Date: 2011-06-22
Speaker: WASSERMAN SCHULTZ (democrat)
Chamber: H

Madam Chair. today I rise in support of H.R. 1249. the America Invents Act. This vital reform to our nations patent system would help spur innovation. foster competition. and create and support American jobs. Democrats in Congress have urged our colleagues across the aisle to bring legislation to the Floor and today we have an opportunity to support legislation to create jobs and support our recovering economy. That is why this legislation is a priority of the Obama Administrationthe bill represents a significant step in the right direction toward American job growth and is crucial to winning the future through innovation. I urge my colleagues to support this bills benefits for American inventors. manufacturers. and jobs. I also urge my colleagues to support this bill because it includes a provision that will help engender muchneeded patient protection and choice for patients undergoing genetic diagnostic tests. As many. of you know. several years ago. I was diagnosed with breast cancer. Through genetic testing. I discovered that I am a carrier of the BRCA2 gene mutation. which drastically increased my lifetime risk of ovarian cancer and recurring breast cancer. As a result. I made the lifealtering decision to have seven major surgeriesa double mastectomy and an oophorectomyfrom a single administration of a single test. You see. there is only one test on the market for this mutation. The maker of this test not only has a patent on the gene itself. they also have an exclusive license for limited laboratories to administer the test. Like genetic tests for colon cancer. Parkinsons disease. Alzheimers disease. stroke. and many other genetic disorders. there is no way to get a truly independent second opinion. In approximately 20 percent of all genetic tests. only one laboratory can perform the test due to patent exclusivity for the diagnostic testing. and often the actual human gene being tested. Just imagine: Your genes hold the key to your survival. having major. bodyaltering surgery or treatment could save you life. but the test results fail to give you certainty. The America Invents Act begins to address this problem. A provision in the Managers amendment simply directs a study by the U.S. Patent and Trademark Office on ways to remove barriers for patient access to second opinions on genetic testing on patented genes. Such a study would address questions about the current effects such patents have on patient outcomes and how best to provide truly independent. confirmatory tests. Given ongoing court cases on the issue of gene patents. let me be clear: the studys focus on second opinion genetic testing is not intended to express any opinion by Congress regarding the validity of gene patents. 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. I know firsthand the stress of wanting a second opinionbut being unable to get it. With so much at stake. it is incredibly important that we give everyone in this situation as much certainty as we possibly can. We owe that much to those whose lives are in the balance.