Wednesday April 23, 2014
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I'm going to do something different this time with an important court case. It involves a company which snipped a piece of DNA out of a human gene, found that it indicates an increased risk for breast and ovarian cancer, created a test for the gene, and sells the test, but has patented the DNA and will not allow anyone else to use the same DNA, available in a human body, to create other tests.
The U.S. Patent and Trademark Office has been awarding patents on human genes for almost 30 years. That is, they have been granting patents to companies, not because they created new genes, but because they found out which genes do what.
Now, however, the Supreme Court is hearing a critical case on the subject. What I'd like to do is tell you about the case, let you read some of the comments being made by the justices, and comment on what may--and should--happen.
First, the explanation:
It has long been settled law that abstract ideas, natural phenomena and laws of nature cannot be awarded patents, the legal protection that gives inventors the right to prevent others from making, using or selling a novel device, process or application. And now opponents of Myriad Genetics Incorporated say their patents on two genes linked to an increased risk of breast and ovarian cancer say such protection should not be given to something that can be found inside the human body.
"Finding a new use for a product of nature, if you don't change the product of nature, is not patentable," said lawyer Christopher Hansen, arguing against the patents. "If I find a new way of taking gold and making earrings out of it, that doesn't entitle me to a patent on gold. If I find a new way of using lead, it doesn't entitle me to a patent on lead."
Several organizations, including the American Civil Liberties Union, the Association for Molecular Pathology, a number of doctors and researchers and some people at risk for hereditary breast and ovarian cancer, have challenged the patents.
The company has used its patent to come up with its BRACAnalysis test, which looks for mutations on the breast cancer predisposition gene, or BRCA. Those mutations are associated with much greater risks of breast and ovarian cancer. Women with a faulty gene have a three to seven times greater risk of developing breast cancer and also a higher risk of ovarian cancer.
Myriad sells the only BRCA gene test. Opponents of its patents say the company can use its patents to keep other researchers from working with the BRCA gene to develop other tests.
Now, in a second post, some of the comments being made by Supreme Court justices.
"Why shouldn't we worry that Myriad or companies like it will just say, `Well, you know, we're not going to do this work anymore?'" Justice Elena Kagan asked.
"I don't think we can decide the case on, `Don't worry about investment. It'll come,'" Kennedy said.
Castanias, the Myriad lawyer, argued that the justices could think about the gene question like a baseball bat. "A baseball bat doesn't exist until it's isolated from a tree. But that's still the product of human invention to decide where to begin the bat and where to end the bat," he said.
That didn't work for Chief Justice John Roberts.
"The baseball bat is quite different. You don't look at a tree and say, well, I've cut the branch here and cut it here and all of a sudden I've got a baseball bat. You have to invent it, if you will," Roberts said. "You don't have to invent the particular segment of the strand. You just have to cut it off."
The court moved on to body parts. Said Justice Sonia Sotomayor, "If you cut off a piece of the whole in the kidney or liver, you're saying that's not patentable, but you take a gene and snip off a piece, that is? What's the difference between the two?"
Castanias tried again, comparing the company's patented genes to medicine.
"It's important to note that molecules have been patented for a very long time. That's what drugs are. And drugs are often made by taking one molecule and another molecule, both of which are known, reacting them in a test tube," he said. "Reactions have been around 100 years just like snipping has been, but they make something new and useful and lifesaving from that."
Roberts still wasn't convinced. "Well, I don't understand how this is at all like that, because there you're obviously combining things and getting something new. Here you're just snipping, and you don't have anything new, you have something that is a part of something that has existed previous to your intervention," he said.
That was the ruling of the original judge who looked at Myriad's patents after they were challenged by the ACLU in 2009. U.S. District Judge Robert Sweet said he invalidated the patents because DNA's existence in an isolated form does not alter the fundamental quality of DNA as it exists in the body or the information it encodes. But the federal appeals court reversed him in 2011, saying Myriad's genes can be patented because the isolated DNA has a "markedly different chemical structure" from DNA within the body.
The Supreme Court threw out that decision and sent the case back to the lower courts for rehearing. That came after the high court unanimously threw out patents on a Prometheus Laboratories Inc. test that could help doctors set drug doses for autoimmune diseases like Crohn's disease. The justices said the laws of nature are unpatentable.
But the federal circuit upheld Myriad's patents again in August, leading to the current review.
How do you feel about all this?
