BART, BRCAnalysis, Breast Cancer Action, breast density, genetic diagnostic testing, Hastings Center, HBOC, Health Writing Activist Monthly Challenge, Hereditary Breast and Ovarian Cancer, invention, mammogram, mutation, Myriad, patents, scientific research, Spanx, US Patent and Trademark Office
Mindlessly channel surfing yesterday afternoon, before I opened an email from Breast Cancer Action, I happened upon Anderson Cooper, in full-blown talk-show host mode, fawning over savvy Spanx inventor, Sara Blakely. Fresh off the cover of Forbes magazine, as the youngest ever self-made female billionaire, the affable Ms. Blakely gave me hope that somewhere inside me, lying dormant, is a billion dollar idea, a simple but powerful invention that will change the world. At the risk of being a snob, I’m hoping when my brilliant idea finally comes to fruition, that it will be something with a little more gravitas. Something a little less Spanx, a little more Penicillin.
To give Ms. Blakely her due, she did what most of us do not. She didn’t experience a light bulb moment and then abandon it. She threw both arms around that idea, held it tight, and arduously navigated her way through a complicated process of patents and trademarks, prototypes and packaging, manufacturing and marketing, schmoozing and selling, until, finally, Oprah called. The rest, as they say, is history. Six years later, Spanx is unquestionably an institution in the “shapewear” revolution, its inventor on the cover of Forbes and, more importantly, in the enviable position of being able to empower other women through the Foundation that bears her name.
It is the patenting of Sara Blakely’s invention and those of others that piqued my interest last evening. A time-consuming and complicated process, the application for a patent involves tedious research and most likely the assistance of a draftsman and a lawyer or two. When Spanx was barely a twinkle in her eye, the inventor did her homework by first researching trademarks and patents. I imagine she started where I did, at the website of the United States Patent and Trademark Office (USPTO). Before filing a patent application, it would be important to know exactly what a patent is, who can have one, what can be patented and for how long, and the law governing it. According to the USPTO, a patent for an invention is “the grant of a property right to the inventor, issued by the United States Patent and Trademark Office.” Already, this is not a fun website. The text is too small and it feels too much like homework. I’m tempted to leave it and go update my status on Facebook instead, but then I find the part about patent law that I have to reread because of the Breast Cancer Action email. “Any person who “invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent,” subject to the conditions and requirements of the law. The word “process” is defined by law as a process, act or method, and primarily includes industrial or technical processes. The term “machine” used in the statute needs no explanation. The term “manufacture” refers to articles that are made, and includes all manufactured articles. The term “composition of matter” relates to chemical compositions and may include mixtures of ingredients as well as new chemical compounds. These classes of subject matter taken together include practically everything that is made by man and the processes for making the products.“
Within the context of Spanx or Penicillin or the telephone, patents makes sense to me. Sort of. I struggle more with what for me is a relatively new idea. I have been living under a rock, because the USTPO has been patenting genes since 1980 when the case of Diamond v Chakrabarty determined that a scientist could patent an invention even if the invention was a living thing. So even though a whole biological organism is not patentable, artificially altered organisms can be patented. Thus, the era of gene patenting began. According to The Hastings Center, a nonpartisan research institution dedicated to bioethics and the public interest since 1969, there has been a flurry of activity – “about 3,000 to 5,000 patents on human genes have been granted in the United States and 47,000 on inventions involving genetic material.” How does that happen? And what on earth does any of it have to do with my genes?
Other than hoping I’d take after my mother who, to her great delight, has often been mistaken as my sister, I have never really considered genes. It was only after being diagnosed with invasive breast cancer that genetics even came up. My physician had explained that because of the location and size of the tumor in my right breast, close to the nipple, that the “simple” mastectomy was the best option. But there was more, as there always is on the cancer trail. With menopause most likely around the corner and my age at diagnosis, my physician recommended the BRACAnalysis test. If the test indicated a mutation in the BRCA1 or BRCA 2 genes, those genes most often associated with breast and ovarian cancer, then she would recommend a double mastectomy and an oopherectomy to boot. Gobsmacked as I was by the prospect of such butchery, it was actually less frightening than the cancer I was just learning about. (I must remind myself at this point that had someone simply informed me of the density of my breast tissue and recommended an ultrasound, the cancer growing inside said tissue all these years may not have evaded three mammograms, thus saving me a lot of trouble). So I provided a sample via buccal wash, and I waited. Again. For two excruciating weeks. When the news came that the test was negative, I was delighted. So delighted, that it didn’t occur to me to ask more questions about the genetic material I had spat into the testtube which had been sent to Myriad Genetics and analyzed by the scientists to determine my risk for hereditary breast and ovarian cancer.
My genetic material. At $3,000, the BRCAnalysis is not a cheap test. Yes. I have health insurance which paid for it. But there are millions who don’t. I have dear friends who would not be able to access this testing, and therefore have less options for treatment and less information about their risk – not to mention the risk of their daughters – for ovarian and breast cancer. But Myriad Genetic Laboratories, Inc. is the only game in town. There is no outside competition to help bring down the price, to make the testing more affordable and accessible for friends like mine.
