Wednesday, August 03, 2011

Split Federal Circuit in Myriad Case Partially Reverses District Court and Finds Isolated Human Genes to be Patentable: Subsequent Supreme Court Review of this Case is Surely Essential

Thank goodness that this matter still has a chance to go to the U.S. Supreme Court, where one can hope that Supreme Court Justices better understand "products of nature" and the "nature of an invention" under the U.S. Constitution and patent laws than the judges on the Federal Circuit.

In a very disappointing split decision, Association for Molecular Pathology v. Myriad Genetics, No. 2010-1406 (Fed. Cir., July 29, 2011), in which Judge Kimberly A. Moore concurred in part and Judge William Curtis Bryson concurred and dissented in part, Federal Circuit Judge Alan D. Lourie wrote an opinion for the Federal Circuit Court reversing a District Court holding that human genes were not patentable subject matter as a "product of nature", and finding on the contrary that isolated genes in the laboratory were "inventions" as new "identities".

Judge Lourie in his opinion specifically finds that isolated genes are inventions as new molecules, as the process of cleaving gives them a distinct identity:
" BRCA1 and BRCA2 in their isolated state are not the same molecules as DNA as it exists in the body; human intervention in cleaving or synthesizing a portion of a native chromosomal DNA imparts on that isolated DNA a distinctive chemical identity from that possessed by native DNA."
That may be the chemist's pride at his work, which Lourie initially studied, but that is not the transformation that is required by the law for patentability. To determine whether the cleaved part of DNA is an "invention", one must properly ask whether any chemist skilled in the the art, cleaving DNA at exactly the same locations, would come up with exactly the same "molecule" and the answer is yes, obviously. Hence, that "molecule" is not a patentable invention. "Finding" is not inventing. "Cleaving" or "cutting" are not inventive processes.

As David Koepsell writes at Who Owns You?, the concurring judge Moore tried a different approach to give the cleaved material a new identity :
"Moore argues that there is some significant chemical distinction between an isolated gene and a gene found in nature because at the ends of the isolated gene are nothing, whereas at the ends of the gene found in nature are more nucleotides. This does not support any claim of morphological difference between the claimed gene or gene parts and the sequence identified as occurring in nature. As I argue in my book, drawing a border does not create, automatically, a new, unique thing, especially where, as here, the information encoded in the string (which directs the functionality of a gene) is nature's own definition of a border."
Note that Judge Moore, previously an electrical engineer, views the isolated gene like an axon, whereas Judge Lourie, a chemist, concentrates on the new "formula identity" of the isolation. Neither is able in their law analysis to escape their technically-imposed and surely subconscious biases. Moore even distinguishes long and short cleaves, a legal standard impossible to apply anywhere. This is one of the problems with thinking that technically-trained AND law-trained judges are a better choice for the Federal Circuit than top-level normal JDs - they are not. Quite the contrary, the technical background seems to serve as a limitation.

Actually, all that happens in the laboratory is that DNA strands are cut into various pieces in the laboratory and various companies are patenting the cut pieces, dividing up the genetic jackpot "pie" of the human organism for their own monopolistic personal profit. THAT does not deserve the monopoly protection of the patent laws via sophistry in describing the cut pieces.

Judge William Curtis Bryson, whose understanding of the law in this case appears to be somewhat advanced to his colleagues, wrote correctly in dissent that only applications of genome knowledge should be patentable, not the genes or parts of genes themselves:
"In its simplest form, the question in this case is whether an individual can obtain patent rights to a human gene. From a common-sense point of view, most observers would answer, "Of course not.  Patents are for inventions.  A human gene is not an invention." The essence of Myriad’s argument in this case is to say that it has not patented a human gene, but something quite different—an isolated human gene, which differs from a native gene because the process of extracting it results in changes in its molecular structure (although not in its genetic code). We  are therefore  required  to  decide whether the process of isolating genetic material from a human DNA molecule makes the isolated genetic material a patentable invention. The court concludes that it does; I conclude that it does not.
At the outset, it is important to identify the inventive contribution underlying Myriad's patents.   Myriad was not the first to map a BRCA gene to its chromosomal location. That discovery was made by a team of researchers led by Dr. Mary-Claire King.  See Jeff M. Hall et al., Linkage of Early-Onset Familial Breast Cancer to Chromosome 17q21, 250 Science 1684 (1990).  And Myriad did not invent a new method of nucleotide sequencing.   Instead, it applied known sequencing techniques to identify the nucleotide order of the BRCA genes.1  Myriad’s discovery of those sequences entailed difficult work, and the identified sequences have had important applications in the fight against breast cancer.  But the discovery of the sequences is an unprotectable fact, just like Dr. King’s discovery of the chromosomal location of the BRCA1 gene.
Of course, Myriad is free to patent applications of its discovery. As the first party with knowledge of the sequences, Myriad was in an excellent position to claim applications of that knowledge. Many of its unchallenged claims are limited to such applications. See, e.g., ’441 patent, claim 21; ’492 patent, claim 22; ’282 patent, claim 9. Yet some of Myriad’s challenged composition claims effectively preempt any attempt to sequence the BRCA genes, including whole-genome sequencing. In my view, those claims encompass unpatentable subject matter, and a contrary ruling is likely to have substantial  adverse effects on research and treatment in this important field. "
By the "formula" reasoning of the majority opinion of the Federal Circuit, a gene is a "product of nature" only in situ in the body and every "cleaved" i.e. "cut" part of a gene is otherwise a potentially patentable "invention" as a new "identity" viz. "formula". Maybe that is how chemists view the world, but MY GENES protest that opinion, in whole and in part. Not YOUR invention, thank you.

Essentially, just because people want to make a lot of money by applying knowledge does not make the foundation of that knowledge a patentable invention deserving of monopoly protection.

If the decision of the Federal Circuit here were allowed to stand, Myriad would retain its monopoly position on a human gene not only in terms of future research on that gene but it would also be able to prohibit doctors in clinics from conducting certain kinds of tests for breast cancer using that gene without Myriad's permission since those tests would involve a human gene upon which they have wrongly been given a patent. As written in the majority opinion:
"As a result of Myriad's patent enforcement actions, Dr. Ostrer was forced to send all patient samples to Myriad, now the sole provider of BRCA diagnostic testing services."
Such monopolist exploitation of the worst kind is not the world the nation's founders imagined when they legislated patent protection. No way.

That is patent law jurisprudence gone wildly wrong.

We posted previously about the Myriad gene patent case at:

How SWEET It Is! Gene Patents Ruled Invalid as Genes are Found to be Non-patentable Subject Matter

Stephen Colbert on Gene Patents and the Myriad Case : Humor

The Body Snatchers are Alive and Well : In ACLU v. Myriad, the Battle over DNA Patents Rages

See also:

Robert Esmond, Ph.D. and Kevin W. McCabe of Sterne Kessler Goldstein & Fox at Federal Circuit upholds the patentability of isolated DNA in association for Molecular Pathology v. Myriad

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