| UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT |
|
|
| 2010-1406 |
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| THE ASSOCIATION FOR MOLECULAR PATHOLOGY, THE AMERICAN COLLEGE OF |
| MEDICAL GENETICS, THE AMERICAN SOCIETY FOR CLINICAL PATHOLOGY, THE |
| COLLEGE OF AMERICAN PATHOLOGISTS, HAIG KAZAZIAN, MD, ARUPA |
| GANGULY, Ph.D, WENDY CHUNG, MD, Ph.D, HARRY OSTRER, MD, DAVID |
| LEDBETTER, Ph.D, STEPHEN WARREN, Ph.D, ELLEN MATLOFF, M.S., ELSA REICH, |
| M.S., BREAST CANCER ACTION, BOSTON WOMEN�S HEALTH BOOK COLLECTIVE, |
| LISBETH CERIANI, RUNI LIMARY, GENAE GIRARD, PATRICE FORTUNE, VICKY |
| THOMASON, and KATHLEEN RAKER, |
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| Plaintiffs-Appellees, |
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| v. |
| UNITED STATES PATENT AND TRADEMARK OFFICE, |
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| Defendant, |
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| and |
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| MYRIAD GENETICS, INC., |
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| Defendant-Appellant, |
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| and |
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| LORRIS BETZ, ROGER BOYER, JACK BRITTAIN, ARNOLD B. COMBE, RAYMOND |
| GESTELAND, JAMES U. JENSEN, JOHN KENDALL MORRIS, THOMAS PARKS, DAVID |
| W. PERSHING, and MICHAEL K. YOUNG, in their official capacity as Directors of the |
| University of Utah Research Foundation, |
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| Defendants-Appellants. |
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| Appeal from the United States District Court for the Southern District of |
| New York, in case no. 09-CV-4515, Senior Judge Robert W. Sweet |
|
|
| BRIEF FOR AMICUS CURIAE JAMES D. WATSON |
| IN SUPPORT OF NEITHER PARTY |
|
|
| Matthew J. Dowd |
| James H. Wallace, Jr. |
| WILEY REIN LLP |
| 1776 K Street NW |
| Washington, DC 20006 |
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| (202) 719-7000 |
| Attorneys for Amicus Curiae James D. Watson |
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|
| TABLE OF CONTENTS |
| Page |
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| INTEREST OF AMICUS CURIAE JAMES D. WATSON .....................................1 |
| ARGUMENT .............................................................................................................2 |
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|
| I. |
| BECAUSE HUMAN GENES ARE UNIQUE AND CONVEY |
| INFORMATION ABOUT THE ESSENCE OF BEING HUMAN, |
| THEY SHOULD NOT BE PATENTED ........................................................2 |
| II. |
| THE HUMAN GENOME PROJECT WAS INTENDED TO |
| BENEFIT ALL, NOT JUST SELECT COMPANIES....................................8 |
| III. |
| PATENTS ON HUMAN GENES ARE NOT NECESSARY, BUT IF |
| THEY ARE GRANTED, COMPULSORY LICENSES SHOULD BE |
| REQUIRED TO ENSURE FAIR ACCESS..................................................12 |
| IV. |
| RULE 29(c)(5) STATEMENT......................................................................15 |
| V. |
| CONCLUSION..............................................................................................15 |
| CERTIFICATE OF SERVICE |
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|
| TABLE OF AUTHORITIES |
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| Page |
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| Buck v. Bell, |
| 274 U.S. 200 (1927)..............................................................................................6 |
|
| OTHER SOURCES |
|
| Alok Jha, Human Genome Project Leader Warns Against Attempts to Patent |
| Genes, The Guardian, June 24, 2010 .................................................................13 |
|
| James D. Watson, The Double Helix (1968).............................................................1 |
|
|
| Tom Walsh, et al., Detection of Inherited Mutations for Breast and Ovarian |
| Cancer Using Genomic Capture and Massively Parallel Sequencing, 107 |
| Proceedings of the National Academy of Science USA 12,629 (2010).............13 |
|
| James D. Watson, The Nobelist vs. The Film Star: DNA Restrictions |
| Attacked, Washington Post, May 14, 1978, at D1................................................8 |
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| James D. Watson, DNA: The Secret of Life (2003)..........................................11, 15 |
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| J.D. Watson & F.H.C. Crick, |
| A Structure for Dexoyribose Nucleic Acid, 171 Nature 737 (1953).....................3 |
| James D. Watson & John Tooze, |
| The DNA Story: A Documentary History of Gene Cloning (1981) ....................7 |
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| -ii - |
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| INTEREST OF AMICUS CURIAE JAMES D. WATSON |
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| James D. Watson is the co-discoverer of the double helix structure of |
