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.

KEYWORDS:

• Civil society
• gene therapy
• Kymriah
• patent opposition
• public health

Acknowledgements

The author is a Senior Research Assistant at Faculty of Law, Queensland University of Technology (QUT), Brisbane, Australia. The author is working with Professor Matthew Rimmer on his Australian Research Council Discovery Project ‘Inventing the Future: Intellectual Property and 3D Printing'. This paper benefitted from oral presentation and feedback at the Intellectual Property Scholars Conference 2020, Stanford University, California, USA. Some part of an earlier draft of this paper is derived from the author's PhD thesis entitled ‘Community-Based Patent Opposition Model in India: Access to Medicines, Right to Health and Sustainable Development’ submitted at QUT, Australia. The author would like to acknowledge his PhD supervisors Professor Matthew Rimmer and Professor Richard Johnstone. The author appreciates Juliana Veras and Théau Brigand, from Médicins du Monde, for their valuable inputs on objectives and potential impact of Kymriah patent opposition. The author would also like to acknowledge with great appreciation his wife Dr. Shamreeza Riaz for her unconditional support and valuable suggestions. The views presented in this paper are, however, the sole responsibility of the author.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Notes

1 According to the Kymriah medication guide, patients treated with Kymriah need to stay within two hours of the location of their treatment facility for at least four weeks after getting the infusion.

2 See Supplement to Official Journal of the European Patent Office, Schedule of Fees and Expenses Applicable as from 1 April 2012.

3 First article was published by Parter et al. in the Journal of Cancer; second article was published by Kalos et al. in Science Translational Medicine; and third article was published by Parter et al. in The New England Journal of Medicine.

4 The author contacted Juliana Veras via email in late August 2020 to enquire about any actual reduction on price of Kymriah resulting from the successful patent opposition. Her response email is on record with the author.

5 The author contacted Théau Brigand via email in late August 2020 to enquire about any actual reduction on price of Kymriah resulting from the successful patent opposition. His response email is on record with the author.

6 See Supplement to Official Journal of the European Patent Office, Schedule of Fees and Expenses Applicable as from 1 April 2012.

7 In April 2013, an opposition division of the EPO revoked the stem cell patent in the ‘Brüstle’ case. In 2015, civil society organizations from 17 countries successfully challenged Gilead’s Sofosbuvir patent. Moreover, civil society organizations in Europe opposed the Myriad Genetics’ BRCA1 and BRCA2 patents and succeeded in significantly reducing the negative impacts of these controversial patents. https://www.epo.org/news-issues/news/2013/20130411a.html. Accessed June 20, 2020.