Impact of gene patents and licensing practices on access to genetic testing for long QT syndrome

Misha Angrist, Subhashini Chandrasekharan, Christopher Heaney, Robert Cook-Deegan

Research output: Contribution to journalReview article

11 Citations (Scopus)

Abstract

Genetic testing for long QT syndrome exemplifies patenting and exclusive licensing with different outcomes at different times. Exclusive licensing from the University of Utah changed the business model from sole provider to two US providers of long QT syndrome testing. Long QT syndrome is associated with mutations in many genes, 12 of which are now tested by two competing firms in the United States, PGxHealth and GeneDx. Until 2009, PGxHealth was the sole provider, based largely on exclusive rights to patents from the University of Utah and elsewhere. University of Utah patents were initially licensed to DNA Sciences, whose patent rights were acquired by Genaissance, and then by Clinical Data, Inc., which owns PGxHealth. In 2002, DNA Sciences, Inc., "cleared the market" by sending cease-and-desist patent enforcement letters to university and reference laboratories offering long QT syndrome genetic testing. There was no test on the market for a 1-to 2-year period. From 2005-2008, most long QT syndrome-related patents were controlled by Clinical Data, Inc., and its subsidiary PGxHealth. Bio-Reference Laboratories, Inc., secured countervailing exclusive patent rights starting in 2006, also from the University of Utah, and broke the PGxHealth monopoly in early 2009, creating a duopoly for genetic testing in the United States and expanding the number of genes for which commercial testing is available from 5 to 12.

Original languageEnglish (US)
JournalGenetics in Medicine
Volume12
Issue number4 SUPPL.
DOIs
StatePublished - Apr 2010
Externally publishedYes

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Long QT Syndrome
Patents
Genetic Testing
Licensure
Genes
DNA
Mutation

Keywords

  • Arrhythmia
  • Genetic testing
  • Intellectual property
  • Long QT syndrome
  • Patents
  • University of Utah

ASJC Scopus subject areas

  • Genetics(clinical)

Cite this

Impact of gene patents and licensing practices on access to genetic testing for long QT syndrome. / Angrist, Misha; Chandrasekharan, Subhashini; Heaney, Christopher; Cook-Deegan, Robert.

In: Genetics in Medicine, Vol. 12, No. 4 SUPPL., 04.2010.

Research output: Contribution to journalReview article

Angrist, Misha ; Chandrasekharan, Subhashini ; Heaney, Christopher ; Cook-Deegan, Robert. / Impact of gene patents and licensing practices on access to genetic testing for long QT syndrome. In: Genetics in Medicine. 2010 ; Vol. 12, No. 4 SUPPL.
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