About two weeks ago, the Federal Circuit--one of the nation's Courts of Appeals, and therefore the second-highest level of the federal judiciary--handed down its decision in Association for Molecular Pathology v. PTO, a case about the controversial subject of gene patenting. The court upheld the patenting of genes--though not other patents, which cover certain methods of comparing or testing genes, and this has sparked some (to my mind, correct) outrage on the part of researchers, who see gene patenting as an obstacle to research and progress in genetics. Because this is not really about evolution, I examine the decision over at my personal blog, Freespace.
5 Comments
jlesow · 9 August 2011
This is tricky, but it seems to me that patent law tries to distinguish between found objects and objects that have been manipulated in a non- obvious way. I would question patenting a line of cancer cells that have been found, but see some logic in patenting a cell made by lateral gene transfer.
The extraction of a gene shouldn't be patentable. Although the equipment and process used to do the extraction might be. That's the analogy to iron ore to iron. An analogy for genetic engineering might be the creation of a useful new alloy. Such an alloy might occur in trace quantities naturally, but the work involved it testing and perfecting it for commercial use could qualify for a patent.
At least patents expire. Be thankful it isn't a copyright.
harold · 9 August 2011
thomasferraro · 9 August 2011
Harold,
I think you are mistaken. The court DID rule that the genes themselves are patentable.
From the decision:
"we conclude that the challenged claims to isolated DNAs, whether limited to cDNAs or not, are directed to patent-eligible subject matter"
Some of their reasoning:
"It is undisputed that Myriad’s claimed isolated DNAs exist in a distinctive chemical form—as distinctive chemical molecules from DNAs in the human body, i.e., native DNA. Native DNA exists in the body as one of forty-six large, contiguous DNA molecules."
"Plaintiffs argue 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—have a distinctive characteristic—from naturally occurring DNAs, as the Supreme Court has directed, but at one similarity: the information content contained in isolated and native DNAs’ nucleotide sequence. Adopting this approach, the district court disparaged the patent eligibility of isolated DNA molecules because their genetic function is to transmit information. We disagree, as 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."
"Because isolated DNAs, not just cDNAs, have a markedly different chemical structure compared to native DNAs, we reject the government’s proposed “magic micro-scope” test, as it misunderstands the difference between science and invention and fails to take into account the existence of molecules as separate chemical entities. The ability to visualize 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. 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."
"It is suggested that holding isolated DNAs patent eligible opens the door to claims covering isolated chemical elements, like lithium; minerals found in the earth, like diamonds; atomic particles, like electrons; and even organs, like a kidney, and a leaf from a tree. None of these examples, however, as far as we can discern, presents the case of a claim to a composition having a distinctive chemical identity from that of the native element, molecule, or structure. Elemental lithium is the same element whether it is in the earth or isolated; the diamond is the same lattice of carbon molecules, just with the earth removed; the kidney is the same kidney, the leaf the same leaf. Some may have a changed form, quality, or use when prepared in isolated or purified form, but we cannot tell on this record whether the changes are sufficiently distinctive to make the composition markedly different from the one that exists in nature. In contrast, a portion of a native DNA molecule—an isolated DNA—has a markedly different chemical nature from the native DNA. It is, therefore, patentable subject matter."
Your quote about "method claims" is just that, addressing claims about methods of purifying and comparing the sequences. A couple of paragraphs earlier, the court writes about "composition" claims:
"The challenged composition claims cover two “isolated” human genes, BRCA1 and BRCA2 (collectively, “BRCA1/2” or “BRCA”), and certain alterations, or mutations, in these genes associated with a predisposition to breast and ovarian cancers."
I agree with you, "the direct patenting of a gene which occurred naturally to be an absurd idea", but the court obviously does not think the same way.
harold · 9 August 2011
@thomasferraro -
Thank you for correcting my misinterpretation, which was, I suppose, based partly on wishful thinking.
This is a most idiotic legal decision. The reasoning you quote appears strained, as if some kind of excuse to arrive at this absurd conclusion was sought.
eric · 10 August 2011