Thursday, August 16, 2012

SCOTUS, Here We Come

So, the Court of Appeals for the Federal Circuit, in reconsidering on remand their decision in the Myriad case has agreed with itself. No big surprise, though I did suggest that, if they wanted to preserve as much gene patenting as possible, they would craft a narrow enough decision, hewing to the Supreme Court's reasoning in Mayo, to withstand scrutiny on the inevitable appeal. They did not. They doubled-down, offering no new substantial reasoning, and basically reiterating their previous arguments. Bryson too stuck to his guns, the ones that will prevail in the Supreme Court, as he dissented and found the claims to the BRCA1 and 2 mutation sequences to be claims over ineligible subject matter. He stated it plainly, thus:

"Myriad is claiming the genes themselves, which appear in nature on the chromosomes of living human beings. The only material change made to those genes from their natural state is the change that is necessarily incidental to the extraction of the genes from the environment in which they are found in nature."

So the majority once again believed that the process of "extraction" of the nucleotide sequences devised by nature from the adjoining nucleotides was sufficient, even under Mayo, to be eligible subject matter under §101. Bryson once again disagreed, and now it's up to the Supreme Court. Let's recall that in Mayo, the decision of the CAFC was unanimously in favor of patent eligibility of a diagnostic method. This is not the case here, Bryson dissented. Let's also recall that the Supreme Court unanimously overturned the CAFC in Mayo, finding that the patents over methods of dosing based upon measuring metabolites were effectively claims over laws of nature. Man didn't make those relationships. Man didn't make the sequences in the Myriad case either, and odds are good that the Supreme Court will side with Bryson on this score. But one never knows, they could find some relevant difference between the cases. I don't see it. As he points out,

"Just as a patent involving a law of nature must have an 'inventive concept' that does 'significantly more than simply describe . . .natural relations' *** a patent involving a product of nature should have an inventive concept that involves more than merely incidental changes to the naturally occurring product."

To conclude, I see in Bryson's dissent a glimmer of the test I have been arguing for to divide the natural from the man-made. My test is: is the thing claimed dependent upon human intention and design? Bryson states:

"In that setting,  man has defined the parts that are to be retained and the parts that are to be discarded, and he has molded the retained portion into a product that bears little resemblance to that which occurs naturally."

He then correctly points out that genes are in fact defined by nature, with stop and promoter codons, and this is what allows them to function in protein synthesis. Man didn't create these boundaries, we merely identify them. So, I still hope that the Supreme Court will draw the bright line I am arguing exists between nature and artifact: the necessary and sufficient conditions for not being natural are: the intention and design of man. I look forward to hearing from those who disagree with a solid counterexample.

Meanwhile, it ain't over 'till the Supremes sing.