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Draft:LAPaL

LAPaL (Long-Acting Therapeutics Patents and Licenses Database)

Introduction The Long-Acting Therapeutics Patents and Licensing Database (LAPaL) was established to provide comprehensive data on long-acting medicinal products and drug delivery technologies available worldwide. This open-access resource aims to facilitate collaborations in the long-acting therapeutic space and promote access to these treatments. LAPaL includes detailed information on the main characteristics of the drugs and drug technologies and an overview of their intellectual property landscape (1) (2). It was launched in 2021 by the Medicines Patent Pool with backing from Unitaid and offers comprehensive and up-to-date information on the technical specifications, developmental progress, and intellectual property (IP) status of certain long-acting treatments to improve health outcomes in low- and middle-income nations (2) (3). Dr. Lobna Gaayeb, Head of Scientific Affairs, Medicine Patent Pool, and Dr Adeniyi Olagunju, Senior Lecturer, University of Liverpool lead this database. The primary interest of LAPaL in long-acting medications for chronic diseases such as HIV, malaria, hepatitis, and mental health disorders lies in their potential to enhance patient compliance, improve clinical efficacy, reduce safety concerns, and, in some instances, decrease the rate of relapse (4,5).

Aim and Objective of LAPaL The main aim of the LaPaL database was to provide open-access information on pharmacological features and intellectual property status of selected long-acting therapeutics and their potential applications (2).

Components of LAPaL and its inclusion criteria

(i) Compounds The database includes compounds with a prolonged half-life and a sustained release profile, with dosing schedules ranging from once a week to once a year. This criterion ensures that the listed medications offer extended therapeutic benefits and may improve patient adherence. Compounds are categorized into small molecules and biotherapeutics for effective scientific comparison (1). Recently, the database was updated with several long-acting biotherapeutics due to its recognition by physicians and a higher rate of approval from the US Food and Drug Administration (6).

(ii) Regulatory Affairs and Clinical Trial Updates The LAPaL website provides extensive information on regulatory approval status and registered clinical trials on marketed and investigational long-acting drugs, serving as a reliable scientific resource for medical professionals and researchers working on prolonged and sustained-release medications (1,2). While there is a strong demand for LA products for HIV treatment or prevention, the approval process for these items is more complex compared to oral medicines. Oral products are used for treating HIV, TB, and other medical illnesses, and have established and reliable mechanisms in place to ensure their quality and compliance with regulations (7). So to consolidate the global regulatory approval status of LA drugs, there is a landscape created in the LAPaL website that allows users to toggle in the world map and identify individual LA drug approvals (1).

(iii) Technologies To be included in the LAPaL database, a technology must be patented under a single assignee and have a pipeline of drug candidates in clinical trials with sustained or prolonged therapeutic activity. This ensures that the showcased technologies have unified intellectual property control and are relevant in producing long-acting medicinal products. Additionally, statistical analysis for the technologies can be performed based on therapeutic areas and administration routes (2).

Database Highlights

• Comprehensive Listings: LAPaL provides detailed information on a wide range of long-acting substances and technologies, including assignees, patent status, and descriptions of medicinal drugs and their mechanisms of action. • Search and Filter Capabilities: Users can search for specific compounds or technologies using various filters, such as therapeutic area, patent status, and assignee. This feature enables researchers and developers to access relevant information quickly (1). • User-Friendly Interface: The database features an easy-to-use interface that facilitates navigation and enhances user experience. Information is organized clearly, allowing users to find the required details efficiently (8). • Patent and Licensing Information: Each patent entry includes comprehensive details, such as filing dates, patent numbers, and jurisdiction. Additionally, licensing opportunities are highlighted, offering potential avenues for collaboration and partnerships (3) (9). One can find information about global patents of compounds and drug technologies along with their expiry date (2,10). • Regular Updates: The LAPaL database is regularly updated to reflect new patents, changes in patent status, and the addition of new long-acting therapeutic drugs, ensuring users have access to the latest information. The data curators of the University of Liverpool are responsible for updating the scientific content in the database (5). • Educational Resources: The website offers educational resources to help users understand the complexities of patenting and licensing long-acting therapies. These resources are beneficial for professionals with varying levels of experience.

