Activists gathered outside a Kiev Court to highlight the huge amount of money being wasted on an overpriced drug, due to what our partner organization has assessed to be unmerited patents on the product. An examination of the patents was agreed by the Economic Court of Appeal but over a year later activists are still waiting for the analysis.
Patents granted to AbbVie for HIV drug lopinavir/ritonavir (brand name Aluvia/Kaletra) allow the company to maintain a monopoly. Our partner, the All Ukrainian Network of People Living with HIV (‘the Network’) has assessed the patents to lack novelty and invention and are therefore unmerited.
The impact is that the drug costs the Ukrainian government a significant portion of its overall health budget, meaning that only a fraction of people are being treated compared to what would be possible if competition were introduced.
Back in May 2016, the Network filed a lawsuit claiming that AbbVie’s patents are invalid. After what looked like deliberate delay tactics on AbbVie’s behalf, the first success for the Network came in October 2017, when Kiev’s Economic Court of Appeal agreed to examine the patents.
Now, activists from the Network gathered outside Kiev’s Commercial Court – over a year later- to demand that this agreed upon patent examination takes place promptly. Until the patents for lopinavir/ritonavir are invalidated, other affordable generic versions of the drug cannot enter the Ukrainian market and the potential additional 138,000 patients that could benefit will have to continue to wait.
There are new concerns that the delay is due to a bias in the selected examiner. Sergey Kondratyuk, a legal expert at the Network says: “An examination that lasts about a year may most likely indicate the bias of the expert in favor of the pharmaceutical company.” He would like to see a new expert allocated, one who recognises that evergreening patents such as these should be rejected or invalidated. He also urges for the process to be sped up so that AbbVie does not continue to benefit from this monopoly.
Money going up in smoke
The Network has calculated that the Ukrainian government overpays more than one million hryvnias (UAH) a day by purchasing AbbVie’s monopolised product. In 2018 the government spent UAH 536 million (more than 19 million USD) solely on the purchase of Aluvia/Kaletra, providing just 27,000 patients with HIV treatment. If the patents are invalidated, allowing generics to enter the market, the Network has calculated that it would be possible to buy this drug at a price about three times lower, spending UAH 163 million (5-6 million USD) a year. This would potentially fund treatment for another 138,000 patients with HIV. An estimated 240,000 people are living with HIV in Ukraine.
“It’s criminal,” says Dmytro Sherembei, the Head of the Network. “Patients who need treatment today cannot wait for such a long examination. We demand an appointment of a new expert and immediate start of the novelty and inventiveness examination in relation to the patents owned by AbbVie. After all, the expert appointed by the court a year ago, has not yet completed the work.”
The Network filed a court motion requesting a change in expert, which unfortunately was rejected on 21 January 2019. The examination will continue with the same expert appointed. While the Network is disappointed with this decision it will focus on advocating for the right outcome. The Ukrainian press and the public are also closely following this story. We believe a fair decision from the examiner would invalidate AbbVie’s patents and increase access to HIV treatment in the country.