Biotechnology & the Law

Updated May 20, 2015.
Prepared by Nancy McMurrer and Mary Whisner for Law E570, Prof. Mastroianni.
Updated by Cheryl Nyberg (2015) and law librarianship intern Joe Cera (2009).

This guide identifies print and online resources on legal issues affecting the biotechnology industry.

Book titles are linked to records in the Gallagher Law Library catalog so that users can tell whether a particular book is available. Catalog records often contain chapter headings, giving readers a preview. Books that are also found online include hyperlinks.

Note: Access to Bloomberg Law, Lexis, and Westlaw is restricted to University of Washington School of Law students, faculty, and staff and to other users who have individual passwords or IDs. For more information, see Access to Bloomberg Law, Lexis Advance & Westlaw Next. Other databases may be UW Restricted. Tables of files and databases found on LexisNexis and Westlaw are found on a companion page, Biotechnology & the Law: Scientific & Technical Information.


Books

The following titles are useful starting points for learning about biotechnology and the law. Hyperlinked titles lead to catalog records, many of which provide tables of contents.

Biotechnology and the Federal Circuit, 2d ed.
KF3133.B56 B87 2010 at Classified Stacks | Bloomberg Law

Cooper, Biotechnology and the Law, 3 vols. Looseleaf.
KF3133.B56 B563 2007 at Reference Area | Bloomberg Law | Westlaw

A Guide to Biotechnology Law and Business.
KF3133.B56 B64 2007 at Classified Stacks

For other books, search the Gallagher Law Library catalog.


News

Bloomberg BNA Biotech Watch

Biotech Watch [UW Restricted]
Published every business day, this newsletter covers a wide range to biotech-related legal activities. UW Law students, faculty, and staff can sign up for email delivery.

BioSpace

BioSpace is "the leading online community for industry news and careers for life science professionals." The website features company profiles by industry, career resources, and news articles.

Law360

Law360 [UW Restricted]
Legal news and analysis on more than 40 topics and a dozen industries (including life sciences). Also available on Lexis Advance.

WestlawNext

WestlawNext News
A large, searchable collection of items from blogs, magazines and newsletters, newspapers, transcripts, and wire services. Subscribers can set up "alerts" to automatically receive items that match the individual's interests.

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Company & Industry Information

To identify companies in the biotech industry, consult one or more of the following sources:

Biotechnology Industry Organization

Biotechnology Industry Organization
Billed as "the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products.

Hoover's Online

Hoover's Online [UW Restricted]
A commercial service that provides diretory and other information on companies, industries, and people.

For more sources, consult the Companies & Industries section of the Business research guide from the UW Foster Business Library.

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Government Agencies

Several U.S. government agencies have responsibilities for biotechnology issues.

U.S. Department of Agriculture

Agricultural Biotechnology
Contains information on genetically-engineered plants and animals and the federal government's role. Includes a glossary.

Biotechnology Regulatory Services
Provides links to relevant laws, regulations, environmental permits and petitions, and related information. From the USDA's Animal and Plant Health Inspection Service.

Information Systems for Biotechnology
Note the Annotated Database of WWW sites pertaining to Agricultural/Environmental Biotechnology

National Agricultural Law Center
Includes an extensive bibliography of articles and other publications and a useful starting page for research on the legal aspects of biotechnology.

U.S. Environmental Protection Agency

Environmental Protection Agency
Plays a relatively minor role in federal regulation of biotechnology. See the Regulatory Framework and Biotechnology Activities for more information.

U.S. Department of Health and Human Services

U.S. Department of Health and Human Services
The parent agency for several agencies involved in biotech.

Food & Drug Administration, Biotechnology
Contains guidance documents and related information.

National Center for Biotechnology Information
Offers a number of highly specific scientific databases on genes and gene sequencing.

National Human Genome Research Institute
Provides information about research, grants, and news. Includes a section on Issues in Genetics that covers ethical, legal, and policy issues in genetic research.

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Federal Regulations

For sources and descriptions, see the Gallagher guide on U.S. Administrative Law Research.


Intellectual Property Law

See also the Gallagher guides on Copyright Law and Patent Law.

Books

Representative titles include:

Biotechnology & Nanotechnology: Regulation under Environmental, Health, and Safety Laws (2009).
K3925.B56 N35 2009 at Classified Stacks | Lexis

Biodiversity and the Law: Intellectual Property, Biotechnology, and Traditional Knowledge (2007).
K3488.B566 2007 at Classified Stacks

Intellectual Property in Molecular Medicine (2015).
K1519.B54 I56 2015 at Classified Stacks (on order as of May 19, 2015)

Pharmaceutical and Biotech Patent Law (2008, updated through 2011).
Includes a glossary (Appendix A) and "Primer on Basic Biotechnology Concepts" (Appendix B).
KF3133.B56 S46 2008 at Classified Stacks | Bloomberg Law

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

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Patents

DNA Patent Database

DNA Patent Database
"[C]ontains 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." Updating ceased in March 2015.

University of Washington Libraries

Patent Searching
A guide to conducting your own patent search using the tools available at the University of Washington Engineering Library.

WestlawNext
Patents & Applications
A searchable database of patents filed with the U.S. Patent and Trademark Office as well as patents filed in China, Europe, France, Germany, Japan, South Korea, and the United Kingdom (dates of coverage vary).

Derwent World Patents Index
Another searchable database, beginning in 1963.

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Product Liability Law

Books

American Law of Products Liability 3d, 20+ vols. Updated regularly.
KF1296.A97 1987 at Reference Area | Westlaw

Madden & Owen on Products Liability, 3 vols. Updated through 2013.
KF1296.K55 2000 at Classified Stacks | Westlaw [called Owen & Davis on Products Liability]

Products Liability, 11 vols.
KF1296.A6 F7 at Reference Area | Lexis

Products Liability Law, 2d ed. (Hornbook series)
KF1296.O835 2008 at the Reference Area

Products Liabilty in a Nutshell, 9th ed. (2015).
KF1296.Z9 N6 2015 at Reference Area

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

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Cases

WestlawNext

Products Liability Cases
Contains federal and state cases from 1945 to date.

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Laws

Products liability laws are primarily state-based.

Lexis Advance
50-State Survey: Products Liability

Table cites to state laws and regulations, including provisions on rebuttable presumptions and statutes of limitations. Updated Dec. 2014.

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