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Monopolies, Rulings and Controversies on BRCA1 and BRCA2 Patents

Last November I was contacted by a journalism student attending Emory University in Atlanta, Georgia. She was working on a paper about BRCA gene mutation testing, the monopolies held by two genetic testing companies and the recent controversial rulings on patents. She also wanted to include some thoughts and insights from a person directly influenced by both breast cancer and a positive BRCA2 test outcome. That would be me!

I was impressed with the fact this young woman even knew about BRCA testing and the recent controversial US Department of Justice ruling. I see this as real progress! Sadly, I think there are still some, even in the medical profession, who are not “up” on this topic. I want to thank her for getting me to think once again about this topic. Also, I’d like to thank her for caring enough to write about such a thing. I was delighted to talk with her because it meant some of what we are all working toward is working.

Number one, awareness about the availability of BRCA gene mutation testing has grown tremendously since my family first became acutely aware of this DNA mystery about four years ago. When my mother decided to get the BRCA test, I was not supportive I reluctantly must admit. My reasoning was we already knew our family was at a greater risk than the normal population, so why add to our sense of doom and gloom? We could simply stay on top of our health and monitor things, surely that would be enough. Obviously, that theory didn’t work out too well for me.

In addition to there being more awareness about the existence of this available test, many women are now proceeding to not only have the testing done, but also are taking proactive preventative measures such as choosing to undergo prophylactic mastectomies and oophorectomies. These women are taking their test results and acting upon them. They are deciding to take action before cancer strikes. They are making bold, personal and difficult decisions about their lives and bodies, sometimes even being chastised as a result, with some critics even going as far as calling these women self-mutilators.

Why do people so often feel they have the right to judge the decisions of others anyway?? (Ah, a topic for another day’s post!)

Now that more women are aware of the test and are also willing to act upon the results, we need to get past the next hurdle. It seems to me that hurdle is the cost, due in large part, because of the monopolies two companies have. Something about this seems wrong to me. I am not opposed to any company making money on a test or technique they have perfected. I am opposed to women (and men) being denied access to information about their own genes because of prohibitive cost, limited availability of testing and restrictive insurance coverage. There must be some kind of middle ground.

I am certainly no legal expert, but I believe the main issue surrounding this controversy is the dispute over whether any company has the right to patent human genes. This controversy came to the forefront in 2009 when Myriad Genetics tried to patent the BRCA1 and BRCA2 genes. This resulted in a lawsuit brought by various individuals, medical researchers and others represented by the American Civil Liberties Union and the Public Patent Foundation whose basic challenge stated that patents on BRCA1 and BRCA2 genes impeded access to testing and information about oneself.

The main premise was a person’s genes remain part of nature and are therefore ineligible to be patented.

In March of 2010, Judge Robert W. Sweet of the U.S. District Court in Manhattan, ruled the patents invalid in his 152 page document basically agreeing with that premise. Simply stated, the human gene was discovered, not created and hence should not have been patented.

Naturally, Myriad appealed and asked the US Department of Justice to offer an opinion. Perhaps to everyone’s surprise, late in October of 2010, the DOJ agreed with Judge Sweet’s ruling that human genes should not be eligible for patents because they are part of nature, things discovered not created. They belong to mankind, not any one company.

Proponents of the right to patent say similar gene patents have been granted for decades (this is true) and genes isolated from the body are considered to be chemicals, and therefore eligible to be patented. Both sides of the debate admit these are major developments. Clearly the lines have been drawn in the sand. This debate is not going away anytime soon. There will be no surrendering, not when millions of dollars in profits are at stake. Also, no changes are expected in the near future on granting or rescinding patents until all litigation ends. Who knows how long that will take?

I say what about the lives at stake?

A woman with a BRCA gene mutation is at greater risk for breast cancer in her lifetime. She is at greater risk for recurrence. She is at greater risk for ovarian cancer and possibly other cancers as well. In addition, once a carrier develops cancer, (like me), more drastic treatment options also must be considered. In addition, as genetic science advances, surely more yet unknown gene mutations will offer valuable information for future patients with varying diseases. This matter does need to be resolved.

