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Biotechnology & the Law

Legal Research Guides

Updated July 8, 2003.
Prepared by Nancy McMurrer and Mary Whisner for Law E570, Prof. Mastroianni.
 

Introduction -- Research Strategies

This quarter you may have opportunity to use

As you work on your case studies, you will draw on different types of sources. For example, for Part I, you might use scientific and technical sources, a company’s website, and news sources. For Part II, you might use legal newsletters and federal regulations. For Part III, you might use a patent law treatise, law review articles, and federal cases. For Part IV, you could use other legal sources.

Throughout you might use a variety of secondary sources to give you an overview and leads to other material. For instance, if you are starting out with a product name and know nothing about the product, you might want to begin by looking for a news story that will indicate what sort of product it is (agricultural or medical), how long it has been around, and what company manufactures it. From there you will be able to look for more detailed information -- e.g., technical articles, information about the company, and so on.

Working with the different sources, you will need to be sensitive to the different perspectives they present. For example, the description of a new biotechnology product that a company includes in its annual report to shareholders or on its website might be different from the description of the same product by an industry observer in a trade journal. A consumer group’s website or a health magazine might offer a very different view of the product.

Organization of Handout

The sources listed in this handout are roughly in the order that you might use them for your case studies:

  • Part I, development of product, uses of product, public policy and ethical concerns.
    • Scientific and Technical Information -- Newsletters, Indexes
      • Biotechnology Online Resources - Combined Full-Text Databases
      • Biotechnology Online Resources - Newsletters and Other Current Awareness Tools
      • Biotechnology Online Resources - Indexes
      • Agriculture - Newsletters and Current Awareness Tools
      • Agriculture - Indexes
    • Company Information
    • Selected Websites for Biotechnology Research
  • 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.
    • Intellectual property law
    • Patent research
  • Part IV, potential liability associated with the product and means by which the manufacturer might protect against liability.
    • Product liability law

Part I.Scientific and Technical Information -- Newsletters, Indexes

Dates indicate when coverage begins.

Biotechnology Online Resources - Combined Full-Text Databases

Source

LexisNexis

Westlaw

ASAPII Group File. Covers health, trade and industry, and includes popular magazines.

NEWS;ASAPII (1983)

Biotechnology Stories. Trade and industry news.

MARKET;BIONWS

Combs Biotechnology Directory. Business and product information from Asia, Hong Kong, Taiwan, Germany, Australia, India.

BUSREF;BIODIR (HGKBIO, TWNBIO, GRMBIO, ASTBIO, INDBIO)

Gale Newsletter Database. Covers 650 business & industry newsletters, including biotechnology.

MARKET;IACNWS (1991)

GALE-NEWS (1988) (specific coverage varies); GALE-NEWS-C (current full year).

Health and Wellness Database. Consumer and professional journals (70% full-text); consumer pamphlets (all full-text). Also on UW Libraries Research Databases

HWD (coverage varies. Generally 1989)

Health News. Articles from hundreds of newsletters and journals (including many listed individually elsewhere in this handout). Includes biotechnology.

HTHNEWS (1984)

Healthcare Industry Multibase. Newspaper and magazine articles.

HEALTH-WNPRO (1984)

IAC Biotechnology. Biotechnology newsletters.

NEWS;IACBI (1994)

Intellectual property law reviews and texts.

LAWREV;IPLR (coverage varies)

IP-TP (coverage varies)

Legal newsletters on many topics (including medicine and intellectual property).

LEGNEW; NWLTRS (coverage varies)

LEGNEWSL (coverage varies)

McGraw-Hill Publications Online. Business and industry newsletters.

MH-PUBS (1985)

MH-PUBS-C (most recent 12-24 mos.)

Pharmaceutical News Index. Includes blue, pink, rose, gray, gold, green and beige sheets.

PNI (12/1975)

PNI-C (most current year)

PROMT (Overview of Market and Technology). Company, product, industry, technologies information. 1000 sources, 60% full-text.

MARKET;PROMT (1985)

PROMT (1972); PROMT-C (current full year)

Science and Technology News. Articles from newspapers, magazines, journals, newsletters, transcripts, and wires.

TECNEWS (1983)

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Biotechnology Online Resources - Newsletters
and Other Current Awareness Tools

Source

LexisNexis

Westlaw

Applied & Environmental Microbiology. Abstracts of monthly academic journal.

APENVMICRO (1997)

BBI Newsletter. Pharmaceutical and biomedical industry coverage.

