1589MO - Opposition to a patent covering tisagenlecleucel: Using intellectual property (IP) legislation to defend sustainable access to cancer therapies

Background

Since 2013, cancer care professionals have raised concerns about cancer treatment high prices. As prices on cell therapies have skyrocketed over $350,000, there is now a consensus that cancer drugs’ high prices may become a barrier to universal access to new cancer therapy, and to the sustainability of public health systems. High prices on new cancer drugs are linked to monopolies, misuse of patents and lack of public scrutiny regarding the quality of patents. This situation has hindered rational policy making. Patent oppositions have been recognized as one effective way to contest abusive monopolies. Used since 2005 by NGOs from the Global South in their fight against HIV/aids, this legal procedure has allowed for public scrutiny of patents, raised awareness on the weakness of health inventions patents, and strengthened patentability analysis standards. Following this path, in July 2019, Médecins du Monde and Public Eye questioned a Car-t treatment tisagenlecleucel patent at the European Patent Office (EPO) based on its lack of inventive step.

Methods

We have filed a patent opposition to the patent EP3214091. A patent opposition is a legal procedure for challenging the validity of a granted patent based on lack of novelty, inventive step and/or industrial application. As a result, the patent may be maintained, amended or revoked. When revoked, the legal effects associated with the patent are suspended, including monopoly rights.

Results

In November 2019, in response to our patent opposition, Novartis and the University of Pennsylvania requested revocation of the patent. In December 2019, the EPO revoked patent EP3214091. Our patent opposition was effective to scrutinize patent EP3214091. This result weakened tisagenlecteucel monopoly and produced a strong argument for public officers to demand fairer prices. Other patents are in force that still do not allow the production of biosimilar versions of tisagenlecleucel.

Conclusions

We have showed a method through which monopoly abuses on new cancer treatments can be regulated. A stronger mobilization of oncologists is necessary to prevent abusive monopolies in order to safeguard sustainable access to cancer treatments.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Médecins du Monde and Public Eye.

Disclosure

All authors have declared no conflicts of interest.