Ramblings & ephemera

What patents on life has wrought

From Clifton Leaf’s “The Law of Unintended Consequences” (Fortune: 19 September 2005):

The Supreme Court’s decision in 1980 to allow for the patenting of living organisms opened the spigots to individual claims of ownership over everything from genes and protein receptors to biochemical pathways and processes. Soon, research scientists were swooping into patent offices around the world with “invention” disclosures that weren’t so much products or processes as they were simply knowledge–or research tools to further knowledge.

The problem is, once it became clear that individuals could own little parcels of biology or chemistry, the common domain of scientific exchange–that dynamic place where theories are introduced, then challenged, and ultimately improved–begins to shrink. What’s more, as the number of claims grows, so do the overlapping claims and legal challenges. …

In October 1990 a researcher named Mary-Claire King at the University of California at Berkeley told the world that there was a breast-cancer susceptibility gene–and that it was on chromosome 17. Several other groups, sifting through 30 million base pairs of nucleotides to find the precise location of the gene, helped narrow the search with each new discovery. Then, in the spring of 1994, a team led by Mark Skolnick at the University of Utah beat everyone to the punch–identifying a gene with 5,592 base pairs and codes for a protein that was nearly 1,900 amino acids long. Skolnick’s team rushed to file a patent application and was issued title to the discovery three years later.

By all accounts the science was a collective effort. The NIH had funded scores of investigative teams around the country and given nearly 1,200 separate research grants to learn everything there was to learn about the genetics of breast cancer.

The patent, however, is licensed to one company–Skolnick’s. Myriad Genetics, a company the researcher founded in 1991, now insists on doing all U.S. testing for the presence of unknown mutation in the two related genes, BRCA1 and BRCA2. Those who have a mutation in either gene have as high as an 86% chance of getting cancer, say experts. The cost for the complete two-gene analysis: $2,975.

Critics say that Myriad’s ultrarestrictive licensing of the technology–one funded not only by federal dollars but also aided by the prior discoveries of hundreds of other scientists–is keeping the price of the test artificially high. Skolnick, 59, claims that the price is justified by his company’s careful analysis of thousands of base pairs of DNA, each of which is prone to a mutation or deletion, and by its educational outreach programs.

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