Research Exemption Working Group

In October 2004, SIPPI convened a working group to explore options for developing a national and internationally recognized research exemption.

Background
Working Group Participants
Meeting Presentations
Related Resources

Background

Until recently, it had been assumed that an experimental use exemption exists for purely scientific research to study and understand a patented invention. Many researchers still assume their work is immune from infringement litigation. However, in the 2002 decision Madey v Duke, the US Court of Appeals for the Federal Circuit effectively eliminated any practical application of an experimental use defense to patent infringement by non-profit or for-profit entities. The court explained that as long as the patented invention is being used to further an institution's legitimate business, that institution is liable for patent infringement. The Madey v Duke decision court characterized Duke as being in the business of conducting research and obtaining grants. In June 2003, the Supreme Court decided not to review the case.

The US scientific and academic communities are concerned that this ruling may have a chilling effect on their research, by adding legal costs and delays. This is a particular concern for disciplines in which foundational discoveries and research tools are commonly patented.

The situation in other countries is different. Many European countries and Japan have legally recognized research exemptions, but typically the scope is narrow and sometimes poorly defined. These statutory research exemptions also do not cover activities intended to develop new uses for an invention.

Working Group Participants

October 18-19, 2004
AAAS Headquarters, Washington, DC

John Barton, Stanford University, NIH
Steven Caltrider, Eli Lilly
Carlos Correa, University of Buenos Aires
Susan Ehringhaus, Association of American Medical Colleges (AAMC)
Robert Hardy, Council on Government Relations (COGR)
Richard Johnson, Arnold & Porter
James Love, Consumer Project on Technology
Kate Murashige, Morrison & Foerster
Brian Opeskin, Australian Law Reform Commission (ALRC)
Maureen O'Rourke, Boston University School of Law
Arti Rai, Duke University Law School
Josh Sarnoff, American University Law School
Anthony So, Duke University
Katherine Strandburg, Depaul University College of Law

Meeting Presentations

Susan Ehringhaus, AAMS
"Academic Experience Post Madey"

Brian Opeskin, ALRC
"International Research Exemption Issues"
"Research and Experimental Use of Patented Inventions"

Arti Rai, Duke Law School
"Complexities of Designing a Research Exemption"

Katherine Strandburg, DePaul University College of Law
"Creating a Research Exemption that Better Fulfills the Patent Bargain"

Related Resources

If you are interested in learning more about the need for a research exemption to intellectual property protection, and options for creating one, you may wish to begin with the following:

SIPPI Resources

• Project Planning Meeting on the Research Exemption. April 23, 2003.

Publications

• Australian Law Reform Commission. Genes and Ingenuity: Gene Patenting and Human Health. 2004.
  • Chapter 13: An Experimental Use Exemption
  • List of Recommendations
    
    
• Duke University v. John M.J. Madey, Brief for the Association of American Medical Colleges, et. al., as Amici Curiae in Support of Petitioner. Joseph Keves, Jr. and Keith Jones. No. 02-1007. Supreme Court of the United States.
  
  
• Eisenberg, Rebecca. "Patent Swords and Shields." Science, Vol. 299, 1018, February 2003.



• Heller, M. and R. Eisenberg. "Can Patents Deter Innovation? The Anticommons in Biomedical Research." Science Vol. 280, 698-701, May 1998.



• John M.J. Madey v. Duke University. No. 01-1567. United States Court of Appeals for the Federal Circuit. October 3, 2002.



• National Research Council. A Patent System for the 21st Century. 2004.
  • Discussion of proposed models for a research exemption, p. 108-117
    
    
• United Kingdom Royal Society. "Keeping Science Open: The Effects of Intellectual Property Policy on the Conduct of Science." 2003.



• Walsh, Arora and Cohen. "Research Tool Patenting and Licensing and Biomedical Innovation." In W.M. Cohen and S. Merrill, eds. Patents in the Knowledge-Based Economy. Washington, DC: National Academies Press, 2004.