[Congressional Record (Bound Edition), Volume 148 (2002), Part 3]
[Extensions of Remarks]
[Pages 3313-3314]
[From the U.S. Government Publishing Office, www.gpo.gov]




INTRODUCTION OF THE ``GENOMIC RESEARCH AND DIAGNOSTIC ACCESSIBILITY ACT 
OF 2002'' H.R. 3967 AND THE ``GENOMIC SCIENCE AND TECHNOLOGY INNOVATION 
                        ACT OF 2002'' H.R. 3966

                                 ______
                                 

                          HON. LYNN N. RIVERS

                              of michigan

                    in the house of representatives

                        Thursday, March 14, 2002

  Ms. RIVERS. Mr. Speaker, evidence is mounting that the patenting of 
human genes is both inhibiting important biomedical research and 
interfering with patient care. Today I am introducing two bills that 
address these increasingly troublesome effects of human gene patenting.
  Despite resistance from many of our European allies and the popular 
view in this country that owning the rights to a part of the human body 
is inappropriate and even immoral, patenting of human genetic sequences 
is accelerating rapidly. Eight thousand patents on genes or genetic 
material have already been issued by the Patent and Trademark Office 
(PTO), including at least 1,500 on human genetic material. Tens of 
thousands of additional human gene patents await examination by the 
PTO. And while the criteria for awarding gene patents have been 
marginally tightened in recent years, progress toward patenting of the 
entire human genetic sequence continues unabated. There is little doubt 
that most of the significant claims on our genetic code will be tied up 
as private property within a very few years.
  What does it mean to own a human gene patent? It means that the gene 
patent holder controls any use of ``its'' gene, a gene that is found in 
virtually every human being on the planet. The patent holder can 
prevent my doctor from looking in my body to see if I have that gene. 
The patent holder can prevent anyone else from doing research to 
improve a genetic test or to develop a gene therapy based on that gene.
  PTO's grant of total ownership in genes has already led to some very 
unusual moral and medical dilemmas. In one well-publicized case, Miami 
Children's Hospital--the owner of the gene responsible for the fatal 
neurological disorder Canavan disease--is being sued by the families of 
dead and dying children who provided the tissue samples which enabled 
the hospital's researchers to discover the gene's function. The Canavan 
parents had sought the help of hospital researchers in order to develop 
testing that was accessible and affordable to the public. Instead, when 
Miami Children's Hospital discovered the Canavan gene, it secretly 
filed a patent and now prevents doctors from testing or examining 
patients for the gene without paying the hospital a fixed royalty fee, 
even though those doctors could do so without using any product or 
device invented by MCH. The Canavan families claim that the terms under 
which the hospital is licensing use of the gene are slowing progress 
into finding a cure or therapy for the disease.
  In another example, several European laboratories have refused to 
recognize--and are attempting to overturn--a patent held by a U.S. 
company on a gene that is strongly linked to breast and ovarian cancer. 
The patent holder requires that all tests be shipped to its lab in the 
United States under the theory that it has the most accurate genetic 
test available. However, at least one European lab found additional 
mutations for which the patent holder was not testing. European 
geneticists claim that the testing fee charged by the patent holder 
($2,680) is exorbitant, since they can offer an even more sophisticated 
test for half that price, and that the terms of the gene license are 
choking off discovery of other medically important mutations of the 
gene.
  In yet another example, a U.S. firm obtained a patent on a gene by 
specifying its sequence and its possible importance in a number of 
diseases. The firm did not mention AIDS in its patent application. 
Several research groups subsequently discovered the gene's importance 
in the AIDS infection mechanism. These groups now have to deal with the 
gene's patent holder to develop their discoveries, even though that 
owner had no idea of the gene's relevance to AIDS. In a final example, 
Jonathan Shestack, the producer of the movie Air Force One, began 
raising money to fund autism researchers. He learned that progress was 
slow because certain researchers were hoarding patients' tissue 
samples. They wanted to be the first ones to find the gene and gain 
commercially.
  These and other similar results from the patenting of human genes 
have led many in the medical and religious communities to conclude that 
patents should simply not be granted on human genetic sequences. 
Prohibiting gene patents would of course require a major change to the 
patent law, an unlikely outcome given the biotechnology industry's 
strenuous assertion that gene patents are essential to genetic and 
medical innovation. This is an interesting but debatable proposition. 
The two bills that I am introducing today, however, do not directly 
challenge the viability or legality of gene patents. What I seek to do, 
rather, is to carve out some limited exemptions to the applicability of 
gene patents. These exemptions are designed to minimize some of the 
negative impacts of patents on the practice of medicine and the 
advancement of science. They aim to broaden the availability and 
usefulness of gene-based diagnostics in the overall health care system, 
while allowing essential medical progress to continue unabated.
  The ``Genomic Research and Diagnostic Accessibility Act of 2002'' has 
three major provisions.


