Who Owns the Code of Life?

[Valin]

City Journal:

Washington control of genetic data would send us down the road to medical serfdom.

Peter W. Huber

Autumn 2013

 

Myriad Genetics spent half a billion dollars developing a database of mutations of the BRCA1 and BRCA2 genes.

When proteins coded in the genes (as shown in BRCA1 above) fail to do their genetic repair work properly, cancer risk is increased.

 

A vast amount of valuable biochemical know-how is embedded in genes and in the complex biochemical webs that they create and control. Does the fact that nature invented it mean that its up for grabs? Lots of people are eager to grab it, Washingtons aspiring managers of our health-care economy now prominent among them.

 

At issue in the Myriad Genetics case decided by the Supreme Court in June were patent claims involving two genes, BRCA1 and BRCA2. Myriad has spent $500 million analyzing thousands of samples submitted by doctors and patients in search of BRCA mutations that sharply increase a womans risk of developing breast or ovarian cancer. Whenever the company found a mutation that it hadnt seen before, it offered free testing to the patients relatives in exchange for information about their cancer history. As a result, Myriad can now predict the likely effects of about 97 percent of the BRCA mutations that it receives for analysis, up from about 60 percent 17 years ago.

 

In Myriad, all nine justices agreed that merely being the first to isolate a naturally occurring gene or other product of nature doesnt entitle you to a patent. That came as no surprise. A year earlier, in Mayo v. Prometheus Labs, the Court had rejected a patent for a way to prescribe appropriate doses of certain drugs by tracking their metabolites in the patients blood, reaffirming long-standing rules that patents may not lay claim to a law of nature, natural phenomenon, or abstract idea. Previous rulings by the federal circuit court that decides patent appeals had reached similar conclusions in addressing attempts to patent all drugs that might be designed to control specific biochemical pathways. A description of a biological mechanism of action without a description of a new device or method to exploit it in some useful way is merely a hunting license for inventions not yet developed. A patent must describe a complete and final inventiona drug, for example, together with a description of the disorder that it can cure.

 

(Snip)

 

Peter W. Huber is a Manhattan Institute senior fellow and the author of the forthcoming The Cure in the Code: How 20th Century Law Is Undermining 21st Century Medicine.