Gene patenting is in the news once again. This issue isn’t going away any time soon.
In my opinion, this debate boils down to one simple question.
Should one company, in this case, Myriad Genetics, be allowed to patent human genes when lives are at stake?
It seems as if there is a simple answer here and it’s no!
Of course many others do not agree with me. Not surprising, nothing is ever simple when there are millions of dollars at stake.
I don’t wish to rehash the entire history of this issue. If you’re interested in some background information, please take a look at my previous post on this topic: Monopolies & Gene Patents – Think You Own Your Genes? Think Again!
In a nutshell, in 2009 a lawsuit was initiated by the American Civil Liberties Union and the Public Patent Foundation on the behalf of 20 plaintiffs challenging Myriad’s right to patent the BRCA1 and BRCA2 genes and therefore to dictate prices on tests for these mutations. Worth mentioning once again is this fact: Breast Cancer Action was and still is a plaintiff in this lawsuit, the only national breast cancer organization listed as such.
Where are the others?
The suit claims the patents inhibit scientific research as well as patients’ rights to receive potentially life-saving genetic testing.
I agree.
As Daniel B. Ravicher, executive director of the Public Patent Foundation and co-counsel for the plaintiffs, says:
“Nobody ‘invents’ genes, so no one should be able to claim ownership of them. We are not talking about a new drug or a new tool to fight cancer. We are talking about a genetic marker that occurs naturally in the human body. That cannot, and should not, be patented.”
Again, I agree.
Genetic testing is crucial for those like me facing a cancer diagnosis. There is a strong family history for breast cancer in my family; hence genetic testing was called for at the time of my diagnosis. My oncologist almost insisted upon it. My entire treatment course depended upon my test results.
I want every woman and man with an obvious family history to have the same options I had before or after a cancer diagnosis.
Women who do not have cancer yet, but who are deemed to be at high risk for developing breast or ovarian cancer based on results of the BRCA1 or BRCA2 test, have preventative options they may or may not choose to take. For the under-insured or uninsured, the cost of such testing is prohibitive. The initial test series in a family runs around $3,000.
Again, lives are at stake here.
The case has been batted around in the court system since 2009 and finally made its way to a federal appeals court in July 2011. The appeals court decision sided with Myriad. The ACLU appealed that decision to the Supreme Court.
That meant more “wait and see.”
This week the topic landed in the news arena once again and I’m feeling encouraged, but only slightly.
Why am I encouraged?
Because the Supreme Court “set aside” the July 2011 U.S. Court of Appeals decision I mentioned above. I’m not exactly certain what “set aside” means, but I think it means the case is being sent back for further consideration and hopefully a reversal in the decision.
This latest Supreme Court “setting aside” decision is thought to have something to do with another high court’s unanimous decision this week which determined a blood test developed by Prometheus Laboratories of California is ineligible for a patent because it was a “simple application of a law of nature.” This particular lawsuit was instigated by Mayo Clinic.
Things falling under the “laws of nature” category have typically not been eligible for patenting for obvious reasons, well, obvious to most anyway. This is a major component in the Myriad case as well.
Of course, Myriad strongly disagrees and will continue to fight hard to hold on to its BRCA1 and BRCA2 gene mutation patents. You can bet on that. Far too much money is on the table.
The thing I can’t figure out is this:
Why aren’t more people up in arms about this issue?
I understand that roughly only 10% of breast cancer cases are attributed to the BRCA mutations. I understand people like me are in a “BRCA breast cancer club minority.”
However, science is only at the tip of the iceberg here. Genetic testing is still in its infancy. More and more genes are going to be linked to diseases, conditions and who knows how many ailments. More and more medical decisions will be based on genetic test results.
Genetic testing possibilities and subsequent varying prevention and treatment options should be available to all, not just to those who can afford it.
Do we really want any company to have a monopoly on our genes?
Do we really want any company to have so much control over life and death issues?
I know I don’t.
What about you?
How do you feel about the issue of gene patenting?
Why do think more people are not “up in arms about this issue?
Would you have (or have you had) genetic testing?
Susan Beausang
Wednesday 4th of April 2012
Hello Nancy,
I guess good minds surely do think alike. We were probably typing our blogs on this important topic at the very same time.
I believe I read a stat that said something like 20% of our genes are already patented. Right or wrong (the stat, or my memory of it), I think these gene patents extend to far more than BRCA genes, so like you said, we should all be up in arms. And yet I must admit, the only reason I'm aware is because there is so much breast cancer in my family and we learned we have the BRCA2 mutation. Were that not the case, would I be reading up on this? Maybe, but probably not.
I recently had a conversation with a geneticist from UW Madison. She told me that in most of the research grants her lab gets, it is stipulated that they have to patent their discoveries as a requirement of the grants, be they corporate or govt grants. She also commented that among researchers, they don't take most of those patents very seriously as scientists just work around them. Interesting perspective.
