US Court Sides With Gene Patents

Here's a fuller explanation from the opinion (not that I agree with it). They appear to be making a distinction between isolated DNA, which is allegedly nonnaturally processed in a way that renders it patent-eligible, and "native DNA" as it exists inside the human body, which is a natural occurring composition of matter.

It is undisputed that Myriad?s claimed isolated DNAs exist in a distinctive chemical form?as distinctive chemical molecules?from DNAs in the human body, i.e., native DNA. Natural DNA exists in the body as one of forty-six large, contiguous DNA molecules. Each of those DNA molecules is condensed and intertwined with various proteins, including histones, to form a complex tertiary structure known as chromatin that makes up a larger structural complex, a chromosome. See supra, Figure 3. Inside living cells, the chromosomes are further encapsulated within a series of membranes and suspended in a complex intracellular milieu.

Isolated DNA, in contrast, is a free-standing portion of a larger, natural DNA molecule. Isolated DNA has been cleaved (i.e., had covalent bonds in its backbone chemically severed) or synthesized to consist of just a fraction of a naturally occurring DNA molecule. For example, the BRCA1 gene in its native state resides on chromosome 17, a DNA molecule of around eighty million nucleotides. Similarly, BRCA2 in its native state is located on chromosome 13, a DNA of approximately 114 million nucleotides. In contrast, isolated BRCA1 and BRCA2, with introns, each consists of just 80,000 or so nucleotides. And without introns, BRCA2 shrinks to approximately 10,200 nucleotides and BRCA1 to just around 5,500 nucleotides. Furthermore, claims 5 and 6 of the ?282 patent cover isolated DNAs, e.g., primers or probes, having as few as fifteen nucleotides of a BRCA sequence. Accordingly, BRCA1 and BRCA2 in their isolated states are different molecules from DNA that exists in the body; isolated DNA results from human intervention to cleave or synthesize a discrete portion of a native chromosomal DNA, imparting on that isolated DNA a distinctive chemical identity as compared to native DNA.

As the above description indicates, isolated DNA is not just purified DNA. Purification makes pure what was the same material, but was combined, or contaminated, with other materials. Although isolated DNA is removed from its native cellular and chromosomal environment, it has also been manipulated chemically so as to produce a molecule that is markedly different from that which exists in the body. Accordingly, this is not a situation, as in Parke-Davis & Co. v. H.K. Mulford Co., in which purification of adrenaline resulted in the identical molecule, albeit being ?for every practical purpose a new thing commercially and therapeutically.? 189 F. 95, 103 (C.C.S.D.N.Y. 1911). Judge Learned Hand?s opinion for the district court in that oft-cited case held the purified ?Adrenalin? to be patent-eligible subject matter. Id. The In re Marden cases are similarly inapposite, directed as they are to the patent ineligibility of purified natural elements?ductile uranium, 47 F.2d 957 (CCPA 1931), and vanadium, 47 F.2d 958 (CCPA 1931)?that are inherently ductile in purified form. While purified natural products thus may or may not qualify for patent under 101, the isolated DNAs of the present patents constitute an a fortiori situation, where they are not only purified; they are different from the natural products in ?name, character, and use.? Chakrabarty, 447 U.S. at 309-10.11.

Source: http://rss.slashdot.org/~r/Slashdot/slashdotScience/~3/y4lTXcgtlHA/us-court-sides-with-gene-patents

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