The following list consists of reports, position statements, books and articles that deal with gene patents. The reports include those by government agencies as well as non-governmental groups Public interest groups as well as professional organizations have position statements regarding the patenting of genes. The books are non-fiction and include some works that are edited from published articles and essays. Finally, the articles consist of those found in both law and scientific journals .
American Medical Association
Report 9 on the Council of Scientific Affairs (I-0O): Patenting of Genes and their Mutations, Dec. 2000
The American Medical Association (AMA) is a professional organization for physicians concerned with issues that affect patients and the public health. The AMA’s report on gene patents discusses the dilemma that gene patents have raised and possible changes proposed by the U.S. Patent and Trademark Office.
Australian Law Reform Commission
Genes and Ingenuity: Gene Patenting and Human Health
June 2004, available at: http://www.austlii.edu.au/au/other/alrc/publications/reports/99/
The Australia Law Reform Commission (ALRC) is a permanent, independent federal statutory corporation that conducts inquiries into areas of law reform when requested by the Attorney-General of Australia This is the final report of the ALRC on intellectual property rights over genes and genetic related technologies and it includes 50 recommendations for reform.
Australian Law Reform Commission
Issue Paper 27: Gene Patenting and Human Health, July 2003
available at: http://www.austlii.edu.au/au/other/alrc/publications/issues/27/
This ALRC issue paper discusses how Australia can best benefit from protecting biotechnology intellectual property rights while balancing it with the public health It also established the issues and questions that the ALRC would investigate for its final report.
Canadian Biotechnology Advisory Committee
Patenting of Higher Life Forms, June 2002
The Committee advises the Canadian government on all aspects of biotechnology The report investigates, among other things, social and ethical issues invoked by biotechnology and the patenting of human beings. available at: http://cbac-cccb.ca/epic/internet/incbac-cccb.nsf/vwapj/E980_IC_IntelProp_e.pdf/ $FILE/E980_IC_IntelProp_e.pdf
Commission on Intellectual Property Rights
Integrating Intellectual Property Rights and Development Policy
111-36, Sep. 2002, available at: http://www.iprcommission.org/papers/pdfs/final_report/CIPRfullfinal.pdf
The Commission was set-up by the United Kingdom Government’s White Paper on International Development to determine how intellectual property rules should be altered to better suit the needs of developing countries and its people. The Commissionıs final report recommends that developing nations completely exclude the patentability of “diagnostic, therapeutic and surgical methods for the treatment of human and animals.” It also recommends that developing nations apply strict standards to novelty requirements and the scope of claims The background paper for the report was written by Sivaramjani Thambisetty and is available at: http://www.iprcommission.org/papers/pdfs/study_papers/ 10_human_genome_patents.pdf
Why Biotech Patents are Patently Absurd – Scientific Briefing on TRIPs and Related Issues
Feb. 2001, available at: http://www.i-sis.org.uk/trips2.php
The author wrote this report for the Institute of Science in Society, a London based scientific society with the goal of promoting science The report explains the Trade Related Intellectual Property Rights Agreement and argues that it is flawed because it obstructs the rights of poor countries and forces biotechnology patents to be enforced in all member States.
Nuffield Council on Bioethics
The Ethics of Patenting DNA
July 2002, available at: http://www.nuffieldbioethics.org/filelibrary/pdf/theethicsofpatentingdna.pdf
The Council is an independent group established by the Trustees of the Nuffield Foundation, a United Kingdom charitable trust It examined the ethical and social issues of patenting DNA The report breaks DNA sequences into four separate categories of uses to show that a more stringent requirement is needed when dealing with patenting genetic sequences.
Ontario Ministry of Health and Long-Term Care
Genetics, Testing & Gene Patenting: Charting New Territory
Jan. 2002, available at: http://www.health.gov.on.ca/english/public/pub/ministry_reports/ geneticsrep02/report_e.pdf
The Ministry of Health and Long-Term Care is the Ontario governmental body that deals with health and long-term care issues The report is in response to how the latest discoveries in biotechnology might affect the healthcare system in Ontario Among other things, the report states that the Canadian patent system has not progressed as rapidly as the biotechnology industry and needs to be reevaluated.
