Strategic use of patent opposition safeguard to improve equitable access to innovative health technologies: A case study of CAR T-cell therapy Kymriah

Abstract

Kymriah is an innovative cancer therapy which works by removing disease fighting T-cells from patients, genetically modifying or reprogramming the immune cells to attack cancer, and re-infusing them back into the patients. It treats childhood blood and bone marrow cancer. The cost of this new hope-giving gene therapy is CHF 450,000 per treatment. This exorbitantly high price set by Novartis, in exercise of its exclusive rights resulting from patent protection, undermines the real-world impact of this revolutionary therapy. On December 16, 2019, Novartis relinquished its European patent on Kymriah as a result of a successful patent opposition lodged by 'Public Eye' and 'Médicins du Monde'. This case study of Kymriah highlights the potential role of civil society in improving equitable and affordable access to innovative health technologies by using the procedural safeguard of patent opposition. This study finds that patent opposition is an important policy option to alleviate some of the financial burdens of health systems, especially in the wake of COVID-19.

India’s Distinct but Opposing Patent Model Is Under Pressure: Prospects and Challenges in the Global Arena

“…The patent opposition procedures provided by the European Union (EU), the USA and Japan conflict with the Indian patent opposition model. The European Patent Convention (EPC) 6 provides for a supra-national post-grant third-party opposition procedure (Abbas, 2020(Abbas, , 2020b. This inter partes administrative procedure allows third parties to file a notice of opposition at the EPO within nine months after the grant of a European patent is published (Abbas, 2020b).…”

“…The European Patent Convention (EPC) 6 provides for a supra-national post-grant third-party opposition procedure (Abbas, 2020(Abbas, , 2020b. This inter partes administrative procedure allows third parties to file a notice of opposition at the EPO within nine months after the grant of a European patent is published (Abbas, 2020b). 7 Any natural or legal person, other than the patent owner, may file a patent opposition.…”

Chimeric antigen receptor T cells in the treatment of osteosarcoma (Review)

“…During treatment, one child experienced serious complications, but the disease was eventually steadily alleviated. In 2017, the USA Food and Drug Administration (FDA) approved two CAR-T cells targeting the CD19 protein, named Kymriah and Yescarta, for the treatment of ALL and diffuse large B-cell lymphoma, respectively, and ~83% of patients treated with Kymriah achieved a response of ≤5 years after 3 months of treatment ( 10 , 11 ). In 2020, Astolfi et al ( 12 ) published a study indicating that the inactivation of tumor suppressor genes was the primary driver of sarcomas.…”