BBINEWSL (9/1989)

Applied Genetics News. Comprehensive coverage of biotechnology business and issues.

GENMED;APPGEN (1994)

APGEN (11/1991)

BioAccess. Reports on companies making medical diagnosis products. Monthly.

MARKET;IACMH

BIOACCESS (10/1991)

BioCycle

BUSFIN;ABI

BIOCYCLE (1/1992)

Biomedical Market Newsletter. Biotech, FDA activities, medical devices, monthly.

MARKET;IACMH (1994)

BIOMEDMK (9/1991)

Biomedical Materials. Medical applications for polymers and fibers. Monthly.

MARKET;IACNWS (1991)

BioPharm. Health business and trade periodicals, including biotechnology.

BIOPHARM (11/1994)

Biotech Business. Biotech products and companies, biotech licensing. Monthly.

NEWS;BIOTU (11/1996)

BIOTECHB (12/1991 and 1/1993)

Biotech Equipment Update: monthly.

MARKET;BIOEQ (11/1996)

BIOTECHEQ (10/1993)

BioTech Financial Reports

MARKET;BIOFIN (11/1996)

BIOTECHFR (6/1994)

Biotech Patent News

MARKET;IACNWS (1/1991)

BIOTECHPAT (10/1991)

Biotech Week

MARKET;RDSB&I (11/1991)

BIOTECHWK (2000)

Biotechnology Newswatch: scientific, commercial & government developments, bi-weekly.

HEALTH;BIOTEC (5/1981)

BIOTECHNW (9/1986)

Bio World Today

MARKET;IACBI (1994)

BIOWTDY (9/1994)

BT Catalyst. Biotechnology in N.C. 10 times/year.

MARKET;IACNWS (1991)

BTCAT (9/1991)

Chemical Regulation Reporter (BNA): EPA enforcement of the Toxic Substances Control Act & FIFRA.

BNA;CHEMRG (1982)

BNA-CHEM (1/1986)

Drugs of the Future. Product information.

DRUGFUT (1990)

Gene Therapy Weekly. Gene therapy and other biotechnologies.

MARKET;IACNWS (1/1995)

GENT (6/1996)

Genetic Engineering News: includes other biotechnology, biweekly.

MARKET;PROMT (9/1989)

GENENGN (1/1994)

Genetics

GENETICS (1997)

Genomics and Genetics Weekly

MARKET;NEWSRX (9/2001)

GENOMICS (2000)

Life Sciences & Biotechnology Update: monthly.

MARKET;IACNWS (4/1995)

LSBTU (4/1995)

Marketletter: biotech and pharmaceutical industries.

MARKET;IACNWS (1992)

MKTLTR (1/1992)

Medical Textiles: monthly.

MARKET;IACNWS (1991)

MEDTEXT (10/1991)

Membrane & Separation Technology News: monthly.

MARKET;IACNWS (3/1989)

MSTECH (11/1991)

Nature Biotechnology. Monthly trade magazine. Abstracts.

MARKET;PROMT (4/1996)

BIOTECHGY (1994)

Resource. Bimonthly business magazine on trends in technology. (Selected coverage.)

RESOURCE (1997)

Worldwide Biotech: covers pharmaceutical companies internationally, monthly.

MARKET;IACNWS (1991)

WWBIOTECH (12/1991)

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Biotechnology Online Resources - Indexes

Source

LexisNexis

Westlaw

ABI Inform. Business periodicals. Some full text. Available on UW Libraries Research Databases..

ABI-INFORM (8/1971)

BioBusiness. Worldwide coverage of applications of biological and medical research. Indexes articles from about 500 technical and business journals, proceedings; also indexes selected books.

BIOBUS (1985)

BIOSIS Previews. Covers biological and biomedical sciences in 9000 journals and books.

BIOSIS (1969)

BIOSIS93 (1993)

Cambridge Scientific Abstracts Biological Sciences Database. Covers biotechnology.

SCITEC;BIOSCI (1992)

Chemical Engineering & Biotechnology Abstracts. Covers about 400 journals. International. Also includes environmental protection.

CHEMENGABS (1971)

Current Biotechnology Abstracts. Updated monthly.

CB-ABS (4/1983)

Derwent Biotechnology Abstracts. Includes information on patents.

BIOTECH-ABS (1982)

Diogenes. Industry and FDA information.

