Patents in Genomics and Human Genetics

Overview

Journal Annu Rev Genomics Hum Genet

Publisher Annual Reviews

Specialty Genetics

Date 2010 Jul 2

PMID 20590431

Citations 25

Authors

Robert Cook-Deegan

Christopher Heaney

Affiliations

Soon will be listed here.

Abstract

Genomics and human genetics are scientifically fundamental and commercially valuable. These fields grew to prominence in an era of growth in government and nonprofit research funding, and of even greater growth of privately funded research and development in biotechnology and pharmaceuticals. Patents on DNA technologies are a central feature of this story, illustrating how patent law adapts-and sometimes fails to adapt-to emerging genomic technologies. In instrumentation and for therapeutic proteins, patents have largely played their traditional role of inducing investment in engineering and product development, including expensive post-discovery clinical research to prove safety and efficacy. Patents on methods and DNA sequences relevant to clinical genetic testing show less evidence of benefits and more evidence of problems and impediments, largely attributable to university exclusive licensing practices. Whole-genome sequencing will confront uncertainty about infringing granted patents, but jurisprudence trends away from upholding the broadest and potentially most troublesome patent claims.

Citing Articles

"Unnatural resources?": parallels and distinctions between the Newfoundland Genome and traditional resource sectors.

Skeard J J Community Genet. 2024; 15(4):449-459.

PMID: 38896389 PMC: 11410739. DOI: 10.1007/s12687-024-00715-w.

Trade, intellectual property, and the public health bearing.

Babyar J Health Syst (Basingstoke). 2023; 12(1):123-132.

PMID: 36926369 PMC: 10013560. DOI: 10.1080/20476965.2022.2062460.

A survey of direct-to-consumer genotype data, and quality control tool () for research.

Lu C, Greshake Tzovaras B, Gough J Comput Struct Biotechnol J. 2021; 19:3747-3754.

PMID: 34285776 PMC: 8267563. DOI: 10.1016/j.csbj.2021.06.040.

Genomics governance: advancing justice, fairness and equity through the lens of the African communitarian ethic of Ubuntu.

Munung N, de Vries J, Pratt B Med Health Care Philos. 2021; 24(3):377-388.

PMID: 33797712 PMC: 8349790. DOI: 10.1007/s11019-021-10012-9.

Big Data and Public-Private Partnerships in Healthcare and Research: The Application of an Ethics Framework for Big Data in Health and Research.

Ballantyne A, Stewart C Asian Bioeth Rev. 2021; 11(3):315-326.

PMID: 33717319 PMC: 7747238. DOI: 10.1007/s41649-019-00100-7.

References

Eisenberg R . Intellectual property issues in genomics. Trends Biotechnol. 1996; 14(8):302-7. DOI: 10.1016/0167-7799(96)10040-8. View

Huys I, Berthels N, Matthijs G, Van Overwalle G . Legal uncertainty in the area of genetic diagnostic testing. Nat Biotechnol. 2009; 27(10):903-9. DOI: 10.1038/nbt1009-903. View

Chandrasekharan S, Fiffer M . Impact of gene patents and licensing practices on access to genetic testing for hearing loss. Genet Med. 2010; 12(4 Suppl):S171-93. PMC: 3125070. DOI: 10.1097/GIM.0b013e3181d7b053. View

Kiley T . Patents on random complementary DNA fragments?. Science. 1992; 257(5072):915-8. DOI: 10.1126/science.1502558. View

Hardee M, Arcasoy M, Blackwell K, Kirkpatrick J, Dewhirst M . Erythropoietin biology in cancer. Clin Cancer Res. 2006; 12(2):332-9. DOI: 10.1158/1078-0432.CCR-05-1771. View

Lander E, Linton L, Birren B, Nusbaum C, Zody M, Baldwin J . Initial sequencing and analysis of the human genome. Nature. 2001; 409(6822):860-921. DOI: 10.1038/35057062. View

Caulfield T, Bubela T, Murdoch C . Myriad and the mass media: the covering of a gene patent controversy. Genet Med. 2007; 9(12):850-5. DOI: 10.1097/gim.0b013e31815bf965. View

Ankeny R . The natural history of Caenorhabditis elegans research. Nat Rev Genet. 2001; 2(6):474-9. DOI: 10.1038/35076538. View

Marshall E . A bitter battle over insulin gene. Science. 1997; 277(5329):1028-30. DOI: 10.1126/science.277.5329.1028. View

10.

Caulfield T, Cook-Deegan R, Kieff F, Walsh J . Evidence and anecdotes: an analysis of human gene patenting controversies. Nat Biotechnol. 2006; 24(9):1091-4. PMC: 2701726. DOI: 10.1038/nbt0906-1091. View

11.

BEADLE G, TATUM E . Genetic Control of Biochemical Reactions in Neurospora. Proc Natl Acad Sci U S A. 1941; 27(11):499-506. PMC: 1078370. DOI: 10.1073/pnas.27.11.499. View

12.

Lenoir T, Giannella E . The emergence and diffusion of DNA microarray technology. J Biomed Discov Collab. 2006; 1:11. PMC: 1590052. DOI: 10.1186/1747-5333-1-11. View

13.

Berman E . Why did universities start patenting? Institution-building and the road to the Bayh-Dole Act. Soc Stud Sci. 2009; 38(6):835-71. DOI: 10.1177/0306312708098605. View

14.

Fore Jr J, Wiechers I, Cook-Deegan R . The effects of business practices, licensing, and intellectual property on development and dissemination of the polymerase chain reaction: case study. J Biomed Discov Collab. 2006; 1:7. PMC: 1523369. DOI: 10.1186/1747-5333-1-7. View

15.

Chandrasekharan S, Pitlick E, Heaney C, Cook-Deegan R . Impact of gene patents and licensing practices on access to genetic testing for hereditary hemochromatosis. Genet Med. 2010; 12(4 Suppl):S155-70. PMC: 3131230. DOI: 10.1097/GIM.0b013e3181d7acb0. View

16.

Birney E, Stamatoyannopoulos J, Dutta A, Guigo R, Gingeras T, Margulies E . Identification and analysis of functional elements in 1% of the human genome by the ENCODE pilot project. Nature. 2007; 447(7146):799-816. PMC: 2212820. DOI: 10.1038/nature05874. View

17.

Brody B . Intellectual property and biotechnology: the European debate. Kennedy Inst Ethics J. 2007; 17(2):69-110. DOI: 10.1353/ken.2007.0008. View

18.

Boyer H . Wonderful life: an interview with Herb Boyer. [Interview by Jane Gitschier]. PLoS Genet. 2009; 5(9):e1000653. PMC: 2741595. DOI: 10.1371/journal.pgen.1000653. View

19.

Ankeny R . Sequencing the genome from nematode to human: changing methods, changing science. Endeavour. 2003; 27(2):87-92. DOI: 10.1016/s0160-9327(03)00061-9. View

20.

Hopkins M, Mahdi S, Patel P, Thomas S . DNA patenting: the end of an era?. Nat Biotechnol. 2007; 25(2):185-7. DOI: 10.1038/nbt0207-185. View