[Congressional Record (Bound Edition), Volume 157 (2011), Part 7]
[Extensions of Remarks]
[Pages 9831-9832]
[From the U.S. Government Publishing Office, www.gpo.gov]




                      OPPOSITION TO GENE PATENTING

                                 ______
                                 

                     HON. LOUISE McINTOSH SLAUGHTER

                              of new york

                    in the house of representatives

                        Wednesday, June 22, 2011

  Ms. SLAUGHTER. Mr. Speaker, I rise today in opposition to gene 
patenting. The sequencing of the human genome was the most momentous 
medical achievement in this century, with unparalleled implications for 
patients and our economy. And we cannot squander that success by 
patenting genes.
  The Human Genome Project has helped our economy to grow by $796 
billion. Today, 310,000 American jobs are linked to the sequencing of 
the Human Genome. Furthermore, personalized medicine has transformed 
the way doctors care for patients. According to the American Medical 
Association, more than 1,200 genetic tests can be used today to help 
diagnose and treat over 1,000 different diseases. Personalized medicine 
helps to provide safer, more cost-effective medicine.
  Yet, to fully realize the potential of personalized medicine, we must 
ensure that our laws and policies keep pace with our science. Today as 
we consider the patent bill, I would like to clarify the intersection 
between genes and patents.
  Many of us carry within us genes that predispose us to illnesses or 
influence the effectiveness of medications. These genes are natural 
products--not inventions. And as natural products, they should not be 
patented. It's this simple: just as a kidney cannot be patented, 
genetic sequences should not be patented.
  Unfortunately, 20 percent of our genes have already been claimed as 
intellectual property. For several decades, the U.S. government issued 
patents on genes. Thankfully the Department of Justice recognized this 
clear overreach on the part of the United States Patent and Trademark 
Office--and moved to correct this mistake.
  On October 29, 2010, the United States Department of Justice filed an 
amicus brief in which they explained: ``the unique chain of chemical 
base pairs that induces a human cell to express a BRCA protein is not a 
`human-made invention.' Nor is the fact that particular natural 
mutations in that unique chain increase a woman's chance of contracting 
breast or ovarian cancer. Indeed, the relationship between a naturally 
occurring nucleotide sequence and the molecule it expresses in a human 
cell--that is, the relationship between genotype and phenotype--is 
simply a law of nature. The chemical structure of native human genes is 
a product of nature, and it is no less a product of nature when that 
structure is `isolated' from its natural environment than are cotton 
fibers that have been separated from cotton seeds or coal that has been 
extracted from the earth.''
  The United States Department of Justice has come to the inevitable 
conclusion that genes are natural products, and not fit for patenting. 
And last year, a federal court in New York came to the same conclusion.
  Not only is the issuance of patents on genes wrong, contrary to 
common sense, and in violation of Congressional intent, but it also 
damages human health. Gene patents have cut off access to important 
tests. For example, the company that owns sole rights to the BRCA1 and 
BRCA2 sequences--which determines hereditary risk factors around breast 
and ovarian cancer--charges between $3,000 and $4,000 for a single 
test. Other laboratories have offered to perform the test for several 
hundred dollars, but are not able to do so because of the patent on 
those particular genetic sequences. And the information provided by 
this test is critical for medical decision-making: Up to 85 percent of 
those individuals who possess these genetic sequences will be diagnosed 
with breast cancer at some point in their life. By granting a monopoly, 
we risk placing these genetic tests out of reach for patients.
  Furthermore, gene patents stop innovation in their tracks. They 
prevent anyone outside of the patent holder from studying the gene 
sequence under patent. As Dr. Stieglitz of Columbia, a Nobel Prize 
winning economist, wrote, ``Our genetic makeup is far too complicated 
for a single entity to hold the keys to any given gene and to be able 
to choose when, if ever, to share.'' We threaten scientific 
advancement, if we do not allow scientists to untangle the manifold 
implications of specific gene sequences. We can not reap the full 
benefits of personalized medicine if researchers must go to hundreds of 
different patent holders to analyze one patient's genome.
  The battle to keep policy and science marching hand in hand has been 
a long one, and I worked for dozens of years to ensure that the 
nation's laws support genetics policy.
  In 1995, I introduced legislation, entitled the Genetic Information 
Nondiscrimination Act (GINA), in order to prevent genetic 
discrimination. For personalized medicine to flourish, patients needed 
to be able to get genetic tests without the fear that it would endanger 
their employment or their health insurance. Thirteen years after I 
first introduced GINA, it was passed into law. GINA is one of the 
nation's great civil rights laws, which has helped open the door to 
personalized medicine.
  By passing GINA in 2008, the U.S. Congress showed itself to be at the 
forefront of genetics policy. I expect no less of our government when 
it comes to gene patenting. Today, the Patent Office has the 
opportunity to institute evidence-based policy and end the patenting of 
genes, and it must do so.

[[Page 9832]]



                          ____________________