In the race to plumb the human genome, biotechnology companies and research institutions work at a brisk pace to target the triggers of disease and develop therapies to combat them.
The prizes of this work are obvious: Those afflicted with chronic diseases and conditions may receive relief or be cured, and scientists who take the risk and succeed in developing these therapies reap tremendous financial rewards. What guarantees this payoff for researchers is the possession of a patent.
But the very patents that make one biotechnology researcher's gambit worthwhile are likely to stymie the innovations of countless others, say two University of Michigan law professors.
In a paper published in the 1 May issue of Science, Michael Heller and Rebecca Eisenberg highlight what they believe is a growing problem in the patenting of biotechnology inventions: By granting ownership to parts of genes and pathways to genes, the government is fast creating a kudzu of overlapping patents and intellectual property rights. This maze is adding to the already steep cost of drug development, estimated by the industry at anywhere from US$7 million to $300 million for a company to develop a single drug.
"You have researchers who need to go to all the previous owners to get licensing agreements just to develop their inventions," said Eisenberg, a professor who has spent fourteen years studying biotechnology patent law.
Patent laws were designed to spark innovation by encouraging inventors to share their discoveries with the public. Successful patent applications in the eyes of the Patent and Trademark Office describe unique inventions and how they will work. In exchange for making inventions public, creators are granted exclusive ownership of the work for a period of 20 years to allow them to recoup the investment on their work. This exclusivity allows other inventors to create related developments, but they must negotiate licensing agreements with patent owners.
And while researchers interviewed by Eisenberg and Heller were able to agree that there is a problem with patents, none wanted to go on the record with their stories. "It's a sign of how competitive things are. They didn't want to tip their hands to their work or leave themselves open for litigation," Heller noted.
According to the paper, the trouble with patents in the biotechnology industry is that fragments of genes are patentable. Since 1991, inventors have been able to discover and patent these fragments, including expressed sequence tags, segments of DNA that lead to genes and gene sequences. A gene or gene sequence can have several fragments, so several inventors can own rights to different routes to a gene or gene sequence. This mosaic of rights to fragments of genes creates a potential litigation minefield for inventors who come later into the process.
"What you have is a heterogeneous set of owners -- too many people with rights to exclude," Eisenberg explained.
Through such exclusive ownership, parts of the genomic resources may go overlooked, she added. So instead of an industry that generates waste by misusing or overusing resources, the biotechnology field may become wasteful by the very act of not using resources.
For Heller, what is happening in the process of privatizing genetics research is much like the distribution of property in the former Soviet Union. The associate professor, an expert in property and international law, noticed something quite odd when he visited Russia and the other former republics: Scrap metal kiosks brimming with products lined sidewalks against a backdrop of empty storefronts. Obviously, entrepreneurs were running their businesses, but they weren't able to take advantage of the stores left bare by the exit of socialist-run firms.
The problem? In the transition from government-run stores to private business, no individual had a bundle of ownership rights. Instead, ownership of the storefronts was fragmented among workers' collectives, privatization agencies, and local, regional, and federal governments. So to get use of a storefront, a businessperson had to work out agreements with each of the owning parties, a process so wrought with bureaucracy and cost that it wasn't worth the effort. As a result, the storefronts lay fallow.
The myriad of agreements that biotechnology inventors face is every bit as daunting. And the costs are hard to determine, Heller said.
"[With a misuse of natural resources], you can look out your window and see the pollution, but it's hard to see what the costs are when a drug isn't discovered," noted Heller.
Through the publication of their paper, Heller and Eisenberg hope to get the biotech industry to generate data such as the costs to society when a drug isn't developed. "It's a harder kind of research to do," said Heller.
