May 6, 2020 / 10:46 AM / 25 days ago

Who can make Gilead's coronavirus drug, licence free?

(Reuters) - Gilead Sciences Inc is in talks with chemical and drug makers to produce its experimental drug remdesivir, a potential coronavirus treatment, for Europe, Asia and the developing world, the firm has said.

FILE PHOTO: Gilead Sciences Inc pharmaceutical company is seen after they announced a Phase 3 Trial of the investigational antiviral drug Remdesivir in patients with severe coronavirus disease (COVID-19), during the outbreak of the coronavirus disease (COVID-19), in Oceanside, California, U.S., April 29, 2020. REUTERS/Mike Blake/File Photo

Its patent gives the U.S. company exclusive rights to make the antiviral. But international trade rules allow nations defined by the United Nations as least-developed countries (LDCs) to ignore the patent and make drugs such as remdesivir more affordable in their markets.

Here is how production and distribution of remdesivir would work in less developed countries, under World Trade Organisation (WTO) rules.

WHICH ARE THE LEAST DEVELOPED COUNTRIES?

Of the 47 countries in this U.N. category, 36 here belong to the WTO and technically qualify for a waiver on drug patents under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

The countries are: Afghanistan; Angola; Bangladesh; Benin; Burkina Faso; Burundi; Cambodia; Central African Republic; Chad; Democratic Republic of the Congo; Djibouti; Gambia; Guinea; Guinea Bissau; Haiti; Lao People’s Democratic Republic; Lesotho; Liberia; Madagascar; Malawi; Mali; Mauritania; Mozambique; Myanmar; Nepal; Niger; Rwanda; Senegal; Sierra Leone; Solomon Islands; Tanzania; Togo; Uganda; Vanuatu; Yemen and Zambia.

HOW DO LDCs BENEFIT?

The TRIPS pact here allows LDCs to grant a "compulsory licence" for certain uses of a patented invention without the consent of the patent holder.

It originally restricted drug production to serve mainly domestic markets, but amended rules let LDCs export medicines to countries in need because some nations may lack manufacturing infrastructure.

The agreement will run until at least 2033.

One of Bangladesh’s largest drugmakers, Beximco Pharmaceuticals Ltd, told Reuters it planned to produce the drug initially for domestic use and would seek government approval for exports.

WHAT ABOUT OTHER COUNTRIES?

Other WTO members typically have to seek licenses for patented drugs, but may have other recourse.

India, for instance, can issue a compulsory local license to make and sell a drug in circumstances such as public need or if a patented drug is not available at an affordable price. India issued here such a licence in 2012 to a domestic firm to make German drugmaker Bayer's cancer medicine Nexavar.

Indian drugmakers, a key supplier of cheap medicines to the world, have also struck licensing deals. Gilead issued voluntary licenses here to several Indian firms in 2014 to make cheaper versions of its blockbuster hepatitis C drug sofosbuvir for India and other countries in need.

Similar deals are likely for remdesivir, after Gilead said statement here it was negotiating with several generic drugmakers in India and neighbouring Pakistan to license and produce the drug for developing countries. Gilead did not give details.

Cipla Ltd, one of India's largest drugmakers and part of Gilead's hepatitis C pact www.gilead.com/~/media/files/pdfs/other/hcv%20generic%20agreement%20fast%20facts%20101615.pdf?la=en, has said it is working on developing remdesivir, but has not given details. Cipla is among a handful of firms with the specialised capabilities to make injectable drugs such as remdesivir.

HOW MANY DOSES WILL BE AVAILABLE?

Gilead, which has cut by roughly a third the process time to make remdesivir at scale, expects to have more than 1 million courses of treatment by December and to be able to produce several million in 2021.

It also said it would donate the first 1.5 million doses.

While the global drug industry races to develop a treatment or vaccine for the fast-spreading virus, more than 3.68 million infections have been reported worldwide, with over 256,000 deaths.

HOW MUCH WILL IT COST?

The Institute for Clinical and Economic Review (ICER), which weighs drug effectiveness to decide appropriate prices, put the production cost of a 10-day course at $10, but suggested the price could rise to $4,500 based on patient benefits shown in clinical trials.

Beximco said a course of remdesivir treatment could cost between $295 and $781 per patient in Bangladesh.

Reporting by Sayantani Ghosh and Miyoung Kim in Singapore and Zeba Siddiqui in New Delhi; Editing by Clarence Fernandez

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