CONGRESSWOMAN WASSERMAN SCHULTZ: Good morning, and thank you to everyone at the U.S. Patent and Trademark Office for working so hard to coordinate this public hearing today. Thank you in advance to Therese Stanek Rea, Janet Gongola, Stuart Graham, and the entire USPTO legislative team for the incredible work on which you are about to embark. I am so grateful for your attention and dedication to these vital
questions of genetic testing, exclusive licensing, and how that affects patient outcomes.
For all of the advocates attending today's hearing, we are so grateful for the devotion you've given to patients undergoing genetic testing throughout your careers. Your insight and commitment have been vital to developing, nurturing, and realizing the potential of genetic tests for improving medical outcomes.
It is such a pleasure to speak with you all for the first public hearing on this important provision from the America Invents Act. I'm truly delighted that you've all dedicated yourselves to this goal, and I look forward to what the results of this study will bring.
I'm thrilled that this study is among the first wave of America Invents Act provisions to be implemented, and that process begins with you, the USPTO, and all of the advocates and organizations participating in this hearing. Over the next several months, you have the incredible opportunity to investigate this complicated aspect of patent law in need of a
As you know, this study is the result of a provision in the patent reform law Congress passed last summer that will help engender much-needed patient protection and choice for patients undergoing genetic diagnostic tests. My hope is that this study will illuminate ways to remove patient access barriers to second opinions on genetic testing on patented genes.
With the passage of this law, Congress is primarily interested in several important questions. For example, what impact does the current lack of independent second opinion testing have on the ability to provide the highest level of medical care to patients and recipients of genetic tests, and how does this inhibit innovation for existing tests? What would be the effect of providing an independent second opinion genetic test on existing patent and license holders of an exclusive genetic test? What impact does the current exclusive licensing and patents on genetic testing have on the practice of medicine, including but not limited to the interpretation of testing results and
performance of testing procedures. And what is the role that cost and insurance coverage have on access to and provision of genetic diagnostic tests?
These vital questions must be answered because of the complicated reality that we're facing today. Tests are now available for a majority of genetic disorders, such as colon cancer, Parkinson's disease, Alzheimer's disease, stroke, and many others. But in approximately 20 percent of all cases, only one laboratory can perform the tests due to patent exclusivity for the diagnostic testing, and often the actual human gene being tested. Genetic disorders that fall into this patent exclusivity area include breast cancer, Long QT, and certain neurological diseases, such as muscular dystrophy.
I believe that the availability of a second testing procedure in these areas would have several benefits, the most important of which is that it would allow people making life-altering medical decisions based on these genetic tests to seek out an independent second
opinion. By allowing clinical laboratories to confirm the presence or absence of a gene mutation found in a diagnostic test, we can help Americans access the second opinions they truly deserve.
As you may know, I know firsthand the stress of wanting a second opinion but being unable to get it. Several years ago, just after my 41st birthday, I found a lump while doing a routine breast self-exam. It was cancer. Luckily, I found my tumor early and my treatment options initially were fairly straightforward. I was supposed to have a lumpectomy and radiation, and that would have been the end of the story, but an incredibly wise and thoughtful nurse educator asked the right questions about my family's health history that threw my story for a loop.
I never would have known that as an Ashkenazi Jewish woman, a Jew of Eastern European descent, with two paternal great-aunts who had had breast cancer, that there were some significant red flags in my genetic file. I did not know that as an Ashkenazi Jew I was five times more likely to have the BRCA1 or BRCA2 genetic mutation. I did not know that carriers of that
mutation have up to an 85 percent lifetime chance of getting breast cancer and up to a 60 percent chance of getting ovarian cancer.
My nurse suggested that I take the BRCA test, and I could not be more grateful for her knowledge and advice. This process, however, presented a new set of challenges and questions for which no woman could ever be prepared.
Now, as many of you know, there is only one test on the market for the BRCA mutations. The maker of this test not only has a patent on the gene itself, they also have an exclusive license for their laboratories to administer the tests. So, there is absolutely no way for someone who is questioning her genetic risk for breast or ovarian cancer to get a second opinion.
This is intensified by the fact that for many women, the test results are inconclusive. Imagine being faced with this decision: Your genes hold the key to your survival, having major body-altering surgery could save your life, but the test results failed to give you any answers. What would you do in that situation?
You know, you might say that I was
lucky. My tests clearly showed that I had the BRCA2 mutation, but there was absolutely nothing I could do to question these results or receive an independent confirmatory test. So, I had no choice but to make the life-altering decision to have seven major surgeries, including a double-mastectomy and an oophorectomy from a single administration of a single test.
Unfortunately, many women have to face this decision with even less reliable information than I had. No one should ever have to go through this experience without the comfort and the confidence of a second opinion. With so much at stake, it is incredibly important that we give everyone in this situation as much certainty as we possibly can.
I can assure you it was devastating to me to have to make a decision that was as life-altering as a double- mastectomy and six other major surgeries without being able to confirm the results of that genetic test. We owe that much to those whose lives hang in the balance. Many of you helped shape this legislation, and now it is your task to make sure
that your knowledge and experience can be put into practice to help save lives.
I wish you all the best of luck in this important endeavor, and I look forward to hearing all of your ideas and suggestions. Thank you so much, again, for being here today and for your dedication to the health and wellbeing of others. Thank you.