Tom; Very interesting case. It seems to me that it is acceptable to Patent a process used to find, examine, re-combine ( and so on) a Gene or DNA. I do not think is reasonable to issue a Patent on the Gene or DNA, which are natural parts of the human body. It is a slippery slope if parts of a human body become objects to be owned or controlled for profit. I don't know if anyone would want a clone of my Liver, as example, but I feel ownership, title and control over those sorts of things :)
I agree with Justices Sonia Sotomayor and Roberts. The DNA may contain important genetic information, but it is that information which should be patentable, not the DNA, or the slice of it.
I agree with both of you, and I feel this is a VERY important case. If we allow the patent office to keep on making the same devious, lobbyist-and-lawyer-induced decisions the pharmaceutical companies will eventually own DNA, not just part of it--ALL of it.
Consider how devious this argument is: "But the federal appeals court reversed him in 2011, saying Myriad's genes can be patented because the isolated DNA has a "markedly different chemical structure" from DNA within the body."
I happen to be a chemist, not a judge, so I understand exactly what that lawyer did when he spoke to the federal circuit court. DNA, after all, like anything else on the planet, consists of molecules. If I take a whole strand of DNA and analyze it, it will have a given "chemical structure." If I take ANY portion of that strand and analyze it it, of course, as to have a "markedly different chemical structure" from the original DNA.
The same thing would be true if I took a molecule from a potato, onion, or your left ear.
So can some company patent part of a molecule from your left ear?
The real test of a patent is whether or not it is an original creation. Doing what the company and its lawyers are trying to do is the same as if I went out to your car when it was making a noise, disassembled your engine, found the part which was making the noise, discovered which exact bit of that part was the problem, sawed it off, patented it, and would not allow anyone to make anything that then included that part. I did not create that bit; I DISCOVERED it. We do not issue patents for discovery. If we did we'd all paying rent to the family of Chistorforo Columbo.
Here's the crux of patent law: A patent is granted to someone who "invents any new, useful, and non-obvious process, machine, article of manufacture, or composition of matter."
Notice the word "invents." By no stretch of the imagination is snipping a piece of tissue from a human body the same as "inventing" something. Furthermore, it is very questionable that finding a gene, or part of a gene, which causes some problem is "non-obvious." It is as obvious as the nose on your face that SOME gene is the cause of almost any problem we have, or at least a factor in our inability to deal with it naturally. All it takes is enough time to eliminate the ones which are NOT the cause and you have the one which is.
The company wants to get paid for finding which marble in the bag isn't round. If it wants to create a test for finding that marble, it can do it, and sell it, but that is an industrial secret, not a patentable process.
Was this body donated to science? Did they have permission from the family or anyone connected to this person? If not they stole a part of a body they had no right to.
Now is the time for a lawsuit.
I'm sure the body was donated. A lot of people donate without placing any restrictions on what is done with the body. If they knew where some of them end up, and the way they are treated they would think twice. Remeber the recent case where a cemetary in Arizona was found to have scattered parts of huam remains lying around?
Sorry, folks. Forgot to do my usual spell check before I posted that one.
For anyone who wants to know what I really said, here you go.**
I'm sure the body was donated. A lot of people donate without placing any restrictions on what is done with the body. If they knew where some of them end up, and the way they are treated they would think twice. Remember the recent case where a cemetery in Arizona was found to have scattered parts of human remains lying around?
** I often wonder about that. :-)
An interesting book, "The Immortal Life of Henrietta Lacks," by Rebecca Skloot deals with the subject of who owns the right to your cells/genes/DNA. Henrietta Lacks was a poor black woman living in the south during the 1950's. She was diagnosed with cervical cancer. Some of her cells, gotten during her hysterectomy, were sent to the lab for diagnosis. Some were placed in a growing medium and much to everyone's delight the cells grew and multiplied. Up to that time scientists were not successful in the reproduction of human cells. Well, Henrietta's cells grew and grew. They were the basis of much research, they led to the development of many medicines. Once of the things that resulted was the polio vaccine.
While many people and companies profitted from Henrietta's cells, her family remained poor and uneducated.
There is a great deal more in the book. You might want to Google, Henrietta Lacks, Rebecca Skloot, HeLa cells. The book is a very interesting read. It is probably available in the library. I got my copy at Costco.
I've never read that book, but I have read about Henrietta Lacks and the issues involved. And I knew why HeLa cells are called what they are. Fascinating subject. One that makes one think, and a subject that is exactly on target. Thanks!
I'll see if I can get a copy.
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