Transcript NIH and Bayh-Dole

Michael Shmilovich, Esq, CLP
Technology Licensing Specialist
Office of Technology Transfer
National Institutes of Health
U.S. Department of Health & Human Services
FLC Mid-Atlantic Regional
Rocky Gap Resort, Flintstone, MD
September 17, 2008
CRADA and Licensing Timeline
2002
2003
2004
2005
2006
2007
May 2003 – Dr.
Knight begins work
as a special
volunteer at Dr. Ito’s
lab
April 9, 2003 – Peptide
Tech executes CRADA
November 2003 -Washington Biotechnology
buys Peptide Tech
April 9, 2007 – CRADA
expires
May 9, 2006 – Amendment to
CRADA change of name to
CC Biotech
Sept 30, 2004 –
National Phase entry
U.S. only
April 5, 2002 – Prov
App background rights
March 25, 2003 –
PCT application on
background rights
Dec 27, 2007
– Prov App
improvement
Lessons Learned
•
NIH assumed risk
•
Dr. Knight special volunteer;
continues work
•
•
CRADA collaborator name
swap
•
Foreign patent apps for
background rights dropped
•
Long lag time between
CRADA re-start
•
Special volunteer = rights
assigned to U.S. Gov’t
•
Patent costs = EXPEN$IVE
Exclusive license
– Patent on improvements?
Michael Shmilovich, JD, CLP
[email protected]
(301) 435-5019