Do only men and women who can afford the cost of testing deserve to know the information their genes hold? I don’t think so. I, for one, will be keeping an eye on this unfolding story.

I hope those in the legal community can figure out a resolution that benefits everyone. Is that too much to hope for?

If you are interested in learning more, here are a few links to articles dealing further with this controversial topic:

“Gene Patent Ruling Raises Questions for Industry”

“Judge Invalidates Human Gene Patent”

“DOJ Responds to BRCA Gene Patent Dispute with Proposed Rule Change”

Also, the following link is an excellent audio clip from NPR (“Gene Ruling Could Have Wide Implication”), well worth the three minutes or so it takes to listen: 20100330_atc_02

Do you think human genes should be eligible for a patent? I welcome all viewpoints (yes, really!)

12 thoughts on “Monopolies, Rulings and Controversies on BRCA1 and BRCA2 Patents

  1. Great post Nancy! I was just discussing this with a friend. Have you read The Immortal Life of Henrietta Lacks? It really got me thinking about these issues and who really “owns” what our own bodies create.

    On one hand, I don’t think a gene should be patented. On the other hand, I wonder if a company would invest in research if there wouldn’t be a payoff at the end.

    I come down on the side of the first hand though.

    Katie

    1. I agree, great post Nancy !!! You’ve really summed up the issues. I’ve read the book on Henrietta Lacks which I found absolutely riveting. It was unbelievable to think about all those who had profited from the use of Henrietta’s cells, yet her own family were unable to afford basic healthcare. Certainly a lot wrong with the picture.

      On the BRCA gene legal wars ? My feeling is this. If someone is going to own that gene, then this is just another cost that will have to be factored in to any drug therapies that make use of the gene information. Yet another cost, to be borne ultimately by the patient. It’s just another reason, in my mind, that for-profit healthcare is a dirty little business, because at the end of the day it’s about profits first, and the patients and fair access come a not very close second.

      1. Anna, I guess I better read that book since you also mention it. I agree, healthcare for profit can be quite dangerous because the patient always will come in second to money. Thanks for reading and commenting.

    2. Katie, Thanks for your comments. I have not read that book, but will have to get my hands on it. I’m not opposed to companies making money on something, but I am opposed to a tight monopoly. I don’t think our genes should be patentable.

  2. Nancy, well said. I don’t believe either that genes should be patented. Things created by man, not those found in nature. It’s interesting. I remember getting a call from Myriad right before they started my testing. There were three tests for different mutations and the price scale of the last two would be determined by the outcome of the first. So, apparently, our genes are worth more or less depending on what they hold. Fascinating, yet scary stuff. It still comes down to the dollar.

  3. Well, this reminds me of how Monsanto uses their patent on a gene in corn and soy seeds to control nearly all the corn and soybeans in the U.S. This has helped no one but Monsanto, and of course the company is making billions while putting small farms out of business. The company cares nothing about the quality of our food or what is affordable to the average family.

    But enough on that …

    Patenting genes is a BAD idea.

  4. Hi Nancy
    Although I have visited and read your post several times, I really do not feel ‘qualified’ to comment at this time.
    I am going to ask around to see what the situation is in Australia. There are 1 or 2 support group members that have been tested with good reason. I know the testing is very expensive.
    Lindsay’s comment on Monsanto is interesting!
    Nancy, thanks so much for being a regular and loyal reader. I enjoy the wisdom of your words.

    1. Chez, Thanks for reading and commenting. It would be interesting to know what the situation is there in Australia. I wonder where the women you mentioned turn for testing, how much it costs and if genes are patented. Yes, I had not really thought about a company having a patent on corn and soy seeds. I would think they are part of nature too, but I suppose there is some loop hole.

  5. My tissue was taken from me in 1984, and made into the mcf10 cell line. My cells were patented, and are being sold for $429 (research) and $6000 (commercial). Much of what happened to Henrietta happened to me. My DNA is all over the internet. Believe me, the power and money that is involved is beyond what you can imagine.I don’t have the answers, I do know it’s not right!

    1. Susan, Thanks for finding my blog, reading and commenting. It sounds like you have an amazing story. What was the court decision on this (patenting of genes) last week? I’ve been a little out of the loop on that.

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