Widest use of non-exclusive voluntary licensing
Gilead licenses its entire on-patent portfolio of products for diseases in scope to speed the entry of generics into market.
To enable generic medicine manufacturers enter markets in low- and middle-income countries.
Non-exclusive voluntary licences enable the development of generic versions of drugs which increase affordability and access.
When rights-holding companies issue non-exclusive voluntary licences for patented medicines, they enable other manufacturers to develop generic versions of these medicines. This helps to foster competition, support supply, increase affordability and improve access.
What makes this a best practice?
Gilead’s approach to licensing remains a best practice amongst companies evaluated by the Index, as in 2016. Gilead voluntarily licenses its entire in-scope portfolio of on-patent products. The company’s proactive, supportive approach speeds the entry of generic medicines into markets within the countries it includes within agreed licences.
The licensed products are for the treatment of either HIV/AIDS or hepatitis C, and have a high public health value. In many cases the licensed products appear both on the WHO EML and are regarded as first-line treatments: emtricitabine, sofosbuvir, ledipasvir and velpatasvir. Its licences for products for HIV/AIDS are agreed via the Medicines Patent Pool (MPP), whereas Gilead has agreed the licences for products for hepatitis C, the first company to do so directly with generic manufacturers. In both cases, Gilead demonstrates that it plans for (and agrees) licensing terms prior to FDA or EMA approval.
Further, it commits to filing new products for registration in as many low-income countries (LICs) and middle-income countries (MICs) as possible within 12 months of FDA and EMA approval, while publishing where they have filed and whether it was successful. These steps can all work together to support the efficient entry of generic medicines to market, potentially reducing the time before those in need within these countries can access the product.
Partnering for greater reach
Gilead has engaged with the MPP to negotiate licences since 2011 and was the first company to do so. It has signed licence agreements for the treatment of HIV/AIDS via the MPP for bictegravir, cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide and tenofovir disoproxil fumarate. Country coverage within these licences applies to countries that are home to 90% of people living with HIV/AIDS in low-and middle-income countries.
Working directly with generic manufacturers, Gilead licenses products for the treatment of hepatitis C, including sofosbuvir, ledipasvir, velpatasvir and voxilaprevir. The terms Gilead reaches in its bilateral licences are comparable (in transparency and geographic breadth) with the licences negotiated via the MPP. However, compared to its licences for HIV/AIDS products, Gilead’s hepatitis C licences are a more limited tool for providing access to people living with hepatitis C. The regions that are most affected by HCV are WHO Eastern Mediterranean and European Regions, which are typically not covered by Gilead’s hepatitis C licences.
In 2017, Gilead further expanded the number and scope of HIV/AIDS licences it signed with the MPP. It newly licensed bictegravir to the MPP and added two new middle-income countries within the Index scope to the terms of the licence: Philippines and Ukraine.