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Gene Patents Invalidated


The Irish Doggy
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I think this is a good thing in the long run. It will be painful to put the genie back in the bottle however.

 

Judge Invalidates Human Gene Patent

By JOHN SCHWARTZ and ANDREW POLLACK

Published: March 29, 2010

 

A federal judge on Monday struck down patents on two genes linked to breast and ovarian cancer. The decision, if upheld, could throw into doubt the patents covering thousands of human genes and reshape the law of intellectual property

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Ben Sklar for The New York Times

 

Genae Girard, one plaintiff, applauded the decision as “a big turning point for all women in the country that may have breast cancer that runs in their family.”

 

United States District Court Judge Robert W. Sweet issued the 152-page decision, which invalidated seven patents related to the genes BRCA1 and BRCA2, whose mutations have been associated with cancer.

 

The American Civil Liberties Union and the Public Patent Foundation at the Benjamin N. Cardozo School of Law in New York joined with individual patients and medical organizations to challenge the patents last May: they argued that genes, products of nature, fall outside of the realm of things that can be patented. The patents, they argued, stifle research and innovation and limit testing options.

 

Myriad Genetics, the company that holds the patents with the University of Utah Research Foundation, asked the court to dismiss the case, claiming that the work of isolating the DNA from the body transforms it and makes it patentable. Such patents, it said, have been granted for decades; the Supreme Court upheld patents on living organisms in 1980. In fact, many in the patent field had predicted the courts would throw out the suit.

 

Judge Sweet, however, ruled that the patents were “improperly granted” because they involved a “law of nature.” He said that many critics of gene patents considered the idea that isolating a gene made it patentable “a ‘lawyer’s trick’ that circumvents the prohibition on the direct patenting of the DNA in our bodies but which, in practice, reaches the same result.”

 

The case could have far-reaching implications. About 20 percent of human genes have been patented, and multibillion-dollar industries have been built atop the intellectual property rights that the patents grant.

 

“If a decision like this were upheld, it would have a pretty significant impact on the future of medicine,” said Kenneth Chahine, a visiting law professor at the University of Utah who filed an amicus brief on the side of Myriad. He said that medicine was becoming more personalized, with genetic tests used not only to diagnose diseases but to determine which medicine was best for which patient.

 

Mr. Chahine, who once ran a biotechnology company, said the decision could also make it harder for young companies to raise money from investors. “The industry is going to have to get more creative about how to retain exclusivity and attract capital in the face of potentially weaker patent protection,” he said.

 

Edward Reines, a patent lawyer who represents biotechnology firms but was not involved in the case, said loss of patent protection could diminish the incentives for genetic research.

 

“The genetic tools to solve the major health problems of our time have not been found yet,” said Mr. Reines, who is with the Silicon Valley office of the firm Weil, Gotshal & Manges. “These are the discoveries we want to motivate by providing incentives to all the researchers out there.”

 

The lawsuit also challenged the patents on First Amendment grounds, but Judge Sweet ruled that because the issues in the case could be decided within patent law, the constitutional question need not be decided.

 

The decision is likely to be appealed. Representatives of Myriad did not return calls seeking comment. But this month, the company’s chief executive, Peter Meldrum, told investors that “regardless of the outcome of this particular lawsuit, it will not have a material adverse effect on the company,” or its future revenues, according to the Pharmacogenomics Reporter, “or on the future revenues of our products.”

 

Myriad sells a test costing more than $3,000 that looks for mutations in the two genes to determine if a woman is at a high risk of getting breast cancer and ovarian cancer. Plaintiffs in the case had said Myriad’s monopoly on the test, conferred by the gene patents, kept prices high and prevented women from getting a confirmatory test from another laboratory.

 

Janice Oh, a spokeswoman for the United States attorney’s office in Manhattan, which represented the Patent and Trademark Office in the case, had no comment.

 

One of the individual plaintiffs in the suit, Genae Girard, who has breast cancer and has been tested for ovarian cancer, applauded the decision as “a big turning point for all women in the country that may have breast cancer that runs in their family.” Chris Hansen, an A.C.L.U. staff lawyer, said: “The human genome, like the structure of blood, air or water, was discovered, not created. There is an endless amount of information on genes that begs for further discovery, and gene patents put up unacceptable barriers to the free exchange of ideas.”

 

Bryan Roberts, a prominent Silicon Valley venture capitalist, said the decision could push more work aimed at discovering genes and diagnostic tests to universities. “The government is going to become the funder for content discovery because it’s going to be very hard to justify it outside of academia.”

 

John Ball, executive vice president of the American Society for Clinical Pathology, one of the plaintiffs in the case, called the decision “a big deal.”

 

“It’s good for patients and patient care, it’s good for science and scientists,” he said. “It really opens up things.”

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That's a tough one. While I'm sure we would all like more affordable testing, I question if this is the correct ruling. My MIL died of breast cancer, and I have a SIL that currently has cancer and another SIL that had a recent scare, so I see both sides of it, but I'm not sure if we should trample someones rights even if it is for the good of many (unless they are a terrorist then it goes without saying :wacko: )

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IMO this is very short sighted if this ruling stands. Sure, it's good for people in the now that need more affordable testing. If companies don't have this patent protection then what's going to incent them to spend money on the R&D to make the discoveries that make this kind of testing possible?

