Gene Patent Reform Vital
In a few months scientists will have completed a rough first draft of the complete human genome, the 60,000 to 80,000 strings of chemical codes that determine who we are, from brown hair to a predisposition to cancer.
Gene research offers promise for curing major diseases like AIDS and cancer, but progress is threatened by the increasingly aggressive quest of biotechnology entrepreneurs to patent genes as their structures are unlocked. A patent holder can claim exclusive right to use of the gene.
Patents once went only to those who produced inventions that significantly advanced the state of an art. The first human gene patents were awarded nearly two decades ago to companies and research centers that showed how a gene could be used to produce a specific valuable drug product such as human growth hormone or insulin. Since then, however, the patent office has come to issue patents far more broadly. For example, it has given hundreds of patents to biotech firms that did little more than use computers to decode the chemical sequences that make up the genome.
In handing out gene patents this way, the federal government risks impeding valuable research, allowing companies to hide gene sequences as though they were trade secrets and discouraging scientists from understanding and experimenting with genes patented by someone else.
On Wednesday, the patent office outlined what it said were reforms aimed at awarding patents less broadly. The reforms, however, don’t address key problems.
One problem is that when patent owners withhold information about human genes from perceived competitors, they prevent the sharing of knowledge that’s essential to scientific progress. Another is that while future drugs are likely to work by simultaneously affecting the behavior of many genes, current patent laws essentially prohibit drug researchers from experimenting with genes they don’t own. Gene therapies may one day produce miracle cures. But researchers who are permitted to study only a limited number of genes will be severely hampered because diseases often arise from complex interactions between multiple genes and the environment.
One worthy suggestion for reform comes from the University of Michigan’s Rebecca Eisenberg, a legal scholar. She says that rather than handing out broad gene ownership patents that allow companies to hide their gene discoveries from others, the patent office could draw up “cross-licensing arrangements.” These arrangements would legally ensure that companies got a share of profits whenever the gene they helped discover was used in a mass-market drug. At the same time, cross-licensing would guarantee that all scientists could experiment with a given gene without fearing reprisal from a company claiming ownership.
Last month, President Clinton declared that the human genome should be readily accessible to everyone. He should direct the patent office to develop approaches that encourage rather than impede science. This includes reclaiming the original intent of patents, which should balance reward to inventors with benefit to science and the public. Biotechnology companies have every right to a share of profits gained when others market drugs based on genes they helped discover. But genes are natural creations and everyone should have equal access to them.
