May 13th, 2009
Posted by Joel Engardio, ACLU at 08:26am	Free Speech, Women's Rights

Liberate the Breast Cancer Genes

The ACLU has taken on a patent case for the first time in its nearly 90-year history. The government's been allowing private companies to patent human genes. The ACLU thinks that violates the First Amendment and patent law. This is heady, complicated stuff. But when a patent creates a monopoly that restricts the free flow of information, a lot is at stake, and when we're talking about something like genes associated with breast and ovarian cancer, real women are hurt. This video about the case features some of those women's stories.

Please note that by playing this clip You Tube and Google will place a long-term cookie on your computer. Please see You Tube's privacy statement on their website and Google's privacy statement on theirs to learn more. To view the ACLU's privacy statement, click here.

"How can it be that a company controls genes? How is that possible?" Barbara Brenner asks in the video. She's the director of Breast Cancer Action and one of the plaintiffs in the lawsuit.

We hope this short video will inform and inspire. It provides a simple explanation and overview of the issues in our case against the U.S. Patent and Trademark Office, which granted Myriad Genetics patents on the BRCA1 and BRCA2 genes, the genes associated with breast and ovarian cancer. The video also features the women directly affected by the patents. They represent any number of mothers and daughters you may know facing the same obstacles as three of the plaintiffs in our case, Genae Girard, Lisbeth Cerianai, and Runi Limary.

The results from Myriad's genetic test are a strong factor in women's decision to have children. Breast cancer survivor Genae Girard, 39, took Myriad's genetic test to determine if she's at risk for ovarian cancer. Her test results showed that she's at a high risk for the cancer, and should have her ovaries removed. Because only Myriad holds the patents on the genes associated with breast and ovarian cancer, no one else can offer this genetic test without its permission. Therefore Girard can't get a second test, or a second opinion, on whether to have her ovaries removed.

Lisbeth Ceriani, a single mom, simply can't afford the more than $3,000 test. Getting the test paid for by insurance can be difficult.

"I'd like to see my 8-year-old daughter go to college," Ceriani says. "But if I have the mutation, there's a huge chance I'll end up with ovarian cancer in the immediate future. I need to have that test so I can get my ovaries out if I need to before anything happens. I don't like those odds." Myriad's monopoly on the genes, and therefore the genetic test, prevents other companies from offering this potentially life-saving test at a lesser cost to patients.

Dr. Wendy Chung, Director of Clinical Genetics at Columbia University and another plaintiff in the case, says she too often sees women like Girard and Runi Limary who can't seek second opinions and are given little data to understand what their tests results mean because of the patents.

Limary had breast cancer at 28 and took Myriad's test to find out if it was likely to return and if ovarian cancer is a concern. The result was puzzling: Limary was told she had a genetic variant of "uncertain significance." It turns out other Asian-American women like Limary had also received these results. But because patent-holder Myriad has not determined the variant's significance, and other companies are excluded from offering the test, these women are left to guess whether their variants warrant removal of their ovaries along with their ability to have children.

Tania Simoncelli, ACLU science advisor, says a lot is at stake if companies like Myriad are allowed to own genes and have a monopoly on everything associated with those genes.

"They own not only the gene, they own any future tests, any future drug, any future therapy, so we're putting our trust in one single company," says Simoncelli. "There are places where the patent system has gone too far. Too much patent protection can in fact trample our civil liberties."

Please share this video far and wide and let others know why it is important that we stop the government from allowing companies like Myriad to own our genes.

Permalink |	Free Speech, Women's Rights

1. Lise Quinn Says:
   May 13th, 2009 at 10:33am

   This is an outrage! How can an individual like me help to stop this?

2. Steven M. Rosen, Ph.D Says:
   May 13th, 2009 at 12:43pm

   I am writing to you as an individual, although I am employed in the diagnostics industry. I am very troubled by what what the ACLU is doing. In my opinion is it tantamount to advocating the stealing of intellectual property from companies who have made significant investments in delivering healthcare innovation to the public. There is a huge investment that is required to bring a healthcare diagnostic product to market. Companies will not make the investment to discover, development, clinically validate and make commercially available technology which they do not see making a profit. If the ACLU is sucessful in its efforts, companies will start to question whether the payback will be there for healthcare products. Potential cures for disease and new diagnostic tests will never become commercially available. Additionally, I believe the ACLU is wrong in stating that companies are not able to innovate and work with the technology if it is patented. There is clearly a a research exclusion for patents that permits innovation.