DIOGENES (1976)

Drugs & Pharmacology. Contains abstracts of drugs and pharmacology literature, including effects and use of drugs and potential drugs, clinical and experimental aspects of pharmacokinetics and pharmacodynamics, and side and adverse effects. Available on UW Libraries Research Databases.

EMBASE. Indexes 35,000 journals worldwide in medicine and related fields.

EMBASE (1974)

EMBASE85 (1985)

EMBASE-C (most recent 12-14 mos.)

FOODLINE: Food Science and Technology. Worldwide coverage. Updated twice weekly.

FOOD-SCI (1972)

International Pharmaceutical Abstracts. Provides worldwide coverage of pharmaceutical science and health related literature including drug therapy, toxicity, and pharmacy practice as well as legislation, regulation, technology, utilization, biopharmaceutics, information processing, education, economics, and ethics as related to pharmaceutical science and practice. Available on UW Libraries Research Databases.

IPA (1970)

MEDLINE. Indexes articles from more than 3500 journals worldwide. Coverage includes anatomy, organisms, diseases, chemicals and drugs, techniques and equipment, psychiatry and psychology, nutrition, environmental health, biological sciences, physical sciences, social sciences and education, technology, agriculture, food, industry, humanities, information science and communications, and health care. Available on UW Libraries Research Databases.

MEDLNE;MEDLNE (and other files)

MEDLINE

SciSearch: international and multi disciplinary; can be used to "shepardize" articles. Available on UW Libraries Research Databases as Social Science Citation Index.

SCISEARCH (1990)

Trade & Industry. Covers industries, including biotech industry, some full-text articles.

TRD&IND (1981)

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Agriculture - Newsletters and Current Awareness Tools

Source

LexisNexis

Westlaw

AgExporter. Focus on food and agriculture exporting. Publication of USDA. Monthly.

NEWS;ASAPII (1991)

AGEXPTR (1994)

Agra Europe: Europe and worldwide, weekly.

NEWS;ASAPII (1990)

AGRAEURO (1994)

Agra Food East Europe

MARKET;PROMT (3/1992)

EEUAG (1995)

Agri Finance

BUSFIN;BIS (8/1985)

Agri Service International: biweekly.

NEWS;EURASI (10/92)

Agricultural Chemical News. Non US news.

NEWS;GNW (2/1998)

Agricultural News. Articles from newspapers magazines, journals, newsletters, transcripts, wires.

AGRINEWS (1984)

Agricultural Research. Monthly publication of USDA.

NEWS;ASAPII (1991)

AGRESEARCH (3/1994)

Agriculture Industry News.

WNS-AG

Chilton’s Food Engineering. Monthly.

CHILTNFE (3/1994)

Crop Science

CROPSCI (1997)

Dairy Farmer

DRFR (1996)

Dairy Foods Magazine

NEWS;SYFOOD (1989)

Dairy Industry International

NEWS;ASAPII (1990)

DAIRYINTL (1994)

Dairy Markets Weekly

MARKET;PROMT (2/1991)

DAIRYMKTW (1994)

Europe Agri. Daily newspaper covering agriculture in European Union.

NEWS;RDSB&I (1999)

Farm Chemicals: agriculture, pesticides, fertilizers, monthly.

MARKET;PROMT (12/1987)

FARMCHEM (1994)

Feedstuffs: agriculture, grains and feeds, weekly.

MARKET;PROMT (12/1987)

FEEDSTFS (1994)

Food Chemical News: weekly.

MARKET;IACNWS (1/1991)

FOODCHEMN (10/1991)

Food Labeling News: labeling, packaging, and advertising regulation by FDA, USDA, and FTC, weekly.

NEWS;ASAPII (10/1992)

Food Review. Quarterly USDA publication.

NEWS:NFOODR (1989)

FOODREV (1989)

Food Manufacture. Monthly.

MARKET;RDSB&I (1995)

FOODMANUF (1994)

Food Technology. Monthly.

MARKET;PROMT (1988)

FDTECH (1994)

Foodline Current Legislation. Covers food additives and labeling laws in US and 7 EU countries.

FOOD-LEGIS (current)

Health News. Includes agriculture.

HTHNEWS (1984)

Trade & Industry News. Focus on agriculture and tobacco.

MARKET;AGRNWS

U.S. Department of Agriculture Reports

USDAR (3/1996)

World Food Chemical News

MARKET;RDSB&I (1995)

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Agriculture - Indexes

Source

LexisNexis

Westlaw

Agricola. Broad index of over 2000 sources. Covers journal articles, books, technical reports. Available on UW Libraries Research Databases.

