Non-exclusive voluntary licensing outside of HIV/AIDS

Gilead and Bristol-Myers Squibb take the first moves, from companies in scope of the Access to Medicine Index 2016, outside non-exclusive voluntary licensing in HIV/AIDS.

Summary  

  • Context: New products have been launched which present an effective cure for hepatitis C. Several, marketed by Gilead, Bristol-Myers Squibb and Johnson & Johnson have been added to the WHO Model Essential Medicines List (2015).
  • What: Gilead, followed shortly afterwards by Bristol-Myers Squibb, have agreed non-exclusive voluntary licensing terms which allows generic manufacture and supply of these products.
  • Objective: Competition amongst generic manufacturers to supply these products in the markets influenced in the licensing agreements helps to improve affordability and supply of these products.
  • Change: Gilead and Bristol-Myers Squibb were the first companies to deploy non-exclusive voluntary licensing in a disease area outside of HIV/AIDS.

Looking closer

New products have been launched which present an effective cure for hepatitis C. These are known as direct-acting antivirals (DAAs). Several, marketed by Gilead, Bristol-Myers Squibb and Johnson & Johnson have been added to the WHO Model Essential Medicines List (2015).

Gilead has agreed licensing terms for three DAAs for supply to 101 countries via 11 manufacturers: sofosbuvir (Sovaldi®), sofosbuvir/ledipasvir (Harvoni®) and sofosbuvir/velpatasvir (Epclusa®). Epclusa® is pan-genotypic. Pan-genotypic products are particularly important in low-income settings where genotyping diagnostic capacity may be weak.

Bristol-Myers Squibb has agreed licensing terms for the DAA it markets, daclatasvir (Daklinza®), with the Medicines Patent Pool. It has licensed Daklinza® for supply to 112 countries, and to countries beyond the agreed geographic scope where patent rights are not infringed. When this product is combined with Gilead’s Sovaldi®, it has pan-genotypic potential.

This is an important step: non-exclusive voluntary licensing is an important access tool which supports both affordability and supply of patented products. Prior to the period of analysis for the 2016 Index, transparent, non-exclusive, access oriented licences were limited to the HIV/AIDS policy space. This move into hepatitis C helps demonstrate the fact that licensing can be an effective access mechanism for further disease categories, and points the way to its future application in other disease areas.

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