| deoxyribonucleic acid (�DNA�). For this discovery, he and his colleague, the late |
| Francis Crick (along with the late Maurice Wilkins for related work), were |
| awarded the Nobel Prize in Physiology or Medicine in 1962. See James D. |
| Watson, The Double Helix (1968). |
|
| Throughout his career, Dr. Watson has been at the forefront of recombinant |
| DNA research and advances in genetic engineering. From 1956 until 1976, Dr. |
| Watson was on the faculty of Harvard University, leading the effort to focus the |
| biology department on the then-emerging field of molecular biology. Starting in |
| 1968, Dr. Watson was the director of Cold Spring Harbor Laboratory (�CSHL�). |
| From 1994 to 2004, he served as the president of CSHL, and from 2004 until 2007, |
| he was CSHL�s chancellor. Dr. Watson is now Chancellor Emeritus of CSHL. |
|
| Of particular pertinence to the present appeal is Dr. Watson�s role in the |
| Human Genome Project. In 1988, Dr. Watson was appointed Associate Director |
| for Human Genome Research of the National Institutes of Health (�NIH�) and, in |
| 1989, Director of the National Center for Human Genome Research at the NIH. In |
| these positions, Dr. Watson lead the public effort to sequence the human genome. |
|
| Given the significance of the issue at hand, Dr. Watson wishes to write |
| directly to the Court. |
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| -1 - |
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| ARGUMENT |
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| I. BECAUSE HUMAN GENES ARE UNIQUE AND CONVEY |
| INFORMATION ABOUT THE ESSENCE OF BEING HUMAN, |
|
| THEY SHOULD NOT BE PATENTED |
|
| I have read through the various opinions issued in this case.1 Although the |
| opinions admirably describe the scientific details of DNA and human genes, what |
| the Court misses, I fear, is the fundamentally unique nature of the human gene. |
| Simply put, no other molecule can store the information necessary to create and |
| propagate life the way DNA does. It is a chemical entity, but DNA�s importance |
| flows from its ability to encode and transmit the instructions for creating humans. |
| Life�s instructions ought not be controlled by legal monopolies created at the whim |
| of Congress or the courts. |
|
| Even before DNA�s structure was revealed, many scientists recognized the |
| importance of a cell�s chromosomes (which are composed of DNA) to the |
| propagation of life. In 1944, Erwin Schrレdinger, a Nobel Prize-winning physicist, |
| wrote a small book titled What Is Life? In it, he reasoned that chromosomes were |
| the genetic information bearers. Schrレdinger thought that, because so much |
| information must be packed into every cell, the information must be compressed |
| into �hereditary code-script� embedded in the molecular fabric of the |
|
| 1 I have also read the Supreme Court�s decision in Mayo v. Prometheus, although |
| its opaqueness must leave many attorneys wondering if it adds anything at all to |
| the issue of whether human genes ought to be patented. |
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| -2 - |
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| chromosomes. At the time, this was an untested hypothesis; most biologists |
| thought that proteins would be identified as the bearers of genetic instruction. |
| Eventually, chemical techniques advanced, and scientists confirmed that the |
| chromosomes contained our genes. |
|
| As it turned out, the secret to DNA�s ability to create life is its double helical |
| structure, along with its information-coding sequences. Francis Crick and I |
| published the first correct structure of DNA in 1953. J.D. Watson & F.H.C. Crick, |
| A Structure for Dexoyribose Nucleic Acid, 171 Nature 737 (1953).2 The double- |
| helical structure epitomized elegance in simplicity. From a chemical perspective, |
| DNA is little more than two strands of a nucleotide polymer wound together in a |
| double helix formation. The nucleotide polymer consists of various sequences of |
| A, T, G, and C bases. The helical structure has two strands, one complementary to |
| the other. |
|
| As soon as Francis and I deciphered the structure, we immediately |
| understood its significance. With a hint of more to come, we wrote in our article |
| that �[i]t has not escaped our notice that the specific pairing we have postulated |
| immediately suggests a possible copying mechanism for the genetic material.� |
| The double helix structure confirmed DNA�s role as the genetic carrier and created |
|
| 2 At the time, we were in a tight race with Linus Pauling (soon to be a Nobel |
| laureate in chemistry). Fortunately for us, Pauling concluded that DNA was a |
| triple helix�an erroneous conclusion ironically based on a chemical error. |
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| -3 - |
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| the possibility of almost limitless information storage. The various sequences of |
