No more gene patents?

[River]

Since the advent of sequencing and sub-cloning technology in the 80's and 90's, academic and industrial researchers have been taking out patents on the genes they have found. I have personally always found this to be a bit odd, seeing as a gene is a piece of nature, not a human invention. You may as well allow people to patent the pebbles they find in their yards if you allow genes to be patented. I am, by the way, very aware of the amount of work involved in identifying a gene and the lack of work involved in finding a pebble. In fact, I have had first-hand experience with both. In the case of indentifying the gene, the post-doc I was working with, the tech supporting us, and our PI invented nothing. Nor did we take out a patent - the PI and the post-doc felt the same way I did. In fact, the whole yeast community at the time felt that way. On the flipside of that, I do feel that if you construct a new gene or new gene product, that is an invention and it should be patentable. Those engineered plasmids and enzymes you can buy from the likes of Invitrogen and New England Biolabs are not found in nature. Yet for a very long time, "patent everything" has been the rule in biology.

Until now:
U.S. Says Genes Should Not Be Eligible for Patents

The issue of gene patents has long been a controversial and emotional one. Opponents say that genes are products of nature, not inventions, and should be the common heritage of mankind. They say that locking up basic genetic information in patents actually impedes medical progress. Proponents say genes isolated from the body are chemicals that are different from those found in the body and therefore are eligible for patents.

The Patent and Trademark Office has sided with the proponents and has issued thousands of patents on genes of various organisms, including on an estimated 20 percent of human genes.

But in its brief, the government said it now believed that the mere isolation of a gene, without further alteration or manipulation, does not change its 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,” the brief said.

However, the government suggested such a change would have limited impact on the biotechnology industry because man-made manipulations of DNA, like methods to create genetically modified crops or gene therapies, could still be patented. Dr. James P. Evans, a professor of genetics and medicine at the University of North Carolina, who headed a government advisory task force on gene patents, called the government’s brief “a bit of a landmark, kind of a line in the sand.”

I'm not sure what sort of change this will bring to the biotech industry at present. Nor am I sure what it will mean for other types of biological patents, such as the ones my former thesis advisor takes out on the crystal structures that came out of the lab. And, though my name is on one of those patents, I feel the same about patenting a structure of a biomolecule as I do about patenting a gene.

[vison]

I am very glad to think that this will happen.

[Primula Baggins]

Patenting genes has always seemed to me like patenting raw data. Nonsensical. If the gene or crystal structure or whatever is going to have a valuable technological application, develop and patent that.

[axordil]

I do think that creating molecular configurations that don't exist in nature, or if they do are currently unknown, should be an area where patents are possible. Also, an area regulated very, very heavily. Some of the stuff we've come up with since the 30s is nasty.

[elfshadow]

I am very glad to hear this. The idea that you could patent an existing gene always made me very uncomfortable.

[Inanna]

This ruling makes so much sense. They very definition of a patentable product - an industrial invention which has to be applied to commercial use - goes against defining a gene. You can patent the method of finding out a gene/extracting a gene, but not the gene itself. Genes are discovered, not invented.

And as Ax said, if a molecule is invented, then yes, it should be patent-able.

[Ellienor]

Well, since I am a patent attorney dealing with biotech inventions (how did I miss this thread, anyways?) I find that there is a lot of misconceptions out there about "gene patents."

The amicus brief filed by the DOJ didn't go so far as to say no gene patents should be granted. They came out against patenting full length genes as they exist in nature (exon/intron) but stated that cDNA (what gets copied into RNA and into a gene product) should be patentable. Disappointingly, they also came out against methods to detect disease based on identifying a particular allele of a gene. (The Myriad genetics case/BCRA) patents (diagnostic use of a gene.)

