Ukraine fights for affordable access to a life-saving COVID-19 treatment

100% Life, MMA’s partner in Ukraine, has opposed a patent on tocilizumab, a monoclonal antibody that blocks interleukin-6, an inflammatory protein.  Tocilizumab, which was originally used to treat rheumatoid arthritis, has been found to be part of effective treatment for hospitalised patients with severe COVID-19- related pneumonia, because it can reduce hyperactive immune responses that worsen COVID-19.   

The United Kingdom’s Recovery Trial and a study published in the New England Journal of Medicine found that using corticosteroids and tocilizumab in people with severe COVID-19 pneumonia reduced their risk of being put on a ventilator or dying, and gets them out of the hospital sooner.

On June 24, 2021, the U.S. Food and Drug Administration (FDA) issued an emergency authorization for the use of tocilizumab for adults and children (age 2 years and older) hospitalized with severe COVID-19, receiving systemic corticosteroids and who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.

100% Life requested that tocilizumab’s patent be annulled by submitting a claim to Kyiv’s commercial court on December 30, 2021. The claim is based on the grounds that the patent filed lacks novelty and inventive step, hence not fulfilling patent requirements; it has already been accepted for consideration, with a first hearing scheduled on April 4, 2022.

The claim targets the patents on the pharmaceutical combination of the drug, which hinders the development of potential biosimilar competitors. If the patent is revoked, the monopoly on tocilizumab could be dismantled, allowing production of more affordable biosimilar versions.

“We believe that our intervention will contribute to better access to tocilizumab in Ukraine for both COVID-19 and rheumatoid arthritis patients. If biosimilars have the possibility to enter the Ukrainian market, it would allow the State to optimise its procurement funds, diminishing the financial burden of this drug in public expenses and making room for other needs” – says Mykyta Trofymenko, Intellectual Property Counsel at 100% Life.