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August 13, 2003

Six contrasting views on the noncoding DNA patents and business strategy of Genetic Technologies (GTG).

FRANCIS COLLINS
Director
National Human Genome Research Institute

"I personally find it surprising that the GTG patent was issued, given the requirements of the PTO's (U.S. Patent and Trademark Office's) novelty, non-obviousness, and utility standard. After all, there were many prior published reports on the correlation of variation in noncoding regions with important mutations, going back at least to Kan and Dozy's The Lancet report on the sickle mutation back in 1978. But the validity of the patent is something for the attorneys, the PTO, and the courts to weigh in on — not me.

I am much more concerned about the company's aggressive licensing strategy. The research exemption, while not codified by law in the U.S., is a tradition that normally protects academic researchers from charges of patent violation, based on the assumption that the public is best served by the free exercise of scientific creativity in the not-for-profit sector. If it turns out that GTG's approach ends up blocking or restricting access to such broadly enabling technology, then that is of great concern to me and the entire genomics community.

I hope that GTG will seriously consider making its invention freely available to anyone who wishes to use it for noncommercial purposes. Saying that the license fee is only a nominal sum is not reassuring — the legal requirements alone will be enough to scare off some users, [and] asking for any license fee at all starts one down a slippery slope toward significant restriction of academic research.

A good model for implementation of patent and licensing policy can be found in the NIH Research Tools guidelines (see ott.od.nih.gov/NewPages/RTguide_final.html), and we would have preferred to see GTG follow that model."



CHARLES CANTOR
Chief Scientific Officer
Sequenom

"It's very hard to disable an issued patent. While I didn't think the patent was terribly strong — it wasn't an absolutely clear-cut case — in my view it would be a protracted court fight. I felt we would win it in the end, but it wasn't worth it.

What made the license attractive is that we had the ability to pass on the sublicense to our customers. This meant that people who use things that read more closely on the patent would still be able to get access to the patent. This made our platform more attractive. Since we prefer to mount our SNPs in coding DNA, our preferred embodiment does not infringe the patent."



KATE H. MURASHIGE
Patent Attorney
Morrison & Foerster, San Diego

"I think this is straight in line with the Duke v. Madey decision (see page 1), which the Supreme Court just refused to consider. Duke v. Madey didn't change the law, but it pinpointed the fact that just because you are not working with a for-profit company doesn't mean you are not doing commercial research ... it explicitly said universities are businesses, too.

So GTG is clearly operating within the law and maybe just ruffling a few feathers because it's a departure from what people ordinarily do. But it's very hard for me to get up in arms about it. I don't find its strategy [regarding academic licensing] offensive, though it may be stupid, and I don't know that there's that much money in it."



ROBERT COOK-DEEGAN
Director
Center for Genome Ethics, Law, and Policy, Institute for Genome Sciences and Policy at Duke University

"The crucial questions are about the prior art. The presumption is very heavily in favor of a patent holder. If you can find prior art, that's often the only way to overturn it. Why would GTG go after university-based researchers, unless they're planning on doing this with hundreds of universities? If they were doing what most companies do, they would not enforce the patent on universities. Going after universities, and thus increasing costs of research for everyone, is just the sort of thing people are worried about in the wake of Duke v. Madey. If they choose to enforce the patent against companies and universities, the choices are to pay the license fees or try to kill the patent — sign up or take your chances in court. The third option — quietly ignoring the patent — is gone now.

If this and another case or two begin to seem like a trend, then support for a legislative research exemption in U.S. law will grow. No one has wanted to go there, because an exemption is hard to define without killing some markets for research tools — we don't want to kill the instrumentation markets. But a patent like this on a seminal method could draw everyone's attention to the problem. Ultimately, a patent enforced against publicly funded research means the taxpayer is footing the bill."



BETH ARNOLD
Patent Attorney
Foley Hoag, Boston

"I'm not surprised to hear that companies such as Sequenom and Perlegen have signed on to a license, since by licensing they avoid patent infringement claims being asserted against their customers. But I am a little surprised about the University of Utah ... In the past, universities have asserted that basic researchers are exempt from infringement based on 'experimental use' or based on the Hatch-Waxman exemption. However, recent cases, such as Duke v. Madey and Integra v. Merck KGaA, indicate otherwise. One reason companies have not asserted tool-type patents against university researchers, even when fairly certain of widespread infringement, is because they realize that a court would not assess much in the way of damages for infringement based on truly 'academic' research use. A court would also be reluctant to issue an injunction prohibiting that research."



BARBARA RUSKIN
Patent Attorney
Fish & Neave, New York

"GTG is entitled — and likely obligated — to protect and enforce its IP assets by challenging potential infringers in a legal setting if they refuse to license. If you do not enforce a patent against a known infringer, your patent loses its future value. A potential infringer that is unwilling to pay a license fee may defend itself by proving that it does not infringe the patent and/or that the patent is invalid, e.g., that the invention is not novel or is obvious in view of the prior art. That's what the patent system is all about.

Aside from a single product claim, directed to an HLA locus-specific primer, all of GTG's other claims are method claims for using noncoding DNA. New uses for old or otherwise unpatentable products are themselves patentable. There is nothing outrageous about GTG owning rights to patented, innovative methods using noncoding DNA just because noncoding DNA constitutes such a large part of the genome and it turns out to be so useful in methods of genetic analyses.

I think that GTG has done what every entrepreneur company dreams of — it appears to have realized far earlier than most the utility of 'junk DNA.' Sydney Brenner talked more than a decade ago about the difference between 'garbage' versus 'junk' DNA, and ... [it seems] presumptuous for scientists to believe that noncoding sequences were 'junk' just because they didn't appreciate their role or value in molecular evolution, gene regulation, chromosomal structure, etc."


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