Gene patenting upheld

| 5 Comments

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

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.

An interesting and, I think, relevant topic.

Actually, “gene patenting”, strictly speaking was NOT upheld here. Rather, it was determined that what was patentable was not the genes per se.

Obviously, I can’t claim to endorse or disparage this decision overall, but I can certainly say that to my eye, it appears to logically consistent with scientific reality. First of all, the term “gene” approximately means, from a scientific perspective a segment of DNA (or in some viruses, RNA) which, in the appropriate context and with appropriate factors present, can provide a template which directs the natural synthesis of a given protein or peptide. (Different definitions existed before the fact that DNA is the genetic material of cellular life was discovered, but this is about right for now.) This is my terser paraphrase, but an almost exactly identical definition is used in the decision.

(A side issue, not directly addressed but which I will note here, is ‘where does “gene” end and “allele” begin’? For example, the normal human hemoglobin A gene and the sickle cell gene are both “genes” for the same thing, but different “alleles”. However, the decision appears to be logical and grounded in correct science without

But if the “golden hamster glucose-6-phosphate 1-epimerase gene” is an example of what we mean by a “gene”, it’s absurd to say that this entity can be patented. It’s like allowing someone in the logging business to “patent” a species of tree. They can patent the saw they cut the trees down with. But the gene, and the tree, are natural resources that have occurred in nature, probably for millions of years?

This is exactly the logic the court uses.

All but one of the challenged method claims cover methods of “analyzing” or “comparing” a patient’s BRCA sequence with the normal, or wild-type, sequence to identify the presence of cancer-predisposing mutations. Representative method claims include claim 1 of the ’999 and ’001 patents:

In short, my understanding here is that they have not upheld patents on human genes (an absurd idea, since essentially every human being on earth has at least one copy of each a BRCA-1 and BRCA-2 gene in their genome, and at least many millions have mutations which the techniques in question are designed to analyze.

However, what is determined to be patentable is the mechanism of analysis. I do not and cannot argue that the patents surrounding this are valid, of course, but they are not direct patents of genes.

(My understanding is that there have been cases in which actual patenting of genes has been attempted, mainly in an agribusiness setting. This is off the top of my head and may be wrong; feedback welcome. This becomes more complex, as I believe that pre-molecular era products of genetic engineering - that is to say, bred strains of plants or animals - have been patented, at least in some form, such as seeds. Whether such strains contain unique mutations which were selected for by the breeding and are virtually never seen in any other strains is one interesting question.

I personally consider the direct patenting of a gene which occurred naturally to be an absurd idea, but patenting a seed strain that was developed through hard work and ingenuity may seem less absurd. Also, if a novel gene or allele produced by genetic engineering can be patented is a complex topic.

Also, a good solid basic review of genetics is contained in the legal document; recommended.)

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.

@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.

Quote from the court:

We disagree, as it is the distinctive nature of DNA molecules as isolated compositions of matter that determines their patent eligibility

I expect there are any number of long-chain, naturally occuring starches that fold up or straighten out differently when isolated (compared to in the body). Are those patentable too?

Heck, forget long-chain. This paper says dilute sucrose in water has a different conformation (than other types). Stand back boys, I’m gonna patent sugar water!

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This page contains a single entry by Timothy Sandefur published on August 8, 2011 2:13 PM.

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