Patent Law Prof. Merges. Section 101: Issues in the Life Sciences 9.1.2011. Main Themes. Living Subject matter Gene Patents. Historical progression. Chakrabarty – on the cusp of “classical genetic engineering”
Section 101: Issues in the Life Sciences
5. Why is this decision so important if Chakrabarty could have obtained process claims anyway?
6. Would a cloned human be patentable under this decision? How broad is this holding?
“Congress thus recognized that the relevant distinction was not between living and inanimate things, but between products of nature, whether living or not, and human-made inventions.”
The Committee Reports accompanying the 1952 Act inform us that Congress intended statutory subject matter to “include anything under the sun that is made by man.” S. Rep. No. 1979, 82d Cong., 2d Sess., 5 (1952) . . .
-- casebook p. 70
This is not to suggest that § 101 has no limits or that it embraces every discovery. The laws of nature, physical phenomena, and abstract ideas have been held not patentable.
Thus, a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated law that E = mc2; nor could Newton have patented the law of gravity. Such discoveries are “manifestations of . . . nature, free to all men and reserved exclusively to none.”
“While it is of course possible logically to call this a purification of the principle, it became for every practical purpose a new thing commercially and therapeutically.”
-- p. 168
Everyone, not already saturated with scholastic distinctions, would recognize that Takamine’s crystals were not merely the old dried glands in a purer state, nor would his opinion change if he learned that the crystals were obtained from the glands by a process of eliminating the inactive organic substances. The line between different substances and degrees of the same substance is to be drawn rather from the common usages of men than from nice considerations of dialectic.
-- P. 166
13. A method for detecting a deficiency of cobalamin or folate in warmblooded animals comprising the steps of:
assaying a body fluid for an elevated level of total homocysteine; and
correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate.
’658 patent, col. 11, ll. 58-65.
Drafted its own cert question: “First, measure the level of the relevant amino acids using any device, whether the device is, or is not, patented; second, notice whether the amino acid level is elevated and, if so, conclude that a vitam in B deficiency exists. Is the patent invalid because one cannot patent “laws of nature, natural phenomena, and abstract ideas”?
But one can reduce any process to a series of steps. The question is what those steps embody. And here, aside from the unpatented test, they embody only the correlation between homocysteine and vitamin deficiency that the researchers uncovered. In my view, that correlation is an unpatentable “natural phenomenon,” and I can find nothing in claim 13 that adds anything more of significance. . . .
-- casebook p. 132
Relying on a large set of DNA samples from families with inherited breast and ovarian cancers, the inventors correlated the occurrence of cancer in individual family members with the inheritance of certain marker DNA sequences. This allowed the inventors to identify, or “map,” the physical location of the BRCA genes within the human genome and to isolate the BRCA genes and determine their exact nucleotide sequences. This in turn allowed Myriad to provide BRCA diagnostic testing services to women. – p. 8
1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO: 2.
(The “Myriad” Case)
2010 U.S. Dist. LEXIS 35418 (Apr. 5, 2010)
In light of DNA's unique qualities as a physical embodiment of information, none of the structural and functional differences cited by Myriad between native BRCA1/2 DNA and the isolated BRCA1/2 DNA claimed in the patents-in-suit render the claimed DNA. "markedly different." This conclusion is driven by the overriding importance of DNA's nucleotide sequence to both its natural biological function as well as the utility associated with DNA in its “isolated” form.
. The preservation of this defining characteristic of DNA in its native and isolated forms mandates the conclusion that the challenged composition claims are directed to unpatentable products of nature.
Manufacture implies a change, but every change is not manufacture, and yet every change in an article is the result of treatment, labor, and manipulation. But something more is necessary . . . . There must be transformation; a new and different article must emerge having a distinctive name, character, or use.
[A]lthough the parties and the government appear to agree that isolated DNAs are compositions of matter, they disagree on whether and to what degree such molecules fall within the exception for products of nature. – p. 10
The distinction, therefore, between a product of nature and a human-made invention for purposes of § 101 turns on a change in the claimed composition’s identity compared with what exists in nature. [Patentable:]…. compositions that human intervention has given “markedly different,” or “distinctive,” characteristics. – p. 11
Purified vs. merely isolated:
[I]n nature, isolated DNAs are covalently bonded to such other materials. Thus, when cleaved, an isolated DNA molecule is not a purified form of a natural material, but a distinct chemical entity. In fact, some forms of isolated DNA require no purification at all, because DNAs can be chemically synthesized directly as isolated molecules.
It is also important to dispute the dissent’s analogy to snapping a leaf from a tree. With respect, no one could contemplate that snapping a leaf from a tree would be worthy of a patent, whereas isolating genes to provide useful diagnostic tools and medicines is surely what the patent laws are intended to encourage and protect. Snapping a leaf from a tree is a physical separation, not one creating a new chemical entity.