Competition blocked, innovation slowed.

• Position: Gene Patents

Exclusive licenses to gene patents, most of which are held by academic institutions and based on taxpayer-funded research, do more to block competition in the testing market than to spur the development of new technologies for gauging disease risk, reveal researchers at the Duke University Institute for Genome Sciences & Policy, Durham, N.C.

As single-gene tests give way to multi-gene or even whole-genome scans, exclusive patent rights could slow promising new technologies and business models for genetic testing even further. The findings emerge from a series of case studies that examined genetic risk testing for 10 clinical conditions, including breast and colon cancer, cystic fibrosis, and hearing loss. In seven of the conditions, exclusive licenses have been a source of controversy, but in no case was the holder of exclusive patent rights the first to market with a test.

"That finding suggests that, while exclusive licenses have proven valuable for developing drugs and biologics that might not otherwise be developed, in the world of gene testing they are mainly a tool for clearing the field of competition, and that is a surefire way to irritate your customers, both doctors and patients," maintains Robert Cook-Deegan, director of the IGSP Center for Genome Ethics, Law & Policy. "It's notable that a gene linked to cystic fibrosis is not subject to an exclusive license, yet there is now a vibrant market for tests to identify carders of the cystic fibrosis gene. This suggests the problem is not patents, per se, but how they are being licensed, particularly by universities."

More than two-thirds of the...