Evidence map›Paper›PMID 30900262›Full record

ArticlePrenatal diagnosis2019

The continuing saga of patents and non-invasive prenatal testing.

Naomi Hawkins, Dianne Nicol, Subhashini Chandrasekharan, Robert Cook-Deegan

Abstract read
In one paragraph

Article in Prenatal diagnosis, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Naomi HawkinsLaw School, University of Exeter, Exeter, UK.ORCID 0000-0002-8290-7233
Dianne NicolLaw School, University of Tasmania, Hobart, Australia.
Subhashini ChandrasekharanRipple Effect Communications Inc, Rockville, Maryland.
Robert Cook-DeeganRipple Effect Communications Inc, Rockville, Maryland.ORCID 0000-0002-8251-4237

Funding

Intellectual Property and Access to Noninvasive Prenatal Genetic TestingR01HG007074 · NHGRI · DUKE UNIVERSITY · PI CHANDRASEKHARAN, SUBHASHINI · 2013 to 2015
$1.1M
NHGRI NIH HHS R01 HG007074NIH HHS R01 HG007074
6 · The paper itself

Abstract

objectiveThis paper examines the Intellectual Property (IP) landscape for non-invasive prenatal testing (NIPT) in three key regions: the United States; Europe, with particular focus on the United Kingdom; and Australia.

methodWe explore the patent law issues against the commercial and healthcare environment in these regions and consider the implications for development and implementation of NIPT.

resultsThere are many patents held by many parties internationally, with litigation over these patents ongoing in many countries. Importantly, there are significant international differences in patent law, with patents invalidated in the USA that remain valid in Europe. Despite the many patents and ongoing litigation, there are multiple providers of testing internationally, and patents do not appear to be preventing patient access to testing for those who can pay out of pocket.

conclusionThe patent situation in NIPT remains in a state of flux, with uncertainty about how patent rights will be conferred in different jurisdictions, and how patents might affect clinical access. However, patents are unlikely to result in a monopoly for a single provider, with several providers and testing technologies, including both public and private sector entities, likely to remain engaged in delivery of NIPT. However, the effects on access in public healthcare systems are more complex and need to be monitored.

Indexed as

Prenatal DiagnosisAustraliaCell-Free Nucleic AcidsEuropeFemaleGenetic TestingHumansLegislation, MedicalPatents as TopicPregnancyProfessional PracticeUnited KingdomUnited StatesCell-Free Nucleic Acids

Identifiers

PMID30900262
PMCPMC6551523

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.