Judge Invalidates Patent for a Down Syndrome Test


NY Times:

Judge Invalidates Patent for a Down Syndrome Test

A federal judge has invalidated the central patent underlying a noninvasive method of detecting Down syndrome in fetuses without the risk of inducing a miscarriage.
The ruling is a blow to Sequenom, a California company that introduced the first such noninvasive test in 2011 and has been trying to lock out competitors in a fast-growing market by claiming they infringe on the patent
Sequenom’s stock fell 23 percent on Thursday, to $1.92.
The judge, Susan Illston of the United States District Court in Northern California, issued a ruling on Wednesday that the patent was invalid because it covered a natural phenomenon — the presence of DNA from the fetus in the mother’s blood.

The ruling was a sign that the Supreme Court’s decision in June declaring that human genes may not be patented because they are products of nature could make it more difficult to patent diagnostic techniques.

Good, I hope this ruling is upheld.


Except the doctrine of unintended consequences could be at work here. If scientists are not allowed to patent diagnostic techniques, it likely will result in less research to discover new diagnostic techniques.

I suspect your “good” is based on the implied assumption that such a test would be used to give parents an out for an abortion. To that end I agree with your “good”. However, such a test could also be used to help expectant parents to properly prepare to welcome a special needs child.


My “good” is because I agree with the ruling. The Supremes ruled 9-0 that human (or other) genes cannot be patented in a case about breast cancer detection:

The case concerned patents held by Myriad Genetics, a Utah company, on genes that correlate with an increased risk of hereditary breast and ovarian cancer. The patents were challenged by scientists and doctors who said their research and ability to help patients had been frustrated. After the ruling, at least three companies and two university labs said that they would begin offering genetic testing in the field of breast cancer.
“Myriad did not create anything,” Justice Clarence Thomas wrote for the court. “To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.”

As for unintended consequences, sure some companies will lose out because they no longer have a monopoly but on the whole I think consumers will benefit.


Interesting article and a fair note of opposing points - should genes be patented? No. It’s a wonder that plant genes are patented, though those that are bioengineered aren’t exactly a natural creation in the first place.

Should diagnostic techniques be open for patent? Absolutely. It’s the separation of the two - the technique from the knowledge contained - that’s the important distinction here. I wonder if this is a matter of how the case was argued. It could honestly be that the test itself relied entirely upon earlier research and so the patent already belonged to another company.


I agree that genes should not be patented. But this case isn’t about the genes, it’s about a test to determine genetic make-up - specifically a test for a genetic marker.

As for unintended consequences, sure some companies will lose out because they no longer have a monopoly but on the whole I think consumers will benefit.

Anti-monopoly laws only make sense AFTER there are products on the market. Consumers benefit when there are more choices. This is why, for example, most drug patents expire at 17 years. Drug companies have an incentive to bring new drugs to the market and a chance (though a small one) to earn a profit before the patent runs out. Consumers benefit because, after the patent expires, there are more choices.

If no patent can be issued, there would be no way a company could recoup research costs. They would have no incentive to develop new tests. The consumers will lose because there will be** fewer **choices.


From what the article says, I have to agree with you. The patent did not seem to be about the technique used, because those techniques are conventional ones. But it seemed to rest instead on the discovery of a previously unknown * natural phenomenon*, namely the presence of fetal DNA in mothers’ blood. Newly discovered or not, a natural phenomenon ‘belongs’ to all of us in whom it occurs - no company should be allowed to claim ownership of normal bodily functions.


Read the last para of the article again: the patent rests on the phenomenon itself, according to the writer, not on the techniques used in the test.


In her ruling, Judge Illston said that the presence of the DNA in the pregnant woman’s blood was a novel discovery but could not be patented because it was a natural phenomenon. And claims in the patent over how to detect that DNA were not eligible for a patent because they involved conventional genetic techniques.

It says just what I said. The patent was for a method of detecting the DNA, not for the genes. Using that logic, no one would be able to patent any screening test other than those that detect foreign substances. So tests for blood disorders, infections, sickle cell anemia, etc. would be unpatentable and therefore research in the areas of medical testing would grind to a halt.


I’m afraid you misunderstand: the methods were not invented by the company - they are “conventional genetic techniques” i.e. already available and widely used methods. How can you patent a test that you did not invent yourself?


Ah, you are right. I read it several times and thought this was a test or at least a technique of administering a test that had been developed by the company. :o


No worries. :slight_smile: I happen to have come across this sort of thing before, so I’m familiar with how this new trend in patenting works.

I’m all for innovation and research, but this idea of companies trying to patent God’s creation really rubs me the wrong way - and it’s not only in genetics. There have been cases of companies going to third world countries and trying to patent folk remedies which have been in use for generations. A unique product, sure, by all means patent it; a new technique, I’m all for that - but not the biological substance from which it is generated!


At least this case went to court.
There are a lot of “patent trolls”. Patents are often granted without any research by the gov’t to see if the technology is already patented of in the public domain.
So you start a business and here comes a lawyer accusing you of infringement threatening you to force you out of business of cut his client in for X%. Even if you have the resources to win in court (expensive) the troll can pull out another patent and say, “You’re also infringing this one.”

After podcasting started to catch on Apple tried to sue for copyright infringement (not the same thing, but similar).


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