TCS Daily

Michael Crichton Is Right About Gene Patents

By Lori Andrews - January 23, 2007 12:00 AM

In the December 20 TCS Daily, Michael Rosen penned an article is which he stated that Michael Crichton was wrong about gene patents. But it is Rosen who is wrong.

The U.S. Supreme Court has consistently held the line that products of nature are not patentable. But Rosen claims that gene patents are not patents on products of nature. He says that what is being patented is an "isolated and purified" invention made out of a gene. As a legal scholar who has analyzed over 1000 claims in gene patents as well as legal cases around the world that deal with gene patents, I can say that Rosen is wrong about this. Patents used to be sought on cDNA constructs (in which a researcher took out the non-coding regions of the gene sequence and patented the cDNA of the coding regions), but now gene patents are being granted on the actual sequence of mutations and genes as they occur in the body. See, for example, Patent No. 5,654,155 (issued Aug. 5, 1997) and Patent No. 6,762,293 (issued July 13, 2004) or any of the many patents on single nucleotide polymorphisms.

Moreover, even the early cDNA patents ran afoul of the legal rule that a product of nature is not patentable - even if it is isolated and purified and even if discovering it took a lot of work -- if the purported "invention" behaves in the same way as the original product of nature from which it was created. In one Supreme Court case, the patent applicant had mixed several types of root nodule bacteria capable of inoculating the seeds of plants. The crux of the Court's finding was that the combination of bacteria species did not produce a new invention, but served more of a packaging function - just as the cDNA does in the case of gene patents. The Court stated that "The bacteria perform in their natural way. Their use in combination does not improve in any way their natural functioning. They serve the ends nature originally provided and act quite independently of any effort of the patentee." The Court further offered, in perhaps the most oft cited language of the case, "Patents cannot issue for the discovery of the phenomena of nature. . . . The qualities of these bacteria, like the heat of the sun, electricity, or the qualities of metals, are part of the storehouse of knowledge of all men. They are manifestations of laws of nature, free to all men and reserved exclusively to none." Similarly, the person claiming ownership of an isolated and purified human gene is seeking a monopoly on its natural functions - the ability of a gene sequence to anneal to its complementary strand (which allows diagnosis) and the ability to produce proteins. There's no "invention" there - the genes are performing their natural functions.

Rosen is also wrong about the reach of gene patents. A patent on a Groucho Marx moustache (the example Rosen uses) would still allow someone else to patent another fake moustache (say a Fu Manchu moustache). But the patent on the BRCA 1 breast cancer gene allows no chance for another inventor to invent around it. Gene patents give the patent holder the right to the gene sequence, to any substantially equivalent version of it, and to any mutations in it (even those later discovered by someone else) for all diagnostic, research and treatment purposes. The holders of gene patents have not patented any technology or any concrete invention. Yet the holder of the BRCA 1 gene can charge whatever royalty it wants on an any test of that gene and doctors are prevented from using existing or even new technologies to assess a woman's BRCA 1 gene - because to do so they would have to look at the sequence and the patent holder has a right to that naturally-occurring sequence!

If a researcher wants to study a gene, he or she must obtain a license or infringe. Some gene patent holders have stopped research on "their" genes by competitors. This is contrary to the purpose of the patent law - which is to stimulate innovation, not retard it. This is also why Americans must put up with inferior genetic tests to those available in other countries. In countries where the breast cancer genes and hemachromatosis genes were not patented, and thus were freely available for all researchers to analyze, more mutations have been discovered, allowing for better diagnostic testing.

The final points that Rosen makes (also with no evidence) are that "the American gene patent engine has driven many of the most important breakthroughs in the life sciences" and that gene patents are necessary to recoup the vast amount of time, money and resources spent by the person who sequences the gene.

Incentives are certainly important for innovation. But Rosen fails to acknowledge the vast amounts of money taxpayers put into gene sequencing (including into the discovery of the BRCA 1 gene). Why should taxpayers have to pay twice - once by funding the discovery of the genes and then for the inappropriate licensing fee charged by the patent holder?

