[Congressional Record (Bound Edition), Volume 153 (2007), Part 3]
[Extensions of Remarks]
[Pages 3637-3638]
[From the U.S. Government Publishing Office, www.gpo.gov]




     THE INTRODUCTION OF THE GENOMIC RESEARCH AND ACCESSIBILITY ACT

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                          HON. XAVIER BECERRA

                             of california

                    in the house of representatives

                        Friday, February 9, 2007

  Mr. BECERRA. Madam Speaker, I rise today with the hope of fixing what 
I believe to be a regulatory mistake--a mistake that at first glance 
may seem minor in scope, but upon further examination has dramatic, 
costly and harmful implications for every American.
  I speak of the practice of gene patenting, where private 
corporations, universities and even the Federal Government are granted 
a monopoly by the United States Patent and Trademark Office on 
significant sections of the human genome.
  It is my belief that this practice is wrong, ill-conceived and stunts 
scientific advancement. And it is for this reason that today I 
introduce the Genomic Research and Accessibility Act to put an 
immediate end to this practice.
  Fifty-four years ago this month James Watson and Francis Crick 
discovered the structure of Deoxyribonucleic acid (DNA), the molecule 
that contains the genetic information of nearly all living organisms. 
Few discoveries have matched theirs in the understanding of the make up 
of the human species. This discovery led to the 1990 founding of the 
Human Genome Project, a U.S.-initiated and funded undertaking through 
the Department of Energy and the National Institutes of Health and in 
collaboration with geneticists from China, France, Germany, Japan and 
the United Kingdom. Its goal was to code three billion nucleotides 
contained in the human genome and to identify all the genes present in 
it. This dramatic undertaking has given us a greater grasp of many of 
life's most basic--and tramatic--questions.
  The Project's efforts have led to the discovery of approximately 
35,000 genes.
  Madam Speaker, 20 percent of these genes have already been patented. 
Put another way, one-fifth of the blueprint that makes you--me--our 
children--all of us--who we are is owned by someone else. And we have 
absolutely no say in what those patent holders do with our genes.
  This cannot be what Watson and Crick intended.
  Here are a few examples of the implications of gene patenting:

       1. Gene patents interfere with research on diagnoses and 
     cures. Half of all laboratories have stopped developing 
     diagnostic tests because of concerns about infringing gene 
     patents. One laboratory in four has had to abandon a clinical 
     test in progress because of gene patents.
       2. In countries where genes are not patented patients get 
     better tests for genetic diseases than in the United States.
       3. Forty-seven percent of geneticists have been denied 
     requests from other faculty members for information, data, or 
     materials regarding published research. The practice of 
     withholding data detrimentally affects the training of the 
     next generation of scientists. Almost one fourth of doctoral 
     students and postdoctoral fellows reported they have been 
     denied access to information, data and materials.
       4. Disease-causing bacteria and viruses have now been 
     patented. The genome of the virus that causes Hepatitis C, 
     for example, is owned. This can lead to major problems, for 
     if someone else wants to introduce inexpensive, timely public 
     health testing for this (or another) common infectious 
     disease, the patent holder can prevent it.
       5. Few in this chamber would ever forget the SARS epidemic. 
     From November 2002 to July 2003, this respiratory disease 
     spread to 24 countries, killing 774 of the 8,096 people who 
     contracted it. Scientists were apprehensive about vigorously 
     studying the disease because three patent applications were 
     pending and they were fearful of possibly facing charges of 
     patent infringement and subsequent litigation.
       This is a serious problem and it is growing.
       My legislation, the Genomic Research and Accessibility Act, 
     is straightforward: it ends the practice of gene patenting. 
     It gives guidance to the United States Patent and Trademark 
     Office (PTO) on what is not patentable--in this case, genetic 
     material, naturally-occurring or modified. It is not 
     retroactive--it does not rescind the patents already issued. 
     But, fortunately, the Framers of our Constitution in their 
     infinite wisdom made the point that any recognized invention 
     deserved a monopoly for only a limited time. Congress has 
     defined that scope of protected status to be 20 years from 
     the point the patent application was filed. Thus, if we enact 
     this bill into law quickly, we will reach balance in less 
     than two decades--a patent-free genome that does not hinder 
     scientific research, business enterprise, or human morality.
       I do not wish to lay blame on anyone who has sought out a 
     gene patent, for they all saw an opportunity and capitalized 
     on it. But that opportunity should never have existed in the 
     first place, and thus, it is time that we

