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Monopolies and Gene Patents – Think You Own Your Genes? Think Again!

Late last month, the ongoing controversy regarding the legality of gene patenting became even murkier and unfortunately, the situation does not appear closer to resolution.

Why does this matter?

Well, because lives are at stake. And lots of dollars.

Women who test positive for the BRCA 1 or BRCA 2 genetic mutations have a much greater risk of developing breast and ovarian cancers in their lifetimes. Men with these gene mutations also face greater risk for breast cancer and possibly other cancers as well.

Genetic testing for these particular two gene mutations is becoming more and more prevalent, but not less expensive. Insurance companies are watching closely from the side lines.

Here is a very brief synopsis of the situation as I understand it.

In 2009, Myriad Genetics applied for patents on the BRCA 1 and BRCA 2 genes. Shortly thereafter, the American Civil Liberties Union and the Public Patent Foundation filed suit against Myriad, the University of Utah Research Foundation and the U.S. Patent and Trademark Office claiming such patents inhibited a patient’s right to obtain valuable information in regard to hereditary breast and ovarian cancers.

On an important side note, Breast Cancer Action was and is a plaintiff in this lawsuit, the only national breast cancer organization listed as such.

Where are all the others? I’m just asking…

I applaud BCA for taking this bold stance!

In March 2010,  United States District Court Judge Robert Sweet ruled the patents were improperly granted based on the “law of nature” which basically means things in nature are discovered, not invented and therefore cannot be patented.

Myriad appealed to the Department of Justice assuming it would uphold its long standing government position on granting gene patents. To the surprise of many, undoubtedly especially to Myriad, it did not, but instead upheld Judge Sweet’s decision declaring these particular human genes should not be eligible for patents.

You guessed it, more appeals.

On July 29, 2011 a higher U.S. federal appeals court reversed things once again, this time by affirming Myriad’s right to indeed patent the two human genes in question.

The controversy continues.

Proponents of the patent (Myriad and their lawyers, among others) insist Myriad is testing for chemical forms of the genes, not as they appear naturally in the body, so a patent is indeed reasonable. The Biotechnology Industry Organization warned denying such patents has the potential to “undermine U.S. global leadership and investment in the life sciences.”

Those opposing the two gene patents believe such patents interfere with a patient’s right to access information about herself. They maintain the genes are part of nature and are not eligible for patents on moral and ethical grounds.

“Moral and ethical grounds” don’t stand much of a chance in a courtroom I’m afraid.

Steven Salzberg, professor of computer science and genetics at the University of Maryland, says,

“If you want to look at your own genome and see if you have a mutation, you should be able to do that without paying a license fee to someone else.”

I agree.

And this fee is not cheap. The cost for testing the first person in a family is around $3,000. The price for subsequent testing within the same family becomes considerably less expensive, around $400 per person, because the cause of the problem has already been “zeroed in on.” They know exactly what to look for, hence the cheaper price tag.

You might assume I’d be on the side of no patents for human genes and I am. However, as most of you know, I am a supporter of scientific research and I realize potential implications/problems may or may not materialize if patents are denied.

In this case, I do believe a patent is a mistake, and a big one.

Why?

If Myriad is allowed to maintain its right to patent these two genes, Myriad remains in control. Myriad would decide if these mutations could be further researched by others. Myriad would decide what tests could be offered to patients. Myriad would decide how much to charge for these tests.

In short, patients seeking genetic information about breast and ovarian cancer would have only one option, Myriad.

And what about the uninsured or the under-insured?

Is it simply sorry, no testing for you?

Is this what our healthcare system has come to?

What if Myriad chose (or was forced) to give up the patent idea and share the knowledge? Just think of all the time and money presently being spent on law suits that could be saved and put to better use on things like, well, more research.

What if Myriad lowered the cost of the tests on the premise that lower costs would mean more people would be tested? Wouldn’t more testing ultimately result in more profits?

Like usual, it comes down to dollars and lots of them.

In my opinion, it’s never good when one entity holds all the cards.

As of now, Myriad’s monopoly continues.

The next few years will undoubtedly see huge advances in genetics.

What kind of precedent do we want to set here, or have we already done so?

Is it too late?

There is a need here for far more intelligent minds than mine to sort this stuff out. I hope they can.

Lives are at stake. And dollars.

Perhaps I’m naively hanging onto the hope that lives are more important than dollars. I sure hope so.

 

If you would like to DO something regarding this issue, get informed. BCA is offering a free webinar later this month. 

What are your opinions on this issue of patenting human genes?

Have you had (or would you want to have) genetic testing?

What suggestions for action do you have?

 

                                                                   

23 thoughts to “Monopolies and Gene Patents – Think You Own Your Genes? Think Again!”

  1. Nancy,

    This is so disturbing. I don’t believe in patenting human genes, and Myriad seems like a real piece of work.

    Thank you for such an informative, important posting.

    I have had genetic testing for the BRCA1 and BRCA2 mutations, and my insurance covered it, as I had a history of breast cancer. My oncologist told me that if I have a mutation my ovaries must go. I did not have either mutation, so I kept my ovaries, but I worry nonetheless….

