‘Remedesivir’ supply- Gilead signs Pact with generic drug makers

May 19, 2020
Under Trial Drugs

By Sukku and Divyansh Trivedi

Gilead Sciences Inc, producer of the broad-spectrum antiviral medication named Remdesivir which is being tested as a specific treatment of the COVID-19 virus, has announced that on May 12, 2020 it has signed ‘non-exclusive licensing’ pacts with five generic drugmakers based in India and Pakistan to further expand the supply of its experimental COVID-19 treatment.[1]

Also read COVID-19, Ventilators and Patents

The licensing pacts will allow the following five companies to make and sell the remdesivir drug in 127 Countries –

  1. Jubilant Life Sciences Ltd
  2. Cipla Ltd
  3. Hetero Labs Ltd
  4. Mylan N.V.
  5. Ferozsons Laboratories Ltd

Gilead stated that these 127 countries consist of mostly all low-income and lower-middle income countries along with several that are upper-middle and high-income countries that face significant obstacles to healthcare access. These include Bangladesh, Tunisia, Afghanistan, Cambodia, India, Nepal, North Korea, Thailand, Algeria, Pakistan, Indonesia, South Africa and Sri Lanka among other nations. A full list of the 127 countries can be viewed here.

Under the licensing agreements, the companies have a right to receive a technology transfer of the Gilead manufacturing process for remdesivir to enable them to scale up production more quickly.

Gilead further said that the licensees will have liberty to set their own prices for the generic product that they produce. As per the statement issued by Gilead, all five licenses will be royalty-free until the World Health Organization (WHO) declares that the public health emergency arising because of the COVID-19 outbreak has ended, or until another product other than Remdesivir or any vaccine is approved to prevent or treat COVID-19, whichever is earlier.

Earlier this month, the antiviral drug Remdesivir received authorization for emergency use to treat COVID-19 patients by the U.S. Food and Drug Administration.[2]

The interest in Remedesivir has been growing because there is no other approved treatment for COVID-19 and hence, all eyes are on Gilead for the reasonable pricing and proper distribution of the limited supply of the drug.

Patent Pool: Need of the Hour

This move of Gilead should be applauded, as the need of the hour calls for companies to come together and sharing their IP rights thereby fighting the battle against the COVID 19 as one. Infact the World Health Organization’s director-general has also endorsed the idea of creating a voluntary pool to collect patent rights, regulatory test data, and other information that could be shared for developing drugs, vaccines, and diagnostics.[3] Patent pools are agreements between two or more patent owners to license their patents to one another or to a third party.

Vaccination, Coronavirus and Intellectual Property Rights

Compulsory licensing and COVID-19

Additionally, some countries have also taken emergency legal measures in form of Compulsory Licensing. countries like USA, Chile, Ecuador & Germany have also resorted to the ‘Compulsory Licenses’ for COVID-19 medicines, vaccines and other medical tools. The government of Israel has also issued a compulsory licence for patents on a medicine they were investigating for use for COVID-19.[4]

A compulsory license is issued by the owner for the use of their rights against payment and the price of which is either fixed by law or ascertained through some form of adjudication or arbitration.

The COVID-19 outbreak, which has been declared a Pandemic has severely hit nations worldwide and subsequently the Government of India has also taken several precautionary measures to curb and lower the impact of the deadly virus.

Keep watching this space for more updates on Corona Virus.

[1] https://www.gilead.com/purpose/advancing-global-health/covid-19/voluntary-licensing-agreements-for-remdesivir

[2] https://www.gilead.com/news-and-press/press-room/press-releases/2020/5/gileads-investigational-antiviral-remdesivir-receives-us-food-and-drug-administration-emergency-use-authorization-for-the-treatment-of-covid19

[3] https://www.statnews.com/pharmalot/2020/04/06/covid19-coronavirus-patents-voluntary-pool-world-health/

[4] https://www.msfindia.in/covid-19-msf-calls-for-no-patents-or-profiteering-on-covid-19-drugs-tests-and-vaccines/

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