   Steven M. Rosen, Ph.D

   Email: Stevenmarkrosen1@yahoo.com

3. SD Says:
   May 14th, 2009 at 3:43pm

   Dr Rosen is a self serving member of the industry that we condone. We as researchers are supposed to help, not hinder, people with disease. This issue crosses the boundaries of patent protection. Nail the bastards.
   I have been a medical researcher for 25 years and am sick of the patent abuse in this country.

4. Erik Kallstrom Says:
   May 16th, 2009 at 6:35pm

   I am currently doing research to determine the interest in America's space program. If you have a minute please take my survey at:

   http://spaceprogrambudget.questionpro.com

   Your time very important for our research and your opinions matter! Thank you ~ Erik Kallstrom - ERAU Graduate student.

5. big T Says:
   May 18th, 2009 at 7:23am

   do you bastards ever run to the rescue of any white christian males???? it seems all you are interested in is ultra-liberal causes for negros, female , men that take it in the hind end , (that is not right,no matter who you are), lillie lickers. you forget about the people that founded this country,white european christian male. give you the right to do what you need, to pursue happiness.

6. Michael Dutton Says:
   May 18th, 2009 at 5:39pm

   I suppose it should behoove me that our government would actually allow a company to purchase a patent on a gene. I suppose I should be surprised that a U.S. company would actually want to "corner the market" on an R&D health issue.
   But I'm not surprised because I've learned that our government and the majority of U.S. companies would do absolutely anything - anything - to turn a profit, regardless of consequence.

7. Michael Dutton Says:
   May 18th, 2009 at 5:46pm

   Oh, yes ... Doctor Rosen - perhaps healthcare, including research & development, represent fundamental areas within the human experience that should NOT be subsets of the capitalist enterprise.
   Perhaps it's political heresy, but ... healthcare should be non-profit.

8. Jim Fyfe, Ph.D. Says:
   May 18th, 2009 at 5:56pm

   As a researcher in the drug industry, I was very troubled when companies/individuals began to be allowed to patent genes. It was unprecedented, illogical and unwise to let people to patent something that nature had produced. It would have been analogous to someone discovering and thus patenting an enzyme in the body. No one did that! We used the information that scientists learned about nature's enzymes to synthesize compounds that affected the enzymes, and come up with medicines. But yet here we were allowing patenting of nature's genes. Outrageous!

9. brian t bayer Says:
   May 18th, 2009 at 6:05pm

   ceo's at certain american co.s need to have a dna test
   to determine if they are at all human!

10. Jody Ranney Says:
    May 18th, 2009 at 6:13pm

    My first response is how could this happen? Genetic patenting! It probably happened because no healthy, sane person would conceive of it, therefore the issue was not covered in the patent codes. Now that the insanity is public information, then we need to salute and support the ACLU's efforts to protect the countless women whose lives are affected by the techno-corporate greed of Myriad (by any name). Public abuse under the control of private business is not new. Genetic patents mandating access to health information based on ability to pay is evil. Shame on Myriad or anyone who invests and promotes their vileness.

11. OA Says:
    May 18th, 2009 at 6:36pm

    These genes are "invented" by Mother Nature and not Myriad. The company has only discovered the genes and can not file a patent as an inventor and have the right to them unless the inventor(s) has assigned the rights to the company which is unlikely in this case.

    Neither is it possible to patent ideas that has already been made public. Since these genes probably have existed for thousands of years in people, they have also been public the same period.

    In a previous case where a company was claimed to have gotten a patent on a gene, what they really got was patent on a method to keep the genes alive outside the body and not the gene itself. If Myriad has a patent on a new method to find a certain gene sequence, that's fine but it shouldn't prevent anyone to find an alternative method to find the same sequence.

12. DH Says:
    May 18th, 2009 at 6:53pm

    I assure you big T does not speak for all "white christian males".

13. dojoro Says:
    May 18th, 2009 at 8:24pm

    It's an impossible task. Close 1,000,000 babies' DNA has been tagged and stored in a "warehouse" in Minnesota before the protest by the Nurse Association was started ... and without their parents permission.

