By Nancy Stordahl
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 BCAction 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.”
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.
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. BCAction 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?