Geneva, 12 December 2018: The Medicines Patent Pool (MPP) and Unitaid have jointly published a study into the patent landscape for the long-acting technologies that could have major impact for preventing or treating major diseases in low- and middle-income countries. The report can be accessed here.
The report provides an overview of the intellectual property status of long-acting products for major diseases that are under development or already on the market.
Specifically, the report finds that the patent situation for long-acting products can be complex, with patent protection on the drugs themselves, on the technologies needed to manufacture them, and, in some cases, on the delivery devices. In the case of nanoformulations for example, there is high potential for multiple overlapping patents. The delivery platforms are often applied to multiple products and are covered as well by extensive intellectual property protection. The above complexity, as well as other factors summarised in the report, may present challenges to the freedom-to-operate and eventually access to long-acting products adapted to the needs of LMICs.
The report also finds that, in terms of the geographical breadth of patent protection for different long-acting products, the situation varies significantly between products. However, in general, products appear to have patents pending or granted in key countries for generic manufacturing.
“There is huge potential for long acting technologies to make a substantial difference to treatment adherence in low- and middle-income countries, for diseases including HIV, hepatitis C and tuberculosis. But this won’t happen by itself.” said Charles Gore, Executive Director, the MPP.
“Much collaboration is still required to develop them and then ensure affordable access. This report, by mapping the patent landscape for these technologies, will help accelerate this process.”
Developing a healthy market for long-acting products in LMICs has its challenges. The report can aid in understanding the range of different actors involved in the development of long acting formulations and the opportunities for partnerships that could lead to faster development and wider access.
“To avoid the pitfalls of the past, when new medicines were introduced first in high-income countries and only much later in LMICs, we need to be thinking ahead of the curve to prepare for a healthy market and prompt access to these game-changing long-acting tools”, said Lelio Marmora, Executive Director of Unitaid.
Intellectual Property Report on Long-Acting Technologies was compiled by the MPP and Unitaid and provides a patent landscape of intellectual property protection for long-acting products marketed or under development for prevention and treatment of HIV, hepatitis C, tuberculosis, and malaria.
The information is correct as of October 2018. This report should not be interpreted as a freedom to operate analysis. It provides a snapshot based on the information that was available to the MPP and Unitaid at time of writing. Users are encouraged to seek further advice as appropriate.
For more information:
Long-acting technologies for infectious diseases in LMICs – The Lancet, October 2018
About the Medicines Patent Pool:
The Medicines Patent Pool (MPP) is a United Nations-backed public health organisation working to increase access to, and facilitate the development of, life-saving medicines for low- and middle-income countries. Through its innovative business model, the MPP partners with civil society, governments, international organisations, industry, patient groups and other stakeholders, to prioritise and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations. To date, the MPP has signed agreements with nine patent holders for thirteen HIV antiretrovirals, one HIV technology platform, three hepatitis C direct-acting antivirals and a tuberculosis treatment. The MPP was founded by Unitaid, which serves as sole funder for the MPP’s activities in HIV, hepatitis C and tuberculosis. The MPP is now expanding its activities to cover Essential Medicines, which requires engagement with many new stakeholders, including potential funders.
Head of Communications
Medicines Patent Pool
Unitaid brings the power of new medical discoveries to the people who most need them. Through time-limited investments, we identify the best health innovations with the potential to alleviate the burden of major diseases and set the stage for their large-scale introduction by governments and partners such as PEPFAR, the Global Fund and WHO. Our investments result in better ways to prevent, diagnose and treat diseases including HIV/AIDS, hepatitis C, tuberculosis and malaria more quickly, affordably and effectively. A growing number of our projects address more than one disease, maximizing the effectiveness of health systems as a whole, and more than half of our portfolio is linked to antimicrobial resistance.
Head of Communications