In big news – which happened late on a Friday afternoon – the Department of Justice has filed an amicus brief arguing that at least one common kind of gene patents should not be granted or found valid.
The brief cane in the appeal to the Federal Circuit of the Myriad BRCA 1 and 2 patent case. Judge Sweet of the Southern District of New York ruled early this year that many of Myriad’s claims were invalid. He overturned some of the composition of matter claims on the ground that the information in genes could not be patented and overturned the diagnostic testing claims based on an application of the CAFC’s decision in Bilski. Myriad appealed everything.
Now, reversing decades of US government policy and practice, the government has sided with the plaintiffs on the appeal of the Myriad case on the issue of patentability of “isolated” human genes. The brief goes through the precedents and argues that mere “isolation” or “purification” has never been enough for a patent.
The feds argue that cDNA or other manipulated DNA can be patented but that “natural” DNA, even if isolated, cannot be. They therefore argue that Judge Sweet erred in invalidating any Myriad claims “that are directed solely to cDNA”. [emphasis added] They do not make the “DNA = information, not a composition of matter” argument that Judge Sweet made. The feds do note that, in the future, even cDNA claims might be rejected as obvious.
I am not a patent person, but I do wonder what, even if accepted, the government’s position would mean in the real world. I wonder what it means for organic chemicals that exist (or might exist? or probably exist?) in nature but are produced in pure form for the first time. And I wonder what it means for Myriad’s genetic tests – could they still have a patent on the process of comparing a person’s DNA to the wild type (and known variants) of the BRCA 1 and 2 sequence even if they didn’t have a composition of matter patent on that sequence?
And, among other things, it’s interesting to see the government admit forthrightly that its position reverses decades of US government policy. Wonder who made which arguments to whom to have this issue decided – presumably, it involved more than the Civil Division of the Justice Department!
Here’s a link to the NY Times article, which in turn contains a link to the brief itself.
Interestingly (?), no PTO lawyer is listed on the amicus brief.