The Patent Court of Korea has rejected Jazz Pharmaceuticals’ application for registering its acute myeloid leukemia (AML) treatment Vyxeos (ingredient: daunorubicin/cytarabine).

The court confirmed the original decision of the Intellectual Property Trial and Appeal Board (IPTAB) that rejected the Irish company’s request to register Vyxeos’ patent through its subsidiary Celator Pharmaceuticals.

Vyxeos is an advanced combination drug that mixed daunorubicin with cytarabine into liposomes. The two ingredients are conventional chemotherapies manufactured in powders. Physicians can combine them with an injectable solution and administer it intravenously. In the first treatment, the drug is injected intravenously for 90 minutes on the first, third, and fifth day.

Vyxeos is indicated for newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).

Jazz Pharmaceuticals obtained approval for the AML treatment in the U.S. last year. The treatment is also available in Belgium, France, and Ireland.

The drugmaker claimed that the technique of combining the two agents within liposomes was the world’s first in AML treatment. The fixed drug combination ratio of Vyxeos improves therapeutic effect and should be recognized as advancement in the invention, the company said. Jazz Pharmaceuticals had applied for the registration of substance patent.

However, the IPTAB denied the inventive step because such techniques were invented in 2015 and 2016.

In 2005, Celator Pharmaceuticals registered a patent for “Liposomal Formulation of Anthracycline Agents and Cytidine Analogs,” which was a prior invention, the IPTAB said.

The invention states that combining daunorubicin and cytarabine in a fixed ratio by encapsulating them in properly designed liposomes can significantly improve antitumor activity.

Disagreeing with the IPTAB’s ruling, Celator Pharmaceuticals asked the patent court to nullify the earlier decision. However, the court ruled in favor of the IPTAB, saying there was no inventive advancement.

According to a clinical trial on patients including the elderly with t-AML or AML-MRC, 38 percent of those treated with Vyxeos achieved complete remission while 26 percent of the other group treated with the standard chemotherapy did so, the drugmaker said.

Patients treated with Vyxeos had 9.6 months survival time on average, longer than 5.9 months of survival time of those treated with the standard chemotherapy.

lhs@docdocdoc.co.kr

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