Law works by analogy. If you take a plant containing medicinal compounds, and you isolate and purify the actual chemical that has the therapeutic effect, (aspirin, say), that is very clearly a patentable invention. Just because "it exists in nature" is not keeping this new chemical from being patentable, because somebody figured out what it was. So people have analogized to that, and seen new genes as something that was ISOLATED AND PURIFIED away from the body as patentable. The key is that the gene is ISOLATED AND PURIFIED. As it exists in your body it is outside the scope of any patent. It is when it is isolated and manipulated in the lab, that any rights attach.

The other piece is that gene patents are steadily being seen as less and less valuable. For many reasons. One is that the literal sequence of a cDNA or a gene to code for a gene product is not all that useful, for the reason is that genes tend to be quite robust to slight changes. In other words, you can often have structural variations at the DNA level that do not change the eventual amino acid sequence, leading to an unchanged protein, OR you can have a change or two in amino acids, and still have a protein with unchanged function (depending on where the change is.)

Most of the action is going to diagnostic uses of genes, i.e., testing to see if somebody has a particular allele (variant) of a gene and diagnosing disease or recommending a particular treatment. And this type of patent is under particular scrutiny lately by the Supreme Court and Federal Circuit. This is a commercial and industrial use and allows people to have the monopoly they need to develop the diagnostics tests and sell them.

There's a lot of nuance in this area, but people just tend to go "patent genes? Bad Idea11111!!!!!!!!"

I could go on at greater length but I've got some genes to patent.....

[Primula Baggins]

Thanks, Ellie! That's enlightening.

[Ellienor]

And River, what your former lab was patenting (structures) are a classic type of "research tool" type patent. I assume the crystal structures were of biological molecules (proteins, and the like?) One thing that people do is patent unique crystal structures (polymorphs) of small molecules, which I assume you are not doing.

So your former lab's patents would be something like "Use of crystal structure [insert coordinates] to find agents that inhibit [x]." Those types of patents have little value since it's exceedingly hard to prove that somebody is "infringing" (practicing the method). Also, it's essentially a "tool" for research.

The real money in licensing is composition of matter (claims to a compound per se) or use to treat a particular disease. Research tool claims are generally not as valuable. And that is the type of patent that can traditionally be obtained by universities, since they seek more basic knowledge.

[Voronwë the Faithful]

Thanks, Ellie. I had thought about saying something, but it's not an area that I am particularly knowledgable about, so I was hoping that you would show up.

[Holbytla]

Would something like the Monsanto soybean patent fall into this category?

[Ellienor]

tell me more about the "Monsanto Soybean Patent"....

http://www.nytimes.com/2009/12/18/business/18seed.html

is it this?

[Holbytla]

Yes that is the one thank you. And thanks for the article, I hadn't read that one before. The practice by Monsanto is, if nothing else, unsavory to me. Not allowing people to save seeds due to intellectual property rights seems wrong.

[BrianIsSmilingAtYou]

Yes that is the one thank you. And thanks for the article, I hadn't read that one before. The practice by Monsanto is, if nothing else, unsavory to me. Not allowing people to save seeds due to intellectual property rights seems wrong.

I agree. I would think (according to common sense) that the reverse should be true.

Either the people should be able to save the seeds (since Monsanto has allowed the pollen to propagate and therefore should be considered as letting it loose and therefore relinquishing rights in that particular pollen), or else Monsanto should be liable for paying for the value of any seeds that could not be saved (since they are responsible for "contaminating" them via the pollen).

If Monsanto wants to insist on its intellectual property rights, then the first option is not viable; therefore, they should be compensating any farmers for contamination of their seed crop, just as a polluter would be liable for compensation for contaminating land, or a river, or lake.

BrianIs AtYou

[elfshadow]

Ellie, I know about the controversy over Myriad's patents on BRCA1 and BRCA2 with exclusive testing rights, but not many of the details. The testing Myriad did was simply sequencing the genes, correct? If there were no special procedures that Myriad developed to do the gene testing, I don't see why they should have the right to exclusive testing. The gene already existed, and the process they used to test for the mutation also already existed. I understand the enormous amount of work that went into finding the link between the BRCA 1/2 mutations and breast and ovarian cancer. I just don't see what is specifically patentable.