Ruling Confirms AOP Health's Position
On 24th April 2026, the Higher Regional Court of Frankfurt upheld an arbitral award in favour of AOP Orphan Pharmaceuticals GmbH (AOP Health), confirming PharmaEssentia Corp.’s liability in a patent dispute. This decision marks a significant legal victory for AOP Health in their ongoing conflict with the Taiwanese pharmaceutical company.
The dispute involved BESREMi®, a treatment for rare blood cancers, which AOP Health acquired rights to develop and commercialise in Europe and other regions from PharmaEssentia in 2009. BESREMi® was launched in 2019 and has become a significant treatment option for polycythemia vera, a rare blood cancer. AOP Health has made this innovative treatment available to approximately 12,600 patients across Europe, the Commonwealth of Independent States (CIS), and the Middle East.
Dr. Rudolf Widmann, one of the founders of AOP Health, commented, “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.”
Background of the Dispute
The conflict began in 2017 when PharmaEssentia attempted to terminate the agreement with AOP Health. In October 2020, an ICC Arbitral Tribunal rejected these attempts and awarded AOP Health approximately EUR 143 million in damages. PharmaEssentia’s counterclaims were dismissed entirely. However, the tribunal noted procedural issues in the calculation of damages, which led to further legal scrutiny.
Following this, PharmaEssentia initiated another legal action in November 2020, alleging damage claims against AOP Health. Meanwhile, AOP Health countered by claiming damages due to delays in BESREMi®’s European approval and the misuse of its clinical trial data for PharmaEssentia’s US marketing authorisation. The second arbitration resulted in a partial final ICC arbitral award on 17 February 2025, which held PharmaEssentia liable for intentional breaches. During this time, AOP Health continued to expand BESREMi®’s reach and solidified its role in the market for rare disease treatments.
Subsequent set-aside proceedings confirmed the arbitral award’s essential aspects, though procedural flaws were noted. Despite these challenges, the Frankfurt Higher Regional Court’s decision reinforces the enforceability of the award, dismissing PharmaEssentia’s appeal. AOP Health believes this decision underlines its commitment to ensuring continued supply of BESREMi® to those in need. An appeal to the German Federal Court of Justice remains possible, but AOP Health remains confident in its legal standing.
The court’s decision is expected to have a lasting impact on the pharmaceutical industry, particularly in how international agreements are enforced. As a result, AOP Health is poised to continue its focus on innovative treatments for rare diseases.
