Derek Lowe has a post up about the reversal of a prior court’s decision that had struck down Myriad Genetic’s patent claim to BRCA testing. “BRCA” is a gene, mutations of which are associated with breast cancer. The gene name stands for “BReast CAncer”, and there are two different BRCA genes, BRCA1 & BRCA2. Myriad had sought to patent these genes, in effect positioning themselves to be the only company that could perform the test to see if a patient carried a mutation in one or both of the genes.
In Myriad’s favor, an appeals court reversed the prior decision, reasoning that a single molecule, in this case a very small piece of naturally occurring DNA, which is isolated and chemically modified in order to perform a test with it, is eligible for patent. If you read closely the portions of the decision Derek posted, you’ll see what the appeals court said this decision was about, and specifically what it wasn’t about. The appeals judge ruled the case was not about “patentability”, but rather “patent eligibility”. I confess the two are synonymous to me, but I’m not a lawyer.
The court’s reasoning turns on the fact that while the BRCA1 (or 2) gene does exist naturally, it exists as one (very) small piece of a vastly larger polymer, i.e. nuclear DNA. That is, the individual BRCA genes (1 & 2) do not exist naturally as a separate and isolated molecules in the cell, which, if they did, would make them ineligible for patent protection.
Pretty slippery reasoning if you ask me. But as one commenter to the post said, new DNA sequencing technologies, which are getting better and cheaper all the time, will likely render the implications of this decision moot.