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After Myriad, what makes a gene patent claim 'markedly different' from nature?

Nature Biotechnology volume 35, pages 820–825 (2017)Cite this article

Subjects

Examining the types of claim amendments that have transformed isolated gene claims from patent-ineligible into eligible subject matter provides clarity into the threshold of eligibility for gene-related patents.

While nearly four years have passed since the US Supreme Court's decision in Association for Molecular Pathology v. Myriad Genetics, its impact is still not fully understood. The Supreme Court held that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring”1. The decision left open many questions and was “far from illuminating”2. The US Patent and Trademark Office (USPTO) has published an updated examination guidance on patent-eligible subject matter every year since 2014 (refs. 3,4,5). This guidance comments on and gives examples of eligible and ineligible claims after Myriad1, Mayo Collaborative Services v. Prometheus Laboratories, Inc.6 and Alice Corporation v. CLS Bank International7 but has not settled debates8. Some believe that the Myriad decision will have a profound effect on the genomics industry and biotech innovation9. At the opposite end of the spectrum, some commentators believe that the Myriad decision is of little practical importance, because “patent attorneys are developing strategies to 'draft around' Myriad and related cases to ensure their client patents will withstand scrutiny going forward”10. Still others argue that the impact of Myriad remains uncertain11 because, even considering USPTO guidelines and the Supreme Court decision, there is considerable ongoing legal debate about the criteria for eligible gene patents and what makes a claim “markedly different” from ineligible natural products8,12,13.

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Figure 1: Methodological overview, including automated search, manual classification and expert prosecution history review steps.

References

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Authors and Affiliations

  1. Mateo Aboy, Johnathon Liddicoat, Kathleen Liddell, Matthew Jordan and Cristina Crespo are at the Centre for Law, Medicine, and Life Sciences (LML), Faculty of Law, University of Cambridge, Cambridge, UK.,

    Mateo Aboy, Johnathon Liddicoat, Kathleen Liddell, Matthew Jordan & Cristina Crespo

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Aboy, M., Liddicoat, J., Liddell, K. et al. After Myriad, what makes a gene patent claim 'markedly different' from nature?. Nat Biotechnol 35, 820–825 (2017). https://doi.org/10.1038/nbt.3953

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