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 don’t.

• 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, cont’d.

• 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.