Researchers at the Duke Institute for Genome Sciences & Policy (IGSP) published a new report that gene patents, most of which are held at academic sites and developed with public funds, do more to block competition in the gene testing market than to stimulate innovation.
With the industry moving to multiple gene tests and/or whole or partial genome scans, these patents could be even more of a factor impeding development of novel tests.
The Duke study which will appear in Genetics in Medicine examines 10 clinical conditions ranging from colon cancer to cystic fibrosis. In 7 of the cases, there were exclusive patents controversies. In ZERO of these cases was the exclusive patent holder first to market.
Exclusive patents have helped bring drugs & biologics to market by providing incentives for development. But, in the gene testing arena it appears that exclusive licenses mainly clear the field of competition. The study also concluded that patents per se weren't the problem, it was whether license rights to use the patents were exclusive or not. Also, the granting of overly broad patent rights for genes is problematic.
Interestingly, the study looked at the BRCA genes recently subject to the Utah/Myriad court case and concluded the test resulting from that patent wasn't particularly expensive and despite exclusivity, but because of the very broad claims under the patent there was virtually no way for companies to pursue an alternative - cheaper/faster test without risking patent infringement. The problem with patents Myriad was operating under is that they effectively gave Myriad "rights" to 80% of genes listed in GenBank at time patent was filed -- essentially this was a mistake at the patent office in granting this broad claim.
I look forward to reading the Genetics in Medicine article after its April 15th publication.
Posted by Bruce Lehr April 14th 2010.