Research Guides: Student Project: Patentability of Genes: Secondary Sources

Library of Congress Subject Headings

Treatises for Understanding Patents

Chisum on Patents
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This is the standard treatise on patent law.
Moy's Walker on Patents
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This is an authoritative treatise on patent law that covers topics from patentability to infringement.
Intellectual Property and Antitrust Law
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William C. Holmes, Part I. Overview of the Intellectual Property Laws, Chapter 1. Patent Law, § 1:10. Patentable subject matter.

Patent Law Digests

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Matthews Annotated Patent Digest, Section 20:17. Pure or synthetic forms of naturally occurring compositions. This section describes the changes in the court's position over time regarding the patentability of isolated DNA molecules. Prior to the Supreme Court's decision in Myriad, the Federal Circuit ruled that natural DNA isolated from the body was sufficiently different than DNA as it is found in the body because chemical bonds are cleaved to excise it from the chromosome. The Supreme Court reversed this ruling in part, stating that natural isolated DNA was not patentable, but synthetic complementary DNA (cDNA) was patent eligible because introns in the natural DNA are spliced out of the DNA in the process of synthesizing cDNA from messenger RNA in the laboratory.**

Law Review Articles

Christopher Bergin, Take off Your Genes and Let the Doctor Have a Look: Why the Mayo and Myriad Decisions Have Invalidated Method Claims for Genetic Diagnostic testing, 63 Am. U. L. Rev. 173 (2013).
"This Comment analyzes the legal framework established by the Supreme Court and U.S. Court of Appeals for the Federal Circuit to decide patent eligibility for genetic diagnostic tests. It concludes that, while the world was spellbound by the ethical quandary of compositional claims on human genes, the recent Supreme Court and Federal Circuit decisions have surreptitiously eliminated genetic diagnostic tests as patentable subject matter under § 101 of the United States Patent Act." American University Law Review Website http://www.aulawreview.org/.
Caitlin E. Lanning, Mapping Our Future: The Impact of Gene Patents on Scientific Research and Health Care in the United States, 26 J.L. & Health 375 (2013).
This article addresses the fact that while the Leahy-Smith America Invents Act (AIA) of 2011, is the largest transformation to U.S. patent law since 1952, and implements numerous positive changes to the U.S. patent system, it fails to address any of the concerns raised by gene patent critics over the past few decades. The author feels that gene patents should be categorized as patentable subject matter within the AIA, but under a separate patent category with specifically engineered regulations designed to promote scientific research and collaboration that will in turn foster quicker results in diagnostic technologies and treatments. Cleveland-Marshall College of Law, Journal of Law and Health Website http://engagedscholarship.csuohio.edu/jlh/vol26/iss2/8/.
Kate M. Mead, Gene Patents in Australia: A Game Theory, 22 Pac. Rim. L. & Pol'y J. 751 (2013).
This comment represents the controversy as a game between Australia and the rest of the developed world, where it “cooperates” if it continues to respect gene patent rights and it “defects” if it declares genes unpatentable. From Australia’s perspective, the immediate economic benefits of eliminating gene patents may outweigh its costs. However, the long-term costs of eliminating gene patents may be unacceptable to proponents of gene patents. Id at 751.
Douglas L. Rogers, After Prometheus, Are Human Genes Patentable Subject Matter?, 11 Duke L. & Tech. Rev. 434 (2013)
This article argues that neither DNA isolated from the human body, nor DNA created synthetically, should be patentable. As determined by the US Supreme Court in Myriad, and as described in this guide, and elsewhere, cDNA is chemically distinct from natural DNA.
Gregory Dolin, Exclusivity Without Patents: The New Frontier of FDA Regulation for Genetic Materials, 98 Iowa L. Rev. 1399 (2013).
This Article proposes a non-patent exclusivity system administered by the Food and Drug Administration; the innovators who bring new therapeutic or diagnostic products to market would receive exclusive rights to market their products for a limited time. Id at 1399-1400.
Patenting DNA: Balancing the Need to Incentivize Innovation in Biotechnology with the Need to Make High-Quality Genetic Testing Accessible to Patients, 61 Kan. L. Rev. 257 (2012)
This article discusses the science related to gene patents and focuses on the need to incentivize research versus the need to make genetic testing available and affordable to patients.
Genes and the Supremes: Will the Supreme Court Uphold Patents for Isolated Gene Sequences, 45 Tex. Tech L. Rev. 533 (2013)
This article was written just before the Myriad decision. It provides an excellent primer on DNA and a history of gene patents in the US.
Gregory C. Ellis, Emerging Biotechnologies Demand Defeat of Proposed Legislation That Attempts to Ban Gene Patents, 15 Rich. J.L. & Tech. 1 (2008).
"The purpose of this article is to examine current United States patent
law and policy with respect to gene patents, and to argue that the benefits
of gene patents far outweigh any disadvantages." Id at 5. Although, written in 2008, prior to the Myriad decision, this article emphasizes key points in support of gene patents.
Stephen H. Schilling, DNA as Patentable Subject Matter and a Narrow Framework for Addressing the Perceived Problems Caused by Gene Patents, 61 Duke L. J. 731 (2011).
"This Note proposes a narrowly tailored set of solutions to address the concerns about gene patents without destroying the incentives for companies to create and commercialize inventions derived from these and similar patents." Id at 731.
Matthew L. Karlan, Patent Policy, Natural Products, and the Gene Patent Debate: Seeking the Proper Judicial Mode of Analysis, 67 N.Y.U. Ann. Surv. Am. L. 95 (2011).
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The article discusses the arguments on both sides for gene patentability. It points out that the U. S. Patent and Trademark Office (USPTO), and the courts have recognized biotechnology processes, and the subsequent products as subject matter under the Patent Act. The article concludes that "any inquiry into whether gene patents generally, or a specific gene patent in particular, promote progress in the useful arts is highly fact-intensive and requires deep insight into both molecular genetics and the biotechnology industry." Id at 134-35.
Robert S. Schwartz, Genes for Free: The Effect of Publication of the Human Genome on the Patentability of Genes and Gene-Based Inventions, 23 Pace L. Rev. 731 (2003).
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This 2003 article predicted that the publication of the human genome would stimulate reform for patentability standards for biotechnology inventions. Id. at 755.

