The American Journal of Bioethics 2.3 (2002) 21-22
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Let's Get Physical1
Warren D. Woessner
Schwegman, Lundberg, Woessner & Kluth, P.A.
In "How Can You Patent Genes?" (2002), Rebecca Eisenberg quickly departs from debating the question posed by the title to address the much more interesting question of "How Can You Patent Genetic Information?" She correctly notes that "genes" isolated and purified by biotech researchers are simply chemical entities—albeit big, complicated ones. Patent claims to DNA molecules are, in fact, examined in the Patent Office using the same legal standards that are used to examine claims to other purified natural products, such as vitamins or steroids, or even to industrial chemicals, such as plastics and herbicides (Eisenberg).
However, a DNA sequence is a chemical formula for a DNA molecule. As such, in a patent claim, it can be used to describe the actual molecule; for example, a compound of SEQ ID NO:1. A DNA sequence can also represent the order of the bases in the molecule per se, as in claim 1 of the Human Genome Sciences, Inc. (HGS) patent application (a computer-readable medium having recorded thereon the nucleotide sequence depicted in SEQ NO:1) (Human Genome Sciences, Inc., et al. 1996). 2 This reduces a very complex molecule to a stored string of four letters—for example, AAATGAAC . . . ; it has been converted to "information."
Eisenberg then summarizes the maxims of patent law that exclude issuance of patent claims on laws of nature, natural phenomena, and abstract ideas, as well as the Patent Office's Examination Guidelines for Computer-Implemented Inventions, which bar patents on data stored in a computer-readable medium (Eisenberg). However, in view of what she identifies as a trend toward expanding the scope of patent-eligible subject matter by the Federal Circuit, she concludes that "it is not obvious why DNA sequence information stored in a computer-readable medium should be categorically excluded from patent protection" (Eisenberg).
I planned a paragraph here to chide Eisenberg for being an alarmist who was blurring the distinction between the computer-readable and molecular forms of DNA—blurring that she ascribes to "contemporary [genomic] technology." However, like many biotechnology patent attorneys, I had largely ignored the State Street Bank decision (State Street Bank & Trust Co. v. Signature Financial Group, Inc., 149 F.3d 1368 [Fed. Cir. 1998], cert. denied, 119 S. Ct. 851 ), except as it might affect claiming methods of doing medical business, such as diagnostic tests. A closer reading has convinced me that the Federal Circuit has indeed blurred the boundaries of patentable subject matter, and that Eisenberg's concerns are far from trivial.
In the midst of its thorough analysis of precedent, the Court states:
When a claim containing a mathematical formula implements or applies that formula in a structure or process which, when considered as a whole, is performing a function which the patent laws were designed to protect (e.g., transforming or reducing an article to a different state or thing) then the claim satisfies the requirements of § l01. (1375; emphasis added)
While a process is claimed as a series of transformative steps, a structure is not. It is impossible to see how a structure "is performing a function which the patent laws are designed to protect." A structure just sits there, like the formula or "algorithm" C5(p)d carved into a brick. 3 Someone may be able to use the formula to calculate the distance across a lake after walking around it, but the brick does not contribute to this process any more than the magnetic storage medium contributes to the process of identifying matching fragments of DNA from a test sample. What the brick and the storage medium provide are the physicality needed for the putative invention to fall within 35 U.S.C. sec. 101.
This section of the patent statutes limits inventions that can be patented to machines, manufactures (manufactured articles), compositions of matter, or processes. Accordingly, Eisenberg does not dispute the patentability of claims to a process involving using DNA sequence information in a...