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If a gene is modified, it can be patented. Look at the corporation that owns patents on their GM corn and soy beans.

 

If a gene is simply removed from a chromosome and not modified, it cannot be patent. Nothing has changed outside of the gene being removed, it is still the same gene with the same chemical structure. That's like saying I can patent my finger nails when I clip them.

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If a gene is modified, it can be patented. Look at the corporation that owns patents on their GM corn and soy beans.

 

If a gene is simply removed from a chromosome and not modified, it cannot be patent. Nothing has changed outside of the gene being removed, it is still the same gene with the same chemical structure. That's like saying I can patent my finger nails when I clip them.

 

Right. If you don't do anything to a gene other than isolate it, it should not be patentable IMO. I can see a patent for the method of isolating a gene or the test for the particular mutated gene, but to patent the naturally-occurring gene itself? I say no.

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Right. If you don't do anything to a gene other than isolate it, it should not be patentable IMO. I can see a patent for the method of isolating a gene or the test for the particular mutated gene, but to patent the naturally-occurring gene itself? I say no.

 

 

Precisely - otherwise someone owns a patent on the carrot, no?

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If a gene is modified, it can be patented. Look at the corporation that owns patents on their GM corn and soy beans.

 

If a gene is simply removed from a chromosome and not modified, it cannot be patent. Nothing has changed outside of the gene being removed, it is still the same gene with the same chemical structure. That's like saying I can patent my finger nails when I clip them.

 

Agree, though, I must admit I am more concerned with what you may do with your nail clippings than if you can patent them.

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Right. If you don't do anything to a gene other than isolate it, it should not be patentable IMO. I can see a patent for the method of isolating a gene or the test for the particular mutated gene, but to patent the naturally-occurring gene itself? I say no.

 

 

Precisely - otherwise someone owns a patent on the carrot, no?

 

I think that this disregards the significant process and intellectual property involved in isolating a gene. It's not like walking down the cereal isle and saying "Oh look...there are the Cheerios." Finding a specific gene that affects a specific thing is something that takes significant research and investment.

 

Companies make those investments so that they can capitalize on them financially. That is their entire incentive, and the patent process is the only thing that protects that incentive.

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Agree, though, I must admit I am more concerned with what you may do with your nail clippings than if you can patent them.

 

 

Well, I should have said toenail clippings. In the fetish world, people pay up to $500 for a small vial filled with toenail clippings. Some people boil them in water to make toenail tea, others simply pick their teeth with them while others like to poke various body parts with a jagged, yellowish toenail. Lots of money in feet.

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I think that this disregards the significant process and intellectual property involved in isolating a gene. It's not like walking down the cereal isle and saying "Oh look...there are the Cheerios." Finding a specific gene that affects a specific thing is something that takes significant research and investment.

 

Companies make those investments so that they can capitalize on them financially. That is their entire incentive, and the patent process is the only thing that protects that incentive.

 

 

 

You're confusing my anaolgy: if a company spends 4 billion dollars isolating the gene of a carrot that does not mean they own a patent on carrots.

 

Their processes that could affect the carrot's genes are certainly patentable. But they don't own a patent on anything that makes up my body, not should they yours.

Edited by Pope Flick
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Tough subject. Crichton addresses this very issue in his novel Next.

 

Interesting timing too - the patenting of genes typically generates extremely high costs of related treatment, which contributes to the cost of health care.

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Right. If you don't do anything to a gene other than isolate it, it should not be patentable IMO. I can see a patent for the method of isolating a gene or the test for the particular mutated gene, but to patent the naturally-occurring gene itself? I say no.

Exactly. Isolating a gene is just a miniature version of isolating a bodily organ like a heart.

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  • 2 weeks later...
:D

 

 

:wacko:

 

 

This is rather obscure, since it's an entire website, and I don't know where to look for your non-verbal point. :D

 

I did say this earlier:

 

Their processes that could affect the carrot's genes are certainly patentable. But they don't own a patent on anything that makes up my body, not should they yours.

 

 

So if this is genetically modified corn that's resistant to diseases, then I guess they have ownership of this corn that's genetically resistant to diseases. The trickier part would arrive if all other corn went extinct and this was all that was left. But again, I'd like you to be WAY more specific here...

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This is rather obscure, since it's an entire website, and I don't know where to look for your non-verbal point. :wacko:

 

I did say this earlier:

 

 

 

 

So if this is genetically modified corn that's resistant to diseases, then I guess they have ownership of this corn that's genetically resistant to diseases. The trickier part would arrive if all other corn went extinct and this was all that was left. But again, I'd like you to be WAY more specific here...

My bad as I was on vacation and only checking in for a minute. Monsanto has purchased or created most of the genetically modified foods produced in this country. Even if a genetically modified seed blows into a farmers field, the farmer must pay for the right to grow that crop. Giving large corporations carte blanche to patent genetically modified foods has consequences. This movie on Hulu does a much better job explaining the situation than I can.