14. Pat W. Says:
    May 18th, 2009 at 11:19pm

    This patenting of genes is fraught with problems. Did you know that Monsanto patented the traditional crop seeds of Iraq so that Iraqi farmers would have to pay that company to grow their own crops? The opportunities to establish monopolies to hold specific populations for ransom will be found everywhere.

15. DMK Says:
    May 18th, 2009 at 11:46pm

    It is bigoted fools like yourself that makes the ACLU necessary. To protect everyone from having their rights infringed upon. Equal rights are for everyone not just wasp males like you big T.

16. rrr333 Says:
    May 19th, 2009 at 8:49am

    since when have they needed help big T?

17. Scott Says:
    May 19th, 2009 at 9:41am

    Dr. Rosen has, of course, purposely gone around the issue. Genes themselves shouldn't be patentable, however, the test that Myriad has developed can. Patent the test, not the gene. There is likely the same amount of cost in developing the test once the gene is identified, than the gene discovery itself. Myriad should get accolades for finding the genes, but the discovery is for humanity, not just for one company.

18. KS Says:
    May 19th, 2009 at 10:07am

    I'm a proud card-carrying ACLU member, but I'm bothered by the way they present this case. You cannot patent genes as this story claims. You can patent methods to screen for a gene or to isolate a gene. There are a number of other things you can patent along the way, but you cannot "patent a gene".

    Any other company is perfectly free to come up with another method to screen for this gene, but they can't use the patented method.

    Please straighten up the reporting here ACLU.

19. Jeff Liu Says:
    May 19th, 2009 at 12:24pm

    Put people ahead of greedy big corp's monopoloid profit.

20. roald Says:
    May 19th, 2009 at 12:39pm

    big T...The white european, christian [not completely true] males who founded this country were wise enough to realize that founding a nation that was no different than the one they left was wrong. Instead they devised a Constitution that limited the powers of the State to take away the freedoms and liberties of its citizens. The ACLU continues the work of our founders.

    If you read the blogs here, you will see that the ACLU has indeed come to the defense of white christian males when the State acts against its Constitution. Unfortunately, some of those white christian males are in prison or have a conflict with other white [correct version of] christian male.

21. jorge riveros Says:
    May 19th, 2009 at 1:39pm

    Congratulations, keep me informed and I will tell my friends,acquientances and family and let me know which senators should we call. TKS.

22. Tracy B Says:
    May 20th, 2009 at 12:34pm

    This is an outrage. I want to say i cant believe it- but of course i can.. Its an obvious concern - because it's the beginning of something that could potentially shape every persons life - in the future - provided the pharmecutical companies are not stopped. . Which im sure we(supporters & the aclu) will win the case.. we just all need to do what we can to ensure that it doesnt happen.. If we all speak up - they can not hold us back.

23. G Says:
    May 20th, 2009 at 2:45pm

    I personaly find it insane that a company is technically allowed to own a portion of you these genes are in men and women genes are the building blocks of people and therefore they patented something that is potentialy in everybody its beyond violation of your rights its claiming ownership of a piece of a person... whats next companys buying stock in your soul...

24. david Says:
    May 21st, 2009 at 8:47pm

    while a united states company took such acrtion i expect this patient would not be honored outside its boarders despite current patient treaties that exist.

25. Alex from IL Says:
    May 22nd, 2009 at 2:54pm

    Gene patents are uninovative, why are they even granted patents? Gene patents infringe on the basic right of first sale (first-sale doctrine). Such patents are stealing from the public domain. Gene patents and never-ending copyright is theft from every living person.

26. Jay Dratler, Jr. Says:
    May 27th, 2009 at 8:09am

    Your lawyers may already be aware of it, but I have an article that criticizes early-stage patenting of preliminary research results like gene sequences on mathematical and economic ground. The article uses simple mathematics to prove that the cost and time required for practical use of these patents through licensing will be astronomical.

    The article can be found on line at the following URL: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=959462

    Jay Dratler, Jr.
    Goodyear Professor of Intellectual Property
    University of Akron School of Law

27. sarah chapman Says:
    May 27th, 2009 at 10:14pm

    This decision to patent scientific knowledge would hamper most scientific exploration. How can scientists share their findings, test any scientific findings to help prove or disprove these. Suc patents equates science with inventions of such things as automobile parts. And all in the name of profit. How will future scientists be able to really function under these restrictions? And certainly the meical profession will suffer as will the patients they serve.

