blow

If Novartis chooses to enforce the judgment, it would prevent Pharmathen from selling Okrodin to its pharmaceutical distributors such as Teva or Casi Pharmaceuticals. However, the court has now granted Pharmathen an appeal, scheduling the oral hearing for 30 September.

In the Dutch proceedings, the court rejected Pharmathen’s argument that the 2019 judgment in Greek summary proceedings should be recognised on the basis of Greek law. This was on the grounds that the Dutch case does not concern the same parties.

Rutger Kleemans

New clients and old

A team from Freshfields Bruckhaus Deringer, led by partner Rutger Kleemans, acted for Novartis. Freshfields has worked alongside Novartis since 2009, representing the company in instances such as its preliminary injunction proceedings against Mylan and Teva over its drug Gilenya (fingolimod).

Novartis also has close ties with Freshfields’ patent teams in Düsseldorf and Munich. The German and Dutch patent teams frequently work together for the Swiss company in patent disputes.

Acting on behalf of Pharmathen is Amsterdam IP boutique, Vondst, with a team headed up by partner Otto Swens. This is a new client for the Dutch firm. Previously, it has represented similar generic pharmaceutical companies such as Teva and Viatris. The IP boutique also has a good relationship with Novartis’ generics subsidiary, Sandoz.

Occasionally, the firm also acts for originators in disputes against other originators.

For Novartis
Freshfields Bruckhaus Deringer (Amsterdam): Rutger Kleemans, Jelle Drok (partners); associates: Ruben Ladde, Auke-Frank Tadema
V.O. (Amsterdam): Martin Klok (patent attorney)

For Pharmathen
Vondst (Amsterdam): Otto Swens, Ricardo Dijkstra, Arvid van Oorschot (partners)
De Vries & Metman (Arnhem/Amsterdam): Lilian Hesselink, Jeannette Verbart (patent attorneys)

District Court of The Hague, The Hague
Edger Brinkman (presiding judge)

JUVE Patent updated this article on 06.12.2022 to reflect new information on the case.