Non-Legal Perspectives On Isolated DNA: The Watson And Holman Amicus Briefs In The Myriad Remand

25 June 2012 PharmaPatents Blog

The most interesting briefs in the Federal Circuit remand of Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU “gene patenting”/BRCA1 case) may be those submitted by James D. Watson and Christopher M. Holman, which each present non-legal perspectives on the issues before the court.

The Watson Amicus Brief

The Watson amicus brief is by far the most eloquent, and reads like an earnest plea from the co-discoverer of the double helix structure of DNA. Watson’s thesis is that

Life’s instructions ought not be controlled by legal monopolies ….

Watson is bothered by the characterization of DNA as a mere chemical compound, and emphasizes “DNA’s informational role in life.”

The entirety of the DNA machinery focuses on transferring and utilizing the genetic information.

The Watson brief recounts Dr. Watson’s involvement in the Human Genome Project and his unsuccessful attempts to prevent the patenting of human genes. As an alternative to a ban on gene patents, Watson proposes a scheme of compulsory licensing.

[A] compulsory license can provide reasonable access to human genes and genetic information—which is what scientists in general want, had the lawyers and courts not complicated matters.

(Really?! When all else fails, blame the lawyers!)

Watson tempers his opinion with a disclaimer that underscores the dilemma facing the court:

I do not suggest that all patents relating to recombinant DNA technology should be abolished.

Not surprisingly, Dr. Watson does not provide any analytical framework for distinguishing what he considers “good patents” from those that he would abolish.

The Holman Amicus Brief

The Holman brief is the most technical, and discusses the science behind the isolated DNA and cDNA claims at issue in Myriad. Professor Holman (a patent law professor with a Ph.D. in molecular biology) takes on several “unfounded assumptions” that are reflected in the Federal Circuit’s first Myriad decision, in an effort to steer the court to a decision that “accurately reflects science” and “provides appropriate incentives for innovation.”

At the outset, Prof. Holman imposes his own claim construction on the Myriad claims:

Properly construed, the challenged claims are limited to synthetic DNA molecules that are structurally and functionally distinguishable from their native counterparts.

(If the Federal Circuit agrees, could the analysis end there?)

Prof. Holman explains that while other “biomolecules” often are physically isolated from their natural environments, “[t]his is not the approach taken in isolating human genomic DNA.

Instead of literally isolating gene sequences directly from chromosomal DNA, biologists create genomic DNA libraries comprising synthetic DNA molecules that retain the nucleotide sequence of genomic DNA, and isolated “genomic DNA” from this synthetic source.

The brief explains further that “[o]nce the DNA sequence of a gene has been determined, there is generally little reason to go back and repeat this process,” since the DNA sequence of interest can be made synthetically “by more convenient means.” The brief also explains that “genetic testing does not involve cleaving the BRCA gene out of a native chromosome, but rather [uses] synthetic copies produced outside the body.” The brief emphasizes that isolated DNA also lacks the methylation patterns of human genomic DNA, further distinguishing it structurally and functionally from a product of nature.

Prof. Holman takes issue with the distinction drawn by the U.S. Government and Judge Moore between isolated DNA and cDNA. In particular, Prof. Holman notes that “cDNA is nothing more than a rote copy of a naturally occurring mRNA molecule.” (In so doing, he asserts that the presence of uracil nucleotides instead or thymine nucleotides is no more or less of a difference than the native methylation patterns absent from isolated DNA.) Prof. Holman emphasizes that, like isolated DNA, cDNA “did not actually originate in the cell” although “it retains the informational content of a native polynucleotide sequence.”

Prof. Holman also criticizes the original Federal Circuit decision (and Judge Moore’s concurrence in particular) for underestimating the significance of the different utility of isolated DNA. In particular, Prof. Holman emphasizes the “economically and therapeutically” important category of protein therapeutics, which cannot be obtained in sufficient quantity from human sources. Prof. Holman cautions the court against “dismiss[ing] this important use of isolated DNA … particularly when … biotechnology companies that produce biotech drugs … are not parties to the litigation.”

Prof. Holman also takes issues with Judge Bryson’s assumption (reflected in his original dissenting opinion) that Myriad’s claims “effectively preempt any attempt to sequence the BRCA genes, including whole-genome sequencing.” Pro. Holman explains that there are many different ways to sequence DNA that do not require the production of any specific isolated DNA sequences.

Getting The Court’s Attention 

I will not presume that the Federal Circuit will be in any way influenced by either of these briefs, but having read all of the briefs filed in the Myriad remand myself, I can say that the Watson and Holman breifs provided a refreshing break from the natural phenomenon vs. law of nature, Prometheus vs. Chakrabarty debate. For that reason alone these briefs may get the court’s attention.

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