I suppose I should let you know that Myriad Genetics and I have an intimate relationship. I belong to Myriad Genetics. This corporation, in fact, owns me. When the staff of the USPTO approved Myriad’s application for a patent on on the BRCA1 and BRCA2 genes, they essentially allowed Myriad Genetics to claim ownership of, and exclusive rights to, my genetic material. Here I was, minding my own business, thinking I owned my own body, and that I would have to indicate on my driver’s license if I wanted any of its parts to be given away, posthumously, of course. I suppose for years, I have been of the same mind as that espoused back in 1997 in A Briefing on the Proposed EU Directive on the Legal Protection of Biotechnological Inventions:
Most people assume that their bodies are their own – and no-one else’s. They assume that their blood is theirs, unless they care to donate some of it. They assume that, while they are alive, their kidneys, their eyes, their spleens, their hearts are theirs – and will go with them to their graves unless they chose to gift them to others. They might also assume that their genes – the inherited biological material inside each of their cells – are theirs, rather than anybody else’s.
Apparently, my assumptions about my own genes have been all wrong. My genes belong to Myriad Genetics. As do yours. Sobering to realize that when I spat out my genetic material, it was seized by a corporation crafty enough to have filed a patent on it. A mere mortal such as myself, however, could not file a patent application on her own genes, being unable to identify a sequence in the DNA code which would, as I explained earlier, constitute a “new and useful process.” So I can only continue to hold out hope for a patent on my as-yet-to-be-formed billion dollar idea, some “manufactured article” … like Spanx.
Isn’t it grossly unfair that one company can monopolize the genetic diagnostic testing options available for women? Isn’t it wrong for one corporation to reign supreme over the ability for women to ask for a second opinion when genetic testing results are inconclusive or before they have to make critical life-changing treatment decisions like having both breasts and ovaries removed? Isn’t it wrong that one corporation exerts total control over important scientific research that potentially could save lives. Not quite on the level of Spanx and not yet on the cover of Forbes, but Myriad Genetics, is doing rather well. Just give it time. On its corporate website, it boasts of being “a leading molecular diagnostic company dedicated to making a difference in patient’s lives through the discovery and commercialization of transformative tests to assess a person’s risk of developing disease, guide treatment decisions and assess risk of disease progression and recurrence. With fiscal year 2011 revenue of over $400 million and more than 1,100 employees, Myriad is working on strategic directives, including new test introductions, companion diagnostics, and international expansion to take advantage of significant growth opportunities that further the Company’s mission.” I’ll say Myriad is making a difference in my life and the lives of lots of other people, because Myriad owns our lives. Because Myriad owns the patent on “breast cancer genes,” so only Myriad can test for them. Again, the language of cancer is important. Words matter. As I have written before, myths matter. Even though BRCA1 and 2 are referred to as the “breast cancer genes,” each and every one of us has these in our bodies even if they don’t have mutations.
So it is hardly surprising that when I woke up this morning, it was to thoughts of all things genetic. Even before coffee, I dragged out my “cancer portfolio” to peruse my test results and pathology reports. For me, the “comprehensive” in Comprehensive BRACAnalysis, had initially conveyed such relief. It didn’t occur to me to read beyond “No Mutation Detected.” Had I done so, I would have discovered that there was another test that, for an additional cost, would have detected genetic defects missed by the original BRACAnalysis. This newer test, The BRACAnalysis Rearrangement Test (BART), is also owned by Myriad Genetics. Well, of course it is. Late last year, CNN reported that back in 2006, Myriad, began selling this new test BART, which as I scan my own test result, “would identify large genomic arrangements undetected” by the $3,000 BRACAnalysis. Apparently, doctors had assumed BART was included in the original analysis. In reality, however, Myriad offered it separately and charged $700. “No Mutation Detected” is a bold declaration and cause for celebration, but I would have gladly accepted, in bold print and capital letters, at the top of the report, “Make Sure You Ask For The Supplemental BART Too!”
As an increasingly empowered patient, I know I should have read the report more closely. After all, it was about me. Quite honestly, when the result came in the mail, I went ahead and filed it with all the other cancer papers without reading it. My doctor’s office had called to tell me it was negative and didn’t mention the BART, so I haven’t thought about it. Not until last night, when I opened the email from Breast Cancer Action imploring people who have been tested to share their stories about genetic testing with the staff of the good old US Trademark and Patent Office. Breast Cancer Action is actively pursuing a lawsuit against Myriad and its patents on our lives and needs our help. People like you and people like me can help tell the truth by sharing our stories and comments to inform the USTPO’s report for Congress on genetic diagnostic testing. If the answer to what causes cancer lies in my genes and your genes, then no corporation should hold exclusive rights to them or to all the research performed on them. Anyway, aren’t we all supposed to be in this race for a cure together?