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The Angelina Jolie Connection: The Debate Over Patenting Human Genes

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From the star's op-ed in the New York Times all the way to the Supreme Court, the debate over human gene patents is heating up.

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The History of Gene Patenting

The door for gene patenting was opened by the 1980 Supreme Court case Diamond v. Chakrabarty, in which a genetic engineer for GE (NYSE:GE), Anada Chakrabarty, won the right to a patent for a genetically engineered bacterium with the ability to break down crude oil. The argument against Chakrabarty, made by Sidney Diamon, the Commissioner of Patents and Trademarks, maintained that living organisms cannot be subject to patent. The engineer won the case when the Court ruled, after a 5 to 4 vote, that the organism had in fact been manufactured, writing that "the fact that micro-organisms are alive is without legal significance for purposes of the patent law."

Two years later, the first patent of a gene was issued to three scientists from the University of California at Berkeley who had isolated a recombinant DNA transfer vector that coded for the gene chorionic somatomammotropin. This patent would also result in legal problems, with allegations made that Genentech had stolen the patented vector and used it in the development of Protropin, a growth hormone intended for the treatment of dwarfism. That case wouldn't end until 1999, with a settlement.

After these first two landmarks, and with the monumental sequencing of the human genome, more and more patents were filed for genetic material. About 20% of human genes have been patented over the past 30 years.

The Case Against Gene Patenting

Arguments against gene patenting claim it is wrong both as a matter of science since it limits research, and as a matter of business since it limits innovation and opportunities that could be created by that research.

BRCA1 is a very useful indicator for scientist and doctors. In women who have the gene BRCA1, there is a 50% to 60% chance of developing breast cancer by the age of 70, while there is a 35% to 46% chance of developing ovarian cancer by 70. Obviously many women would want to know if they possess the gene, and therefore, a likelihood of cancer, and only Myriad and the companies it licenses to can conduct the test. Therefore prices are extremely high. (Myriad charges $3,500 for the diagnostic test.)

To understand what is at stake with the upcoming upcoming Supreme Court decision, I spoke with Dr. Diane Allingham-Hawkins, the Senior Director of Genetic Test Evaluation Program at the health care consulting firm Hayes, Inc. According to her, gene patents restrict who can do what kind of test, limiting the potential for beneficial research. Even though patents protect only isolated genetic material, and not that material in its natural form, for scientific research, it's only the isolated form that is useful. Only Myriad or a company it licenses the patent to can do any kind of legal research on BRCA1.

Allingham-Hawkins referred us to a 2012 US Court of Appeals for the Federal Circuit case, Association of Molecular Pathology et al v. US Patent Office et al, which began in 2009 and is the case that will be heard by the Supreme Court in 2013. One of the dissenting judges in 2012, Judge Bryson, employed a leaf analogy, comparing a gene that has been isolated from the human body to a leaf that has fallen or been removed from a tree. A leaf plucked from a tree is not patentable material, and as Bryson maintained, a gene should not be, either. Of course, this analogy discounts the expertise and labor required to successfully isolate a genetic material, but the point has resonated with bioethicists who fundamentally disagree with the practice of gene patenting, as well as genetic researchers and smaller companies who want to broaden their research and business.

Ethically, the question is simple: Should we be allowed to patent, to hold exclusive rights to a naturally occurring material, even if it requires a great deal of work to isolate for scientific purposes?
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