Organisation for Economic Co-operation and Development
Genetic Inventions, Intellectual Property Rights and Licensing Practices: Evidence and Policy
2002, available at: http://www.oecd.org/dataoecd/42/21/2491084.pdf
The Organisation for Economic Co-operation and Development consists of thirty member countries that are concerned with economic and social issues The report focuses on problems that gene patents may cause researchers, firms, or clinical users when they attempt to gain access to information found in gene patents. The report also discusses possible solutions to some of the problems.
President’s Council on Bioethics, Staff Working Paper
Patenting Human Organisms
July 2002, available at: http://www.bioethics.gov/background/workpaper8.html
The President’s Council on Bioethics was created by the President of the U.S., George W. Bush, to advise him on advances in biotechnology that may raise ethical issues. Background information on the patenting of human organisms, as well as issues that arise out of the patenting of human organisms are discussed in this paper. The Council concludes by presenting a narrowly focused project if the Council were to further pursue this issue.
United Nations Educational, Scientific and Cultural Organization (UNESCO) and International Bioethics Committee (IBC)
Report of the IBC on Ethics, Intellectual Property and Genomics
Jan. 10, 2002, available at: http://unesdoc.unesco.org/images/0013/001306/130646e.pdf
UNESCO is a United Nations agency that deals with the latest ethical issues in hopes of providing greater international cooperation among its almost 200 member States.> It assigned the IBC with the task of creating a report based upon a symposium held in early 2001, entitled, “Ethics, Intellectual Property and Genomics.” The report discusses how the mapping of the human genome can best serve humanity.
The American College of Medical Genetics is a professional organization for medical genetics professionals. It takes the position that genes, as naturally occurring substances, should not be patentable and that any gene patents with clinical uses should be broadly licensed under reasonable terms. The organizationıs statement is available at: http://www.acmg.net/resources/policies/pol-015.asp
The American Medical Association is a national professional organization for physicians concerned with issues affecting patients and the public health. It is concerned that gene patents could make genetic medicine prohibitively expensive. Its position statement is available at: http://www.ama-assn.org/ama/pub/category/2314.html
The American Medical Student Association is a student-governed organization for physicians-in-training. The Association has put together a primer on gene patents, including its position that gene patents are harmful to patients and violate traditional patent law standards. The primer is available at: http://www.amsa.org/pdf/genepatents.pdf
The American Society of Human Genetics is a professional organization for human geneticists. It has expressed concern that allowing patents on particular genetic sequences would create a race among competing laboratories to patent their discoveries, reducing the degree to which important scientific information could be effectively shared. Its position statement is available at: http://genetics.faseb.org/genetics/ashg/policy/pol-08.htm
The Association for Molecular Pathology is an international scientific society designed to advance clinical molecular diagnostic and prognostic medicine. It has taken the position that gene patents should not be used to limit medical professionals’ access to genetic testing materials and that gene patents should therefore be widely licensed. The statement is available at: http://www.molecularpathology.org/prc/prc%2Dtests.htm
The BioIndustry Association, a trade association in the United Kingdom’s bioscience sector, sponsored the “Manifesto for Biotechnology.” It states that gene patents are a necessary requirement for the advancement of biotechnology because companies could not afford to fund their research without them. The Manifesto is available at: http://www.bioindustry.org/dbfiles/CGItemp25523.pdf
The “Primer on Genome and Genomic Research” is sponsored by the Biotechnology Industry Organization (BIO) and contains its position that patent protection for gene discovery is consistent with federal law. BIO is a Washington, D.C. based biotechnology trade organization. Its statement is available at: http://www.bio.org/ip/primer/printer.asp
The College of American Pathologists is a professional organization that aims to better serve the interests of patients, pathologists and the public by encouraging excellence in the field of pathology. Its position statement on gene patents entitled, “Genes Patents Detrimental to Care, Training, Research,” is available at: http://www.cap.org/apps/docs/advocacy/advocacy_issues/ Issue_Genepat.html
The Council for Responsible Genetics is an American nonprofit organization of professionals and other concerned citizens. It has taken the position that there can be no claim of ownership over any living organism; this extends to the position that patents should not be granted on any biological material, including genes. The organization explains its position in a paper entitled, “DNA Patents Create Monopolies on Living Organisms,” and it is available at: http://www.actionbioscience.org/genomic/crg.html
