Taming Gene-Patent ‘Gold Rush’
Within weeks, scientists are expected to release a rough draft of the entire human “genome,†the string of chemicals in DNA that governs how we grow and in large part how we behave. Some of the decoded gene sequences have already advanced medical care by allowing doctors to test people’s predisposition to diseases like breast and prostate cancers. Research into cures for myriad other diseases is expected to skyrocket once scientists can see the rudimentary map of the 80,000 genes in the human genome.
However, in a development that has amazed and incensed many leading geneticists, disputes over patent law are already threatening to deprive scientists of full access to this revolutionary new blueprint, arguably the most significant biological advance in history.
The rush to decipher human genes has triggered a money-making free-for-all akin to the Gold Rush, only this time the participants are rushing not to the land bureau but to the U.S. Patent and Trademark Office, which has handed out patents on more than 2,000 genes so far and has more than 25,000 patent applications on human genes pending.
Each time a biotechnology company wins a patent on a gene it claims to have discovered, it gets the right to keep information about that gene secret and even to sue any scientist who experiments on that gene without its permission.
Patent Commissioner Q. Todd Dickinson is now finalizing guidelines that will rein in part of this genetic stampede by tightening the rules for obtaining a patent; the new guidelines will require researchers to discover a gene’s “theoretical function.â€
Critics say that still gives overly broad rights to biotech companies. “Theoretical function,†they say, is just a fancy term for “hunch.†Biotech companies, however, rightly argue that they should be able to profit from funding the study of a gene even if their study doesn’t reveal that gene’s overall function.
Dickinson can address the concerns of both scientists and entrepreneurs by requiring that companies receiving gene patents make affordable “cross-licensing agreements†available to any researchers wishing to experiment with “their†genes. Such an agreement would protect an entrepreneur’s right to profit while ensuring that genetic data are fully accessible to all scientists.
Perhaps the best reason Dickinson should be wary of granting sweeping new gene patent rights to biotech companies is that their genetic discoveries were partly generated through federal funds. As Times staff writers Peter G. Gosselin and Paul Jacobs reported last week, a computerized device, called a DNA sequencer, that biotech companies have been using to decode genetic information was developed partly through federal taxpayer funds.
Excessively broad privatization of the genetic code could impede the rapid progress that is expected to yield a rough draft of the human genome next month. The Gold Rush is no paradigm for scientific research.
