Comments on: Up Next in Gene Patents: Waiting for a Ruling (Again) and SACGHS Meets (Again)

By: Ron Ranauro

Ron Ranauro — Mon, 08 Feb 2010 19:27:20 +0000

One of the speakers at the Molecular Medicine Tri-Conference warned that limits on Gene patents for diagnostic purposes is a “slippery slope” for the Patent Office. The argument being “where do you draw the line, for example will image biomarkers be excluded from patent protection. Do you think there is any merit to this concern?

By: Matthew Markus

Matthew Markus — Wed, 03 Feb 2010 20:27:02 +0000

Yes, I agree that isolated GENES might have utility in so much as they are used in genetic engineering. For instance, one could easily claim that an artificial plasmid that codes for insulin is both novel and useful. In the Myriad case, though, the “isolated gene” is non-functional. Myriad makes no attempt to code a BRCA1 protein from the isolated gene and it is not even clear that the “gene”, as isolated by Myriad, even has any meaningful biological properties. Therefore, we are really dealing with isolated DNA from which inferences are made. I just hope that the ACLU is able to tease out these important distinctions.

By: John Conley

John Conley — Wed, 03 Feb 2010 19:39:23 +0000

Matthew -

Thank you for the comment, but I disagree. First, isolated GENES (as opposed to, say, ESTs) clearly meet any historical utility standard. That’s a non-starter. Second, patent lawyers and their clients strongly prefer composition of matter claims to process claims (as a VC just emphasized to my biotechnology law class this morning). Third, of the three processes you identify below, only (3) would have any shot at novelty and nonobviousness. Finally, and most importantly, it’s highly unlikely in my view that the ACLU would make such a concession. They’re undertaking a radical frontal assault on gene patents–that’s the whole point of the litigation. To make the suggested concession would fatally undermine the case they’ve chosen to make.

- John

By: Matthew Markus

Matthew Markus — Wed, 03 Feb 2010 18:34:43 +0000

It seems to me that the ACLU could concede that isolated DNA is different from natural DNA and still have a strong case. The key would be to focus on utility. More specifically, there are three potentially patentable areas around isolated DNA:

1.) The process of isolating the DNA.
2.) The process of transforming the isolated DNA into bits (i.e. information).
3.) The process of transforming the bits into risk profiles (i.e. knowledge).

In this sense, patenting isolated DNA is equivalent to patenting patterns of bits. Both patterns of bits and isolated DNA really have no “specific, credible, and substantial utility” in and of themselves. From a public policy perspective, patenting isolated DNA would also retard investment in, and development of, the third type of process listed above (assuming that processes of the third type can surmount Bilski hurdles).