The Human Genetics Alert is an independent public interest group based in London It is funded by a British charity and focused on human genetics issues. It argues that allowing the patenting of genes created a gold rush that caused biotechnology companies to make every effort to monopolize genetic discoveries. Its view and stance that gene patents should be rescinded and rejected is available at: http://www.hgalert.org/topics/lifePatents/patent.htm
The Human Genome Organization (HUGO) is an international group of scientists, based in London, involved in the Human Genome Project. It released a statement in 1995 recommending that genetic sequences not be patented for fear of rewarding those who make basic scientific discoveries at the expense of those who develop those discoveries into diagnostic tests and therapies. The statement is available at: http://www.gene.ucl.ac.uk/hugo/patent.htm
HUGO updated its position in 2000 following the promulgation of the European Union’s Directive 98/44/EC. This updated position statement is available at: http://www.gene.ucl.ac.uk/hugo/patent2000.html
The International Federation of Pharmaceutical Manufacturers Associations is a worldwide, nonprofit organization representing the research-based pharmaceutical industry and the manufacturers of prescribed medicines. In a speech, as a response to a report that called for a ban on all gene patents, the Director General argues that gene patents are beneficial to public health because they help fund research. The speech is available at: http://www.ifpma.org/News/SpeechDetail.aspx?nID=33
The National Society of Genetic Counselors is a professional organization, based in the U.S., for genetic counselors. It argues that the development of genetic technology is expensive and that patents on gene sequences can provide an important source of funds to pay for that development. It therefore generally supports gene patents in concept, although it suggests that broad licensing under reasonable terms will help ensure that gene patents do not restrict development. Its position statement is available at: http://www.nsgc.org/newsroom/position_dna.asp
The Royal College of Pathologists of Australasia (RCPA) is a professional organization that promotes the science and practice of pathology in Australia and New Zealand. It has taken the position that human genes are naturally occurring substances and therefore not patentable. The organization is mainly concerned that patents on basic genetic technology could limit future development of genetic technology The RCPA’s position statement on the patenting of human genes is available at: http://www.rcpa.edu.au/applications/DocumentLibraryManager2/upload/Patenting%20of%20 Human%20Genes.pdf
Lori B. Andrews and Dorothy Nelkin
Body Bazaar: The Market for Human Tissue in the Biotechnology Age
(Crown: New York 2001)
The authors argue that permitting the patenting of genes will allow a market to develop where human beings are commercialized. They also provide a look into the future at where the world may end up if society continues on the path of human commercialization.
John Bryant, Linda Baggott la Velle, and John Searle, eds.
Bioethics for Scientists
(John Wiley & Sons: Chichester, West Sussex, England 2002)
This collection of essays uses factual and philosophical ideas to provide an introduction to modern life sciences. The chapter titled, “Patenting Human Genes: Ethical and Policy Issues,” by Audrey R. Chapman addresses the patenting of human genes.
Audrey R. Chapman
Unprecedented Choices: Religious Ethics at the Frontiers of Genetic Science
(Fortress Press: Minneapolis 2003)
The views and concerns of churches and theologians regarding biotechnology are examined in this book. The author discusses genetic patenting in the chapter titled, “The Patenting of Life.”
As the Future Catches You: How Genomics & Other Forces Are Changing Your Life, Work, Health, & Wealth
(Crown Business: New York 2001)
An analysis and examination of how biotechnology has progressed in conjunction with the economy is discussed in this book. The author also touches upon the possible ill affects of such advances. Gene patents are discussed in the chapter titled, “Revolution . . . in a Few ZIP Codes.”
R. Grunwald and F. Vogel Patenting of Human Genes and Living Organisms
(Springer-Verlag Telos: New York 1994)
Conflicting viewpoints on the application of the law to recent advances in biotechnology are covered in this book.
Bartha Maria Knoppers
Populations and Genetics: Legal and Socio-Ethical Perspectives
(Kluwer Legal International, NY 2003)
The expansion of genetic research from individuals and families to communities and whole populations is discussed in this book of selected papers.
Science in the Private Interest: Has the Lure of Profits Corrupted Biomedical Research?
(Rowman & Littlefield Publishers, Inc.: Lanham, MD 2003)
The rising conflict for academic researchers between advancing science and commercial profits is examined in this book. The author discusses reasons why the private funding of academic research has improved scientific discoveries as well as reasons why it has caused people to question the integrity of researchers.
David Magnus, Arthur L. Caplan, and Glenn McGee, eds.
Who Owns Life?
(Prometheus Books: Amherst, NY 2002)
Recent concerns with the commercialization of people and advances in biotechnology are addressed in this compilation of essays.
Thomas H. Murray and Max Mehleman, eds.