                           Research Exemption

  Section 2 exempts from patent infringement those individuals who use 
patented genetic sequence information for non-commercial research 
purposes. This provision would apply to all genetic sequence patents, 
not just human gene patents. Contrary to the understanding of many 
scientists, patent law does not protect from patent infringement 
scientists doing basic, fundamental, non-commercial research when they 
use patented tools, techniques, and materials. Surveys performed by 
researchers at Stanford University have shown that many universities 
and hospitals are avoiding promising genetic research areas because of 
patent infringement concerns. Another study published earlier this year 
in the Journal of the American Medical Association found that a 
majority of geneticists are being denied access to colleagues' data. 
The JAMA study concluded that withholding data may hinder scientists' 
ability to replicate the results of published studies and to pursue 
their own research, and may hurt the education of new scientists. 
Creating a research exemption would make genetic patent law comparable 
to copyright law, which has a ``fair use'' defense that permits 
socially valuable uses without a license.
  It is important to note that this section would not overturn the 
commercial rights of patent holders. If a research utilizing the 
exemption makes a commercially viable finding, he or she would still 
have to negotiate any rights to market the new discovery with the 
patent holder.


                        Diagnostic Use Exemption

  Section 3 would exempt medical practitioners utilizing genetic 
diagnostic tests from patent infringement remedies. This section builds 
on a provision in patent law, enacted in 1996 after its passage in the 
House by an overwhelming majority, which exempts health care providers 
from patent infringement suits when they use a patented medical or 
surgical procedure. The 1996 law was authored by two legislator/
doctors--Representative Ganske and Senator Frist--and eliminated the 
distasteful possibility that doctors would use a less safe surgical 
procedure rather than risk infringing a patent.
  Some biotechnology companies and researchers argue that monopolistic 
control of genetic diagnostic tests is essential. They claim that 
without significant investment--investment made possible only by the 
prospect of total control of the diagnostic revenues--the tests never 
would have been developed in the first place.
  This argument begs the question of whether current patenting policies 
are in fact serving the broader interests of patients. In my view, they 
are not. Costs for patented tests can become prohibitive, especially 
when licensing fees are stacked through a series of tests. Negotiating 
licenses and fees can be time-consuming and can limit genuine medical 
progress. And most importantly, control of testing protocols and 
results in a single laboratory can retard medical knowledge, which has 
historically progressed through the free exchange of information among 
the entire medical community. The prospect of owning a profitable 
genetic test may indeed drive some early innovation, but monopolistic 
control of a genetic test will ultimately stifle innovation.
  I have referred to some of the problems that patents have caused in 
the field of genetic diagnostics. In a February 7, 2002 article in the 
journal Nature, four U.S. bioethicists concluded that ``gene patents 
affect the cost and availability of clinical-diagnostic testing.'' One 
of the authors, Mildred Cho from Stanford University, has conducted 
broader surveys suggesting that nearly half of all diagnostic labs have 
been forced to quit doing certain tests because of gene patents. This 
is not an outcome that promotes broad, fairly priced diagnostic 
medicine.
  I believe that the interests of patients and the overall health care 
system in this country will be far better served if laboratories, 
universities, and the private sector are free to use

[[Page 3314]]

patented information for the development of diagnostics tests. To those 
who argue that medical innovation will be stifled by this approach, I 
would point out that surgeons have been refining their techniques for 
centuries without patent protection. Furthermore, many genetic advances 
have and will continue to be made without the allure of profits. Dr. 
Francis Collins discovered and patented a cystic fibrosis gene at the 
University of Michigan over ten years ago. Dr. Collins, the current 
director of the Federal gene-mapping effort, was not motivated by 
profits and neither was the university. That test is broadly licensed 
today at a nominal fee and remains an easily affordable service 
available to thousands of expectant parents.


