Roche Suspends Patents on Tocilizumab in LMICs After WHO Recommends it as Treatment for Severe COVID-19
Tocilizumab, manufactured by Roche.

Swiss pharmaceutical company Roche has suspended its patent rights on the medication tocilizumab in low- and middle-income countries (LMICs) for the duration of the pandemic, the company announced Tuesday.

This follows the World Health Organization (WHO) recommendation on Monday for   interleukin-6 (IL-6) receptor blockers to be given to patients hospitalised with severe or critical COVID-19. 

The interleukin-6 (IL-6) receptor blockers, tocilizumab and sarilumab, reduced the risk of death and ventilation when combined with corticosteroids, according to a study published the same day in the Journal of the American Medical Association (JAMA).

However, the medicines are currently very costly, as reported by Health Policy Watch. Describing the WHO’s new guidance as “an important development for patients hospitalised with severe or critical COVID-19”, Roche said it had been “working around the clock” to try to meet the need for tocilizumab.

“We have increased our own production capacity significantly and have been working with external manufacturers on transferring our technologies to further increase global supply. Despite all these efforts, it may still not be enough to meet the unprecedented demand for Actemra/RoActemra,” the company explained.

By announcing that it would not be asserting any patents against tocilizumab in LMICs “during this current pandemic”, Roche said that it wanted to “provide legal certainty for biologic manufacturers”.

“We are working closely with the WHO on the implications of this guideline and on mechanisms (WHO PreQualification) that may enhance access in LMICs,” Roche added in a statement.

“At the same time, we strongly believe that robust intellectual property (IP) systems are a prerequisite for innovation and improving treatments for the benefit of every human being and society as a whole,” the company asserted.

“IP protection is mandatory to address the huge healthcare challenges the world is facing – also beyond COVID19. It has been the basis for the industry’s quick and comprehensive response to the challenges of the pandemic – an unprecedented success of healthcare innovation.”

Earlier in the week, Médecins Sans Frontières (MSF) called on Roche, the world’s only producer of tocilizumab, to lower its price “to make it affordable and accessible for everyone who needs it”.

“Even though tocilizumab has been on the market since 2009 for treatment of rheumatologic diseases, access has remained a challenge,” according to MSF. 

“Roche kept the price of this drug very high in most countries, with price tags ranging from US$410 in Australia, $646 in India to $3,625 in the USA per dose of 600mg for COVID-19.”

Regeneron holds the patent for the second drug, sarilumab, in “at least 50 low- and middle-income countries, raising immediate challenges of ensuring uninterrupted production and supply by diverse producers in these countries”, according to MSF.

Interestingly, a trial on sarilumab conducted by Regeneron and Sanofi on whether it could reduce mechanical ventilation in severely ill COVID-19 patients was abandoned a year ago after failing to show statistically significant results.


Image Credits: Roche.

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