United States Court of Appeals for the Federal Circuit (“CAFC”) issued its’ decision in the Myriad case related to patenting DNA and related methods on August 16, 2012. Here is the summary analysis and comments of the Myriad DNA patent case. Substantial parts of the text below are chosen and selected extracts of the CAFC’s decision.
What made Myriad Composition claims patent-eligible
The principal claims of the patents relate to isolated DNA molecules. The isolated DNA molecules are not found in nature. They are obtained in the laboratory and are man-made, the product of human ingenuity. While they are prepared from products of nature, so is every other composition of matter. But, as such, they are different from natural materials, even if they are ultimately derived from them. Isolated DNA is a tangible, man-made composition of matter.
Myriad’s claimed isolated DNAs exist in a distinctive chemical form 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 to form a complex tertiary structure known as chromatin that makes up a larger structural complex, a chromosome. Isolated DNA, in contrast, is a free-standing portion of a larger, natural DNA molecule. Isolated DNA has been cleaved or synthesized to consist of just a fraction of a naturally occurring DNA molecule.
The isolated DNAs of the present patents constitute a situation, where they are different from the natural products in “name, character, and use.” In nature, the claimed isolated DNAs are covalently bonded to other materials. Thus, when cleaved, an isolated DNA molecule is not a purified form of a natural material, but a distinct chemical entity that is obtained by human intervention.
Invalid arguments by Plaintiffs: isolated DNAs retain the same nucleotide sequence as native DNAs
Plaintiffs argued that because the claimed isolated DNAs retain the same nucleotide sequence as native DNAs, they do not have any “markedly different” characteristics. This approach, however, looks not at whether isolated DNAs are markedly different from naturally occurring DNAs, but at one similarity: the information content contained in isolated and native DNAs’ nucleotide sequences.
It is the distinctive nature of DNA molecules as isolated compositions of matter that determines their patent eligibility rather than their physiological use or benefit. Patent eligibility of an isolated DNA is not negated because it has similar informational properties to a different, more complex natural material. The claimed isolated DNA molecules are distinct from their natural existence as portions of larger entities, and their informational content is irrelevant to that fact. Genes are in fact materials having a chemical nature and, as such, are best described in patents by their structures rather than by their functions. In fact, many different materials may have the same function (e.g., aspirin, ibuprofen, and naproxen).
“Magic Microscope” test rejected
Court rejected the government’s proposed “magic microscope” test. The ability to visualize a DNA molecule through a microscope when it is bonded to other genetic material, is worlds apart from possessing an isolated DNA molecule that is in hand and usable. It is the difference between knowledge of nature and reducing a portion of nature to concrete form, the latter activity being what the patent laws seek to encourage and protect. The government’s microscope could focus in on a claimed portion of any complex molecule, rendering that claimed portion patent ineligible, even though that portion never exists as a separate molecule in the body or anywhere else in nature, and may have an entirely different utility. Visualization does not cleave and isolate the particular DNA; that is the act of human invention.
Method claims of “Comparing” or “Analyzing” Sequences abstract mental steps, not patent-eligible
Myriad argued that its claims to methods of “comparing” or “analyzing” BRCA sequences satisfy the machine-or-transformation test because each requires a transformation—extracting and sequencing DNA molecules from a human sample—before the sequences can be compared or analyzed.
The claims recite, for example, a “method for screening a tumor sample,” by “comparing” a first BRCA1 sequence from a tumor sample and a second BRCA1 sequence from a nontumor sample, wherein a difference in sequence indicates an alteration in the tumor sample. This claim thus recites nothing more than the abstract mental steps necessary to compare two different nucleotide sequences: one looks at the first position in a first sequence; determines the nucleotide sequence at that first position; looks at the first position in a second sequence; determines the nucleotide sequence at that first position; determines if the nucleotide at the first position in the first sequence and the first position in the second sequence are the same or different, wherein the latter indicates an alteration; and repeats the process for the next position.
Method of Screening Potential Cancer Therapeutics patent-eligible
This claim 20 of the ’282 patent, is directed to a method for screening potential cancer therapeutics via changes in cell growth rates of transformed cells. Those transformed cells arose from human effort; i.e., they are not natural products. Plaintiffs nonetheless challenge claim 20 as directed to the abstract idea of comparing the growth rates of two cell populations and as preempting a basic scientific principle—that a slower growth rate in the presence of a potential therapeutic compound suggests that the compound is a cancer therapeutic.
The claim 20 does not simply apply a law of nature. Claim 20 applies certain steps to transformed cells that are a product of man, not of nature. By definition, performing operations, even known types of steps, on, or to create, novel, i.e., transformed subject matter is the stuff of which most process or method invention consists.