On April 15, 2013, the Supreme Court heard a challenge by a group of scientists to Myriad Genetics’ patent of the BRCA1 and 2 genes. On May 14, actress and humanitarian Angelina Jolie revealed that she’d had a preventive double mastectomy because testing had shown her to be positive for the BRCA1 mutation, bringing further attention to the Supreme Court’s upcoming decision.
Everyone has BRCA1 and 2 genes (BReast CAncer genes one and two). The function of the BRCA genes is to repair cell damage and keep breast cells growing normally. But when these genes contain abnormalities or mutations that are passed from generation to generation, the genes don’t function normally and breast cancer risk increases. Abnormal BRCA1 and BRCA2 genes may account for up to 10% of all breast cancers, or 1 out of every 10 cases.
Myriad has held a patent on these gene sequences for over a decade. The scientists challenging the company say that you can’t hold a patent on something that occurs naturally, even if you discovered it. They say giving exclusive rights to Myriad limits others’ ability to use the BRCA sequences to develop new therapies and tests. Women with these gene mutations, as well as breast cancer advocates, are concerned that the patent is stifling research and new discoveries that could help save their lives now. They contend that any obstacle in the way of progress in research must be removed. The removal of these limitations could help patients by reducing the costs of new tests and therapies and by stimulating potentially life-saving discoveries.
Myriad says that they need the patent in order to ensure profitability, so that they can attract investors and have enough funding to surmount the enormous costs of bringing the BRCA test to market. For example, one supporter of the company said that the average cost of bringing a new drug, therapy, or test to the market is 1.2 billion dollars. Myriad and its supporters are concerned that if the business isn’t profitable, discovery and innovation simply will not happen.
But the need to make money and the need for innovation is not what’s being argued in this case. The fundamental question is whether or not the sequence of a gene is patentable. In arguments before the court, several analogies were made. Imagine that the BRCA sequence is a baseball bat. The bat is cut out of the wood and is invented and therefore patentable. No one knew the bat was there until someone came along and thought it up and cut the wood in just the right places. Another analogy likened the sequence to the ingredients for cookies: eggs, flour, etc. You could patent a certain combination of the ingredients (a new type of cookie for instance) but you cannot patent the ingredients themselves.
Personally, I believe that more competition and variety in the marketplace of ideas will yield the best results for my patients. I also acknowledge the fact that the cost of bringing a new test or therapy to the market is extremely expensive and that profitability needs to be part of the equation.
What we really need are two things. The first is smarter regulation to reduce the burdens and costs of developing drugs, tests, and therapies. We are now seeing critical shortages of generic cancer drugs; this is partly related to the fact that cancer medications are so expensive to produce and the payback is too low for doing so. Secondly, the biomedical industry needs a revolutionary advance in technology: an innovation that fundamentally changes the way drugs and tests are developed and brought to market.
Breastcancer.org will be following this case closely and will provide updates as developments occur. We welcome your comments below!
AlaskaAngel says:
Dr. Wojciechowski, I see you are a speaker on the topics of ethics and the biology of cancer.
For me as a cancer patient now 11 years out from dx and tx, something is missing from the current discussion that is before the Supreme Court regarding the use of genetic testing and the future of diagnosis and treatment.
What I don’t see is any organized effort being made to come up with a clearly defined ethical system for the exploration and development of “individualized treatment” through genetic analysis.
I’m not saying it couldn’t be done. But as a cancer patient I don’t see any reason to believe that “competition” would bring about less expense and more individualized treatment for more patients. Developing targeted drugs that may turn out to benefit the few or the many is expensive regardless. Given that as patients we still have no honest clear way of documented follow up for patients who opt out of standard treatment protocols, and we still have no straightforward comparison testing to show us the relative value for very early stage bc of taking something like vitiamin D3 or metformin in comparison to standard treatment with such drugs as tamoxifen, we continue not to have the informatnio we need to decide for ourselves what risks we prefer to take, or not. As an early stage HER2+++ patient who theoretically might only need to take trastuzumab, we are prevented by ethics from even FINDING OUT whether that “works” just fine for very early stage bc, and instead are left with an “ethical” system that leans toward subjecting these patients to all the added risks and discomfort and extended economic loss of chemotherapy in addition to trastuzumab.
Sincerely,
AlaskaAngel
Brian Wojciechowski, M.D. says:
AlaskaAngel:
You have hit on a very important point: that despite breast cancer being the most well-researched cancer, we still don’t have definitive answers to fundamental questions like the one you are asking about HER2+ early-stage disease. It underscores the need for more women to enroll in clinical trials and how more sophisticated, expensive tests can create more questions than they answer. It is self-evident that more competition in the marketplace would drive the cost of those tests down.
AlaskaAngel says:
Thank you for your response, Dr.
Wojciechowski.
I was tested for BRCA1 and BRCA2 10 years ago with indeterminate results, and received the written promise that if at some ponit in time further information for my genetic profile in regard to BRCA 1 or BRCA 2 was developed, I would be notified. Despite the passage of a decade and the curent reportedly simplified, less expensive process for genetic profiling, I’ve received no further communication from Myriad regarding my genetic profile. If the current process is so much improved, I wonder why there wouldn’t be additional information for me by now.
It is my understanding that the BRCA1 and BRCA2 testing done outside the USA is less expensive due to different patent laws in other places. Is that true?
A.A.
re34646 says:
I hold 7 patents, and have been through patent training a few times. The types of patents which may be obtained are described at http://www.uspto.gov/patents/index.jsp. Note that one requirement for all of these patents is that they must be ‘new’.
If the BRCA1 and BRCA2 genes are invented by someone, they can be patented. Discoveries of nature cannot be patented. As an example, Isaac Newton could not patent gravity, or a person cannot patent a native ak tree. However, if a person creates a hybrid oak tree, or a new method of using gravity, those can be patented.
If they are discovered, they cannot be patented. And that is the case.
The process to detect the BRCA1 and BRCA2 genes, or special equipment to detect them could be patented. But since the genes already exist, they cannot themselves be patented.
re34646 says:
Just reviewed Myriad Genetics patent, available online at http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=3&f=G&l=50&co1=AND&d=PTXT&s1=brca1&s2=%22myriad+genetics%22&OS=brca1+AND+%22myriad+genetics%22&RS=brca1+AND+%22myriad+genetics%22.
This patent is for a method of detecting the BRCA2 gene, not the gene itself. My earlier comment that the gene itself cannot be patented would be correct, but Myriad may have rights for the processes used to detect the gene. That does not prevent other companies from creating other processes to detect the genes.
Brian Wojciechowski, M.D. says:
AlaskaAngel: I do not know about the price outside of the US. I suggest that you contact Myriad to get this issue ironed out.
re34646: The United States solicitor general, Donald Verrilli (basically the government’s lawyer at the Supreme Court) has argued in the case before the court that while the gene itself is not patentable, the cDNA sequence is. cDNA is a trimmed down version of the gene that a scientist produces in the lab to use for applications. If this is the result, I think that would be a good outcome for all interested parties.
AlaskaAngel says:
Hi Dr. Wojciechowski,
Now that the Supreme Court has issued a unanimous decision about this issue, hopefully genetic testing will be much more available. I don’t think I will ever hear from Myriad, the company that charged several thousand for my BRCA1 and 2 testing.
Thanks for your blog posts,
AlaskaAngel