Voluntary Licensing Agreements for Remdesivir

May 14, 2020 - 9:35 am Categories: Licensing 0 Comments

Gliead is rapidly working to fight with this outbreak of novel COVID-19. Remdesivir is a potential drug for the treatment for COVID-19. Remdesivir has formally not been approved as treatment of COVID-19. USA is using appropriate authorities for the investigation of the drug. That there are multiple clinical trials going on check safety and efficiency of the drug Remdesivir Covid-19 treatment   

Gilead is working with regulatory agencies to provide remdesivir to the patients. Till date Gliead is providing the emergency access to remdesivir for several hundred patients in the United States, Europe and Japan

According to the report of medical news website STAT the drug Remdesivir is showing positive response to the patients of COVID-19. The University of Chicago Medical centre has also participating in the study of the antiviral medication and said that there are rapid recoveries of the symptoms of Covid-19 because of this drug. The drug Remdesivir has earlier tested in Ebola patients has now being tested for COVID-19 patients. Gilead is not only doing their own clinical trial but has made the drug available to studies run by other sponsors.

Gilead has now signed non- exclusive voluntary licensing agreement. Wherein it has given licence to drug makers of India and Pakistan to expand the supply of an experimental drug used on COVID-19 patients.

“Non- Exclusive licence is a licence that can be granted to more than one entity. For example, a patent holder can grant non-exclusive licences to multiple generic drug manufacturers.

A voluntary licence is a voluntary agreement reached between the patent holder (licensor) and the licensee. Terms and conditions of such a licence are agreed between the patent holder and licensee, and can specify in which countries a medicine can be sold and what the royalty will be. The MPP is a mechanism that manages voluntary licences between multiple licensors and licensees”.

The companies which will be manufacturing Remdesivir drug are :

Indian companies, Noida-based Jubilant Life Sciences Ltd, Mumbai-headquartered Cipla Ltd , Hyderabad-based Hetero Labs Ltd and the other two one is US based companies Mylan NV and  Pakistan based Ferozsons Laboratories Ltd. These companies are allowed to develop and sell drugs in 127 countries.

In these 127 countries ,the countries are mostly low income, low middle income,  & several upper-middle and high-income countries.

Furthermore USFDA has granted Emergency Use Authorization (EUA) for Remdesivir drug to treat COVID-19 patients. Japan has also approved this drug for treating of COVID-19 patients.

Gilead has transfer technologies to those five generic drug companies for manufacturing, so that these drugs are available as soon as possible . Gilead also said that they will be setting their own price for the generic product they produce.

It is also stated that the drugs will be royalty free- until or unless the WHO declare end of public health emergency concerning Covid-19 or when there is vaccine other than remdesivir to treat or prevent COVID-19 , whichever is earlier.

That the agreement permits distribution in the following countries:

Afghanistan, Algeria, Angola, Anguilla,Antigua & Barbuda, Armenia, Aruba, Azerbaijan, Bahamas, The Bangladesh, Barbados, Belarus, Belize, Benin, Bermuda, Bhutan, Botswana, British Virgin Islands, Burkina Faso, Burundi, Cambodia, Cameroon, Cape Verde, Cayman Island, Central Af R., Chad, Comoros, Congo Rep., Cook Islands, Costa Rica, Cote d’Ivoire, Cuba, Curacao, Djibouti, Dominica, Dominican Republic, Egypt, El Salvador, Equatorial Guinea, Eritrea, Eswatini (Swaziland), Ethiopia, Fiji, Gabon, Gambia, The Georgia, Ghana, Grenada, Guatemala, Guinea, Guinea Bis, Guyana, Haiti, Honduras, India, Indonesia, Jamaica, Kazakhstan, Kenya, Kiribati, Korea, Dem. People’s Rep. (North Korea), Kyrgyzstan, Lao DR (Laos), Lesotho, Liberia, Libya, Madagascar, Malawi, Maldives, Mali, Marshall Islands, Mauritania, Mauritius, Micronesia, Fed. Sts.,Moldova, Mongolia, Montserrat, Morocco, Mozambique, Myanmar, Namibia, Nauru, Nepal, Nicaragua, Niger, Nigeria, Pakistan, Palau, Panama, Papua New Guinea, Philippines, Rwanda, Samoa, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Sint Maarten (Dutch part),Solomon Islands, Somalia, South Africa, South Sudan, Sri Lanka, St. Kitts and Nevis, St. Lucia, St. Vincent and the Grenadines, Sudan, Suriname, Tajikistan, Tanzania, Thailand, Timor-Leste, Togo,Tonga, Trinidad & Tobago, Tunisia, Turkmenistan, Turks & Caicos, Tuvalu, Uganda, Ukraine, Uzbekistan, Vanuatu,Vietnam, Zambia & Zimbabwe

INDIA

In India earlier also Gilead in the year 2014 signed 9 Indian companies for its blockbuster Hepatitis drug Sofobuvir.

The Indian company “Jubilant Life Sciences” said that they are having clinical trials and regulatory approvals , they further said that the Remdesivir drug will be launched shortly. It was further said  by the company that “We also plan to produce the drug’s Active Pharmaceutical Ingredient (API) in-house helping its cost-effectiveness and consistent availability”

As for Cipla it will be permitted to manufacture the drug for all the 17 countries which includes India and South Africa under the brand name of Cipla. That the Ceo of Cipla Limited said that  “At Cipla, it is our continuous endeavour to ensure that no patient is denied access to life-saving treatments. Our partnership with Gilead represents this unwavering commitment and is a significant step towards saving millions of lives impacted by the pandemic,”

About the Author: Aishani Singh, Litigation Associate at Khurana & Khurana Advocates & IP Attorneys. In case of any queries please contact/write back to us at aishani@khuranaandkhurana.com