High price of lopinavir/ritonavir challenged in Ukraine

Economic Court of KyivAll-Ukrainian PLHIV Network challenges patent, and exclusive right to manufacture lopinavir/ritonavir

On 21 June 2016, the All-Ukrainian Network of People Living with HIV (the Network) participated in the first court hearing to invalidate a patent, which currently protects the drug combination lopinavir/ritonavir from market competition. Lopinavir/ritonavir is a fixed dose combination drug for the treatment of HIV/AIDS, and is named Aluvia or Kaletra, depending on where you live.

The Economic Court of Kiev opened the court proceedings in response to a lawsuit filed by the Network. It is the first time in Ukraine when a patient organization has filed a lawsuit to invalidate a patent on a life-saving medicine.

As part of the proceedings the Economic Court of Kiev will consider the claim of the Network and will evaluate patents for compliance with the patentability criteria for novelty and inventive step. If it is determined that the contested patent does not meet the criteria, it will be declared invalid. The Network argues that a combination of lopinavir/ritonavir is not new and does not involve an inventive step. Therefore, the exclusive rights to manufacture this combination drug allows the patent holder to have an undeserved monopoly on the sale of this medicine in Ukraine.

During the court hearing the Network’s motion was granted – the defendant was not allowed to perform any actions (e.g., transfer of rights) to the contested patent, before there is a final decision in the case. The Network has also filed additional evidence to support the lawsuit.

In response to a petition from the defendant – the company Abbvie – to defer consideration of the case, the court announced a break in the proceedings and scheduled the next court hearing for 18 July 2016.

As the combination of lopinavir/ritonavir is the most widely used antiretroviral medicine in Ukraine, if the Network is successful in its claim, it will be possible to manufacture and import cheaper generic versions. This should lead to significant savings for the treatment of HIV in Ukraine, and will mean more people will have access to HIV treatment.

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