    It is unthinkable that a court of law would permit this to happen.

28. Thayne Says:
    Jun 23rd, 2009 at 10:14pm

    This story is wrong the patent is not on the gene but the diagnostic method used to find that particular sequence

29. Brenda Shapiro Says:
    Aug 9th, 2009 at 4:38pm

    I am a mother of two daughters who both tested for the BRCA 1 gene six years ago when their Dad was diagnosed with pancreatic cancer. Both daughter's tests were taken in NYC on the same day. One daughter's test came back positive for the gene and my other daughter came back negative. Both tests taken by a genetic counselor in NYC at Cornell Hospital and both blood tests were sent to Myriad. Six years later, my daughter who is now 29 was ready to have her double mastectomy.We met with all the correct doctors. Over the six years we had the mammographies, the MRI's with mira luna, she even began seeing a therapist who was going to help her with this moment in her life and try to come to peace with it. I wanted to make sure that we had done everything that we possibly could before she was wheeled into surgery. I asked for another BRCA test. The doctors did not think it was necessary. After all, Myriad did the testing and "they never make a mistake". The test was taken and two weeks later,my daughter called me sobbing and hysterical, the test returned, it was NEGATIVE... As happy as I was for one, I knew in my heart it was in the end my other daughter who had to be positive. Myriad admitted to mixing up their blood samples six years ago. It was my other daughter who was positive. All this time and heartache with one daughter, bittersweet shock for the other. What if I had not demanded another test? If Myriad had not been the only lab to do the testing I would have known six years ago because I would have had another test done on both of my girls and had it sent to another lab just "to make sure". Myriad has the patent on the testing and the gene. I am grateful it was discovered but not one person, not one company should be the "be all end all" when it comes to having such an effect on one person's life, one family's life. I hope that this helps you in your fight to make sure that other companies can also have the right to test for this gene. Mistakes are often made. At least with other companies testing, maybe you can keep it from happening as it happened to my girls. Thank you for listening. Brenda Shapiro, Las Vegas, Nevada 89135

30. Blake Van Says:
    Aug 13th, 2009 at 5:04pm

    Monopolies Like Monsanto and Myriad are using profit tools to secure and block any challenge to there profits, by using Patents and copyrighting tactics to force any and all profits to go directly to them, for life plus 90 years. I just saw on HULU about GMO corn seed is patented with a breast cancer gene and when a University researcher and R&D was sued when doctors tried to study the gene to stop its "Rapid Growth factor". Farmers in Mexico and Canada are being Sued when "Cancer Corn seed" cross pollinates and contaminates the poor farmer fields.
    Europe Ban GMO products and GMO crop seed. (I don't eat GMO) Big Phama with the Help of FDA have stopped the sale of a form of Vitamin B-6, a Nutrient required from human health, until the drug company can develop a "Profitable Product" this form of B-6 I use now but when Big Phama gets to "Monetize It" I will no longer be able to afford it.

    This is a moral issue, Plus a legal one, that we must stop. we must the profiting from body parts and gene patenting.

    Remember if the parasitic corporation owns your genes you cant even look at them with out there control, or authorization, when they have this control they control us. Financial Suicide if we sacrifice our freedom and Privacy.

31. Dino Mason Says:
    Aug 17th, 2009 at 6:33pm

    Hyppocrates, the ancient Greek and the father of medicine has turned over in his grave at the prospect that medical science is used for corporate profit and for personal profit of certain "physicians" who love money more than healing the sick. Steven Rosen's, PHD argument is false. Research, when co-mingled with the profit motive is not neutral, but bad science.
    Lets not forget the cigarette commercials by scientist and doctors who claimed that research "proved" that smoking cigarettes are not dangerous to human health.
    The patent of human genes and genetic seed engineering or any other similar patent ought to be universally illegal. I hope that the ACLU wins this case for the sake of all of us, for freedom and justice.
    The truth is that the only reason a corporation obtains a patent is for profit not human good.

