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IP News Bulletin

Dutch Court stops the sale of Cancer Drug due to patent infringement



Following a prior unsuccessful attempt by Novartis to assert infringement in the Greek courts, the District Court of The Hague has imposed a preliminary injunction. A cross-border injunction has been issued as a result of the ruling, which prompted the Swiss-American multinational corporation to pursue Pharmathen in the Netherlands (case ID: C/09/625801 / KG ZA 22-201).


It is currently forbidden for Pharmathen, a company with Greek legal roots, and its affiliates to sell the medicine Okrodin. In addition, the court has set a €100,000 penalty that must be paid right away for any full or partial violations of the rules. Additionally, it mandated that Pharmathen pay the proceedings' costs, which are currently anticipated to be €80,676.


The Netherlands, Austria, Belgium, France, Germany, Greece, Italy, Liechtenstein, Portugal, Spain, Switzerland, Turkey, and the UK are among the countries where Novartis has successfully enforced its patent.


EP 23 77 519 B1, a slow-release hormone therapy used by medical experts to treat cancer patients, is the subject of the dispute. In November 2022, the patent becomes inactive. The drug is probably worth hundreds of millions of euros to either party in Europe because the development of the pharmaceuticals is especially challenging and because they are widely used as cancer treatments.


The conflict started in 2019 when Pharmathen SA, a generic pharmaceutical manufacturer, filed a lawsuit against Novartis in Athens. It requested a determination that EP 519 was not violated.


Later, Novartis filed a preliminary injunction request in October 2019, and the Greek tribunal rejected it after concluding that Pharmathen did not violate EP 519.


Novartis asked the Greek court to overturn the PI judge's decision to dismiss its application claim at the merits hearing.


The merits court, however, denied both corporations' claims in November 2021 for procedural reasons. Parties cannot challenge a preliminary injunction ruling in Greece.


Pharmathen SA later received approvals to sell its injectable octreotide LAR medicines under the trade name Okrodin in the Czech Republic and Germany in 2021. Pharmathen SA has additionally submitted requests for market authorizations in France and the UK.


Following this, Novartis sent Pharmathen a cease-and-desist letter; however, the court found that Pharmathen did not react.


Novartis chose not to file a lawsuit against Pharmathen in the Greek courts because the company already has a presence in the Netherlands. It was allowed to request a cross-border injunction by going to the Dutch courts as an alternative.


Pharmathen would not be able to sell Okrodin to Novartis' pharmaceutical wholesalers, such as Teva or Casi Pharmaceuticals, if Novartis decided to implement the ruling. The oral hearing will now take place on September 30 after the court granted Pharmathen's appeal.


The court in the Dutch proceedings rejected Pharmathen's claim that the Greek summary proceedings' 2019 verdict should be recognised on the basis of Greek law. The justification for this was that different parties aren't involved in the Dutch lawsuit.


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