The Ethics of Gene Patenting

A gene patent is defined as "a patent on a specific isolated gene sequence, its chemical composition, the processes for obtaining or using it, or a combination of such claims." It's important to note that the patent only applies to the isolated gene sequence as it exists outside of the body, not to the gene as it exists as a component of a chromosome in the body of a human or any other living organism.

Dr. James Watson, co-discoverer of the double-helix structure of DNA, has stated about DNA that "It is a chemical entity, but DNA's importance flows from its ability to encode and transmit the instructions for creating humans. Life's instructions ought not be controlled by legal monopolies created at the whim of Congress or the courts."

What privileges does a gene patent grant to the patent holder? Take Myriad Genetics' patent on BRCA1 (and BRCA2) as an example. BRCA1 is a caretaker gene that helps to repair damaged DNA in certain tissue cells, or destroy a cell if the DNA cannot be repaired. If BRCA1 itself becomes damaged, then DNA is not repaired properly, resulting in a higher risk of certain cancers (with breast cancer being most prominent). Myriad Genetics' patent gives them exclusive control over certain methods that isolate and detect this gene. This means that only certain laboratories, affiliated with Myriad Genetics, are legally allowed to test and sequence the gene. As you can imagine this limits peer review of the validity of Myriad's test for determining if BRCA1 is damaged, as laboratories and scientists not affiliated with Myriad have no access to the methods to isolate the gene. It also stops other organisations from developing their own tests or applications and uses for the gene, considering its patent. Some reading on an American court case against Myriad's patents.

Is gene patenting ethically right? Does it place limitations on the scientific method, prioritising money over progress? Should genes even be patentable?

I understand why a gene sequence would be patentable. Without the patent, institutions might not have the monetary incentive to develop uses for the gene, be it in testing or diagnostics or whatever else. Private institutions would probably find it harder to receive funding to develop applications for the gene without the prospect of it being a profitable venture. Still, though, the whole thing doesn't sit right with me. I agree with Dr. James Watson when he said life's instructions ought not to be patentable; something as natural and basic as a gene should not be under the control of an individual or a corporation. A gene should not belong to anybody, nor should the uses of a gene be limited by any other individual.

What do you think?

Procrastastudy

Are you extending this discussion to the issue of the rather underhanded way these genes and samples are obtained? Once the sample leaves the body you have no control over it. This has resulted in people being brought back in for 'on going treatment' were in reality they are simply being used to further research under false pretenses. My biggest issue is there in all honesty - pay the guy and be upfront about whats going on.

ancapailldorcha

I can't think of any reason why genetic information should be patentable unless it was designed by a company. Patents exist to protect intellectual property. Music and other forms of art are or are meant to be expressions of an individual's creativity while the likes of drugs must be designed and if they could not be protected there would be no incentive to invest in development of novel therapies. No-one chooses or designs their own DNA, it's a naturally occurring substance. So why should private organisations be able to patent something that's not their own intellectual property?
In the case of findings resulting from investigating people's samples, they should be told. The company should still be able to patent any IPs which may result as they did the investigating and investment but the person from whom the sample originated should receive a share of the profits in my opinion.
I'd recommend the book "The Immortal Life of Henrietta Lacks" for anyone interested in the subject. Henrietta Lacks was an African-American woman who died of cervical cancer. Her cancerous cells were the first cell line that was ever cultured as they were unnaturally aggressive and hardy. They led to uncountable scientific discoveries and completely revolutionised the field of medicine. Her family didn't make any money whatsoever from the cells despite all the discoveries they made possible.

Procrastastudy

Procrastastudy wrote: »

Are you extending this discussion to the issue of the rather underhanded way these genes and samples are obtained? Once the sample leaves the body you have no control over it. This has resulted in people being brought back in for 'on going treatment' were in reality they are simply being used to further research under false pretenses. My biggest issue is there in all honesty - pay the guy and be upfront about whats going on.

The discussion could include that issue, but I'd prefer if it kept to the more fundamental aspects of the situation (but I can't control a discussion, so feel free to discuss what you like!). I understand what your issue is, but aren't similar "tactics" used in a whole host of medical fields? It's not unique to the field of genetics or genetic therapy. I think that a discussion on medical ethics would eclipse the more fundamental issue of whether it is ethically right for an individual or corporation to be able to patent a gene, something that is, in essense, absolutely natural and potentially more important than any simple chemical compound.

ancapailldorcha wrote: »

I can't think of any reason why genetic information should be patentable unless it was designed by a company. Patents exist to protect intellectual property. Music and other forms of art are or are meant to be expressions of an individual's creativity while the likes of drugs must be designed and if they could not be protected there would be no incentive to invest in development of novel therapies. No-one chooses or designs their own DNA, it's a naturally occurring substance. So why should private organisations be able to patent something that's not their own intellectual property?

