By now probably almost everyone has heard or read about the Supreme Court’s decision on June 13th to strike down Myriad Genetics’ patents on the BRCA1 and BRCA2 genes. In case you haven’t, you can catch up here or here.
All nine Supreme Court Judges concurred on this one; the decision was unanimous. Did we really need nine judges from the highest court in the land to tell us that patenting human genes is a no-no?
Apparently so…
Seriously though, this decision was/is a huge deal. Some have been downplaying the impact of it all mostly because of the compromise part that says cDNA (complimentary or synthetic DNA) is allowed to be patented. Admittedly, I’m still a bit confused about this whole cDNA part of the conversation, but it seems reasonable (I hope) that this is how things went down and that this material is still eligible to be patented. For a brief and sort of helpful video explanation about cDNA, click here.
Bottom line here is if Mary-Claire King, the geneticist who discovered the BRCA1 and BRCA2 genes, says she is delighted about the Supreme Court ruling, well, that’s good enough for me. I’m delighted too!
I am not a scientist. I am not a law expert. I am not a doctor. I am not a researcher. I am not a businesswoman.
I am, however, a woman with a BRCA2 gene mutation.
I am a woman whose family has faced the serious and life-changing issue of hereditary cancer. I am a woman who has seen the words positive for a deleterious mutation slapped onto my purple folder. I am a woman who understands about the difficult decisions regarding removing body parts prophylactically or otherwise. I am a woman who cares about other women (and men) having access to life-saving information, testing, treatment and preventive options. I am a woman who cares about research and the future of personalized medicine for all.
After this ruling, things are still far from perfect. Our health care system in the U.S. is still a mess. Disparity is a huge concern. Perhaps many more questions will now bubble up as a result of this decision. There will undoubtedly be more stuff to sort out.
But, this is still a landmark ruling. It’s still progress. It’s still a huge deal.
Why?
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Myriad’s monopoly is broken. Their reign in ‘the land of BRCA testing’ has come to an end. Other researchers can now study, test and analyze this kind of genetic material without worrying about licensing requirements and patent infringements.
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This ruling is also super important for further study benefiting those who test negative after undergoing genetic testing, but still obviously have a hereditary risk factor going on. Again, the research door has been swung open.
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Second opinions are now possible without getting permission from Myriad. Other companies can now offer this kind of test; they are and more will.
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The cost of genetic testing will tumble allowing more individuals to have access to life-saving information and therefore life-saving options/actions, hopefully along with genetic counseling.
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No monopoly means competition, which means a built in checks and balance system will now become a reality.
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A corporation can no longer claim ownership of human genes.
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The decision the Supreme Court reached was morally, ethically and legally the right one.
This decision will potentially impact the future of personalized medicine for everyone and today directly impacts many who live with hereditary risk.
So yes, this is a victory.
I’d like to say thank you to all who helped make this happen. I don’t even know who you all are, but I thank you still.
A special thank you to all the plaintiffs, those who worked on their behalf, the ACLU and my friends at Breast Cancer Action and FORCE; your hard work was/is much appreciated.
BCAction Executive Director Karuna Jaggar had these words to say:
“The importance of this ruling is far-reaching for breast cancer and for all of us who care about corporate control of our genes. In the fast-paced, ever-changing landscape of cancer research, access to genomic information is vital.
One of the single greatest barriers to breast cancer research, improved testing, new diagnostic tools and targeted therapies related to the BRCA genes was today struck down.”
Well said.
A landmark decision – indeed it was.
Were you surprised by the Supreme Court’s decision on this matter?
What do you see as the greatest benefit arising from this decision?
Do you have anything to add to help clarify the cDNA angle here?
Image via Breast Cancer Action
Beth L. Gainer
Tuesday 25th of June 2013
I am delighted about the decision as well. No one should patent genes. How ridiculous the whole thing sounds, too.
Nancy
Wednesday 26th of June 2013
Beth, I know, right? Thanks for reading and commenting.
Michael Wosnick
Wednesday 19th of June 2013
For another explanation of why the US SC did not go far enough, this article expressing my thoughts exactly:
http://www.realclearscience.com/articles/2013/06/19/courts_gene_patent_decision_not_based_on_biology_106565.html#.UcHz38-RswM.twitter
Nancy
Thursday 20th of June 2013
Michael, Thanks for the link with the added information regarding cDNA. I agree with you. It seems the Supreme Court didn't go far enough.
Susan Zager
Tuesday 18th of June 2013
I too am thrilled about this decision from the Supreme Court. I am also confused about the cDNA but your video was helpful.
I tried reading about it and I found an explanation saying that scientists make cDNA by slicing DNA into RNA and “reverse transcribe” it. Then the RNA is converted back to DNA form without the original introns."
Because all the plaintiffs (especially Breast Cancer Action) are very happy with the decision, (as well as Mary-Claire King), if the cDNA was problematic, I think they would give a detailed explanation and let us know why. If I am wrong I hope someone will tell us!
