Patent Licensing Agreement of Remdesivir -The Drug Used for Treating COVID-19
Remdesivir is a drug that is showing positive results against Coronavirus. The drug was developed by a United States based biopharmaceutical company, Gilead Sciences Inc. The company has signed a non-exclusive, voluntary patent licensing deal with pharmaceutical companies located in India, Egypt and Pakistan in May, 2020 for producing Remdesivir. The patent licensing agreement is between Gilead sciences and Cipla Ltd., Dr. Reddy's Laboratories Ltd., Eva Pharma, Ferozsons Laboratories, Hetero Labs Ltd., Jubilant Lifesciences, Mylan; Syngene, a Biocon company, and Zydus Cadila Healthcare Ltd. It allows these licensees to produce the drug and distribute them in 127 countries. Among these 127 countries, the majority belong to African or Asian Continents (mostly low/middle-income countries).
According to the terms of the agreement:
There will be a technology transfer of the manufacturing process for Remdesivir from Gilead to the licensees to enable the scale-up in production.
The pricing of the drug is left to the discretion of the licensees.
The drug can be sold with the name provided by the licensee.
The licenses are royalty-free until: a. The World Health Organisation declares the end of Public Health Emergency of International Concern regarding COVID-19, or b. The discovery of another pharmaceutical product or vaccine approved to treat or prevent COVID-19.
Know more about the drug:
The drug had demonstrated in viro and in vitro activity in animals against viral pathogens MERS and SARS which are structurally similar to COVID-19 as they are from the coronavirus family of viruses. The Phase 3 clinical trials was carried out by providing 2 dosing of the drug for 5 or 10 days to COVID-19 patients. It initially had a sample base of 400 patients but soon expanded to 5600 patients. The success rate was recorded at 64.5% for the 5-day treatment and 53.8% for the 10-day treatment. The result also showcased that patients who were treated within 10 days of symptom onset reacted more positively to the drug than those who were treated after 10 days of symptom onset. This drug had previously been tested for treatment of Ebola virus, but was held to be ineffective in that regard. The World Health Organisations conducted investigative trials in different parts of the world like China and Saudi Arabia among many to test the drug as a part of their Solidarity trials initiative.
Gilead Sciences Inc, Press Releases, Gilead Announces Results From Phase 3 Trial of Investigational Antiviral Remdesivir in Patients With Severe COVID-19, https://www.gilead.com/news-and-press/press-room/press-releases/2020/4/gilead-announces-results-from-phase-3-trial-of-investigational-antiviral-remdesivir-in-patients-with-severe-covid-19
World Health Organisation, R&D Blueprint, Outline of trial designs for experimental therapeutics, https://www.who.int/publications/i/item/outline-of-trial-designs-for-experimental-therapeutics
World Health Organisation, “Solidarity” clinical trial for COVID-19 treatments, https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments
Gliead Sciences, Voluntary Licensing Agreements for Remdesivir, https://www.gilead.com/purpose/advancing-global-health/covid-19/voluntary-licensing-agreements-for-remdesivir