The activists of the Network of PLWH required the judges of Kyiv Commercial Court of Appeal to cancel the patents issued in breach of law (the so-called “evergreen” patents), establishing a monopoly for a costly medicine “Lopinavir”/”Ritonavir” (“Aluvia” trademark). If these patents are canceled, Ukraine will be able to procure less expensive medicines and treat another 125 thousand of people living with HIV. The patients mounted a symbolic scaffold near the court building, offering the judges a choice whether they doom or save HIV patients with their resolution.
“If the court fails to take a decision and cancel the “evergreen” patents, we could witness the death sentence for dozens of thousands of Ukrainians living with HIV! This may be a historical precedent when a commercial court of appeal takes a decision on execution”, says the Chairman of the Coordination Council of the Network Dmytro Sherembey.
Currently the existence of two “evergreen” patents for Lopinavir and Ritonavir prevents the cheaper analogues of brand HIV medicines, the so-called generics, from entering the market. According to the activists, the patents ‘for the drug administration method” or “for a combination” are used by major pharmaceutical companies in competitive struggle and have virtually no benefits for the scientific development. These patents safeguard the super-lucrative monopoly of pharmaceutical companies and debar other manufacturers from the market. The activists of the Network of PLWH created the first precedent in the history of Ukraine, having filed a lawsuit to protect the rights of HIV-positive Ukrainians to the treatment.
“These patents allow the manufacturer to hold a market monopoly and establish the prices advantageous for them. In other words, the big pharma is making money out of the people’s suffering. We should put an end to this,” said Serhiy Dmytriev, Policy and Advocacy Director of the CO “All-Ukrainian Network of People Living with HIV”.
Currently the state spends 40% of the budget for all medicines for HIV-positive patients to procure “Lopinavir”/’Ritonavir” alone. This is USD 19.5 million annually, which suffices only for 26 thousand of patients. If the patents are canceled and other manufacturers producing or importing generics would be able enter the market, the price for this drug will drop thrice. These medicines would then cost the government USD 6 million annually, while another 125 thousand of Ukrainian could be able to receive free treatment.
“In many countries of the world the patent for this drug was not issued or was canceled. As the result, these countries do not have monopoly for this medical product, and the competition between manufacturers allowed to significantly decrease the price for “Lopinavir”/’Ritonavir”. For comparison, the price per one package of “Lopinavir”/’Ritonavir” in Ukraine is currently USD60.80. If the patent is canceled, it can be about USD19 per package. The difference is significant, isn’t it?”, says Mykyta Trofimenko, the Network lawyer.
On May 31, 2016 the Network of PLWH filed a lawsuit to the Kyiv Commercial Court of Appeal to invalidate the patents for “Lopinavir”/’Ritonavir” combination of medicines. The claim of the Network is grounded on the following considerations: the challenged patents do not meet the law requirements of novelty and inventive step, while the patent holder (AbbVie Inc., USA) monopoly allows it to overprice the drug. On March 6, 2017 the Commercial Court of Kyiv dismissed the claim without even ordering an expert evaluation on whether the patents meet the requirements of law. The following reasons for dismissal were stated: the challenged patents do not violate the lawful rights or interests of the plaintiff and, in the judges’ opinion, the drug price might not decrease even if the patents are canceled. These reasons for dismissal are totally ungrounded and inconsistent from the legal point of view.
Based on the results of the court session taking place on May 11, the judges postponed the consideration for Tuesday, May 16, 10:45. The decision to announce a break in the proceedings was grounded by the need to examine the documents and arguments provided by the Network of PLWH and AbbVie in more detail. The representative of the Network of PLWH and the representative of the State Intellectual Property Service of Ukraine were present at the session. AbbVie representatives did not attend the session, however, they submitted a motion to postpone the case consideration for 6 months.
The activists consider such actions of the company to be a manipulation, an attempt to drag the court process and avoid consideration of the matter of the patents compliance to the law requirements. They expect that on Tuesday the court will proceed considering the case on the merits and will appoint an expert evaluation on whether AbbVie patents comply with the requirements of law. This will become an important step forward to case consideration, because the opinion of the court expert evaluation will provide the grounds for the court to take a resolution on canceling the patents which may decide the fate of dozens of thousands of patients.