Law360 is providing free access to its coronavirus coverage to make sure all members of the legal community have accurate information in this time of uncertainty and change. Use the form below to sign up for any of our weekly newsletters. Signing up for any of our section newsletters will opt you in to the weekly Coronavirus briefing.
Sign up for our Consumer Protection newsletter
You must correct or enter the following before you can sign up:
Thank You!
Law360 (May 13, 2020, 2:16 PM EDT ) Gilead has struck deals with Mylan and other generic companies to make and sell its experimental COVID-19 drug remdesivir for 127 countries, drawing criticism from a consumer advocacy group that the arrangement "picks winners and losers" and that remdesivir should be in the public domain.
In a press release Tuesday, Gilead said that it has signed nonexclusive licensing deals with five generic makers based in India and Pakistan to manufacture remdesivir for "nearly all low-income and lower-middle income countries as well as several upper-middle- and high-income countries that face significant obstacles to healthcare access."
The companies — Mylan, Cipla Ltd., Ferozsons Laboratories Ltd., Hetero Labs Ltd. and Jubilant Life Sciences Ltd. — can set the prices for their own generic versions of remdesivir, Gilead said.
They also don't need to pay royalties until the World Health Organization declares that the novel coronavirus is no longer an international health emergency, or until a non-remdesivir product or vaccine is approved to treat COVID-19, whichever comes first, the release states.
In addition to India and Pakistan, countries including Afghanistan, Cuba, Egypt, Indonesia, North Korea, the Philippines and South Africa are on the list, though the U.S. is not.
In a statement Tuesday, Mylan CEO Heather Bresch said that the company is "committed to continue deploying our resources and expertise in the fight against COVID-19 by applying our R&D and manufacturing capabilities to help expand access to this potential treatment option as it is further evaluated by regulatory authorities."
Not everyone was lauding the arrangement, however. Peter Maybarduk, who heads Public Citizen's access to medicine program, said that Gilead's deal "picks winners and losers" by forcing excluded countries to buy remedesivir "at its monopoly price" or else beat Gilead's patents.
"More than donating remdesivir doses, Gilead should donate its technology," Maybarduk said in a statement Tuesday. "Remdesivir should be in the public domain. Gilead should commit its patents, data and know-how to the public domain so that researchers around the world can investigate its efficacy and manufacturers can help bring supply to scale."
The announcement comes a few weeks after the U.S. Food and Drug Administration granted emergency use authorization to Gilead's remdesivir for treatment of COVID-19 patients.
Remdesivir, which was used to treat Ebola, may now be used to treat suspected or laboratory-confirmed COVID-19 cases in adults and children hospitalized with "severe disease," the FDA said in a May 1 statement.
--Additional reporting by Hailey Konnath. Editing by Alyssa Miller.
For a reprint of this article, please contact reprints@law360.com.
