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Breast cancer genes can't be patented, federal court rules

March 29, 2010 |  4:28 pm

Until today, women who wanted to know whether they had inherited a version of the BRCA1 and BRCA2 genes that increased their risk of breast or ovarian cancer could find out only by sending their DNA to Myriad Genetics Inc.The Salt Lake City company patented the two genes in the 1990s and invented a test to identify some of the telltale mutations.

You might be asking yourself how a company could get a patent on a gene, which isn’t a man-made invention. You wouldn’t be alone. Several medical groups have wondered that too. So have the American Civil Liberties Union and the Public Patent Foundation. Last year, they challenged those patents in a federal district court in New York.

On Monday afternoon, they won. U.S. District Judge Robert Sweet ruled that the U.S. Patent and Trademark Office never should have granted the patents in the first place because the genes are “a law of nature.”

The Patent and Trademark Office has granted patents for roughly 20% of human genes. The office’s rationale was that the patents can be earned by isolating and purifying genes from their “natural state.”

In oral arguments last month, Myriad’s attorney said that companies wouldn’t have any incentive to develop genetic tests if they weren’t allowed to patent genes and warned that a ruling against Myriad could “undermine the entire biotechnology sector,” according to this report from GenomeWeb. The company has not yet commented on the ruling.

The ACLU and other groups argued that women – and the whole of science – have already suffered as a result of the way Myriad treats its BRCA patents. On its website devoted to the case, the ACLU says that individual patients are harmed because Myriad’s monopoly on genetic testing for BRCA1 and BRCA2 keeps prices high and prevents them from getting a second opinion from another company. Scientists are also harmed because the company restricts their ability to conduct research on the genes, according to the ACLU.

Myriad hasn't said whether it would appeal the decision.

You can read the original lawsuit here.

-- Karen Kaplan

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Comments (4)

This is excellent news! James Watson co-discoverer of DNA was opposed to such patents and when NIH overuled him he left, or was forced out, in 1992. As the judge correctly notes these are products of nature not intellectual products. Now we are in the absurd position of being able to cheaply and rapidly sequence a persons entire genome. Is every single nucleotide polymorphism found in the individual by the testing company open to being patented. It is to my mind akin to buying a microscope and then claiming a patent on whatever components of life I find there. What about, again as the judge noted, the problem with stifling scientific advance by not being able to openly study the gene in question. I would go one further and say that no DNA sequence whether created artificially or found through sequencing may be patented. Quite often these sequences end up in self replicating or potentially self replicating organisms. There is an interesting story of a microbiologist who is claiming she was inadvertently infected by a genetically engineered virus. The company however, is refusing to release the sequence of the virus in question. Well what if that virus or a future one turned out to be contagious. Can you even place a patent on a computer virus, how much more foolish to claim there is patent protection is the virus might someday be able to kill you. At the very least, requests by health practitioners or public health officials should over rule patent claims, whether a sequenced part of a genome or one made from scratch. Glad to see this ruling.


A Circuit Court of Appeal recently killed another parent on a biological discovery (the NF-Kappa-Beta protein) stating the patent was a “wish” but not an invention.

This ruling is another kill on biological patents which are “discoveries” but not inventions.

PATENTS ARE FOR INVENTIONS. If you can’t show that it is an invention, then you can’t patent it. Period. Wishful thinking aside.

A discovery is NOT an invention. It is the uncovering of fact.

Discovering the moon doesn't make the moon patentable. Invent the rocket to go to the moon. Then you can patent the invention of the rocket.

There is no invention when it comes to discovering a fact of nature - e.g. genes or proteins, etc. Invent something like a drug that can interact with the gene. Then you get to patent that invention. But the gene or protein, itself, is not patentable.

Patents are for inventions.

Show us the invention before you can be given a patent. What did you create that is patentable?

Discoveries are not creations. They are not inventions.

This ruling returns us to sanity.

Here you go.

The problem is the public hasn't helped good scientists who spoke out against this practice 20 years ago. I am a cancer survivor who happens to be a scientist who discovered the Cell Death Signal Gene Theory circa 1986 only to be black listed so U of Waterloo could commit federal fraud (see for details) Even though I had peer support from M.D.Anderson Cancer Center the fraud was more important than saving lives.Worst my work has been black listed and suppressed. What people don't understand about genes , is that they ,ULTIMATELY, will be found out as an intricate organic computer code. And any code breaks down to mathematical sequences. Therefore, Myriads patent on the breast cancer gene is a farce because ultimately it is a mathematical function that could be generated from a sequence. And all genes and all genomes will be found to be mathematical functions/constructs.Like natural mathematical sequences, these can't be patented any more than the free sequences of song birds.I said this 2o years ago.I survived my cancer because of my theories,but don't you just wonder how many people I could have saved from dying if I hadn't been black listed so fraud could be covered up?


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