Biotechnology & the Law

Updated June 5, 2009.
Prepared by Nancy McMurrer and Mary Whisner for Law E570, Prof. Mastroianni.
Updated by Joe Cera (2009).

This guide is organized in roughly the order that you might use them for a case study. If you need help getting started, take a look at Research Strategies.

  • Part I, development of product, uses of product, and public policy and ethical concerns
  • Part II, the product’s journey through the regulatory maze: Federal regulations
  • Part III, the intellectual property protections available to and chosen by the manufacturer of the product
  • Part IV, potential liability associated with the product and means by which the manufacturer might protect against liability: Product liability law

Note: Many of the databases described in this guide require individual users to have passwords or IDs (LexisNexis and Westlaw) or are UW Restricted. Tables of files and databases found on LexisNexis and Westlaw are found on a companion page, Biotechnology & the Law: Scientific & Technical Information.


Part I

Development & Uses of the Product; Public Policy & Ethical Concerns

Tables of relevant files and databases found on LexisNexis and Westlaw are found on a companion page, Biotechnology & the Law: Scientific & Technical Information.

Treatises & Overviews

The Gallagher Law Library Catalog is a good place to start. Running a search using the term "biotechnology" will often return multiple resources about biotechnology and various other subjects. Examples:

  • Biotechnology and the Law, 3 vols. K1519.M5 C66 2002 at Reference Area. Updated annually.
  • Biotechnology and the Law. KF3133.B56 B563 2007 at Classified Stacks. Table of contents
  • The Regulatory Challenge of Biotechnology: Human Genetics, Food and Patents. K3925.B56 R444 2007 at Classified Stacks. Table of contents
  • A Guide to Biotechnology Law and Business. KF3133.B56 B64 2007 at Classified Stacks. Table of contents

Company & Industry Information

See other sources at UW Foster Business Library - Company Research Guide and UW Health Sciences Library, Healthlinks Biotechnology Industry.

Selected Websites

University of Washington Healthlinks links to local biotechnology companies and genome sciences sites. Search "biotechnology" for links to other resources.

University of California provides a research guide for biotechnology news and information and includes information on grants for biotechnology.

U.S. Department of Agriculture, Agricultural Biotechnology, with links to the Environmental Protection Agency and the U.S. Food and Drug Administration, includes information on laws and regulations, research, permits, and product approval processes.

The Agriculture Network Information Center is a project of the National Agricultural Library (U.S. Department of Agriculture), land-grant universities, and other institutions. It covers biotechnology and other agricultural issues. See also Agricola, the National Agricultural Library's index to agricultural literature.

The National Agricultural Law Center is funded with federal appropriations through the National Agricultural Library and conducts legal research into agricultural and food issues and provides a gateway to agricultural law resources on the Internet. It is also connected with the Drake University School of Law Agricultural Law Center, which concentrates on state and local food policy issues.

Information Systems for Biotechnology (ISB) "was established in 1988 as part of the National Biological Impact Assessment Program (NBIAP), a program administered by USDA's Cooperative State Research, Education, and Extension Service (CSREES). ISB is funded on an annual basis through a renewable grant to the Agricultural Experiment Station at Virginia Tech." Note the Annotated Database of WWW sites pertaining to Agricultural/Environmental Biotechnology.

Hosted by Cornell University, the Agricultural Biotechnology Support Project II is a USAID-funded consortium of public and private sector institutions that supports scientists, regulators, extension workers, farmers, and the general public in developing countries to make informed decisions about agricultural biotechnology. The consortium develops innovative, pragmatic solutions, building on the successes of the Agricultural Biotechnology Support Project (ABSP) that was led for over a decade by Michigan State University. ABSPII works collaboratively with the Program for Biosafety Systems (PBS) and the South Asia Biosafety Program (SABP). This site is useful for international policy questions (e.g., technology transfer).

A project of the National Library of Medicine at the National Institutes of Health, the National Center for Biotechnology Information was established in 1988 as a national resource for molecular biology information. The NCBI "creates public databases, conducts research in computational biology, develops software tools for analyzing genome data, and disseminates biomedical information - all for the better understanding of molecular processes affecting human health and disease."

The National Human Genome Research Institute was established in 1989 to carry out the role of the National Institutes of Health (NIH) in the International Human Genome Project (HGP). Its website contains information about research, grants, health, policy and ethics, and educational resources relating to genome studies.

Biotech: Life Sciences Resources and Reference Tools is produced by faculty and staff at Indiana University and University of Texas at Austin. The site includes a dictionary of life sciences terms, annotated links to other resources.

The World Wide Web Virtual Library Biotechnology Directory is maintained by Cato Research Ltd., a clinical research group. Updates stopped in June 2008, but the website may still be used for the directory of more than "1500 URLs of companies, research institutes, universities, sources of information and other directories specific to biotechnology, pharmaceutical development and related fields. It places emphasis on product development and the delivery of products and services."

The Organisation for Economic Co-operation and Development's OECD Biotechnology website includes a link for biosafety research, BioTract Online, and OECD's searchable Biotech Product Database.

Council for Biotechnology Information is the product of a group of biotechnology companies offering information about agricultural biotechnology in North America. "The council is committed to providing objective, balanced information to help you better understand and appreciate the benefits biotechnology offers, as well as to encourage informed debate about the issues it raises."

The DNA Patent Database "serves as a resource for policy makers and members of the general public interested in fields like genomics, genetics and biotechnology. The DNA Patent Database (DPD) contains a collection of DNA-based patents and patent applications issued by the United States Patent and Trademark Office (USPTO) and makes the full-text of such patents and applications available to users at no cost." It includes news and resources related to genomics, genetics and biotechnology.

Genentech, Inc. is an example of a website of a prominent biotech firm. The website includes products, information on future products ("Pipeline"), and company information such as the most recent annual report ("Investors")

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Part II: Federal Regulations

For the journey through the regulatory maze, see the Gallagher guide on U.S. Administrative Law Research.


Part III: Intellectual Property Law

LexisNexis and Westlaw both have collections of intellectual property databases, including statutes, cases, and secondary materials. See the Gallagher guide on Patents.

Consult treatises, such as:

  • Acquiring and Protecting Intellectual Property Rights. KF2979.C465 1985 at Reference Area
  • Biodiversity and the Law: Intellectual Property, Biotechnology, and Traditional Knowledge. K3488.B566 2007 at Classified Stacks
  • Intellectual Property Rights in Frontier Industries: Software and Biotechnology. KF3024.C6I57 2005, at Classified Stacks
  • Pharmaceutical and Biotech Patent Law. KF3133.B56 S46 2008 at Classified Stacks

For more books, search the Gallagher Law Library catalog for the keywords "biotechnology" and "intellectual property".

For law review articles, search LegalTrac.

Patent Research

The Engineering Library is a patent depository. See Patent and Trademark Information at the University of Washington Engineering Library, which links to Selected Patent and Trademark Information Available via the Internet and Patent Searching at the UW Engineering Library.

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Part IV: Product Liability Law

Consult treatises, such as

  • American Law of Products Liability 3d, 20+ vols. KF1296.A97 1987 at Reference Area
  • Madden & Owen on Products Liability, 3 vols. KF1296.K55 2000 at Classified Stacks
  • Products Liability, 11 vols. KF1296.A6 F7 at Reference Area
  • Products Liability Law, 2d ed. (Hornbook series). KF1296.O835 2008 at the Reference Area

For more books, search the Law Library catalog by keyword "products liability".

For law review articles, search LegalTrac, Hein Online, or the law reviews and journals databases on LexisNexis and/or Westlaw

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