                         Information Disclosure

  Section 4 of the bill would require public disclosure of genomic 
sequence information contained within a patent application when federal 
funds were used in the development of the invention. The data would be 
released within 30 days of patent filing, rather than the current 18 
months.
  This provision is one that should be applied broadly to federally 
funded research programs, although I have limited it to genomic data in 
this bill. Legislation enacted in the 1980's enabled universities and 
small businesses to patent discoveries made with federal funding--a 
change in patent law that has driven much high-technology innovation in 
the U.S. economy. Section 4 would not affect the patent rights of these 
universities and small businesses. It would, however, require that 
genetic data in a patent application be disclosed promptly through 
normal scientific channels, both to preclude wasteful duplication of 
effort by other research teams and to promote broad dissemination. 
Since the public funded the research, it seems only reasonable that the 
patent applicant be asked to share the publicly funded results as 
broadly and as quickly as possible.


     The ``Genomic Science and Technology Innovation Act of 2002''

  This bill provides for an in-depth study by the White House Office of 
Science and Technology Policy on the impact of Federal policies, 
especially patent policies, on the rate of innovation, the cost, and 
the availability of genomic technologies.
  A 5-4 Supreme Court ruling in 1980 opened the door for gene patents, 
which have been central to the development of the U.S. biotechnology 
industry. Ever since, except for a few minor changes like the Ganske-
Frist amendment, genes and other genetic sequences have been treated 
pretty much like chemicals by the Patent Office. This is not surprising 
because the Patent Office responds to the will of the Congress and the 
courts. What is surprising is that there has been almost no thoughtful 
or scholarly study of the effect of human gene patenting on either 
scientific progress or the overall health care system. Do patents serve 
patients well? Do they help or hinder scientific progress? Do they 
promote innovation? These are fundamental questions that would perhaps 
have engaged the attention of the Office of Technology Assessment had 
the Congress not foolishly abolished it in 1995. The Human Genome 
Program, who has spent nearly $100 million over the past 10 years on 
``Ethical, Legal, and Social Implications'' of the genome project, has 
funded almost nothing in this area. Meanwhile, the Patent Office 
continues to review and grant patents, almost by blind momentum alone, 
without serious consideration of whether these human gene patents are 
helping us achieve our broader societal goals.
  Congress has the ability to change the patent law if it is not 
serving the public interest. We do so in small or large ways nearly 
every Congress. It is clearly time to review whether this body of law 
is working. It is obvious from some of the anecdotes that I have cited 
that the current system is causing strains. Many labs and universities 
are steering in the biomedical sciences is becoming increasingly 
sticky. Genetic tests could become prohibitively costly or 
inaccessible, or could become engulfed in wasteful, legalistic cross-
licensing scrimmages.
  This bill would direct the OSTP, through the National Academy of 
Sciences if it wishes, to study these issues, to report to the Congress 
with its findings, and to lead the development of Federal policies 
based on these findings. This would be the first systematic study of 
where human gene patenting policy is taking us, and it is long overdue.
  Some may see a contradiction between these two bills--namely, that 
the second bill calls for a study of problems for which I have already 
proposed solutions in the first bill. However, I believe there is ample 
justification for the limited reforms I propose in the ``Research and 
Diagnostic Act'' and that in short order these steps will be shown to 
serve the public good. A decision on whether Congress should make even 
more dramatic changes to the genetic patenting regime (for example, by 
making the diagnostic exemption retroactive) should await further study 
and discussion. The study called for in the second bill would provide 
us with guidance for those additional steps.
  Abraham Lincoln described the patent system as ``adding the fuel of 
interest to the fire of genius''. I am concerned that the current 
Federal patent policy as applied to genetic sequences may be smothering 
the fire of genius. Patents are intended to encourage openness and to 
prevent trade secrets. Current policy, however, appears to be 
inhibiting research and information sharing, and choking off innovation 
and the broad availability of novel genetic technologies. I hope that 
the two bills being introduced today will serve to focus attention on 
these issues. More importantly, I hope that they will ensure that the 
fantastic advances in medical genetics are fully harnessed for the 
benefit not just of patent holders, but also of the broader public.

                          ____________________