    1. Beth, Thanks for sharing about your testing and it’s wonderful your insurance covered the cost. They are getting better about doing so. Some people still keep genetic information quiet, but at least that need for secrecy is slowly diminishing. Thank goodness! I’m glad you weren’t positive, but then you did get cancer anyway so… I understand about the worries, Beth.

  2. This blog baffles me. I can’t understand how someone can hold a patent on a gene mutation. If that’s the case, why can’t a patent be held on a disease like cancer or diabetes?

    And this is upheld by the U.S. Supreme Court, but what about other countries? How would this “ownership” apply around the world.

    Myriad should not have spent all this money on lawsuits and instead put it towards research about what to do when women (and men) have the BRCA gene mutual.

    Wow.

    1. Tina, This issue has not made its way to the Supreme Court yet. I think it might eventually get there. It’s working its way through the system. You raise a good question about other countries. I think if Myriad gets the patent they control things everywhere, but I can’t say for sure. And as for a patent on a disease, well, I don’t think that could happen, but who knows? Thanks for commenting. It does get baffling doesn’t it? I’m surprised more people aren’t upset by this really. This is just the tip of the iceburg.

  3. That is a lot of information for me to digest.

    I am not in favor of gene patenting. Companies like Myriad are entirely bad news. So the purpose of Myriad wanting this patent is so that no other company can offer genetic testing for the BRCA gene mutation, correct? And if Myriad is the only company, it will charge as much as it wants?

    1. Lindsay, I don’t think the company is bad actually, I just don’t think they should be allowed to patent these two genes. And yes, if Myriad does get to patent them, they are pretty much holding all the cards as I understand it. Unless the government steps in to regulate pricing, which I don’t see happening. Thanks for the comments.

    1. Chez, Even without a lot of knowledge about the particulars of this topic, you do have an opinion based on common sense and what is right, Chez. Thanks for expressing it!

  4. Thanks for this posting, Nancy. It’s helpful to have a summary of what is happening. My doctor had suggested I get tested for the gene . . . though I had no idea how expensive it is! Yowzers. My knees buckle at the cost (and my wallet). . . I’ll have to check whether it is covered where I live.

    1. Catherine, Do you have a strong family history, Catherine, or is it because of your young age at diagnosis that your doctor suggested testing? Perhaps both. The initial test is expensive, but insurance companies are starting to do a better job coverinig, so do check that out. Thanks so much for commenting. I appreciate it.

  5. Nancy,
    I’m with you, thinking that lowered genetic testing prices would mean more women and families would get tested and therefore, Myriad would make more money. One of the problems may come with the fact that only about 10% of breast cancers are BRCA positive. Granted, 10% of new breast cancer women who are tested would be a huge revenue generator for Myriad at even $1,000 a test. I’m afraid it is that money trumps lives. Terrible, isn’t it?

    XOXOXO,
    Brenda

    1. Brenda, I agree with you that one of the problems is that only abou 10% of bc cases are linked to brca, but I feel like this issue is an issue that will explode in the near futrue as we learn more and more about genetic links to all kinds of things. What we do now matters. Sadly, I think you might be right about money trumping everything. Thanks for your comments, Brenda.

    1. Caitlin, Thank you for your comments. You’re absolutely right, gene patenting is bad for women’s health. I actually think it’s bad for everyone’s health, if not now, in the future. Thanks for the link. I checked it out and agree it’s a helpful overview. Thanks again for the work BCA does concerning this issue!

  6. Good reporting and good writing Nancy. I wish I could say it’s unbelievable what the medical and medical-related industries get away with, but sadly, none of it surprises me anymore. Thank you for keeping this stuff in front of us. Maybe, maybe one day it’ll change.

    For positive news on BRCA and other hereditary cancers (at least in that there are things you can do for yourself), please visit my site and check out “Might you have a hereditary cancer: what you can do about it” (parts 1 and 2). The blogs are about four articles down. http://www.1UpOnCancer.com

    Rachel

  7. Dear Nancy,

    First off: thank you for clearly and concisely addressing this problem and explaining why the recent decision to uphold the patent is a bad one–for us all.

    I am the 10th woman on my mother’s side of the family to be diagnosed with BRCA1 breast cancer in the past two decades, and I know how important BRCA testing can be in saving lives (it probably saved mine, in fact.)

    I have so many questions: I wonder what this BRCA patent will do to other BRCA research. Why would other researchers want to engage in this topic if Myriad owns it? What does that do to families like mine?

    I also have a question: would you be willing to post your article on my blog: Cells Gone Wild? I think my audience would find your contributions significant. Maybe you could be a guest blogger and compose a short preface, perhaps?

    Thx!
    Teri 🙂

    1. Teri, I’m sorry you lost your mom when you were so young, plus all those other cases in your family, that’s really difficult to deal with. There are many unanswered questions surrounding this whole gene patenting issue. The ramifications will be felt for years and will affect other yet unknow genes. Sure, I would love to have my article posted on your site. “Cells Gone Wild,” that’s quite the name! I’ll be checking it out and contacting you soon. Thanks for commenting on this important issue, Teri.

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