Encyclopedia of Ethical, Legal, and Policy Issues in Biotechnology
(John Wiley & Sons, NY 2000)
This collection of articles examines the ethical, legal, and public policy perspectives on a broad range of topics in biotechnology.
Playing God?: Genetic Determinism and Human Freedom
(Routledge: New York 2002)
Ethical questions involved in genetic science and the idea that geneticists are playing God are examined in this book. The book deals with gene patents in the chapter titled, “Should We Patent God’s Creation?”
The Biotech Century: Harnessing the Gene and Remaking the World
(J. P. Tarcher: New York 1998)
Discussions of how advances in biotechnology have changed society, as well as possible future changes are considered in this book. The book includes a section on patenting genes and the power of the patent holder in the chapter titled, “Patenting Life.”
Biopiracy: The Plunder of Nature and Knowledge
(South End Press: Boston 1997)
A critical examination of advances in biotechnology and how they have adversely affected society are examined in this book. Gene patents are discussed in the chapter titled, “Piracy Through Patents: The Second Coming of Columbus.”
Derek G. Springham and Vivian Moses eds.
Biotechnology – The Science and the Business
(T&F; STM: Amsterdam 1999)
A basic understanding of the connection between business and biotechnology can be gained from this textbook. L.L. Greenlee deals with gene patents in the chapter titled, “Patents: Paradigms in Collision.”
Brian Tokar, ed.
Redesigning Life?: The Worldwide Challenge to Genetic Engineering
(Palgrave-Macmillan: New York 2001)
This collection of essays discusses how advances in biotechnology have affected society. Gene patents are discussed in the chapter titled, “Patents, Corporate Power and the Theft of Knowledge and Resources.”
Biotech Patents: Equivalency and Exclusions Under European and U.S. Patent Law
(Kluwer Law International: New York 2002)
Conflicts between biotechnology and traditional notions of patent law are examined in this book. Part of the focus is on the granting of patents and their scope.
Technology & Impact
Corporate Takeover Exploiting the US Patent System, A Single Company has Gained Control Over Genetic Research and Testing for Breast Cancer And Scientists, Doctors, and Patients Have to Play by its Rules
Boston Globe Mag., Feb. 24, 2002, at 10
Myriad Geneticsıs patent on a breast cancer gene and how it has affected scientists, doctors and the public are examined in this article. Also included are specific examples of when the patent may have been infringed, but the possible infringement lead to a greater discovery.
David Blumenthal, Michael Gluck, Karen Seashore Louis, Michael A. Stoto, and David Wise
University-Industry Research Relationships in Biotechnology: Implications for the University
232 Science 1361 (1986)
The affect that university-industry research relationships have had on university research in biotechnology is examined in this article. The authors conducted a survey of university researchers to determine if their behavior is affected if they receive funding from the biotechnology industry. One of their findings is that academic researchers that are funded by biotechnology companies are four times more likely to withhold findings than those without private funding.
David Blumenthal, Eric G. Campbell, Melissa S. Anderson, Nancyanne Causino, and Karen Seashore Louis
Withholding Research Results in Academic Life Sciences
277 J. Am. Med. Assın 1224-28 (1997)
A survey of university life science faculty shows the prevalence of data-withholding. Nearly 20% of the respondents reported that they had delayed publishing their results for more than 6 months to preserve the rights to their discovery.
Elizabeth A. Boyd, Mildred K. Cho, and Lisa A. Bero
Financial Conflict-of-Interest Policies in Clinical Research: Issues for Clinical Investigators
78 Academic Medicine 769-74 (2003)
Possible issues with conflicts of interest when university research is funded by private corporations are examined in this article. The authors interviewed two clinical investigators from different institutions with differing conflict of interest policies in place to observe how their views would differ. Conflict of interest examples are relevant in gene patents because much of university research in genes is funded by private corporations.
Eric G. Campbell, Brian R. Clarridge, Manjusha Gokhale, Lauren Birenbaum, Stephen Hilgartner, Neil A. Holtzman, and David Blumenthal
Data Withholding in Academic Genetics: Evidence From a National Survey
287 J. Am. Med. Assın 473-80 (2002)
Geneticists and life scientists from one hundred universities were surveyed to examine how financial benefits for researchers inhibit the free-sharing of discoveries. The article shows that nearly half of the researchers were denied requests for information regarding published reports at least once in the last three years.
