Impact of gene patents and licensing practices on access to genetic testing for long QT syndrome.
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.
Angrist
Misha
M
Center for Public Genomics, Center for Genome Ethics, Law and Policy, Institute for Genome Sciences and Policy, Duke University, Durham, NC 27708, USA.
Chandrasekharan
Subhashini
S
Heaney
Christopher
C
Cook-Deegan
Robert
R
D005796:Genes; D005820:Genetic Testing; D006801:Humans; D008004:Licensure; D008133:Long QT Syndrome / Q000175:diagnosis* / Q000235:genetics; D010330:Patents as Topic; D014589:Utah
Curr Opin Cardiol. 2005 May;20(3):175-81
15861004
Nat Genet. 1996 Jan;12(1):17-23
8528244
Circulation. 2000 Feb 15;101(6):616-23
10673253
Heart Rhythm. 2004 Nov;1(5):600-7
15851227
Genetics. 2007 Feb;175(2):827-42
17179070
N Engl J Med. 2008 Jan 10;358(2):169-76
18184962
Am J Clin Pathol. 2008 Mar;129(3):391-7
18285261
Heart Rhythm. 2008 May;5(5):704-9
18452873
Circ Res. 1999 Feb 19;84(3):290-7
10024302
Expert Rev Mol Diagn. 2006 May;6(3):365-74
16706739
Clin Chem. 2001 Aug;47(8):1390-5
11468227
Nat Med. 2004 May;10(5):463-4
15122246
Fed Regist. 1988 Dec 2;53(232):48645-8
10302929
Heart Rhythm. 2006 Jul;3(7):815-21
16818214
Eur Heart J. 2007 Feb;28(4):388-91
17032689
Heart Rhythm. 2005 Jun;2(6):675-7
15922282
Am J Med Genet A. 2006 May 15;140(10):1033-40
16575896
Circulation. 2007 May 22;115(20):2613-20
17502575
Circulation. 2007 May 15;115(19):2481-9
17470695
Hosp Pract (1995). 1997 Jun 15;32(6):115-8, 123-9, 134, passim
9194805
Health Law J. 2002;10:123-46
14748275
Pathology. 2007 Jun;39(3):345-8
17558863
Heart Rhythm. 2005 Dec;2(12):1294-300
16360080
Asian Pac J Cancer Prev. 2007 Jan-Mar;8(1):55-9
17477772
J Am Coll Cardiol. 2007 Mar 13;49(10):1092-8
17349890
Genet Test. 2006 Fall;10(3):147-56
17020464
Heart Rhythm. 2009 Sep;6(9):1304-5
19716086
Cell. 1995 Mar 10;80(5):805-11
7889574
J Electrocardiol. 2005 Oct;38(4 Suppl):64-8
16226077
J Clin Oncol. 2002 Mar 15;20(6):1480-90
11896095
Circulation. 2009 Nov 3;120(18):1752-60
19841300
Circulation. 2006 Nov 14;114(20):2096-103
17088455
Science. 2006 Sep 29;313(5795):1853
17008491
Acad Med. 2002 Dec;77(12 Pt 2):1315-28
12480642
Surg Clin North Am. 2008 Aug;88(4):723-38, vi
18672138
Circulation. 2005 Mar 8;111(9):1199-201
15753228
J Cardiovasc Med (Hagerstown). 2006 Apr;7(4):250-6
16645398
Circulation. 2001 Jan 2;103(1):89-95
11136691
Res Vet Sci. 2009 Jun;86(3):421-6
18926550
Genomics. 1998 Jul 1;51(1):86-97
9693036
J Am Coll Cardiol. 2008 Jun 17;51(24):2291-300
18549912
J Am Coll Cardiol. 1999 Feb;33(2):327-32
9973011
Nat Biotechnol. 2006 Mar;24(3):320-3
16525405
Pediatr Clin North Am. 2004 Oct;51(5):1289-303
15331285
Heart Rhythm. 2012 Dec;9(12):1977-82
22885918
Proc Natl Acad Sci U S A. 1996 Nov 12;93(23):13200-5
8917568
Circulation. 2009 Nov 3;120(18):1745-8
19841296
Circulation. 2008 Apr 29;117(17):2184-91
18427136
Health Care Manage Rev. 2005 Apr-Jun;30(2):93-102
15923911
N Engl J Med. 2003 May 8;348(19):1866-74
12736279
Clin Chem. 1999 May;45(5):739-45
10222376
JAMA. 2004 Sep 15;292(11):1341-4
15367556
Nat Biotechnol. 2005 Aug;23(8):937-8
16082359
J Cardiovasc Electrophysiol. 2003 Apr;14(4):337-41
12741701
Cell. 1999 Apr 16;97(2):175-87
10219239
J Am Coll Cardiol. 2006 Feb 21;47(4):764-8
16487842
Cardiovasc Res. 2005 Aug 15;67(3):388-96
15913580
Cardiology. 2008;110(2):116-22
17971661
Science. 2003 Aug 22;301(5636):1052
12933996
Circulation. 2007 Nov 13;116(20):2325-45
17998470
Proc Natl Acad Sci U S A. 2008 Jul 8;105(27):9355-60
18591664
Circulation. 2007 Jul 31;116(5):561-71
17664385
Pathol Res Pract. 2008;204(9):633-6
18573618
Trends Biotechnol. 2006 Mar;24(3):115-20
16443296
Circulation. 2006 Sep 5;114(10):e385-484
16935995
Circulation. 2008 Apr 29;117(17):2178-80
18443247
JAMA. 2005 Dec 21;294(23):2975-80
16414944
Hum Mol Genet. 1995 Sep;4(9):1603-7
8541846
J Intern Med. 2006 Jan;259(1):39-47
16336512
Nature. 2002 Jan 10;415(6868):213-8
11805845
J Mol Cell Cardiol. 2008 Apr;44(4):633-46
18336833
Heart Rhythm. 2009 Sep;6(9):1297-303
19716085
Genomics. 1996 May 15;34(1):9-16
8661019
Circulation. 1999 Feb 2;99(4):529-33
9927399
Mol Diagn Ther. 2006;10(3):153-62
16771601
Cell. 1995 Mar 10;80(5):795-803
7889573
J Postgrad Med. 2003 Apr-Jun;49(2):179-81
12867702
J Med Genet. 2001 Oct;38(10):705-10
11594341
J Clin Pathol. 2006 Jul;59(7):744-7
16679356