Friday, June 15, 2012

Amicus Briefs In Remand of Myriad

Today is the deadline for filing amicus briefs for the Federal Circuit to consider when it decides the Myriad gene patent litigation, i.e. The Association for Molecular Pathology v. US Patent and Trademark Office, on remand. The first time the Federal Circuit heard the case, I joined with Robert Cook-Deegan in filing a brief arguing that the isolated DNA claims should not be declared patent ineligible, but rather that their validity should be assessed under the more conventional requirements of patentability, i.e., novelty, nonobviousness and enablement. This time I went it alone, and filed a brief on my own behalf, available here (I believe that Bob will also likely be filing his own brief).

In my latest brief, I focus largely on the nature of genomic DNA and cDNA, and the processes by which they are "isolated," and argue that the challenged isolated DNA claims (when properly interpreted) are limited to synthetic molecules that did not originate in the human body, and which are substantially different from naturally occurring chromosomal DNA both structurally and functionally. I also address an argument made by the US government in its amicus brief, i.e., that cDNA is fundamentally different from isolated genomic DNA, and as a result claims limited to isolated cDNA should be considered patent eligible, while claims encompassing isolated genomic DNA are not patent eligible. To the contrary, I argue that isolated genomic DNA and cDNA are quite analogous, and are not different in a way that would justify differential treatment under the patent eligibility doctrine.

I also point out that the Federal Circuit’s earlier decision includes a number of unfounded assumptions regarding the utility of isolated genomic DNA, and the impact of isolated DNA patents on genetic testing and whole genome sequencing. The brief concludes by observing that a determination that any of the challenged isolated DNA claims is patent ineligible could cause serious unintended collateral damage to biotechnology, and should not be made cavalierly based on an overly simplistic and imprecise interpretation of the claims and speculation as to their potential preemptive effect.

Protein Sciences Corporation has filed its own Amicus brief, available here, which argues that:
Prometheus applies to method claims and does not change this Court’s correct decision as to the Representative Composition Claims, i.e., that isolated DNA molecules and cDNA are patent eligible subject matter under § 101; and that applying Prometheus to the Comparing or Analyzing Claims produces the same result as in Myriad, because the “transformed cells containing an altered BRCA1 gene causing cancer” are not naturally occurring cells, [and thus] the growing of those cells in the presence and absence of a putative cancer therapeutic in the Growth Rate Claim cannot be a method calling for applying a law of nature.
Eli Lilly has also submitted a brief, available here, which does not address the isolated DNA claims, but argues that claim 20 (the method claim reciting the use of BRCA gene in cell-based assay to screen for potential drug candidates) is patent ineligible if it includes a "mental step."

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EG said...

Professor Holman,

Thanks for submitting you supplemental brief in the Myriad case to try to inject some correct "science," as well as a correct view of what Myriad's isolated DNA sequence claims. The position taken by the ACLU and PubPat that these claims "patent human genes" is utter "mythology" and should be characterized as such.

Anonymous said...

The technical description of a complicated process for replicating a naturally occurring sequence does nothing to explain how the resulting sequence is not identical to the naturally occurring one. Your argument obfuscates rather than clarifies.

Anonymous said...

Equating an isolated and purified DNA molecule with a cell's chromosomal DNA is like saying a glass of drinking water is just the same as the Pacific Ocean, because anyone can see that they are both 'water'.

I think a lot of the misunderstanding around the Myriad case stems from the fact that any layperson (such as a District Court judge) can understand DNA sequence as a string of characters – A,C,G, and T – and because that is what is understood, that is what is considered important. What gets lost is that a DNA sequence is a simplified description of JUST ONE ASPECT of a chemical molecule, and does not fully describe the molecule itself.

Myriad's DNA claims are to isolated DNA molecules, which are structurally AND functionally VERY DIFFERENT chemical molecules than chromosomal DNA as it exists in a cell. Is that putting it simply enough? Or are you interested in all the chemical reactions that can be done with an isolated DNA molecule but not with chromosomal DNA, because (among many other reasons) the ends of the isolated DNA molecule are different?

Anonymous said...

More begging the question, since even were we to accept that there were some difference between the two, under Prometheus, if the claim to the string effectively claims a naturally occurring composition of matter (the nucleotide sequence at issue, in this case) then it is ineligible under 101. Nothing in what Holman's brief argues, nor your response above, shows that the product embodying the sequence at issue in the patent is not effectively a product of nature. The beginning and end of the gene are, after all, defined by the promotor and stop codons nature created, not by man, and the sequence of nucleotides has not been altered between them. So, how is the sequence at all man's creation, rather than natures's?

Anonymous said...

The previous comments are a perfect illustration of the conflation, in the minds of many, of the DNA sequence and the molecule itself.

The ends of the MOLECULE are chemical moieties - a phosphate group at the 5' end and a hydroxyl group at the 3' end (to put it simply) - and have nothing to do with the sequence of bases attached to the backbone of the molecule. The structure and availability of the chemical groups at the ends of the molecule are important determinants of the reactions it can undergo and thus its functionality, and are very different (among many other characteristics) when one compares an isolated DNA molecule and chromosomal DNA in a cell.

But apparently this is too hard for a layperson to understand, and so the emphasis on the DNA sequence - to the complete exclusion of other extremely relevant aspects of the molecule - continues.

Anonymous said...

Yet, let's read the claims at issue:

"1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.

2. The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1.

5. An isolated DNA having at least 15 nucleotides of the DNA of claim 1.

6. An isolated DNA having at least 15 nucleotides of the DNA of claim 2."

What of those isolated DNAs having the sequences described is man-made? Not a bit. The continued question begging revolves around the simple question at issue on remand: are the claims over something that is essentially a product of nature, or of something created by man. The DNAs at issue are defined by sequences having no part of them created by man, but are merely isolated according to natural laws, specifically those evolutionary devices that cause genes to be read correctly, not anything man devised. The uses are irrelevant to that question, many natural things are useful. Many products of nature can be made more useful through isolation, but they remain products of nature. Take, for example, any element on the periodic table of elements. Here, a natural landmark was discovered, and that discovery is useful for finding a propensity for cancers, but the processes by which the genes were discovered are well known, and the actual product attempted to be monopolized in the claims was not itself created by man, but is rather a natural product, or natural phenomenon of the type that Chakrabarthy makes clear is ineligible under section 101.

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Thanks for submitting you supplemental brief in the Myriad case to try to inject some correct "science," as well as a correct view of what Myriad's isolated DNA sequence claims. The position taken by the ACLU and PubPat that these claims "patent human genes" is utter "mythology" and should be characterized as such.

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