Mildred K. Cho, Ryo Shohara, Anna Schissel, and Drummond Rennie
Policies on Faculty Conflicts of Interest at U.S. Universities
284 J. Am. Med. Assın 2203-08 (2000)
A survey of one hundred U.S. institutions that received the most funding from the National Institutes of Health was conducted to examine their conflict of interest policies. The authors concluded that a wide variation of policies exists and that a more universal and specific policy would best serve the long-term interests of the institutions.
Mildred K. Cho, Samantha Illangasekare, Meredith A. Weaver, Debra G. B. Leonard, and Jon F. Merz
Effects of Patents and Licenses on the Provision of Clinical Genetic Testing Services
5 J. of Molecular Diagnostics 3-8 (2003)
To examine the potential effects of a physician’s ability to perform genetic tests, the authors conducted a telephone survey of clinical laboratory directors that perform DNA-based genetic tests. The authors concluded that clinical laboratories have been adversely affected by patents and licenses on genes and genetic tests.
Q. Todd Dickinson, John Kilyk, Jr., Arti K. Rai, and Jack Spiegel
The Human Genome Project, DNA Science and the Law: The American Legal System’s Response to Breakthroughs in Genetic Science: Intellectual Property and Genetic Science
51 Am. U. L. Rev. 371-99 (2002)
This panel discussion, as part of a symposium, focused on two issues. First, whether granting gene patents has stimulated inventions in biotechnology. Second, how the patent system changed collaborations in science and competition and whether this has had an adverse affect on our lives. The panel included people who have spent time at the US Patent Office, in private practice, in academia, and at the National Institutes of Health.
Michelle R. Henry, Mildred K. Cho, Meredith A. Weaver, and Jon F. Merz
DNA Patenting and Licensing
297 Science 1279 (2002)
A telephone interview study was conducted by the authors to learn more about the patenting of gene sequences and their impact on future biotechnology discoveries. The authors learned that nonprofit organizations made more genetic discoveries, but were less likely to attempt to patent their discoveries.
The Profit of Scientific Discovery and its Normative Implications
75 Chi.-Kent L. Rev. 15-39 (1999)
The commercialization of biotechnology and how it has impacted the traditional structure of science is discussed in this article. The author also touches upon how such commercialization was aided by granting intellectual property rights to discoveries in biotechnology.
Bruce A. Lehman
Making the World Safe for Biotech Patents
6 J. of Biolaw & Bus. 3-7 (2003)
The author, who at the time was the President of the International Intellectual Property Institute, provides background on why the biotechnology industry has turned people against the patent system. He then proposes that biotechnology companies should reach out to underdeveloped parts of the world as a way for them to quell criticism over the patenting of genes.
Jon F. Merz and Michelle R. Henry
The Prevalence of Patent Interferences in Gene Technology
22 Nature Biotechnology 153-54 (2004)
The relatively high number of interferences filed in the biotechnology and organic chemistry industry compared to numerous other industries is examined in this article. Interference is the process in the United States Patent and Trademark Office that allows it to determine which party was the first to invent.
Jon F. Merz, Antigone G. Kriss, Debra G. B. Leonard and Mildred K. Cho
Diagnostic Testing Fails the Test: The Pitfalls of Patents are Illustrated by the Case of Haemochromatosis
415 Nature 577-79 (2002)
The authors conducted a survey of laboratories that appeared capable of offering the genetic test for hereditary haemochromatosis to study the impact of the patent on the HFE gene. The authors concluded that the patents on the HFE gene had an adverse affect on the development and availability of the test.
Jon F. Merz
Disease Gene Patents: Overcoming Unethical Constraints on Clinical Laboratory Medicine
45 Clinical Chemistry 324-30 (1999)
The adverse affects of disease gene patents on a physician’s ability to treat patients are discussed in this article. The author explains why he believes that compulsory licensing should be required for physicians providing medical services.
Dianne Nicol, Margaret Otlowski, and Don Chalmers
Consent, Commercialisation and BenefitSharing
9 J.L. & Med. 80-94 (2001)
The rights of the source of biological material in commercialization and profit-sharing are considered in this article. The authors suggest that a donorıs waiver of interest in commercial uses should be made clear at the initiation of the research. They also suggest that it should be made clearer to donors that they will not be able to share in profits obtained through their participation.