Moreover, scientists were searching for and finding genes long before patents were available and there is no evidence that the grant of gene patents (as opposed to the patent on the gene sequencing machine) sped this search up. Indeed, when biologists began the Human Genome Project, they had no idea they would be able to patent genes. They were in it for Nobel Prizes, academic advancement, and professional status. The U.S. Supreme Court's Diamond v. Chakrabarty decision, allowing the patent on a genetically engineered bacteria, gave molecular biologists the assurance they would own any life forms they invented by combining genes in ways that did not occur in nature. But when the Human Genome Project was undertaken to spend three billion dollars of taxpayer money identifying all 30,000 human genes, key researchers in the field at the time - C. Thomas Caskey, then at Baylor University and Leroy Hood, then at Cal Tech - warned about the risks of giving intellectual property rights over genes. They said that if scientists were allowed to "own" genes and reap financial rewards by having exclusive rights to any diagnostic or treatment technologies developed with the gene they found, they would be less likely to share copies of the genes they discovered or even share information about those genes. And those harms have come to pass.

America is a world leader in the life sciences not because of gene patents, but because its taxpayer funding of basic research has created scientific knowledge that is available for all. Patents on a test kit for genetic diagnostics or a pharmaceutical product using gene therapy make sense. Tolls for the use of a naturally-occurring gene sequence do not.

Last June, Justice Breyer of the U.S. Supreme Court discussed the reason why it is important not to have patents on products of nature or laws of nature. He said:

The justification for the principle does not lie in any claim that "laws of nature" are obvious, or that their discovery is easy, or that they are not useful. To the contrary, research into such matters may be costly and time-consuming; monetary incentives may matter; and the fruits of those incentives and that research may prove of great benefit to the human race. Rather, the reason for the exclusion is that sometimes too much patent protection can impede rather than "promote the Progress of Science and useful Arts," the constitutional objective of patent and copyright protection.

That is certainly the case with gene patents.

Lori Andrews is professor of law, Chicago-Kent College of Law and the former chair of the federal ethics advisory committee to the Human Genome Project. She has also written a novel, SEQUENCE, about a genetics researcher.



Is this a first?
An intelligent, well-argued, knowledgeable, informed article on TCS? Maybe not, but it's certainly among an elite few.

it is a very intelligent, well-argued, knowledgeable, and informed article. it also completely agrees with the article it claims to be decrying... both say that naturally occuring gene sequences should not be patentable.

Patent protection offshore...
If US Patent protection limits the use of genetic sequences for diagnostic or treatment R&D here in the United States then there might be a significant opportunity for a biotech company to conduct such programs offshore, leading to products and services to be delivered offshore as well. Certainly, many such efforts would chew up a substantial chunk of the 20 years of patent protection. Those products and services would thereby be fine tuned for the US market by the end of that term.

If you could only go to a clinic in Manila, Johannesburg or Prague for important medical treatments then ultimately US voters might beat up on their Congressmen to fix that situation.

What I am saying is that all these biotech operations are global already and if the US choses to restrict "business as usual" here with patent laws then progressive players might simply not play here. If the mother company cannot openly do this than a derivative operation could be launched.

Any number of developing economies (for example the Philippines) might specifically legislate protection for such health service industry activities inside their borders. If there are treaties involved, then we can always sit down and talk about those agreements.

Lawyers and governments who hold back global financial capitalism inside their borders will see affected operations simply move elsewhere. This is the case when industries cannot comply with crippling environmental laws and it should be the case when a business cannot comply with unduly restrictive patent laws. Let the market sort this foolishness out. The goverment and the lawyers will follow the money.

It is confusing...
I had to go back and read the original article again too.

Who is doing whom?
The topic of gene patents brings to mind the two bit prostitute called a "judge", the farmers life long work and Monsanto taking care of competition.
Makes me want to spit nails.

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