Meanwhile for all the reasons you explained this decision is a big victory. A genetics testing company based in Houston called DNATraits announced immediately they would offer the test for $995.00. I am sure other companies will start making the test even less expensive.
At the same time , I am sorry that you and others tested positive for one of the BRCA genetic mutations.
Nancy
Wednesday 19th of June 2013
Susan, There is still a fair amount of confusion (for some of us anyway) regarding the cDNA, but I think we can all agree this decision was an important one and thankfully Myriad's reign is over as far as the two patents go. Thanks for adding your insights here, Susan.
DSpencer
Wednesday 19th of June 2013
The Supreme Court's judgement about natural genes not being patentable (and I assume this extends beyond humans) is clearly a major step and long overdo. In all the discussion about this case, though, it seems to have been overlooked that it is not judges who issue patents but the US Patent and Trademark Office (USPTO) and it was their blunder (I will call it) to issue the patents on BRCA1 in the first place. The USPTO has unfortunately been very poor at making smart decisions when confronted with patent applications related to biological or medical "inventions" and this BRCA case is only one example. I am quite disappointed, well annoyed, that the Supreme Court did not also make an intelligent decision on cDNA (complimentary DNA) because that does have serious implications. To many or most laypeople the topic of cDNA is hard to wrap the mind around. It is important to first point out, though, that cDNA was "invented" by biology a very long time ago. Most people will have heard of HIV, which is one of a class of what are called 'retroviruses', and they synthesize cDNA as part of their normal multiplication cycle. This class of viruses encode on their genomes (which are composed not of DNA but rather of the slightly chemically distinct molecule RNA) a protein, an enzyme (a biological "catalyst"), which can synthesize DNA (a "cDNA") using the RNA as a "template". A cDNA captures the information in an RNA molecule. A few of these enzymes have been commercially available for many years and they are essential to researchers who in the lab wish to produce cDNAs.For technical reasons, DNA is easier and more practical to work with, and cDNAs in particular are often (in fact generally so when talking about systems like humans) far more useful than the actual gene itself. This is related to another biological feature that is found in DNA (and probably even harder for laypeople to grasp) and that is the "intron", a piece of DNA that is inserted into (as part of) the DNA of genes. Introns can be large, and there are often many per gene. The intron interrupts the information contained in a gene and cells have elaborate systems to remove these at the level of what are called messenger RNAs (mRNAs), which are the first step in the actual expression of a gene. As the name implies, the mRNAs are what are used in actually directing the synthesis of the proteins in our cells (and most genes do encode information that ultimately leads to proteins). About the best example I can come up with to try to explain to a non-scientist about cDNAs and why they should not be considered laboratory creations (and should therefore not be regarded as "inventions" and hence patentable) is to imagine that you buy a book and this book for some reason has ended up with lots of blank pages, which, however do have page numbers. There may be one or a small number of blank pages together in a group or a large number in any one group, and they can be distributed throughout the book.These blank pages (and I will call these the book's 'introns', in an admittedly oversimplied analogy) interrupt the book's information content, and they can be removed without affecting book's contents, and indeed provided the page numbering is corrected in the removal process getting rid of the blank pages actually improves the book. I think that any reasonable person would agree that if a book is protected by copyright then taking out blank pages doesn't affect that copyright, because the information in that book has not been altered. Conversely, and maybe a better comparison with cDNAs, if you get a book that is no longer in copyright, with the blank pages I describe, removing the blank pages does not make that book now yours to copyright because the critical content of that book has not changed. Many (indeed probably most) of our genes are like the book with the blank pages; cDNAs are (essentially) the book with the blank pages removed. One final point is that today the cost of having the entire DNA sequence of all of your chromosomes determined is not much higher than what Myriad charges for the BRCA1/BRCA2 mutation analysis and frankly, for someone with a little more money to spare, I would recommend going that route. You will get the BRCA1 and BRCA2 results (and so they can be checked for the bad mutations) but you will also have all of your DNA sequence available in the future so that when other genetic diseases or genetic predispositions are identified you will always be able to check your own DNA out (if you chose to, of course) without paying another cent.
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Kayleigh
Tuesday 18th of June 2013
This is huge for my family. My mother had breast cancer but I tested BRCA 1&2 negative. However as you well know, there may be BRCA 3, 4, 5, etc. that just haven't been discovered yet. My husband's paternal grandmother died of breast cancer...she had two daughters, DH's aunts-- one had reproductive cancer and the other had breast cancer. I feel like my children have this hanging over their heads (boy&girl). Being able to afford testing when the time is right is crucial...finding other genes involved in prediction is crucial. This decision is the first step in that direction, so YAAAAAY!
Still, I just don't feel celebratory, you know? :(
Nancy
Wednesday 19th of June 2013
Kayleigh, You make excellent points. Now the research door has been swung open allowing for further study that might help families like yours. Or at least that door has been unlocked! Myriad cannot control things so tightly anymore. And I know what you mean about the celebratory thing... Thanks for commenting.