Make Medicines Affordable (MMA) partner, 100% Life, filed pre-grant oppositions in August and December of 2024 on Janssen’s rilpivirine patent applications (adult and pediatric formulations) to block the company’s monopoly on this life-saving long-acting HIV drug. 100% Life is the largest patient-led organization in Ukraine, and aims to provide 100% access to treatment to 100% of Ukrainian patients, including people living with HIV.
Rilpivirine, commonly known as RPV, is available in multiple formulations, including a daily oral medication, and in fixed-dose combination tablets, and as a long-acting, intramuscular injection. RPV was approved by the United States Food and Drug Administration in 2011 as part of first-line HIV treatment for adults. However, RPV is not included in the WHO guidelines. Long-acting formulation of cabotegravir with rilpivirine is particularly significant for Ukraine, as war has forced many constraints on people living with HIV in Ukraine creating additional challenges for adherence.
Two pre-grant oppositions, filed with the Ukrainian IP office, seek to prevent Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson (J & J), from being granted patents on RPV for an additional 20 years. The pharmaceutical giant has already obtained at least 7 patents related to rilpivirine in Ukraine valid longer than 20 years from 2002 until 2031, however it is seeking to extend its monopoly in Ukraine even longer – until 2041 with additional secondary patent applications on rilpivirine long-acting formulation in combination with a hyaluronidase and on rilpivirine pediatric formulation – which would continue to keep affordable generic versions of RPV inaccessible to people living with HIV.
Veronika Kochubei, Intellectual Property Counsel at 100% Life, stated that both of Janssen’s patent applications fail to meet the patentability criterion of “inventive step”. Furthermore, it can be argued that the patent application for pediatric rilpivirine also lacks novelty.
Despite J & J’s position on human rights, which states that the company supports everyone’s right to access quality and affordable healthcare, regardless of where they live, and that the company aims to advance “equitable patient access to medicines and medical solutions,” J&J’s RPV patent applications in Ukraine directly contradicts these values, according to health rights advocates. At the same time, cost of the long-acting combination of cabotegravir with rilpivirine costs between US $25,800 to $45,000 in Canada and the U.S., while estimates say it should cost US$ 131 for it to be a cost effective antiretroviral treatment. Similarly to most LMICs long-acting rilpivirine, the long-acting combination of cabotegravir with rilpivirine is unavailable in Ukraine.
“We need to understand that extending the rilpivirine patent monopoly by another 10 years is not good. As only the branded version of the drug will be available on the market, so of course, it will be sold at a high price since there is no competition and no local manufacturing options,” Kochubei said.
According to 100% Life, if the Ukrainian IP office rightly denies Jassen’s patent applications on RPV, patients are likely to access generic and more affordable versions of the drug, which can help people living with HIV have long, healthy lives.
