Appeals Court Upholds DNA Patents

Last year, Judge Sweet of the Southern District Court of New York shocked the legal and scientific communities by ruling that genes cannot be patented, as they constitute products of nature, and the comparison of gene sequences cannot be patented as they are abstract mental processes. Yesterday, the Federal Circuit overruled that decision with regard to genes. Essentially, it held that breaking the covalent bonds that hold the gene to the DNA strand results in a new chemical compound, just as burning sugar breaks it into carbon dioxide and water.

The dissent argued that the genes already existed within the DNA strand, so their isolation is akin to mining a mineral from ore--the process may be patentable, but the mineral itself is not patentable as it is a natural product.

The implications of the ruling are significant, especially as medical science progresses. The lawsuit concerns the BRCA1/2 genes associated with breast cancer, and a diagnostic test for these genes. After the patent was issued, the price for the tests skyrocketed. Furthermore, doctors were unable to tell their patients of test results, and patients whose insurance was not accepted by Myriad, the plaintiff, unless they could pay out of pocket.

Myriad owns the patent on BRCA1/2 genes but they did not locate the gene on the DNA strand. It did not associate these genes with breast cancer. It did not create the process for sequencing DNA. Instead, it applied known sequencing techniques directed at the already identified location on the DNA. Arduous work, yes, but the dissent essentially argues that mining coal is difficult but doesn't make coal patentable.

This case is not over yet. Hopefully, genes will be declared non-patentable once the patent laws are redone.


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