32. Dino Mason Says:
    Aug 17th, 2009 at 7:03pm

    Did we not trust the Bankers, Investment REITS, Mutual Funds and Retirement funds? They bankrupted the citizens and the Nation.
    Are we now asked to trust Myriad and other companies with our genes, with human gene patents? Let me sell you the Brooklyn Bridge.
    The last person I trusted was a used car salesman, he said "trust me"! I did, the car worked.
    Until the motor died one block away. Then he said why don't you by a new car? Trust me!
    Ms. Shapiro's experience with Myriad, inc. is a lesson for all of us.
    Corporations are now playing God, with peoples lives, its vile disgusting, obscene, a violation of Human Rights.

    Please win this case for all of us, who are without voice or power.

33. MJF Says:
    Aug 19th, 2009 at 2:09pm

    How did these people even think of this? How did our so-called representative government allow this? Who do they work for? Where is America? It has been painfully obvious for decades that private corporation health care has never been focussed on people. I completely support your efforts in this lawsuit. Please win this lawsuit and give ordinary human beings at least some voice in our United States. Thank you.

34. GCC Says:
    Aug 20th, 2009 at 1:08am

    To BigT

    You realize this country was founded on a double standard and that they were infact slave owners suggesting their class be the only ones who vote.

    People have the ability to change what they want in their body. Piercings, operations, and even chopping off a limp to save them. They have to make that final call in general situations. Why can't people have the ability to follow up on what one person says with a second opinion?

35. so Says:
    Aug 23rd, 2009 at 8:43pm

    @KS says that the ACLU case is presented incorrectly. He is wrong. In this case, Myriad has patents ON THE GENE SEQUENCE. This means that regardless of how you screen for the test, you are violating Myriad's patents. It also means that if you do research involving the genes and return the results to patients, you are violating the patents. In essence, this stifles research and creates a dangerous health care monopoly.

36. TERRI Says:
    Aug 25th, 2009 at 2:57pm

    Restricting research and studies on any type of learning limits free enterprise and the hope that several minds are better than one. It is unthinkable that the government would limit scientific research and discovery. One entity should not be able to control a naturally-occurring substance that is not manmade. If another company wants to spend time and resourcees to expand knowledge it can only be beneficial to all. what should we do?

37. sallen Says:
    Aug 25th, 2009 at 7:27pm

    What right does the patent office have to sell a patent to anyone who didn't discover an item. This is like patenting electricity. You may patent a certain machine that uses it but not electricity it self. I hope they don't patent trees I would hate to think I could cut down a tree and make lumber because of a patent!

38. stacy Says:
    Sep 7th, 2009 at 2:48am

    This is definitely a heavy situation with many parts and variables.
    Myriad should not have all rights. Myriad should have to surrender all medical/scientific results to a database that is governed with the intent to find/create cures or further progression involving genetics.
    They can still make the money they want so badly.They can sell their information other medical companies at a price that is dictated by outside constituents.
    That's a little broad and fragmented but it's a saner idea than letting a medical company have 100% rights over something like genes because they first discovered it. What would happen if all the great thinkers kept their inventions/revelations to themselves? Where would we be? I just think it lacks compassion, compassion is imperative to the wellness of life.
    We learned it when we were three years old, SHARE!

39. Dorothy Says:
    Sep 16th, 2009 at 5:41pm

    If people would look to God for wisdom He would guide thrm in their trials & help them. He keeps His promises but you must trust Him & obey Him.
    He loves you & wants you to believe in & trust Him.
    It is better to trust in God than in man.