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  • 6 months later...

Update

 

U.S. Says Genes Should Not Be Eligible for Patents

By ANDREW POLLACK

Published: October 29, 2010

 

Reversing a longstanding policy, the federal government said on Friday that human and other genes should not be eligible for patents because they are part of nature. The new position could have a huge impact on medicine and on the biotechnology industry.

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Documents Document: Friend-of-the-Court Brief (pdf)

 

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* Myriad Genetics Incorporated

 

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The new position was declared in a friend-of-the-court brief filed by the Department of Justice late Friday in a case involving two human genes linked to breast and ovarian cancer.

 

“We acknowledge that this conclusion is contrary to the longstanding practice of the Patent and Trademark Office, as well as the practice of the National Institutes of Health and other government agencies that have in the past sought and obtained patents for isolated genomic DNA,” the brief said.

 

It is not clear if the position in the legal brief, which appears to have been the result of discussions among various government agencies, will be put into effect by the Patent Office.

 

If it were, it is likely to draw protests from some biotechnology companies that say such patents are vital to the development of diagnostic tests, drugs and the emerging field of personalized medicine, in which drugs are tailored for individual patients based on their genes.

 

“It’s major when the United States, in a filing, reverses decades of policies on an issue that everyone has been focused on for so long,” said Edward Reines, a patent attorney who represents biotechnology companies.

 

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.”

 

He said that although gene patents had been issued for decades, the patentability of genes had never been examined in court.

 

That changed when the American Civil Liberties Union and the Public Patent Foundation organized various individuals, medical researchers and societies to file a lawsuit challenging patents held by Myriad Genetics and the University of Utah Research Foundation. The patents cover two genes, BRCA1 and BRCA2, and the over $3,000 analysis Myriad performs on the genes to see if women carry mutations that predispose them to breast and ovarian cancers.

 

In a surprise ruling in March, Judge Robert W. Sweet of the United States District Court in Manhattan ruled the patents invalid. He said that genes were important for the information they convey, and in that sense, an isolated gene was not really different from a gene in the body. The government said that that ruling prompted it to re-evaluate its policy.

 

Myriad and the University of Utah have appealed.

 

Saying that the questions in the case were “of great importance to the national economy, to medical science and to the public health,” the Justice Department filed an amicus brief that sided with neither party. While the government took the plaintiffs’ side on the issue of isolated DNA, it sided with Myriad on patentability of manipulated DNA.

 

Myriad and the plaintiffs did not comment on the government’s brief by deadline for this article.

 

Mr. Reines, the attorney, who is with the firm of Weil Gotshal & Manges and is not involved in the main part of the Myriad case, said he thought the Patent Office opposed the new position but was overruled by other agencies. A hint is that no lawyer from the Patent Office was listed on the brief.

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Companies make those investments so that they can capitalize on them financially. That is their entire incentive, and the patent process is the only thing that protects that incentive.

 

Reversing a longstanding policy, the federal government said on Friday that human and other genes should not be eligible for patents because they are part of nature. The new position could have a huge impact on medicine and on the biotechnology industry.

 

And there is your answer. The Federal Government wants to become the incentive. The Feds raise the money and they dole it out to the company that they want to reward for doing the R&D in genetics.

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And there is your answer. The Federal Government wants to become the incentive. The Feds raise the money and they dole it out to the company that they want to reward for doing the R&D in genetics.

 

:wacko:

 

This ruling would do the opposite. The money in medical research is in the patents and resulting drugs/applications, not the R&D. The Feds want to remove one of the avenues to a patent.

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:wacko:

 

This ruling would do the opposite. The money in medical research is in the patents and resulting drugs/applications, not the R&D. The Feds want to remove one of the avenues to a patent.

 

Totally disagree with your assesment. If a company can no longer patent the results of their R&D, why would they spend the money to do so? Why not let some other schmuck company do all of the heavy lifting, and then use their un-patented results to create your own drugs? The result being, nobody would want to spend the money on R&D unless the Feds come in and give them the money to do so.

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Totally disagree with your assesment. If a company can no longer patent the results of their R&D, why would they spend the money to do so? Why not let some other schmuck company do all of the heavy lifting, and then use their un-patented results to create your own drugs? The result being, nobody would want to spend the money on R&D unless the Feds come in and give them the money to do so.

 

You're taking this way too far IMO. Companies can continue to patent based on their R&D. If isolating a gene is not patentable anymore, its not that big a deal. Incentives remain in place. The difference is that now a company has to actually do something other than isolate a naturally occurring gene common to all humanity. These companies did not invent our genes. One shouldn't be able to patent the building blocks of our genome, but they can certainly patent novel processes and drugs which act upon it.

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You're taking this way too far IMO. Companies can continue to patent based on their R&D. If isolating a gene is not patentable anymore, its not that big a deal. Incentives remain in place. The difference is that now a company has to actually do something other than isolate a naturally occurring gene common to all humanity. These companies did not invent our genes. One shouldn't be able to patent the building blocks of our genome, but they can certainly patent novel processes and drugs which act upon it.

 

Agreed.

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