VIENNA -- The Higher Regional Court of Frankfurt upheld the February 2025[1] partial final ICC arbitral award in favor of AOP Orphan Pharmaceuticals GmbH (“AOP Health”) in its dispute with PharmaEssentia Corp. (“PharmaEssentia”). The ruling confirms the award which found the Taiwanese company to be liable for certain damages.

Dr. Rudolf Widmann, one of the two founders of AOP Health, explains: “We very much welcome the Frankfurt Higher Regional Court’s decision that confirms our position. In the interest of our patients, we are dedicated to maintaining stable and sustainable access to BESREMi® and to responsibly navigating future challenges.”

The Product in Dispute

The conflict centers around BESREMi® (ropeginterferon alfa-2b), a product launched in 2019 and developed by AOP Health into an innovative treatment for rare blood cancers, particularly polycythemia vera, through a comprehensive clinical trial program. This makes BESREMi® the best investigated interferon in clinical trials in this indication as documented in the major relevant guidelines[2]. AOP Health had acquired the rights for both BESREMi®’s development and commercialization in the European, Commonwealth of Independent States (CIS), and Middle Eastern markets from PharmaEssentia in 2009. In its seventh year after its approval by European Medicines Agency (“EMA”), AOP Health has successfully made BESREMi® available to an estimated 12,600 patients in AOP Health’s licensed territory.

First Arbitration and Set-aside Proceedings

Since 2017, PharmaEssentia repeatedly attempted to terminate its agreement with AOP Health regarding BESREMi®. In October 2020, an ICC Arbitral Tribunal rejected these attempts and awarded AOP Health approx. EUR 143 million in damages and dismissed PharmaEssentia’s counterclaims in its entirety.

Subsequent set-aside proceedings confirmed the arbitral award in its essentials, but found procedural flaws with respect to damage quantification, impacting the damages awarded.

Second Arbitration

In November 2020, PharmaEssentia initiated a legal action against AOP Health, alleging damage claims. AOP Health in turn claimed damages for delays in BESREMi®’s European approval caused by PharmaEssentia, and the misuse of AOP Health’s clinical trial data for PharmaEssentia’s US marketing authorization. The result was a partial final ICC arbitral award in favor of AOP Health, received on 17 February 2025, which found PEC guilty of intentional breaches and liable for several claims. The tribunal’s decision on the quantum of those claims is yet to be made.

Ruling of Higher Regional Court of Frankfurt Confirms AOP Health’s Position

In May 2025, PharmaEssentia filed an application with the Frankfurt Higher Regional Court to set aside the partial final ICC arbitral award dated 10 February 2025, arguing among other things that the award violated public order and PharmaEssentia’s right to be heard.

On 24 April 2026, the Frankfurt Higher Regional Court dismissed this application in its entirety and declared the award enforceable. An appeal to the German Federal Court of Justice is possible.