Thanks for raising awareness about this! Susan
Nancy
Wednesday 4th of April 2012
Susan, I bet we were typing away at the same time! I've read that too about other human genes being patented already. Still, that doesn't make it right. We are setting precedents here that are going to matter to more and more people down the road. That was an interesting conversation you had with the geneticist. Sadly, researchers and huge companies such as Myriad, don't necessarily think the same way about sharing. Thank you for raising awareness as well, Susan.
AnneMarie @chemobrainfog
Monday 2nd of April 2012
One more point..... when I was tested in 2006, part of the reason for the genetic counseling was to make sure I was aware IF my insurance company paid for the test, it would become part of my medical records AND, although MSK had not seen it happen, discriminatory practices could **not** be ruled out based upon the results. I was told that many women opted to go "out of pocket" to preserve their privacy.
What a mess.... Great conversation in the comments,too!
Nancy
Monday 2nd of April 2012
Ann Marie, You raise a good point about the privacy. I believe a law has since been past that makes it illegal to discriminate based on genetic test results, but still that doesn't mean discrimination doesn't happen does it? It is all such a mess isn't it? Thanks for stopping back.
Jan Baird Hasak
Sunday 1st of April 2012
Thanks for addressing this important issue, Nancy. As a retired patent attorney for pharma but also a breast cancer patient, I have mixed feelings about gene patenting. Perhaps a patent on such genes should have a shortened life from the lives of regular patents.
I think more people are not “up in arms" about this issue because they are unaware of it or don't understand the science behind it. They'd rather leave it for the experts.
I've already had genetic testing, and it cost me $375 out of pocket. Myriad Genetics paid the rest. I'm not sure I would do it again because of the cost.
Thanks for enlightening your readers! You always bring to the forefront issues that many don't wish to tackle. And I admire you for that.
Nancy
Monday 2nd of April 2012
Jan, Thanks for your comment. I know you have a slightly different perspective here since you have been a patent attorney and I appreciate that. I just don't feel it's morally right to patent human genes when the end result is a monopoly, price setting of testing, no competition and the exclusion of women and men that would benefit but cannot access such testing for whatever reason.
lopsided_blogger
Saturday 31st of March 2012
This definitely seems like something that someone should not be able to patent. It's too vital for everyone's basic health and would set a terrible precedent, just as you point out.
I was 37.5 at diagnosis with no known relatives having BC. But since I was young, all my caregivers stressed BRAC testing. I said no for many years, because I just knew it didn't apply in my case and because I worry about what insurance companies and future employers could do with the info. I did decide to do the test when I started having potential ovarian trouble because I wanted some solid evidence for deciding if I should have all that out as well.
It came back negative, just as I thought it would, but it was truly valuable to know that rather than just having my strong hunch.
So it ends up I was glad this test was there and available to me. To think that I would have trouble getting it because of cost or other silliness would not make me happy.
You're right, they're wrong. I think the reason more people aren't up in arms over it is that most of us don't recognize the scope of the problem, or the fact that it really could/does affect so many of us.
Great post!!!
Nancy
Saturday 31st of March 2012
Lopsided blogger, Thanks so much for taking time to comment. You make such good points. The test should indeed be available for whoever it is deemed a good assessment tool. I don't think that many people are even aware of this issue and that's too bad because, as you mentioned again, we are setting precedents. Dangerous precedents I might add. Thanks for adding to this discussion.
AnneMarie @chemobrainfog
Saturday 31st of March 2012
No one has more at stake in this thing than me (at this point). I have TWO wacky genes and they don't know what the hell they mean. My BRCA test, I like to say, was a waste of good blood. For EACH gene I got the same explanation. Could be harmless, could cause cancer, we don't know.
Breast Cancer ACTION is awesome! I got to see Pink Ribbons Inc (which I was going to see anyway) AND I got to distribute some of their materials. They are relentless. Kinda like we are....
The fact that the Supreme Court agreed to hear the case is GOOD. The fact that they returned it to the Appeals Court means there are still issues they haven't sufficiently screwed up in their ruling for the Supreme Court to step in and interpret the law.
Waiting. This is just like doctor followup time... waiting waiting waiting..... Hoping something changes.
Great post, Nancy.
Nancy
Saturday 31st of March 2012
Ann Marie, I guess you are one of those people with a strong family history, but still testing negative. There's a term for that, but I can't remember what it is exactly. It's tough to be in that "questionable gene limbo-land" too. Yes BCA is awesome. I cannot wait to see the movie. Glad you had the opportunity already. Lucky you! Yes, we have to keep waiting for this court business to get resolved... At least we know about the "waiting game" don't we? Thanks for your comments.