Government scientists recently announced that after filling in all the gaps, the Human Genome Sequence is complete.

But as this ScienCentral News Video reports, taxpayers might be short-changed on profits from the multi-billion-dollar project.

Who Owns the Genes?

The human genome has been sequenced. The gaps that remained in the draft sequence published two years ago have been filled in. This promises discoveries of new drugs and therapies targeted at specific disease genes, which will undoubtedly help people. But it will also make a lot of money for the private companies that develop these drugs and therapies. Do these companies deserve to profit from the genome, which was sequenced at public expense? And how do you patent a gene?

The massive amount of information gathered from the Human Genome Project set off a flood of applications to the U.S. Patent and Trademark Office (USPTO) for patents on genes and gene fragments. “The number of issued patents is probably in the multiple thousands,” says Todd Dickinson, former Undersecretary of Commerce for Intellectual Property and director of the U.S. Patent Office, and now a partner at Howrey, Simon, Arnold, and White, a law firm specializing in intellectual property. “The number of pending applications, depending on how you would count a particular gene, may be as high as 20,000.” Biological inventions are patentable if they meet the standard requirements for all patents: They must be novel, useful, not obvious, and described sufficiently for others to reproduce.

Some scientists argue that it’s unethical to patent genes in the first place, because human DNA consists of pre-existing information that has not technically been “invented,” and patenting a part of nature, a basic constituent of life, is the same as allowing one organism to own all or part of another organism. The National Institutes of Health, the major funder for the Human Genome Project, opposes patenting human genes, so all sequence information generated by the project has been deposited into GenBank, a free public database accessible from the Internet. “Everyone on this planet should have the right to have the entire sequence to do whatever they want with it,” says Eric Lander, director of the Whitehead Institute for Genome Research.“And that’s what we’ve guaranteed.”

Or have they?

Some patents have been given for genes and gene fragments whose functions and uses haven’t been determined yet, and NIH, the National Human Genome Research Institute (NHGRI) and many scientists have urged the USPTO not to grant broad patents in such an early stage of research. “If people can patent genes when they don't know what they do, there are two dangers,” explains Gregory Pence, a medical ethicist at the University of Alabama. “The first is that they won't allow somebody else to use the patent. The second is because they don't know what it does, somebody else might discover, ‘Hey, this gene is involved’ and then have to go back and pay that person for the patent.” While the USPTO tightened its requirements for showing "utility" in 1999, NIH still contends they are not stringent enough.

Another problem comes with something termed patent stacking. Dickinson explains: "What if there are a number of entities, a number of research institutions, that have particular gene patents, and the downstream researcher needs access to more than one or needs access to a lot of those, and has to go from owner to owner to owner, and the licenses start to stack up."

“The problem is you may have to get twenty different agreements for all the people and all the things that come together for your clinical conditions,” explains Pence. “That's not something that is really going to stimulate medical research. So it's an unduly cumbersome process that I think was a mistake by the Patent Office in its initial decision to allow patents on human genes.”

image: NIH

Dickinson believes that the issue is not the patenting, it’s the licensing. “The patent system has traditionally encouraged the additional development of the technology, and in pharmaceuticals, for example, without the patent system, we simply wouldn't have many of the pharmaceuticals. I think the same will hold true in the kind of discoveries and therapies that lead from genetic research. The key question is going to be how those licenses are crafted, how easy is the access to the technology, how strict are the requirements that the licensors put on that technology? The entities—whether it's a commercial lab, a university, or a government researcher that gets those patents—need to be aware how important it is that they license them reasonably so that access is optimized, so that people can get those therapies at a reasonable cost and in a reasonable time.”

To prevent patent stacking, Dickinson suggests something called patent pooling, "which people traditionally use in technologies like television, where there's a standard set and everybody puts their patents into a pool,” he explains. “And everybody gets in return the opportunity to license any or all of them out. We may have to look at solutions like that to avoid this stacking problem that some people have cited as a potential concern.”

Pence has another idea. “Congress could amend the patent laws to allow what's called mandatory licensing. It's been done for AIDS drugs in Africa, where basically other companies can make drugs and give a very small royalty back to the original patent holder. Federal judges or Congress could do it after the fact; they'd wipe some of the egg off their face and still allow the person to get some benefit out of all his work.”