Lawrence M. Rausch
International Patenting of Human DNA Sequences
333 National Science Foundation (2002)
This InfoBrief prepared by the National Science Foundation examines gene patents that have been filed in more than one country. The study shows that the United States has accounted for more gene patents than all other countries combined.
Anna Schissel, Jon F. Merz, and Mildred Cho
Survey Confirms Fears About Licensing of Genetic Tests
402 Nature 118 (1999)
A survey of thirty-three patents in the United States that broadly cover the diagnosis of human genetic disorders was performed and the results showed that the exclusive licensing of patents permits clinical testing services to be monopolized. The authors’ results showed how the patent holders licensed their patents and whether or not they would enforce their patents.
John P. Walsh, Ashish Arora, and Wesley M. Cohen
Working Through the Patent Problem
299 Science 1021 (2003)
The authors took a survey of professionals involved in the biotechnology field, including intellectual property attorneys, biotechnology firms, and university researchers, to determine if the granting of gene patents has slowed down discoveries. The authors call for the continuing support of open science where genetic discoveries remain available for researchers to use without worrying about patent infringement.
Social and Policy Implications
Lori B. Andrews
Genes and Patent Policy: Rethinking Intellectual Property Rights
3 Nature Reviews 803-08 (2002)
Policy considerations in determining the patentability of genes are discussed in this article.
Lori B. Andrews
The Gene Patent Dilemma: Balancing Commercial Incentives with Health Needs
2002 Hous. J. Health L. & Polıy 65-106 (2002)
The role that gene patents currently play in society is discussed in this article. The author starts by discussing how gene patents fit into traditional notions of patent law and then critically analyzes if gene patents should be granted. The author then discusses the impact gene patents can have on impeding research, verifying discoveries and public health. The author concludes by discussing available means of changing gene patent policies such as litigation, legislation and administrative action.
Martin Bobrow and Sandy Thomas
Patents in a Genetic Age
409 Nature 763-64 (2001)
The restriction that the patenting of human genes might place on medical advances is discussed in this article. The article also argues that policy-makers are to blame for the lack of proper legislation in controlling the patenting of human genes.
Patenting Life: America Holds the Cards: Ethical Unease is Not about Science – It’s about the Politics of Power
The Guardian, Nov. 15, 2000, at 11
This article provides a general discussion as to why more regulation is required for gene patents. It also explains why the European Patent Office and not the U.S. nor a third world country should determine how to regulate gene patents internationally.
Declan Butler and Sally Goodman
French Researchers Take a Stand Against Cancer Gene Patent
413 Nature 95-96 (2001)
The Curie Instituteıs challenge to Myriad Genetics’s patent on a breast cancer gene is discussed in this article. It outlines the Institutıs main argument against the granting of a European patent to Myriad.
Arthur L. Caplan and Jon Merz
Patenting Gene Sequences
312 British Medical Journal 926 (1996)
The conflict between religious groups and the biotechnology industry over the patenting of human genes is presented in this editorial. The authors then go on to discuss how the debate is actually a secular one and that it seems unlikely that the argument against the patenting of genes will prevail, The authors conclude will arguing that the patenting of genes is contrary to public interest.
Nuno Pires de Carvalho
The Problem of Gene Patents
Wash. U. Global Studies L. Rev. 701-53 (2004)
Previous criticisms of gene patents are touched upon and then the author explains why they fail to address why the patenting of human genes is a problem. The author then explains that a lack of alternativeness of inventions is the core rationale as to why human genes should not be patentable.
Barbara A. Caulfield
Why We Hate Gene Patents
IP Worldwide (2002)
Likening the human genome to a natural resource, the author argues that gene patents are contrary to scientific goals. She argues that the process involved in finding a new gene is no longer as inventive as it used to be and that even if a gene is isolated and cloned, its root of origin remains unchanged.
Timothy Caulfield, E. Richard Gold, and Mildred K. Cho
Patenting Human Genetic Material: Refocusing the Debate
1 Nature Reviews 227-31 (2000)
Some of the concerns with patenting human genes are discussed in this article. It concludes with a discussion of possible ways of dealing with those concerns.
Canada Stops Harvard’s Oncomouse in its Tracks
420 Nature 593 (2002)
The Canadian Supreme Court’s decision to deny Harvardıs request for a patent on a genetically modified mouse is addressed in this article. Although environmental groups considered the decision a victory, it will do little to hamper the global market for the mouse.
