LML’s evidence-based IP research group is pleased to announce that it has published another article in Nature Biotechnology.
The paper titled -- ‘One year after Vanda, are diagnostics patents transforming into methods of treatment to overcome Mayo-based rejections?’ -- examines the effect of the decision in Vanda Pharmaceuticals Inc., v. West-Ward Pharmaceuticals International Ltd. on patent prosecution. Specifically, the paper addresses two research questions:
- One year after Vanda, to what extent have legal arguments and claim amendments based on Vanda been effective in overcoming 35 USC 101 Mayo-based rejections?
- How are applicants transforming diagnostic patent claims into method of treatment claims to overcome Mayo-based subject matter eligibility rejections?
The article was co-authored by Prof. Mateo Aboy, Dr Cristina Crespo, Dr Kathy Liddell, Mr Neil Davey, Dr John Liddicoat, and Prof. Timo Minssen.
This is the fifth publication by this LML research group to be accepted by Nature Biotechnology in four years. Authors from this group previously published:
- ‘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.