AGRICOLA (1970)

Agris International. Focus on worldwide food supply. Related to print index produced by UN’s FAO.

AGRISINT (1975)

Biological & Agricultural Index. Indexes 258 periodicals common to many libraries.

B&A-INDEX (7/1983)

CAB Abstracts. Covers agriculture and related sciences such as veterinary medicine. Indexes material from 11,000 journals in 50 languages.

CAB-ABS (1972)

Current Biotechnology Abstracts. Also covers agriculture.

CB-ABS (4/1983)

FOODLINE: Food Science & Technology: worldwide coverage. Updated twice weekly.

FOOD-SCI (1972)

Promt (Overview of Market and Technology). Company, product, industry, technologies information. 1000 sources, 60% full-text.

MARKET;PROMT (1987)

PROMT (1972); PROMT-C (current full year)

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Company & Industry Information

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Selected Websites for Biotechnology Research

University of Washington Healthlinks

Agricultural Biotechnology

  • U.S. Department of Agriculture, with links to the Environmental Protection Agency and the U.S. Food and Drug Administration.
  • Information on laws and regulations, research, permits, and product approval processes.
  • Includes Animal and Plant Safety Inspection Service.

Agriculture Network Information Center

  • A project of the National Agricultural Library (U.S. Department of Agriculture), land-grant universities, and other institutions.
  • Includes biotechnology and other agricultural issues.
  • See also Agricola, the National Agricultural Library's index to agricultural literature.

National Agricultural Law Center

  • Funded with federal appropriations through the National Agricultural Library.
  • Conducts legal research into agricultural and food issues and provides a gateway to agricultural law resources on the Internet
  • 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

  • "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.

Agricultural Biotechnology Support Project

  • Project at Michigan State University Institute of International Agriculture, funded by grant from USAID.
  • Useful for international policy questions (e.g., technology transfer).

National Center for Biotechnology Information

  • A project of the National Library of Medicine at the National Institutes of Health.
  • "Established in 1988 as a national resource for molecular biology information, 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."

Biotech: Life Sciences Resources and Reference Tools

  • Produced by faculty and staff at Indiana University and University of Texas at Austin.
  • Includes a dictionary of life sciences terms, annotated links to other resources.

The World Wide Web Virtual Library Biotechnology Directory

  • Site maintained by Cato Research Ltd., a clinical research group.
  • "This directory contains well over 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."

OECD Biotechnology, http://www.oecd.org/EN/home/0,,EN-home-27-nodirectorate-no-no-no-27,FF.html.

  • Website of the international Organisation for Economic Co-operation and Development.
  • Includes a link for biosafety research, BioTract Online, and OECD's searchable Biotech Product Database, http://www.olis.oecd.org/bioprod.nsf.

Council for Biotechnology Information

  • Produced by a group of biotechnology companies.
  • 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."

Foundation for Genetic Medicine

Genentech, Inc.

  • Example of a website of a prominent biotech firm.
  • Includes products, information on future products ("Pipeline"), company information such as the most recent annual report ("Investors")

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Part II: Federal Regulations

For a review of how to research federal regulations, see the Gallagher guide on U.S. Administrative Law.

Part III: Intellectual Property Law

LexisNexis and Westlaw both have collections of intellectual property databases, including statutes, cases, and secondary materials.

This is an area where you might find it valuable to consult treatises, e.g.:

  • Donald S. Chisum & Maxim H. Waldbaum, Acquiring and Protecting Intellectual Property Rights (looseleaf treatise). KF2979.C465 1985 at Reference Area
  • Iver P. Cooper, Biotechnology and the Law (looseleaf treatise). K1519.M5C66 2002 at Reference Area
  • Donald S. Chisum, Patents: A Treatise on the Law of Patentability, Validity, and Infringement (14-volume looseleaf). KF3114.C55 at Reference Area

If you do not have a strong background, consider starting with a nutshell or other introductory work. For more titles, use the Law Library catalog. See also the Gallagher guide on Patents.

For law review articles, search LegalTrac.

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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.

Part IV: Product Liability Law

Again you might find it useful to consult treatises, e.g.:

  • Russell J. Davis, et al., American Law of Products Liability 3d (multi-volume looseleaf treatise). KF1296.A97 1987 at Reference Area
  • Madden & Owen on Products Liability. KF1296.K55 2000 at Classified Stacks

For other books, use Marian, the Law Library catalog.

For law review articles, search LegalTrac.

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