Linda J. Demaine and Aaron Xavier Fellmeth
Reinventing the Double Helix: A Novel and Nonobvious Reconceptualization of the Biotechnology Patent
55 Stan. L. Rev. 303-462 (2002)
The authors argue that the recent trend in case law that views gene patents as desirable and legal is based on a misinterpretation of patent law. The authors also evaluate requirements for patentability to show that gene patents fail to meet those requirements.
John J. Doll
The Patenting of DNA
280 Science 689-90 (1998)
The author, who at the time was the Director of Biotechnology Examination at the U.S. Patent and Trademark Office, argues that human genes should not be patentable because it provides an incentive for researchers to invest in research and development. Examples such as the patenting of the building blocks of polymers and a patent on a picture tube are used by the author to support his position.
Rebecca S. Eisenberg
How Can You Patent Genes?
2 Am. J. of Bioethics 3-11 (2002)
This explains why patenting human genes conflicts with traditional notions of the patent system. The author discusses the traditional notions of the patent system and how the science of human genes creates a conflict.
Rebecca S. Eisenberg, Andrew Marks, and George J. Annas
Molecules vs. Information: Should Patents Protect Both?
8 B.U. J. Sci. & Tech. L. 190-217 (2002)
This is a panel discussion in a symposium and it addresses the issue of whether genes should be patentable. The panel includes two law professors and the chief patent counselor of a pharmaceutical company.
Rebecca S. Eisenberg
Re-Examining the Role of Patents in Appropriating the Value of DNA Sequences
49 Emory L.J. 783-800 (2000)
The applicability of patent law to DNA sequences is discussed in this article. The author argues that the patent system was designed to handle issues that are “bricks and mortar” and cannot handle patents on genes because it does not consider whether a conflict with public wellness exists.
Rebecca S. Eisenberg
Patents and the Progress of Science: Exclusive Rights and Experimental Use
56 U. Chi. L. Rev. 1017-86 (1989)
The impact of including an experimental use exception to patent law is examined in this article. The author also discusses why researchers need unrestrained access to scientific discoveries.
Donna M. Gitter
Led Astray by the Moral Compass: Incorporating Morality into European Union Biotechnology Patent Law
19 Berkeley J. Intıl L. 1-43 (2001)
The enactment of Directive 98/44/EC of the European Parliament, which, in part, allowed a patent to be challenged on a moral and ethical basis, is discussed in this article. The author also discusses why both proponents and opponents of the Directive were unhappy with its enactment.
Donna M. Gitter
International Conflicts Over Patenting Human DNA Sequences in the United States and the European Union: An Argument for Compulsory Licensing and Fair-Use Exemption
76 N.Y.U. L. Rev. 1623-91 (2001)
This article addresses the patenting of DNA sequences and the problems that might arise in the United States and the European Union. The author discusses these problems with respect to the development of law, policy and moral arguments. The author then discusses how the public perceptions and attitudes of the United States and European Unions are quite different, even though the legal frameworks are similar. The author then offers a dual reform that would benefit both biotechnology companies and researchers.
Donna M. Gitter
Ownership of Human Tissue: A Proposal for Federal Recognition of Human Research Participantsı Property Rights in Their Biological Material
61 Wash. & Lee L. Rev. 257-345 (2004)
This article argues that the sale of human tissue for research purposes should be permitted and regulated through a Congressional enactment. The author uses two conflicting models from case law and then proposes a hybrid model of the two as a route for legislatures to take in enacting legislation.
Michael A. Heller and Rebecca S. Eisenberg
Can Patents Deter Innovation The Anticommons in Biomedical Research
280 Science 698-701 (1998)
This article argues that the privatization of discoveries in biotechnology can adversely affect public health.
Cynthia M. Ho
Who Deserves the Patent Pot of Gold?: An Inquiry into the Proper Inventorship of Patient-Based Discoveries
2002 Hous. J. Health L. & Pol’y 107-72 (2002)
Patient contributions to discoveries in genetic technology and how the patent system has failed them are addressed in this article. The author then addresses some possible solutions to better serve the interests of the patient.
Molly A. Holman and Stephan R. Munzer
Intellectual Property Rights in Genes and Gene Fragments: A Registration Solution for Expressed Sequence Tags
85 Iowa L. Rev. 735-848 (2000)
This article proposes a solution to the debate over whether expressed sequence tags (ESTs) should be patentable when no commercial value has been shown. The authors then defend their solution by showing that ESTs have some value, that patenting ESTs is almost always a bad idea, and that a better solution is not yet known.
