Medicines Patent Pool Long Acting Initiatives

Speaker: Lobna Gaayeb, Project Manager of Long-acting Technologies at Medicines Patent Pool (MPP)

Lobna Gaayeb

Provided an overview of MPP, the first and only existing patent pooling mechanism, and their collaborative approach towards eliminating gaps in access to LA formulations and facilitating development of LA formulations for LMICs by focusing on voluntary licensing and patent pooling.

Intellectual property protections pose a major barrier to access of LA technologies in LMICs– main conclusions from the 2018 Unitaid-MPP Intellectual Property Report on LA technologies. 
Multi-layered protections exist on the molecule, formulation, delivery device and manufacturing process with LA product patents adding years of exclusivity. Patented platform technologies can be applied to multiple products. Geographical coverage of patent filings vary by product and technology, but key manufacturing countries are often covered.

MPP aims to avoid gaps in access to LA formulations (meaning availability, affordability, quality, acceptability and adaptability) by facilitating voluntary licensing.
MPP negotiates public health driven licenses with patent holders and sublicences drugs to generic pharmaceutical companies within a large network of vetted manufacturers. Competition among generic manufacturers produces cheaper, but high quality medicines and accelerates development of better-adapted formulations for resource-limited settings. 

Common features of MPP licenses. 
The focus is bespoke licenses – each license is tailored to a specific product and context. The terms are negotiated with each patent holder, but all are public health driven and aligned with MPP principles. Common features include: wide geographic scope; non-exclusive (promotes competition); transparency (published on MPP website); quality-assured; complementary; license management (monitor compliance); and technology transfer (to accelerate development of generic versions). 

Strategic MPP partnerships are central to accelerate development and broaden access to LA technologies, and the focus is shifting to earlier stage products. 
MPP services encompass license management to end-user support, including for regulatory issues and roll out. MPP works with a range of stakeholders working in the LA field, including scientific groups, funding agencies and investors, industry, developers, generic manufacturers, and advocacy groups. MPP collaborates with innovators (seeks access commitment), leverages partnerships to facilitate development and affordable access (through licensing and access to a wide network of manufacturers), and includes support for technical and regulatory product development, market analysis and prevention of stock outs (by ensuring adequate competition).

Long-acting Patents and Licenses (LA PaL), the MPP open-access online database, is under development to facilitate information sharing (first version expected late 2021).
LA PaL is intended to complement scientific, clinical and community engagement. The database will ensure information transparency and facilitate matching between drugs and technologies, with a particular focus on patents and licenses. Product identification cards and profiles are in development.

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