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Lean, green gene-counting machine | page 1, 2, 3

Getting more specific, though, my question has to do with how broad the definition of use is. The U.S. Patent and Trademark Office says now that it will grant patents for genes wherever applicants can describe a plausible function. But often those explanations are broad and sketchy. In fact, a highly publicized controversy currently swirls around the development of CCR5 drugs designed to inhibit the transmission of AIDS. While Human Genome Sciences currently holds the patent on the gene that CCR5 targets, the HGS patent application made no mention of the potential HIV connection. And four other research teams, meanwhile, have since filed patents on the same gene that make far more specific claims about the gene's potential role in the fight to stop AIDS. Under these kinds of circumstances, who should properly be able to claim royalties from the sale of CCR5 drugs? That's the kind of dilemma I'm looking at.

Again, part of the problem with this debate is that people want to make sweeping generalizations. But every gene patent that's filed is totally different -- different genes, different information, different arguments, different competitors, different research, different methodologies, different patent examiners, the works.

So to make a generalization from the CCR5 matter would not necessarily do the biotech industry any service. That patent has got to have its day in court. It can be challenged just like any other patent.

But one thing I will say about gene patents from Incyte's perspective is that our customers aren't expressing any of these concerns. And that's true throughout the biotech industry. So that means the very people who have to pay these royalties aren't complaining. And people who wouldn't have to pay any royalties in any event -- which generally are the academics -- seem to be the ones who have a problem. So it's a bit strange, if you don't mind my saying so. A big part of the problem here is that people's knowledge of genes is pretty dim. And their knowledge of patents is even dimmer. You put the two together and you get plenty of confusion.

It seems to me that the debate, from a public policy point of view, should turn on questions like: What evidence do we have that these patents are good for the economy? What evidence do we have that they're bad for the economy? And, as I've just told you, the evidence that they're good for the economy is pretty compelling. You've got this biotechnology industry which is growing extremely fast and creating lots of jobs. There are a number of products -- human growth hormone, insulin, you name it -- that are already out there. And huge pipelines of new products are lining up at all the drug companies. We're making quantum leaps in medical research.

Now, on the negative side, I say to people: Name an example of how one of these patents has restricted research or led to some negative result. Or make me an argument for why it's been bad for the economy. And, you know, I'm still waiting.

Princeton molecular biology professor Lee Silver wrote recently in a New York Times Op-Ed piece that the debate over gene patents should be "focused on fair business practices and regulatory issues, not on ethics." Is that consistent with your view?

Yes. But I wouldn't phrase it that way. I think the real issues here are about licensing. These are not patent issues, for all the reasons I've indicated. From our perspective, the patent system is fundamental to the well-being of the global economy. Issues about any patent, really, always come down to licensing anyway. I think there's a statute that says if you've got a patent on something and you can't produce it, you have to license it. I'm just using that as an example of the sort of remedies out there to ensure the patent system works for the public good. And it's an example of how you can fix patent issues through licensing policy. I think we're looking at all the same issues when it comes to gene patents.

In the Incyte database, for example, there are many new and exciting targets for fighting Alzheimer's, cancer and the like. But we don't develop those drugs ourselves. Our policy is to license the patents broadly for a low, single-digit royalty to drug companies -- which turns out to be great for them. The genes have already been discovered, purified and isolated, so they save years in drug development. We collect a small royalty and license our information broadly. It's a win-win all the way around. And that's the way the system should work. Let's say Incyte didn't do that and wanted a 50 percent royalty off every drug, or would only allow its own researchers to work on a particular gene. Then, maybe some public policy issues would need to be discussed. But again, there's nothing different between that scenario and any other type of licensing arrangement.

It turns out, actually, that one suggestion put forth by a legal scholar at the University of Michigan would have the Patent Office issue "cross-licensing arrangements" in lieu of broad gene ownership patents. Are you comfortable with the Patent Office exploring alternatives like that?

Again, if it ain't broke, why fix it? I really think the lack of empiricism here is quite appalling. Where is the problem? We are licensing these things nonexclusively anyway. I just wish people would take an intellectually honest view of what's actually going on instead of projecting problems before they occur. I mean, I keep on hearing academics say, "This is bad because it'll inhibit research." But I'm still waiting to see the examples. Where is research being stopped? The fact is, through access to our data, researchers now have thousands more genes to work with than ever before.

So, basically, the great debate amounts to a lot of hand-wringing over nothing?

Yes. At this point, that is empirically the case.
salon.com | April 24, 2000

 

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About the writer
Mark Compton monitors technology trends from a comfortable perch midway between the Silicon Valley and Oregon's Silicon Forest.

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Related Salon stories
The gene genie Jeremy Rifkin warns that the coming "Biotech century" will be one big genetic bazaar.
By Jeffrey Obser 05/05/98

Nobel dude Kary Mullis revolutionized genetic research but thumbs his nose at the scientific establishment. It thumbs its nose right back.
By William Speed Weed 03/29/00

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