As far as I can tell, the isolated gene is not considered to be natural, seeing that, in its isolated form, it doesn't exist in nature. A gene patent can cover specific methods for isolating the gene (which is fair, I think), it can also cover specific applications of the gene (more controversial, but somewhat understandable), and it can cover, as far as I understand it, all applications of that gene (absolutely ridiculous, I believe). When it comes to the chemical composition of the gene itself, the patent is similar to a patent on a non-naturally occuring, synthetic chemical or drug.

The main question is, I suppose, does isolating an individual gene from a chromosome result in that gene becoming, in effect, a quasi-synthetic substance, considering that the isolated form cannot exist without the aid of humans?

I'd recommend the book "The Immortal Life of Henrietta Lacks" for anyone interested in the subject. Henrietta Lacks was an African-American woman who died of cervical cancer. Her cancerous cells were the first cell line that was ever cultured as they were unnaturally aggressive and hardy. They led to uncountable scientific discoveries and completely revolutionised the field of medicine. Her family didn't make any money whatsoever from the cells despite all the discoveries they made possible.

I agree, it's a good read. I read it earlier on this year.

ancapailldorcha

gvn wrote: »

As far as I can tell, the isolated gene is not considered to be natural, seeing that, in its isolated form, it doesn't exist in nature. A gene patent can cover specific methods for isolating the gene (which is fair, I think), it can also cover specific applications of the gene (more controversial, but somewhat understandable), and it can cover, as far as I understand it, all applications of that gene (absolutely ridiculous, I believe). When it comes to the chemical composition of the gene itself, the patent is similar to a patent on a non-naturally occuring, synthetic chemical or drug.

The main question is, I suppose, does isolating an individual gene from a chromosome result in that gene becoming, in effect, a quasi-synthetic substance, considering that the isolated form cannot exist without the aid of humans?

My concern is that patenting mutations and variations of genes would discourage academic research. Private companies are likely to only prob leads which might yield a new drug so discouraging academia from studying these mutations could be detrimental in the long run. Of course, new assays and therapeutics derived from the genes should be patentable as those would be considered the company's intellectual property. Taking a sequence to court and aiming for "all" applications be they current or yet to be developed is ridiculous. I see no reason why multiple companies shouldn't be able to research the same gene.
I don't see why isolating a gene should make it quasi-synthetic. I could isolate glucose from an apple but that wouldn't entitle me to patent glucose. Isolating a gene isn't difficult nowadays and companies shouldn't be able to generate patents with such little effort.

ancapailldorcha

At work today, I volunteered to give blood for a study. The informed consent form stated that I would not be entitled to any IPs which might result from the sample and that it was a "gift".

Gurgle

Somebody spends a heap of time and money testing samples, and discovers that a particular gene sequence conveys immunity to ebola. They use this gene sequence to develop an immunization and / or a cure.

It seems reasonable that they get to patent that use of that gene sequence. It doesn't mean they can get a court order to prevent the original donor from breeding, but they can prevent another company from duplicating their treatment using a new sample from the same individual.

Catsmokinpot

Gurgle wrote: »

Somebody spends a heap of time and money testing samples, and discovers that a particular gene sequence conveys immunity to ebola. They use this gene sequence to develop an immunization and / or a cure.

It seems reasonable that they get to patent that use of that gene sequence. It doesn't mean they can get a court order to prevent the original donor from breeding, but they can prevent another company from duplicating their treatment using a new sample from the same individual.

I have underlined the important word in your post, and it's exactly right, they have "discovered" the gene sequence using tools made available by public research as well as private. They haven't created anything and they haven't invented anything. therefore it's not intelectual property.

Just because I discovered wexford on a map doesn't make wexford mine.

If something exists in nature and someone patents it, then if that gene is found in that crop or animal belonging to a farmer, then that person is in violation of patent laws, even though this farmer may have been breeding this type of animal growing this type of plant for years before the patent came into effect.

So, in my opinion patents should only extend to synthetic genes created to code for useful proteins that do not exist in nature.

Also more generally, the discovery of gene sequences are owned by the company and not the actual team of scientists that discover them, and so they're not necessarily the people that benefit from patent laws anyway.