IP and Patent Journal Articles

Penny Gilbert, Court puts DNA and R&D in a spin, 27 The Lawyer 9 (2013)
This article discusses the patent law issues when dealing with products of nature as applied to the Myriad case. The article also addresses the impact of the Myriad decision on patent law in Great Britain.
Unwinding the DNA Double-Helix: An Alternative Resolution to the Federal Circuit's Decision in Association for Molecular Pathology for Simplifying Section 101 Patent Eligibility Requirements, 22 Fed. Circuit B.J. 563 (2013).
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This article was written before the US Supreme Court's decision in Myriad. It suggests an alternative method for determining whether a genetically engineered invention should be patent eligible. It describes a "but for" test that asks whether claimed subject matter can exist, but for human effort. Additionally, the article provides a thorough background on case law history leading to the Myriad decision. It also thoroughly discusses the lower court decisions in the Myriad case.

Selected Books

Title: Can Law Make Life (too) Simple?

Author: Tine Sommer

Publisher: DJOF Publishing, Copenhagen 2013

ISBN-10: 8757431191

ISBN-13: 978-8757431193

This recently published book is the author's thesis for a doctoral degree in Law (Dr. jur.). The author examines, among other things, the issues in patenting complex biological systems. A chapter is dedicated to "Developing gene patenting: The case of Myriad Genetics".

Title: Rethinking Patent Law

Author: Robin Feldman

ISBN 9780674064683
Publication: June 2012

Addresses the question of where do processes of nature end and processes of human inventions begin.

Title: The Role of Science in Law

Author: Robin Feldman

Publisher: Oxford University Press, USA (March 9, 2009)
ISBN-10: 0195368584
ISBN-13: 978-0195368581