Finding new therapeutic uses for existing medicines holds significant potential, since it is often faster to develop a drug for a new use if it is already known to be safe and well tolerated by the human body. Repurposing de-risked compounds with previously known therapeutic effects is also an attractive drug development strategy because it can potentially result in lower overall drug development costs and shorter timelines to market introduction. If successful, the public at large benefits from the repurposing of “old” drugs (known products) to treat more common and rare diseases.
An ongoing debate with pharmaceutical repurposing is whether the current intellectual property (IP) regime, particularly patent protection for medical uses of known compounds and substances, is hindering repurposing activity. This debate is taking place on both sides of the Atlantic, where commentators often argue that the patent system is failing to provide adequate incentives to promote innovation in the field of drug repurposing— medical use patents, they allege, are too difficult to obtain.
'European Patent Protection for Medical Uses of Known Products and Drug Repurposing', co-authored by Prof. Mateo Aboy, Prof. Kathy Liddell, Mr Matt Jordan, Dr Cristina Crespo and Dr John Liddicoat, builds upon the findings of a previous LML study to conclusively address the question of whether obtaining patent protection is hindering repurposing activity. It does this by:
- Comparing the number of medical use patents wit the number of EMA drug authorisations;
- Evaluating the number of jurisdictions in which patent protection is sought for newly authorised drugs
- Evaluating the coverage across therapeutic areas to ensure that there is adequate coverage rather than therapeutic concentration on specific diseases; and
- Evaluating indications of private value of these patents.
This article is the eighth published in Nature Biotechnology by LML’s empirical-based IP research group. Previous papers include:
- ‘Mapping the European Patent Landscape for Medical Uses of Known Products' (2021), which uses EPO data to examine the European patent landscape of first and further medical uses of known products.
- ‘One year after Vanda, are diagnostics patents transforming into methods of treatment to overcome Mayo-based rejections?’ (2019), which examined the effect of the decision in Vanda Pharmaceuticals Inc., v. West-Ward Pharmaceuticals International Ltd. on patent prosecution practice.
- ‘How does emerging patent case law in the US and Europe affect precision medicine?' (2019), which examined the impact of US and European patent case law on patents for (i) biomarkers and nature-based product claims; (ii) method of diagnosis claims and (iii) algorithms, big data and artificial intelligence.
- 'Mayo’s impact on patent applications related to biotech, diagnostics, and personalized medicine' (2019), which examined the impact of the US Supreme Court's decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. on patent subject-matter eligibility and patent prosecution of biotech related patent applications before the USPTO.
- 'Was the Myriad decision a 'surgical strike' on isolated DNA patents, or does it have wider impacts?' (2018), an empirical investigation into the effects of the US Supreme Court's decision in Myriad on patent prosecution for nature-based products beyond isolated DNA;
- 'After Myriad, what makes a gene patent claim 'markedly different' from nature?' (2017), which identified the types of claim amendments that successfully transformed isolated gene claims from ineligible subject matter into patent eligible inventions; and
- 'Myriad's impact on gene patents' (2016), which was a post-Myriad empirical patent landscape analysis.
Empirical studies continue to be a core focus of LML research, and feature significantly in LML's contribution to the CeBIL research programme.