US officials urge to override Gilead patent

Most of US state attorney generals want the government to use its march-in-rights to license remdesivir to others

By Latha Jishnu
Published: Monday 07 September 2020
US officials urge to override Gilead patent. Photo: Wikimedia Commons

Attorney generals (AG), we know, are the chief judicial officers of a nation or its states, appointed (or elected as in some of the 50 states of the US) to enforce the laws of the land. They are sticklers for the law and by no stretch of the imagination can they be activists. Oh, no. Why then were 34 of them, cutting across party lines, writing to the highest health officials of the country to override Gilead’s patents on remdesivir, the most hyped drug in the world? 

It is an unusual step for state AGs to take and possibly the first time so many of them have come together in a bipartisan effort. But then the novel coronavirus disease (COVID-19) pandemic has resulted in an unprecedented situation, with the US ravaged more than any other country.

The law officials have urged the federal government to exercise its march-in-rights against Gilead to ensure that Americans can access sufficient supplies of remdesivir during this pandemic and at affordable prices. Remdesivir, which earlier received emergency use authorisation to treat COVID-19 patients, is said to cut a patient’s hospital stay by five days.

But as Gilead announced its exorbitant rates for the drug, there has been a widespread campaign to rein in the US multinational that has received over $70 million in public funds to develop remdesivir.

The AGs have joined in by accusing Gilead of neither setting a reasonable price nor meeting the health and safety needs of the public during the pandemic.They have written to Health Secretary Alex M Azar urging the federal government to use its march-in-rights to help increase the “dangerously low supply” of this drug and lower the price so that it is accessible to the residents of their 34 states. If not, he should support these states by assigning them the rights through the National Institutes of Health (NIH) and Food and Drug Administration. 

March-in-rights were created in 1980 by the Bayh-Dole Act that aimed at ensuring that the results of federally funded research were actually used for the benefit of consumers.

This law, which is somewhat akin to India’s compulsory licensing provisions in the Patents Act, acts as a safeguard if federally funded inventions are not offered at reasonable terms or used in ways that are detrimental to the public interest. In such cases, the agency that provided the funding can grant licences to third parties. The federal agency which poured money into remdesivir is NIH.

The worries of the states, that have been left to fend for themselves by the Trump Administration, are easy to understand. If Gilead supplies 85 per cent of its remdesivir to the US alone and their concerns is that it will not, only 1.7 million of the 4.6 million confirmed COVID-19 patients in the country (as of August 3) would have access to full treatment. Even if it supplies 90 per cent of its production to the home market it would not be able to meet the contingency.

The system so far has not shown that it has the guts to take on the big drug firms. Several appeals filed by public health groups and even lawmakers on the predatory pricing adopted by these companies have been consistently rejected by NIH. Will the pandemic make a difference?

This was first published in the 1-15 September, 2020 print edition of Down To Earth 

Subscribe to Weekly Newsletter :
Related Stories

Comments are moderated and will be published only after the site moderator’s approval. Please use a genuine email ID and provide your name. Selected comments may also be used in the ‘Letters’ section of the Down To Earth print edition.