Full on-patent portfolio for HIV/AIDS and viral hepatitis now under voluntary licences
With the most non-exclusive voluntary licences for patented products, Gilead has licensed its entire patented portfolio for HIV/AIDS and viral hepatitis (HBV/HCV)
HIV/AIDS and viral hepatitis (HCV)
Non-exclusive voluntary licensing agreements for HIV/AIDS and viral hepatitis (HCV)
To enable generic medicine manufacturers to enter low- and middle-income countries
Since 2016, the Index has recognised Gilead for its leading, proactive approach to licensing, which helps speed the entry of generic medicines into the countries in scope. Previously, the company demonstrated best practice by voluntarily licensing its entire in-scope portfolio of on-patent products. Still with the most non-exclusive voluntary licences for patented products, Gilead continues to lead the way, having licensed its entire patented portfolio for HIV/AIDS and viral hepatitis (HBV/HCV). Other companies demonstrating good practice in this area include AbbVie, Bristol Myers Squibb, GSK [via ViiV Healthcare], Johnson & Johnson and MSD.
By issuing non-exclusive voluntary licences for patented medicines, rights-holding pharmaceutical companies enable other manufacturers to develop generic versions, fostering, thus, competition and supporting supply. This helps make drugs more affordable and broadens patient access. Gilead also publicly reports on the low- and middle-income countries where it has filed for registration and whether filings are successful. More than 90 countries in scope are included in the majority of Gilead’s agreements, with all licences covering all sub-Saharan countries in scope. Many of its licensed products appear on the WHO Essential Medicines List (EML) and are regarded as first-line treatments with a high public health value.
In 2011, Gilead became the first company and private sector partner to negotiate licences with the Medicines Patent Pool (MPP), a United Nations-backed public health organisation that works to increase access to lifesaving medicine in low- and middle-income countries. Since then, with the MPP, it has agreed multiple licences for HIV/AIDS treatment, including for bictegravir, cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide and tenofovir disoproxil fumarate. Nine out of ten people living with HIV/AIDS in low- and middle-income countries are in countries covered by these licences.*
Gilead is also the first company to work directly with generic medicine manufacturers to agree licences for its products to treat hepatitis C (HCV). This disease affects an estimated 71 million people worldwide and complications cause some 400,000 deaths each year.**
Are companies engaging in voluntary licensing to expand access?
Management of the intellectual property (IP) of large R&D-based pharmaceutical companies impacts the availability and affordability of medicines. Enabling generic medicine manufacturers to develop generic versions of medicines can increase affordability, support supply, foster competition and ultimately improve access. A non-exclusive voluntary licence is an important approach, among many, to making a product accessible.
To license its products sofosbuvir, ledipasvir, velpatasvir and voxilaprevir, Gilead has signed agreements with 14 generic medicine manufacturers to manufacture products for use in 105 countries globally, including 90 countries in scope of the Index. Terms of these bilateral licences are comparable with those for MPP licences for HIV/AIDS in their transparency and geographic breadth.
In licensing for both HIV/AIDS and HCV products, Gilead also demonstrates best practice by planning for and agreeing licensing terms prior to gaining first global approval from the US Food and Drugs Administration (FDA) and the European Medicines Agency (EMA) for the majority of coumpounds licensed.