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Patently-O provides this important update to a topic of much concern to Green-Arrow IP clients.
AMP v. Myriad (Fed. Cir. 2010)
In March, 2010, District Court Judge Robert Sweet held Myriad's gene patent claims invalid for failing to satisfy the subject matter eligibility requirements of 35 U.S.C. 101. The ruling was directed toward claims that cover particular isolated DNA molecules (genes) and processes of detecting and screening for those genes, but was written broadly enough to essentially invalidate all patents covering genes that were isolated from an organism.
Last month, I heard a rumor that Obama administration science and legal advisors outside of the USPTO supported Judge Sweet's ruling. At the time I disregarded that suggestion as unlikely. I was wrong. [Andy Pollack at the NYTimes has the scoop]
The US Department of Justice (DOJ) has now filed an amicus brief supporting the lower court decision — arguing that isolated genes are unpatentable because they improperly claim a product of naturer [Link to Brief]:
The district court correctly held . . . that genomic DNA that has merely been isolated from the human body, without further alteration or manipulation, is not patent-eligible. Unlike the genetically engineered microorganism in Chakrabarty, the unique chain of chemical base pairs that induces a human cell to express a BRCA protein is not a “human-made invention.” Nor is the fact that particular natural mutations in that unique chain increase a woman’s chance of contracting breast or ovarian cancer. Indeed, the relationship between a naturally occurring nucleotide sequence and the molecule it expresses in a human cell — that is, the relationship between genotype and phenotype — is simply a law of nature. The chemical structure of native human genes is a product of nature, and it is no less a product of nature when that structure is “isolated” from its natural environment than are cotton fibers that have been separated from cotton seeds or coal that has been extracted from the earth.
. . . .
Thus, the patent laws embrace gene replacement therapies, engineered biologic drugs, methods of modifying the properties of plants or generating biofuels, and similar advanced applications of biotechnology. Crossing the threshold of section 101, however, requires something more than identifying and isolating what has always existed in nature, no matter how difficult or useful that discovery may be.
. . . .
A product of nature is unpatentable because it is not the inventive work of humankind. That essential rule cannot be circumvented by drafting claims for the same natural product removed from its natural environment and proclaiming the result “pure.”
I recently posted my own thoughts on this topic titled "Are Genes So Obviously Patentable," where I made a slightly different point in questioning the patentability of genes under Section 101. That last paragraph, that something from nature cannot be patentable simple because it's purified wreaks havoc on years of rulings. Not that wreaking havoc means the idea is wrong, but I think it will have a hard time standing up to the "article of manufacture" idea that a purified compound becomes essentially man-made when it is purified. I've never found that argument so convincing myself, but it's the one that's made and it has been accepted for decades.
In the case of genes, I find it more persuasive to argue that what's really being patented is the data contained in the gene sequence, and that data or information does not get "purified" when the gene is isolated and purified. It has been long accepted that data, in itself, is not patentable. And I think a reasonable argument can be made that that's precisely what a gene patent attempts to do, patent data.
And of course there are policy concerns. Many other nations essentially say "we don't want to hear your convoluted arguments about articles on manufacture, and products of nature. Genes are not patentable. Move along." We may decide that it's not a good idea to patent genes for policy reasons (to which brute logic and argumentation will not apply).
However, in the end I don't think this will destroy an entire industry (as some will certainly assert). There are ways of using laws of nature in apparatus that perform useful functions (like assigning treatment regimes). So as long as the gene sequence is part of a "machine" or process for designing treatment, then I'd think therapeutics companies would still be OK from an IP standpoint.