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

Published

Journal Article

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.

Full Text

Duke Authors

Cited Authors

  • Angrist, M; Chandrasekharan, S; Heaney, C; Cook-Deegan, R

Published Date

  • April 2010

Published In

Volume / Issue

  • 12 / 4 Suppl

Start / End Page

  • S111 - S154

PubMed ID

  • 20393304

Pubmed Central ID

  • 20393304

Electronic International Standard Serial Number (EISSN)

  • 1530-0366

International Standard Serial Number (ISSN)

  • 1098-3600

Digital Object Identifier (DOI)

  • 10.1097/gim.0b013e3181d68293

Language

  • eng