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      International Drug Repurposing Patent Landscaping, Part 1: Rare Diseases

      Preprint
      In review
      research-article
        1 ,
      DrugRxiv
      REPO4EU
      drug repurposing, patenting, rare diseases
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            Abstract

            In this first installment of a series of papers on landscaping of drug repurposing patents we present an analysis in the context of rare diseases. Using the RepoScope drug repurposing database, developed as part of the REPO4EU Horizon Europe project, we identified 190 documents that were published through the international PCT patent system from 2010 to 2023. These documents claimed utility in a total of 98 rare diseases. We provide detailed tabulated summaries for two representative disease classes: lysosomal storage diseases and muscular dystrophies. High variability in active pharmaceutical ingredients indicated high levels of innovation. Seventy-five percent of rare disease drug repurposing patents were filed by small/medium pharmaceutical companies or universities, often university spin-offs. Big pharmaceutical companies show limited interest in this area, as reflected in their low representation. Approximately one-third of all patent disclosures came from the United States and the European Union. The EU demonstrated a stronger position in patenting for rare diseases than in general pharmaceutical patenting. Patentees from China, Korea, and Japan, who are notable in the general pharmaceutical field, showed limited interest in rare disease drug repurposing patents, in contrast to their publication record in this area.

            Content

            Author and article information

            Journal
            DrugRxiv
            REPO4EU
            2 April 2024
            Affiliations
            [1 ] H.M. Pharma Consultancy;
            Author notes
            Author information
            https://orcid.org/0000-0002-1491-6250
            Article
            10.58647/DRUGARXIV.PR000009.v1
            78ea5fc0-1d4e-4765-bde1-830c2aee768c

            This work has been published open access under Creative Commons Attribution License CC BY 4.0 , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Conditions, terms of use and publishing policy can be found at www.scienceopen.com .

            History
            : 2 April 2024
            Funding
            Funded by: funder-id http://dx.doi.org/10.13039/501100000780, European Commission;
            Categories

            The data that support the findings of this study are available from Dr. Hermann Mucke but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are however available from the authors upon reasonable request and with permission of Dr. Hermann Mucke.
            Medicine,Life sciences
            drug repurposing,patenting,rare diseases

            References

            1. Aartsma-Rus Annemieke, Dooms Marc, Le Cam Yann. Orphan Medicine Incentives: How to Address the Unmet Needs of Rare Disease Patients by Optimizing the European Orphan Medicinal Product Landscape Guiding Principles and Policy Proposals by the European Expert Group for Orphan Drug Incentives (OD Expert Group). Frontiers in Pharmacology. Vol. 12:2021. Frontiers Media SA. [Cross Ref]

            2. Mucke Hermann A.M., Mucke Eva. Sources and Targets for Drug Repurposing: Landscaping Transitions in Therapeutic Space. ASSAY and Drug Development Technologies. Vol. 13(6):319–324. 2015. Mary Ann Liebert Inc. [Cross Ref]

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