Funding and Collaboration

LAPaL is a collaborative initiative funded by the Medicines Patent Pool (MPP), the Long-Acting/Extended Release Antiretroviral Research Resource Program (LEAP), and Unitaid, in partnership with the University of Liverpool and AVAC. The Long-Acting/Extended Release Antiretroviral Research Resource Programme (LEAP) is one of the organizations supporting the LAPaL effort. LEAP is dedicated to advancing antiretroviral research and development, particularly long-acting or extended-release treatments. This focus aims to improve the efficacy and adherence to treatment regimens for chronic conditions such as HIV, tuberculosis, and viral hepatitis by developing formulations that maintain therapeutic drug levels over long periods (11).

Conclusion

The Long-Acting Therapeutics Patents and Licensing Database is a valuable resource for scientists, entrepreneurs, investors, and patients. By providing comprehensive and up-to-date open-access information on long-acting therapeutic substances and technologies, LAPaL supports the development of medications that may improve patient adherence and outcomes. The database's search features, extensive listings, and user-friendly interface make it a useful tool for fostering innovation in long-acting treatment development.

References 1.[1] 2.[2] 3.[3] 4.[4] 5.[5] 6.[6] 7.[7] 8.[8] 9.[9] 10.[10] 11. [11]

  1. ^ LAPaL [Internet]. [cited 2024 Jul 5]. Available from: https://lapal.medicinespatentpool.org/#/
  2. ^ LAPaL - Free Therapeutics Patents Database - MPP [Internet]. 2022 [cited 2024 Jul 5]. Available from: https://medicinespatentpool.org/what-we-do/lapal
  3. ^ Rubens H. The Long-Acting Technologies Patents and Licenses Database - The IMPT [Internet]. 2022 [cited 2024 Jul 5]. Available from: https://theimpt.org/the-long-acting-technologies-patents-and-licenses-database/, https://theimpt.org/the-long-acting-technologies-patents-and-licenses-database/
  4. ^ Flexner C, Thomas DL, Swindells S. Creating demand for long-acting formulations for the treatment and prevention of HIV, tuberculosis, and viral hepatitis. Current Opinion in HIV and AIDS. 2019 Jan;14(1):13–20.
  5. ^ LONGEVITY Project - Centre of Excellence for Long-acting Therapeutics - University of Liverpool [Internet]. [cited 2024 Jul 5]. Available from: https://www.liverpool.ac.uk/centre-of-excellence-for-long-acting-therapeutics/longevity/
  6. ^ Morin S, Segafredo G, Piccolis M, Das A, Das M, Loffredi N, et al. Expanding access to biotherapeutics in low-income and middle-income countries through public health non-exclusive voluntary intellectual property licensing: considerations, requirements, and opportunities. The Lancet Global Health. 2023 Jan 1;11(1):e145–54.
  7. ^ Mhango DV, Mzinza DT, Jambo KC, Mwandumba HC. New management approaches to TB in people living with HIV. Curr Opin Infect Dis. 2021 Feb 1;34(1):25–33.
  8. ^ Privacy_policy_update_2024.pdf [Internet]. [cited 2024 Jul 5]. Available from: https://lapal.medicinespatentpool.org/assets/pdf/Privacy_policy_update_2024.pdf
  9. ^ MPP Home - The Medicines Patent Pool [Internet]. [cited 2024 Jul 5]. Available from: https://medicinespatentpool.org/
  10. ^ Gaayeb L, Das A, James I, Murthy R, Nobre S, Burrone E, et al. Voluntary licensing of long‐acting HIV prevention and treatment regimens: using a proven collaboration‐ and competition‐based mechanism to rapidly expand at‐scale, sustainable, quality‐assured and affordable supplies in LMICs. J Int AIDS Soc. 2023 Jul 13;26(Suppl 2):e26092.
  11. ^ LEAP | Home [Internet]. [cited 2024 Jul 5]. Available from: https://longactinghiv.org/
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