Becoming a Gene King takes more than clever technology. Contenders must navigate the shifting shoals of patent law--a challenge, since no one knows exactly what will be patentable in the future.
Some precedents do exist. Several hundred genes--and their protein products--are currently patented for medical use. But that's a tiny fraction of all human genes. And the few blockbuster patents awarded--such as Genentech Inc.'s on human growth hormone and clotbuster TPA--have sparked fierce court battles.
The looming question: How much information will scientists and managers need to secure a patent? If they find a gene, read its complete code, and show how it works in the body, they can probably win exclusive rights to it--and to the protein it produces, which may have pharmaceutical value. Examples include Amgen Inc.'s two top-selling biotech drugs, Neupogen and Epogen, both of which fetch more than $500 million a year.
UNCHARTED TERRAIN. But what about drugs based on modifications of the protein? Or drugs aimed at particular parts of the biological pathways the genes control? These are still uncharted territories. And things get even murkier when companies decipher, or sequence, just part of a gene. Human Genome Sciences Inc. (HGS) has tens of thousands of "genes" in its database. But most, in fact, are fragments. Where HGS can demonstrate a useful function--say, as a diagnostic tool--the Patent & Trademark Office will probably grant protection. But each fragment will require individual testing and filing.
The changing landscape has led some to question the value of HGS's vast gene storehouse. When HGS began, "they clearly expected that the gene sequences themselves would have some proprietary value," says Viren Mehta, head of research at Mehta & Islay in New York. Now, he says, this looks like a long shot.
So HGS has shifted its focus from amassing sequences to developing and patenting diagnostics and drugs. "We aren't going to be able to protect 90% of human genes," admits HGS founder Wallace H. Steinberg.
Patent controversies can only get worse. As technology for finding and sequencing genes improves, public databases are being flooded with new gene sequences. Merck & Co.'s operation at Washington University alone is producing more than 4,000 a week. And even faster sequencing methods are on the horizon. Startup SEQ Ltd. in Princeton, N.J., boasts of an approach that will be a thousand times faster and a thousand times cheaper than today's technology.
It's also getting easier to snare full genes from fragments. So if the pieces happen to be in public databases, the Patent Office may consider them to be "prior art," making the full gene unpatentable. The same thing could happen if genes get too easy to find and sequence, says Washington patent lawyer Reid Adler: Courts may deem the information "obvious," and thus unprotectable.
With so much legal turmoil, "the potential is there for enormous patent battles," says Randal W. Scott, chief scientific officer at InCyte Pharmaceuticals Inc. Winning the Gene King throne, it seems, may depend as much on lawyers as it does on science.