40. Danielle Says:
    Sep 18th, 2009 at 9:16pm

    Today's advancements in technologies might allow genetic patenting to fall under the category of bioterrorism; and based upon the same premise of the Atomic Energy Act of 1954(42 U.S.C. 2181 (a)), Congress should revoke the right to patent genes. In direct violation of the 1st amendment of the U.S. Constitution, gene patenting restricts the dissemination of all available information which would save lives or offer a proper mode of defense against diseases that kill.
    While there is no question to the fact that DNA itself is natural and unpatentable, a single gene which has been extracted from that DNA becomes a composition of matter. Any new and useful composition of matter is, by law, patentable. HOWEVER, that very composition otherwise extracted from its natural source then becomes a "biological agent" as defined under the U.S. Title Code 18 sect 175. And, to take it one step further, a "biological weapon" includes development, production, transfer, acquisition, RETENTION or POSSESSION of any biological agent, toxin or delivery system for other than prophylactic bona fide research or other peaceful purpose.*
    This leaves only one question. Is the ownership of that biological agent, which may kill, an act of terrorism? Absolutely. Yes. For example, the genes BRCA1 and BRCA2. These two genes are killers in the form of breast cancer and ovarian cancer. And women are being denied the necessary information, which could save their lives, at the whim of the patent holder of BRCA1 and BRCA2.
    The patent holder, Myriad Genetics, reserves the right to restrict any or all information that may lead to prevention, treatment or therapies that will potentially spare lives. They also reserve the right to assign the monetary value associated to that gene, making it hardly affordable. They have in their hands killers/biological agents and are hindering progress in medical advancement. This is hardly a peaceful purpose. Women are dying.
    Bioterrorism may be a harsh word. Truthfully there is no other name. Withholding this type of information from the world is just one more step toward the downfall and inevitable extinction of the human race. We could actually refer to it as genocide-you decide. Because we are a pandemically conscious and phobic society, Congress needs to recognize the magnitude of the terror instilled in those who are already aware that it is in fact a reality that somebody can call "dibs" on an illness or disease and refuse treatment. One could call it the perfect weapon.

    * US Code online via GPO access
    www.gpoaccess.gov
    Cite 18USC175 pp 37-38
    Title 18 Part I chapter 10 section 175

    written by Danielle Boughan daniellebon@live.com for any responses via email

41. Danielle Says:
    Sep 21st, 2009 at 12:22pm

    Today's advancements in technologies might allow genetic patenting to fall under the category of bio-terrorism; and, based upon the same premise of the Atomic Energy Act of 1954(42 U.S.C. 2181 (a)), Congress should revoke the right to patent genes. In direct violation of the 1st Amandment of the U.S.Constitution, gene patenting restricts the dissemination of all available information which could save lives or offer a proper mode of defense against diseases that kill.
    While there is no question to the fact that DNA itself is unpatentable, a single gene which has been extracted from that DNA becomes a composition of matter. Any new and useful composition of matter is, by law, patentable. HOWEVER, that very composition of matter which has been otherwise extracted from it's natural source then becomes a "biological agent" as defined under U.S.Title code 18 sect 175 of the bio-terrorism law. And, to take it one step further, a "biological weapon" includes development, production, transfer, acquisition, RETENTION or POSSESSION of any biological agent, toxin or delivery system for other than prophylactic, protective, bona fide research or other peaceful purpose.*
    This leaves us with only one question. Is the ownership of that biological agent/gene, which may kill, an act of terrorism? Yes. Absolutely. Take for example, the genes BRCA1 and BRCA2. These two genes are the killers in the form of breast cancer and ovarian cancer. They are owned by Myriad Genetics. And, women are being denied the necessary information which could save their lives at the whim of their patent holder.
    The patent holder reserves the right to restrict any or all information that may lead to prevention, treatment or therapies that will potentially spare lives. They also reserve the right to assign the monetary value associated with those genes, making testing hardly affordable. They have in their hands a killer, a toxin, a biological agent; and are hindering progress in medical advancements. This is hardly a peaceful purpose. Women are dying.
    Bio-terrorism may seem a harsh name; but, truthfully, there is no other suitable. Withholding this information is just one more step toward the downfall or extinction of the human race. Maybe we should label it as genocide. We are already a pandemically conscious and phobic society and Congress needs to recognize the magnitude of terror instilled in those who are already aware that it is in fact a reality that someone or some entity can call "dibs" on an illness or desease and refuse treatment. I'll call it the perfect weapon.

    *www.gpoaccess.gov
    cite 18USC175 pp 37-38
    Title 18 Part I Chapter 10 sect 175

42. Little1 Says:
    Sep 30th, 2009 at 3:01pm

    My mother died of breast cancer when I was five and I have been told for years to get a MRI and a battery of other tests done but my insurance, which I pay out of pocket but does cover mammogram, does not cover any of it.

43. Corinne Ouellette Says:
    Oct 23rd, 2009 at 12:06pm

    Compressions from MAMMOGRAMS cause cancer.

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