Academic Experience Post Madey: Impressions, Digressions, and a Few Facts Susan Ehringhaus, J.D. Association of American Medical Colleges October 18, 2004

Talking About the Problem AAMC, AAU, and COGR workshop, September 2003 Implications of Madey Thinking about the future Participants from 30 universities, including research officials, general counsels, technology transfer officials, faculty, deans, and government relations officers

Workshop Goals Assessment of options Status quo Changing licensing practices Seeking legislative relief No policy-setting Candid exchange about experiences and views No disclosure of confidential information or information that would negatively affect ongoing Madey litigation

Pre-Workshop Questionnaire Sought information about patent infringement claims, demands to license technology, characteristics of demands, barriers to changing campus practices Relevant time period, FY 02 and 03 Data are consistent with, though inconclusive about, an increase in assertions that universities are infringing patented technologies

Other Impressions Some institutions are incurring costs as a consequence of infringement claims. Some institutions have relied on the experimental use exception to justify use of patented technology. Some plan to change licensing practices; some dont. Some have altered or abandoned research projects because of infringement claims.

Some Digressions Some antitrust issues Interpretations of Bayh-Dole Indemnity by federal government for claims of infringement against its research grantees/research contractors

More Impressions Need to consider extending to other academic institutions the ability to use university- patented technologies for experimental use, perhaps by retaining academic use rights in licenses Seek best practices Not appropriate to seek legislation now (other IP debates, sovereign immunity, Bayh-Dole, etc.)

The Outcome: The Facts AAMC, AAU, COGR, and NASULGC have launched, through AAAS, a survey of approximately 250 universities to discover: Baseline for patent infringement claims against researchers for research uses of patented technology Whether there is increase over 18 mos. in number of infringement claims/requests/demands to license technology allegedly used in university research Whether or not patent searches are being undertaken as a consequence of Madey Whether or not research practices/directions have changed as a consequence of Madey

The Survey 78 respondents 3 data collection points: 7/1/04 (includes 03 baseline as well as 1/1/04 to 6/30/04); 1/1/04; 7/1/05 Confidentiality assured to the extent feasible by: Outside contractor for survey administration Responses submitted and processed anonymously, no identifiers retained SSL (secure socket layer) connection

The Survey, contd. Resulting data may help institutions to Better assess risk exposure Better calibrate responses Better assess need for changing their practices Better assess need for legislation

The Wrap-Up At completion of the survey, the sponsoring organizations expect to organize another workshop to discuss results and implications for university community. Stay tuned.