Geneva, 9 July 2021 — Following the World Health Organization (WHO) recommending tocilizumab for severely and critically ill COVID-19 patients, Médecins Sans Frontières/Doctors Without Borders issued a statement highlighting that the drug remains inaccessible and unaffordable for the majority of the world. Roche has just announced that Roche and Chugai (joint holders of tocilizumab-related patents) will not be asserting any patents related to tocilizumab for treatment of COVID-19 in low- and middle-income countries during this current pandemic, to provide legal certainty for ‘biologic’ manufacturers that could produce alternative versions.
Leena Menghaney, Global IP advisor, MSF Access Campaign:
“While we acknowledge Roche’s announcement, its non-assertion statement as currently announced is insufficient. The basic patent on tocilizumab held by Roche has expired but the Swiss corporation has continued to pursue a patent extending or “evergreening” strategy to seek additional patents, and holds the de-facto monopoly in the global market. As we continue to witness surges in COVID-19 cases across the globe, and against the backdrop of 4 million deaths, we call on Roche to take the following actions to ensure increased access to tocilizumab:
- Roche’s non assertation of patents should be applicable to all countries – and not just to low- and middle-income countries - so that wherever biological production capacity exists, alternative producers can speed up development and production of biosimilars;
- Roche should disclose the full details of all remaining secondary patents and any pending patent applications and withdraw them to provide full freedom to operate and legal certainty for biosimilar producers; and
- Ensure quick and independent production and supply of tocilizumab by additional manufacturers, Roche should opt for open, transparent and unrestricted transfer of master cell lines, share its regulatory dossier and any other manufacturing information, which is critical for immediate scale-up of production by other manufacturers.
- Roche must also lower the price of this drug to make it affordable and accessible for everyone who needs it.”