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Tufts OpenCourseware
Authors: Kathleen Merrigan, Ph.D., William Lockeretz, Ph.D.


  • U.S. Congress, Office of Technology Assessment, “New Developments in Biotechnology: Patenting Life,” Chap 3, April 1989.
  • Witt, Stephen C., Brief Book: Biotechnology and Genetic Diversity, chart of “The Great Genetic Treasure Map”, California Agricultural Lands Project, 1985.
  • Pew Initiative on Food and Biotechnology, AgBiotech Buzz, “Who Owns That Gene? AgBiotech and Intellectual Property,” Vol. 1, Issue 3, March 3, 2003, and “This Food Contains GM Ingredients: Useful or Useless Info,” Vol 8, Issue 2, Aug 28, 2002.
  • Pew Initiative on Food and Biotechnology, “U.S. vs. EU: An Examination of the Trade Issues Surrounding Genetically Modified Foods,” August 2003.

Key Questions

New Developments in Biotechnology: Patenting Life

  • What is the idea behind granting patents?
  • What are the benefits of obtaining a patent?
  • What criteria are used in granting a patent?
  • Under what conditions can an application for a patent be rejected based on the reason that it is not novel?
  • How is the clause of “non obvious subject matter” resolved when a patent is filed?
  • What does the process of filing a patent involve?
  • Who gets the right to patent any invention resulting out of a program supported by Federal funding? What is the process involved?
  • Do states have different patenting laws than those of the Federal Government?
  • Do states have different registration systems for trademarks compared to those of the federal government?
  • What are the benefits of obtaining a copyright?
  • Which is the best way to secure rights over intellectual property concerning biotechnology?
  • What is the use of obtaining trademarks?
  • How does the Trade Secrets Act protect intellectual property rights?

Who Owns That Gene?

  • Which landmark case set the trend for gene patenting in the US?
  • What are the pros and cons of gene patenting?
  • The author states that the present trend for university researchers is to patent their research results, rather than allow them remain in the public domain. What could be the possible reasons for this?
  • How would a uniform patenting regime affect developing countries?
  • Considering the experience of the complex patent negotiation process involved in developing golden rice, how promising is the concept of humanitarian licenses and their positive benefits for the developing countries?
  • What is the industry argument for gene patenting and against the suggestion that such patenting is hindering research?
  • What is the industry complaint about patenting?
  • What innovation in biotechnology is thought to overcome the problem of incomplete protection provided by the patents?

This Food Contains GM Ingredients: Useful or Useless Information

  • What is the industry argument against labeling GM foods?
  • Under what circumstances would FDA require labeling?
  • What are the arguments in favor of labeling GM foods?
  • What is the general public perception about the safety of GM foods?
  • What are the pros and cons of mandatory and voluntary labeling systems?
  • How is international trade going to affect labeling in the US?

US vs EU: An Examination of the Trade Issues Surrounding Genetically Modified Foods

  • What are the major agricultural products traded between the EU and the US? What is the extent of application of genetic engineering in these products?
  • What are the reasons for the Europeans’ apprehension of biotechnology? Is it justified?
  • Which US agricultural export product was adversely affected by the EU regulation?
  • What regulatory agency oversees GM products in Europe?
  • How has the requirement for labeling GM crops / products changed in Europe? How does this affect US exports?
  • What is the basis for the legislation on traceability of products?
  • How do EU requirement of labeling and traceability affect US trade interests?