Good for DNA research, but could lead to overpriced diagnosticsIsolating genes from human DNA structures is patentable, the US Court of Appeals has ruled.
The Court ruled that the process of isolating genes from human DNA strands left the resultant individual genes with "markedly different chemical structure" from DNA in the human body.
US patent law says that material related to laws of nature cannot be patented. Inventions must also be new, take an inventive step that is not obvious and be useful to industry to qualify for patent protection.
"The ability to visualise a DNA molecule through a microscope, or by any other means, when it is bonded to other genetic material, is worlds apart from possessing an isolated DNA molecule that is in hand and usable," the US Court of Appeals ruling (
105-page/684KB PDF) said.
"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 ruling said.
The decision reverses a decision (
156-page/859KB PDF) by a district court in New York that had ruled isolated human DNA molecules could not be patented.
Medical testing company Myriad Genetics had identified two gene sequences, BRCA1 and BRCA2, which were linked to breast cancer. The US District Court for the Southern District of New York had said that patents the company held over them were "improperly granted" by the US Patent and Trademark Office.
Myriad had argued that it was the method of isolating the gene and not the gene itself that was the subject of its patent. Myriad appealed and in a majority decision the Court ruled that the company could patent isolated genes.
The ruling went against Myriad's opponents, which included the Association for Molecular Pathology and the American College of Medical Genetics. They had argued that the isolated genes were laws of nature and not therefore not patentable. The genes Myriad isolated contained the same molecules as collective human DNA strands, they said.
The Court of Appeals said it was the "distinctive nature" of individual genes "as isolated compositions of matter" that could make them patentable. Patent eligibility should not be determined by the isolated genes' "physiological use or benefit," it said.
Myriad used chemicals to split the genes from the DNA structures and this creates a "distinct chemical entity", the Court said in its ruling.
"Uses of chemical substances may be relevant to the non-obviousness of these substances or to method claims embodying those uses, but the patent eligibility of an isolated DNA is not negated because it has similar informational properties to a different, more complex natural material that embodies it," the ruling said.
"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. We recognise that biologists may think of molecules in terms of their uses, but genes are in fact materials having a chemical nature and, as such, are best described in patents by their structures rather than their functions," the ruling said.
"In this case, the claimed isolated DNA molecules do not exist as in nature within a physical mixture to be purified. They have to be chemically cleaved from their chemical combination with other genetic materials. In other words, in 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 synthesised directly as isolated molecules," it said.
The ruling is likely to be challenged, but this decision of the Court of Appeals will please companies in the US genetics industry, according to one patent law expert.
"This ruling has divided legal opinion and, if upheld, would be welcomed by America's multi-billion dollar DNA industry," David Bloom, a patent lawyer with Pinsent Masons said.
"Those with a vested interest in the commercialisation of human genetics argue that the ability to obtain patent protection encourages investment in DNA research, which serves to further innovation. Those opposed to what is perceived to be the monopolisation of nature fear that the high cost of diagnostic testing, such as Myriad's tests for breast cancer will price many out of the market. The Court's reasoning appears dubious and an appeal is inevitable. On both sides of the fence this case will be watched with interest," Bloom said.
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OUT-LAW.COM is part of international law firm Pinsent Masons.
They might as well be granted the right to patent tree bark, so long as those patenting it have been engaged in "reducing a portion of nature to concrete form, [an] activity being what the patent laws seek to encourage and protect" (I suspect, if so inclined, a patent could be granted me for the act and trouble of having ripped from a Birch a slice of its bark; moreover, I would then be entitled legal recourse for actions of others impinging upon my patents - both the process of "reducing a portion of nature to concrete form" [i.e. mechanically ripping bark from a tree] and likely failure of others to pay royalties for so doing and also using gathered bark in the manufacturing of what-nots and what-you-call-its. Look out makers of birch-bark canoes and upper Mid-west historical nicknacks... I'm coming at you.).
Couldn't we throw a wrench into these malevolent machinations by forming a Bio-tech with the purpose of patenting each of the bases in DNA individually, as well as series of base (i.e. codon sequences) for each of the associated amino acids employed in the production of bodily proteins? If, afterall, the judiciary has ruled "the 'distinctive nature' of genes' as isolated compositions of matter'... make them patentable," then the same can be said of components of those structures, although - as per their ruling - one would necessarily steer clear of arguments implying isolates impart or confer physiological significance to the whole of a larger, structured gene. What seems important is that patented materials - bases and the codon pairings - would be chemically distinct and isolated. It appears we need only to isolate the bases and/or codons from nature to seek patent for both the process and the extracted object involved in that act (Truth be told: the process of isolation used in any modern lab is likely already a patented process and/or employes a patented device designed for doing the same.).
Our Bio-tech's mission would have to be, at least, to provide some arguably defensible service for the sake of commodity or service exchange by virtue of the awarded patent: otherwise, would-be possessors of such patents wouldn't be permitted standing - I guess - amongst the patent-ourgeoisie. Nature's Bio-Tech could start a sea of litigation against all firms or individuals possessing gene patents containing patented bases/base pairing (i.e. codon sequences) filed for patent after the Bio-tech's start up and possession of its own patented bases and codons. Why, because they hadn't paid for their use as per our patents (Note: to cover all our bases - pun intended, of course - Nature's Bio-Tech would have to seek patent for individual bases, codon sequences within single stranded DNA, as well as related double stranded DNA (e.g. individual codon pairing across the double strand of DNA, etc.), and single stranded RNA and mRNA structures.
Please forgive me. The above idea aside, I must ramble: The worst of technology - if our approaches, uses and relationships to and of it are left unchecked and unexamined - is that it can be used to blindly justify and legitimize the wholesale commodification of the public's natural commons and of Nature in and of itself. This article clearly displays this as it happens and is supported by short-sightedness with regard to ourselves as Nature. No doubt, the judiciary is enthralled by the charms of an unexamined relationship to technology, clearly remarking that what Nature does is insignificant compared our abstractions of how it is structured (Isolated nature is given precedence over Nature as physiological, or otherwise, significant.). This is not precedent, as it is a centuries old perspective and ongoing view of our world. And, it shows an inability or unwillingness to related to Nature as within it. Moreover, have the Courts - reflecting honorable juris practice - for example, ever considered the ways in which every technology developed in the history of humanity - and other species for that matter - demand of those possessing and using the technology manifest change to their behavior? Have they gone further and asked of themselves if these changes are desirable for themselves and the public good? What this ruling represents is an expected and predictable consequence of many centuries wherein a short-sighted and immature jurisprudence, bound by societal norms venerating an unexamined technophilia, have allied with societal norms venerating an unexamined commercialism of life and human interaction. If you question this idea of blind veneration, ask yourself why the Court of Appeals imparted volition to the patent laws in saying, they "seek to encourage and protect...," "reducing a portion of nature to a concrete form" [An aside: note the Courts also showed a fair deal of complicity to the industry by granting Myriad rights for more than was argued (i.e. the right to patent individual genes, when Myriad was defending an arguable right to patent a gene isolating process.). Its as if Myriad was called before a Magistrate due to parking violations and was granted the privilege of placing parking lots around town for their sole use.]. The verbiage of the Courts ruling opens a window into some deep philosophical (i.e. where ontology meets metaphysics) underpinnings relating to a Reductionist view of the world, of science and of knowing; and, it is the foundation of this "law-ing." These are mere rules for Things possessing things; and, as a logical consequence, the Things will soon be the things possessed. Already, the Things' food is similarly possessed.