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  1. Sledge, George W. JR., MD

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For one brief period in my life I contemplated becoming a lawyer. As a paranoid undergraduate, I applied to both law school and medical school. I got accepted to more law schools than medical schools, but I wanted to be a doctor, and so here I am. I've never regretted the decision, though every now and then I wonder what might have happened had I gone down that path rather than this one.

  
GEORGE W. SLEDGE JR.... - Click to enlarge in new window, Immediate Past President of the American Society of Clinical Oncology, is Ballve-Lantero Professor of Oncology and Professor of Medicine and Pathology at Indiana University Simon Cancer Center.Write to him about this essay or other topics at OT@LWWNY.com, or add comments directly on his OT blog, at

Might I, for instance, have ended up sitting on the U.S. Court of Appeals for the Federal Circuit, as one of the three judges ruling on Association for Molecular Pathology v. USPTO, Myriad Genetics, et al (http://bit.ly/nwWHlR)?

 

For those who do not keep up on the findings of the Court of Appeals, the court overturned a lower court decision on BRCA testing, ruling that Myriad Genetics' patent was (in large part) a valid one. The ruling is likely to be appealed in turn to the Supreme Court, so the current ruling may not be the final one. But for the moment, Myriad owns the rights to that part of you that makes up BRCA1 and BRCA2. And others own up to about 20% of your genome.

 

The case addressed a fairly simple question: can a piece of the human genome be patented? In general, the history of patents is that you cannot patent products of nature. A lower court had ruled that human DNA represented a product of nature, and as such was not patentable. The Court of Appeals, by a 2-1 vote, decided that the isolated DNA for the BRCA1 and BRCA2 genes was markedly different in chemical composition from the natural form, and therefore eligible for patent protection (for two recent discussions of the ruling, see http://bit.ly/qlbo1b by John Timmer and http://bit.ly/pFuuqF by Gould, Norton, and Temeles).

 

This bizarre finding suggests the legal community's profound ignorance of modern science. Isolating DNA and walking up and down chromosome 17 may have been a relatively big deal in 1994, though even then it was largely grunt work, an essentially inevitable discovery once Mary Clare King demonstrated the chromosomal neighborhood for BRCA1. Given time and appropriate resources, it was going to happen. Today a post-doc could do it in a few days or weeks. The important spadework that led to the isolation of BRCA1 and 2 was not that of Myriad Genetics in any way, shape, or form. They just got there first with knowledge generated by others, and got rich.

 

More to the point, however, was the court's specious reasoning that the process of chemical cleavage involved in the isolation of the BRCA genes "imparts on that isolated DNA a distinctive chemical identity from that possessed by native DNA." Huh? The court apparently doesn't get DNA. DNA is, pure, plain, and simple, a code. It is a carrier of information. All of its practical value, its importance, resides in the code, in the correct sequencing of A, C, T, and G. The lower court, and a member of the appeals court (the lone dissenting member) understood this. The two other members apparently flunked high school biology.

 

Why Does Any of This Matter?

Why does any of this matter? The Myriad patents will run out in a few years, turning off the spigot pouring money into Provo, Utah, so the financial pain experienced by high-risk patients will eventually disappear. But the ruling has the potential to derail our ongoing genomic revolution.

 

What will the $1000 genome (for 3.2 billion base pairs) mean if every Tom, Dick, and Harry can charge three or four times as much for an infinitesimally small fraction of that whole? If you perform deep sequencing (which uses similar isolation procedures), will you have to give several thousands of dollars to each and every one of those groups who have collectively patented 20% of the human genome? What a disaster for modern science, and for our patients, that would be.

 

One can hope that once the case finds its way to the supreme court of the land some reasonable understanding of modern biology will prevail.

 

More from George Sledge on His OT Blog! Recent Posts:

 

* On Empathy

 

* On Amy Winehouse

 

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