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Coronavirus pandemic | Gilead could face compulsory licensing despite patents if supply fails demand: Report

There is a chance Gilead may work out its own licensing deals before being forced into CL by the government.

May 08, 2020 / 10:21 AM IST
Gilead Sciences office (REUTERS/Stephen Lam/File Photo)

Gilead Sciences office (REUTERS/Stephen Lam/File Photo)

Gilead Sciences’ exclusivity over remdesivir may face compulsory licensing (CL) if the company is unable to keep up production with demand. The company currently has a 15-year patent on remdesivir – which is a under trial, potential drug for treatment of COVID-19.

If the drug is successful, it could bring big profits for the company worldwide, but attorneys say this would be subject to Gilead scaling production up to demand – regardless of the patents, said a report by Bloomberg.

The company has already secured three patents and has an unknown number of patent applications for remdesivir pending. Additionally, a 5-year exclusivity from the United States Food and Drug Administration (US FDA) if the drug is successful.

“This is an emergency use drug, so the federal government will certainly want to make this drug available to everyone who needs it… Gilead would be very vulnerable to licensure if it can’t ramp up production,” Steven Roth, a partner and intellectual property attorney with Lucas & Mercanti, LLP in New York said as per the report.

“March-in” rights provisions government to seize patents for inventions created with government funding and license them to other entities. This has so far never been invoked.

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COVID-19 Vaccine

Frequently Asked Questions

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A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

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There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

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Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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CL meanwhile applies even on drugs not funded by the government, but ensures the administration pay the patent holder royalties. On previous occasions, threat of CL caused Bayer AG to lower prices for anthrax after the 9/11 attacks.

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Besides availability, the company is also facing pressure from the public and Democrats to price the drug affordably, and make public supply chain plans.

The company received emergency use authorisation from the US FDA and White House on May 1, and clinical trials are on to test the success of the drug in treating COVID-19 patients.

Gilead did not respond to queries on the matter, as per the report.

Some others however believe Gilead may work out its own licensing deals before being forced into CL by the government.

Not many are worried about profitability, as analysts say that even if that while Gilead said it has spent $1 billion this year on remdesivir, if treatment is priced at $4,500 the company would easily recover $2 billion in revenues.

Follow our full COVID-19 coverage here
Moneycontrol News
first published: May 8, 2020 10:21 am

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