The process and outcomes of a challenge to a European patent for a chimeric antigen receptor (CAR) T-cell (CAR-T) therapy, a highly expensive cancer treatment, were described in a presentation made at the European Society of Medical Oncology (ESMO) Virtual Congress 2020.
“Today there is a strong consensus that [cancer treatment] high prices may become a barrier to universal access to cancer therapy, not only in resource-limited settings, but also in high-income countries,” stated Juliana Veras, advocacy coordinator, Médecins du Monde, which is a European advocacy organization.
She further noted that “the abusive use of patents and that lack of rigorous public regulation on the granting of health-related patents” can facilitate the emergence of pharmaceutical monopolies, contributing to the high prices of some anticancer therapies.
In this presentation, she chronicled the work performed by Médecins du Monde and Public Eye, another European organization focused on research and advocacy, in challenging a European patent for the chimeric antigen receptor T-cell (CAR-T) therapy tisagenlecleucel.
Specifically, in July 2019, opposition to a granted patent for tisagenlecleuel was submitted to the European Patent Office (EPO) on the basis of a lack of innovative step.
Veras reported that this challenge was successful. In November 2019, in response to the group’s patent opposition, Novartis and the University of Pennsylvania requested revocation of the European patent. In December 2019, the EPO revoked patent EP3214091, thereby weakening the tisagenlecleucel monopoly.
Nevertheless, Veras also noted that other tisagenlecleucel patents “are still in force that do not allow for the production of tisagenlecleucel biosimilar versions.”
The revocation was “able to show the abusive nature of the patent filed and granted by the EPO, and its lack of rigorous scrutiny regarding patentability criteria for this important health product,” Veras said in the video presentation. “We now plan to raise awareness to strengthen the state’s ability to negotiate affordable prices for CAR T-cell therapies and new medicines at large.”
Veras added that patent oppositions could also be explored for ibrutinib and pembrolizumab, specifically, as they are treatments protected by a European Supplementary Protection Certificate.
“We have showed a method through which monopoly abuses on new cancer treatments can be regulated,” the authors wrote in their abstract. “A stronger mobilization of oncologists is necessary to prevent abusive monopolies and safeguard sustainable access to cancer treatments.”
Disclosures: Research funding for this study was provided by Médecins du Monde and Public Eye.
Veras J, Durisch P, Urdaneta E, et al. Opposition to a patent covering tisagenlecleucel: Using intellectual property (IP) legislation to defend sustainable access to cancer therapies. Presented at: European Society of Medical Oncology (ESMO) Virtual Congress 2020; September 19-21, 2020. Abstract 1589MO.
This article originally appeared on Cancer Therapy Advisor