Paul Jacobs and Peter G. Gosselin
Experts Fret Over Effects of Gene Patents on Research
L.A. Times, Feb. 28, 2000, at 1
The adverse effect of gene patents on drug research and development is discussed in this article pertaining specifically to a new AIDS drug. The authors discuss how a gene patent was issued to a company that did not know that the gene would play a role in developing an AIDS drug.
S-C Jong and R. H. Cypess
Managing Genetic Material to Protect Intellectual Property Rights
20 Journal of Industrial Microbiology & Biotechnology 95-100 (1998)
Protection of intellectual property rights for discoveries in biotechnology are highly encouraged by the authors. They recommend that strategic and distributive alliances be used as a means of exploiting the economic value of biotechnology discoveries.
Daniel J. Kevles and Ari Berkowitz
The Gene Patenting Controversy: A Convergence of Law, Economic Interests, and Ethics
67 Brook. L. Rev. 233-48 (2001)
The authors state that gene patents became controversial because of the economic interests of the parties involved. The authors argue that this controversy has introduced ethics into patent law for the first time.
Debra G. B. Leonard
Medical Practice and Gene Patents: A Personal Perspective
77 Academic Medicine 1388-91 (2002)
Drawing from her own personal experiences as a molecular genetic pathologist, the author explains why the patenting of genes is bad public health policy. She also rebuts several arguments in favor of gene patenting, such as the need for financial incentive to support research, by arguing that physicians and researchers have performed similar research without financial incentives.
Jon F. Merz
Patents Limit Medical Potential of Sequencing
419 Nature 878 (2002)
In a response to an article that reported that a person’s personal genetic sequence may one day be available for less than one-thousand dollars, the author explains how gene patents make such a proposition nearly impossible. The author specifically points to some US companies that will not license their patented genes and high royalty costs.
Jon F. Merz, David Magnus, Mildred K. Cho, and Arthur L. Caplan
Protecting Subjects’ Interests in Genetics Research
70 Am. J. Hum. Genetics 965-71 (2002)
The authors argue for the greater protection of patients’ rights in genetic research and state that such issues are best resolved early in the research process.
Jon F. Merz, Mildred K. Cho, and Debra G. B. Leonard
Testing for Alzheimer’s
281 Science 1285 (1998)
Ethical concerns and a potential conflict of interest in academic researchers that stand to benefit from their scientific discoveries are highlighted in this letter to the editor. The authors use the example of an article that failed to disclose that a researcher in support of widespread molecular testing for late-onset Alzheimerıs disease stood to benefit from his own testimony.
Jon F. Merz and Mildred K. Cho
Disease Genes Are Not Patentable: A Rebuttal of McGee
7 Cambridge Quarterly of Healthcare Ethics 425-28 (1998)
To better explain why genes should not be patentable subject matter, the authors use an analogy of a method of detecting White Truffles. Although a useful and profitable discovery, both methods are phenomenons of nature and therefore unpatentable subject matter.
David B. Resnik
DNA Patents and Human Dignity
29 J.L. Med. & Ethics 152-63 (2001)
The effect that gene patents have on human dignity is discussed in this article. The author points out that human dignity is not violated by gene patents, but that it is threatened by it because it applies market language to human DNA, lessening the value of human life. The author feels that gene patenting is only part of a larger picture that threatens human dignity and that banning gene patents would not end all threats to human dignity.
Carol A. Schneider, Felicia Cohn, and Cynthia Bonner
Human Genetics: Legal, Medical and Ethical Perspectives: Patenting Life: A View from the Constitution and Beyond
24 Whittier L. Rev. 385-96 (2002)
The patentability of genes and whether they meet traditional notions of patent law are discussed in this article. The authors further argue that there needs to be more debate to determine how gene patents will affect all parties involved.
Sydney Morning Herald, Nov. 9, 2002, at 37
Myriad Genetics and the affect of their breast cancer gene patent in Australia are discussed in this article. It includes the views of patient groups and genetic testing companies on gene patents.
Melissa L. Sturges, Note
Who Should Hold Property Rights to the Human Genome An Application of the Common Heritage of Humankind
13 Am. U. Int’l L. Rev. 219-61 (1997)
The author argues that the Common Heritage principle should be used as a guideline to regulate how the human genome will be used internationally. If the Common Heritage principle were used, the human genome could not be patented and would belong to everyone.