[[Page 3638]]

     as a legislative body put an end to this practice.
       Nor do I find fault with the Patent and Trademark Office. 
     These days, it should not surprise anyone that innovative 
     technology often outpaces innovative policies. Quite frankly, 
     I don't know if the Patent and Trademark Office or anyone 
     else for that matter had the technical expertise to fully 
     understand the implications when the PTO granted the first 
     gene patents. Those first patents set the precedent. The 
     precedent created the practice. And the practice has now 
     proliferated. This would not be the first time in our 
     Nation's history where government has had to play catch up in 
     order to properly understand technological innovation, and it 
     certainly won't be the last.
       Madam Speaker, precedent does not and should not simply 
     guarantee continued practice. Indeed, Congress has the 
     constitutional right to proliferate and reward the 
     advancement of invention, but it also has the responsibility 
     to intervene should that advancement be misdirected or 
     incorrect. Article I, Section 8 of the United States 
     Constitution states that we must ``promote the progress of 
     science and useful arts, by securing for limited times to 
     authors and inventors the exclusive right to their respective 
     writings and discoveries.'' But implicit in those words is 
     the power of discretion--Congress' charge to offer guidance 
     on what exactly merits an exclusive right.
       I make the argument that the human genome was not created 
     by man, but instead is the very blueprint that creates man. 
     The genome and the approximately 35,000 genes it encompasses 
     has existed for millions of years, predating the human 
     species; and suffice to say that it will certainly post date 
     us as well.
       If you agree with me that genes have existed beyond the 
     full grasp of human knowledge and indeed before the dawn of 
     human kind, then you must conclude as I have that they are a 
     product of nature and thus not patentable. Patenting the gene 
     for breast cancer or any other gene is the analogous 
     equivalent to patenting water, air, birds or diamonds.
       But don't take my word for it, Madam Speaker. One need only 
     read the Supreme Court's Diamond v. Chakrabarty decision of 
     1980 to receive guidance on what is truly not patentable. In 
     this landmark decision, Chief Justice William Burger wrote 
     that ``The laws of nature, physical phenomena, and abstract 
     ideas have been held not patentable . . . Thus, a new mineral 
     discovered in the earth or a new plant found in the wild is 
     not patentable subject matter. Likewise, Einstein could not 
     patent his celebrated law that E=mc\2\; nor could Newton have 
     patented the law of gravity. Such discoveries are 
     `manifestations of . . . nature, free to all men and reserved 
     exclusively to none.'''
       Proponents of gene patenting have said they are not 
     patenting genes but instead are patenting ``isolated and 
     purified'' genetic sequences. This is mere wordplay. In 
     practice, these patents are patents on products of nature. 
     For example, a patent on the supposedly isolated and purified 
     breast cancer sequence prohibits a woman's doctor from 
     looking for the breast cancer gene in her blood without 
     paying $3,000 to the patent holder. It prohibits the same 
     woman from donating her breast cancer gene to other 
     researchers because the holder of the patent has the 
     exclusive right to prevent anyone else from doing research on 
     any individual's breast cancer gene. Such restrictions make 
     clear that in effect, patents on isolated and purified 
     sequences are patents on the actual genes found in nature.
       We have overstepped our bounds. We have made a regulatory 
     mistake. We have allowed the patenting of a product of 
     nature.
       Fortunately, we have the power to end the practice 
     expeditiously and for the benefit of all. This bill will 
     allow all doctors and researchers to have access to the 
     genetic sequence, consisting of the chemical letters A 
     (adenine), T (thymine), C (cytosine) and G (guanine). Just as 
     we would never allow a patent on the alphabet that would 
     permit the patent holder to charge people a royalty every 
     time they spoke, we should not allow a patent on the genetic 
     alphabet that comprises our common genome.
       I want to thank my friend, the Honorable Dr. Dave Weldon of 
     Florida, for agreeing to join me in writing and introducing 
     this critical piece of legislation. I am appreciative for the 
     support that this legislation has found in the science and 
     medical communities. The Medical Association, the College of 
     American Pathologists, the American College of Medical 
     Genetics, the American Society of Human Genetics, the 
     Association for Molecular Pathology, the Academy of Clinical 
     Laboratory Physicians and Scientists and a host of others 
     have all made public their wish to see the practice of gene 
     patenting come to an immediate end. I applaud their steadfast 
     support and encourage them to stay vocal until such time as 
     their wish becomes reality and the Genomic Research and 
     Accessibility Act becomes law.
       Enacting the Genomic Research and Accessibility Act does 
     not hamper invention, indeed, it encourages it. Medical 
     innovation and economic advancement will occur if the study 
     of genes is allowed to happen unabated. Incredible 
     manifestations of intellectual property will result: 
     medicines, machines, processes--most deserving of 
     recognition, some potentially life-saving, and all worthy of 
     a patent.
       Madam Speaker, let us take up and pass in short order the 
     Genomic Research and Accessibility Act.

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