Was the Myriad decision a 'surgical strike' on isolated DNA patents, or does it have wider impacts?

Crespo, Cristina; Liddell, Kathleen; Liddicoat, John; Jordan, Matthew

doi:10.1038/nbt.4308

Cited by 12 publications

(4 citation statements)

References 6 publications

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“…8,9 'Naturally occurring' molecules, such as genomic or recombinant DNA, cannot be patented in the USA, 9,10 raising questions as to what constitutes a 'naturally occurring' sequence for the purposes of legal protection. [11][12][13] The large numbers of antibody sequences now becoming publicly available raises the possibility that naturally occurring sequences found via NGS are identical to commercial sequences. 10 This is especially pertinent in the face of large-scale organized efforts to make naturally sourced antibody NGS data 14 and analytics 15,16 more accessible.…”

Section: Introductionmentioning

confidence: 99%

Looking for therapeutic antibodies in next-generation sequencing repositories

Krawczyk¹,

Raybould

Kovaltsuk

et al. 2019

mAbs

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Recently it has become possible to query the great diversity of natural antibody repertoires using nextgeneration sequencing (NGS). These methods are capable of producing millions of sequences in a single experiment. Here we compare clinical-stage therapeutic antibodies to the~1b sequences from 60 independent sequencing studies in the Observed Antibody Space database, which includes antibody sequences from NGS analysis of immunoglobulin gene repertoires. Of 242 post-Phase 1 antibodies, we found 16 with sequence identity matches of 95% or better for both heavy and light chains. There are also 54 perfect matches to therapeutic CDR-H3 regions in the NGS outputs, suggesting a nontrivial amount of convergence between naturally observed sequences and those developed artificially. This has potential implications for both the legal protection of commercial antibodies and the discovery of antibody therapeutics.

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Section: Introductionmentioning

confidence: 99%

Looking for therapeutic antibodies in next-generation sequencing repositories

Krawczyk¹,

Raybould

Kovaltsuk

et al. 2019

mAbs

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“…However, a common corollary of court decisions that change legal practice is that the change unexpectedly spills out into other areas. A study on AMP found that, as of the fifth anniversary of the decision, the US Patent and Trademark Office had cited the case when rejecting claims in nearly 7,000 applications and that 85% of these rejections were to subject matter beyond isolated DNA (1). AMP was thought by many people to be a narrow decision, applying only to isolated DNA, but this study shows that it has wider effects.…”

Section: Where Now?mentioning

confidence: 81%

International Divergence in Gene Patenting

Nicol

Dreyfuss

Gold

et al. 2019

Annu. Rev. Genom. Hum. Genet.

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This review explores the recent divergence in international patent law relating to genes and associated subject matter. This divergence stems primarily from decisions of the highest courts in the United States and Australia on the eligibility of patent claims relating to the BRCA gene sequences. Patent offices, courts, and policy makers have struggled for many years to clearly articulate the bounds of patent claims on isolated and synthetic DNA and related products and processes, including methods for their use in genetic diagnostics. This review provides context to the current divergence by mapping key events in the gene patent journey from the early 1980s onward in five key jurisdictions: the United States, the member states of the European Patent Convention, Australia, Canada, and China. Early approaches to gene patenting had some commonalities across jurisdictions, which makes exploration of the recent divergence all the more interesting.There is insufficient empirical evidence to date to confidently predict the consequences of this recent divergence. However, it could potentially have a significant effect on local industry and on consumer access.

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“…In our view, there is not enough evidence of a problem, particularly given the relatively low number of genetic tests affected. The US experience also shows that law reform in this area is challenging [43], and, especially a decision like Mayo , is likely to lead to undesirable uncertainty for those involved in translational research on new molecular tests [44–46].…”

Section: Resultsmentioning

confidence: 99%

Continental drift? Do European clinical genetic testing laboratories have a patent problem?

et al. 2019

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Recent US Supreme Court decisions have invalidated patent claims on isolated genomic DNA, and testing methods that applied medical correlations using conventional techniques. As a consequence, US genetic testing laboratories have a relatively low risk of infringing patents on naturally occurring DNA or methods for detecting genomic variants. In Europe, however, such claims remain patentable, and European laboratories risk infringing them. We report the results from a survey that collected data on the impact of patents on European genetic testing laboratories. The results indicate that the proportion of European laboratories that have refrained from providing associated testing services owing to patent protection has increased over the last decade (up from 7% in 2008 to 15% in 2017), and that the non-profit sector was particularly strongly affected (up from 4% in 2008 to 14% in 2017). We renew calls for more readily available legal support to help public sector laboratories deal with patent issues, but we do not recommend aligning European law with US law at present. Watchful monitoring is also recommended to ensure that patents do not become a greater hindrance for clinical genetic testing laboratories.

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Was the Myriad decision a 'surgical strike' on isolated DNA patents, or does it have wider impacts?

Cited by 12 publications

References 6 publications

Looking for therapeutic antibodies in next-generation sequencing repositories

Looking for therapeutic antibodies in next-generation sequencing repositories

International Divergence in Gene Patenting

Continental drift? Do European clinical genetic testing laboratories have a patent problem?

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