| bases could be translated by a cell�s machinery, and that information would be |
| used to create new proteins for the cell.3 |
|
| Later scientists discovered that certain DNA sequences controlled the |
| expression of other genes. One of the earliest discovered of these control |
| sequences was the �TATA box.� The TATA box contains the core DNA sequence |
| 5�-TATAAA-3� or a similar variant. Specific proteins can bind to this sequence, |
| which promotes the transcription of other specific genes. Extracted from the |
| chromosome, a nucleic acid molecule having the TATAAA sequence has little, |
| physically inherent value. Its significance arises because that sequence is useful |
| information to the cell�s genetic machinery. The TATAAA sequence leads to the |
| expression of genes that affect the cell and ultimately our human experience. |
|
| The terminology of DNA underscores DNA�s informational role in life. In a |
| living cell, DNA is used to make RNA, and then RNA is used to make |
| polypeptides, i.e., protein. The first step�DNA to RNA�is called transcription. |
| The second step�RNA to proteins�is called translation. Both words connote the |
| conveyance of information. The information encoded by a human gene is first |
|
| 3 Amusingly, after I gave my first presentation of our DNA structure in June 1953, |
| Leラ Szilヌrd, the Hungarian physicist and inventor of the nuclear chain reaction, |
| asked whether I would patent the structure. That, of course, was out of the |
| question. |
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| -4 - |
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| transcribed into RNA (DNA and RNA are similar molecules, thus similar |
| languages, so the genetic information is merely transcribed from one format to |
| another). Then, the genetic information is translated from RNA into protein. |
| (RNA and protein are different biochemical �languages,� hence translation). The |
| entirety of the DNA machinery focuses on transferring and utilizing the genetic |
| information. |
|
| When cells replicate, they make copies of the genetic code for the progeny |
| cells. New strands of DNA are synthesized in a process analogous to the way |
| scriveners of years past would copy legal documents. Just as scriveners would |
| copy legal documents word by word, a cell copies the DNA molecule letter by |
| letter (A, G, T, or C). And just as scriveners proofread their work, the DNA |
| polymerase�the enzyme that replicates DNA�has a built-in proofreading |
| mechanism. But as with all proofreading, the system is not perfect, and errors |
| occur. �Typographical� errors with DNA replication can lead to genetic |
| mutations�which can cause devastating diseases or can lead to evolutionary |
| improvements. |
|
| To this day, we continue to learn how human genes function. We estimate |
| that humans have approximately 22,000 genes. We have yet to fully understand |
| the functions of all human genes, but this lack of understanding is further reason |
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| -5 - |
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| that scientists should be permitted to experiment on human genes free from any |
| threat of patent infringement. |
|
| The social history of human genes also reveals DNA�s informational |
| uniqueness. In the early part of the twentieth century, many in society believed |
| that the answers to all of society�s ills resided in the human genome. From that |
| belief grew the eugenics movement�an ill-fated movement founded on an |
| incomplete understanding of genetics. |
|
| Even the legendary Supreme Court justice Oliver Wendell Holmes |
| misunderstood the role of genes in human development. In the landmark case of |
| Buck v. Bell, 274 U.S. 200, 207 (1927), Justice Holmes expressed a view about |
| genetics that prevailed during his time: |
|
| It is better for all the world, if instead of waiting to execute degenerate |
| offspring for crime, or to let them starve for their imbecility, society |
| can prevent those who are manifestly unfit from continuing their |
| kind. . . . Three generations of imbeciles are enough. |
|
| We now know that many factors affect a person�s mental acuity, genes being some |
| of them. But Justice Holmes and other supporters of the eugenics movement could |
| not appreciate, at that time, the precise role of the human gene. |
|
| In years to come, with the right advances in genetic engineering, we may |
| well be able to treat or rectify mental disabilities and physical diseases which today |
| are deemed incurable. Such hope is all the more reason that scientific research on |
| human genes should not be impeded by the existence of unnecessary patents. |
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| -6 - |
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| More importantly, we would not want one individual or company to monopolize |
| the legal right to the beneficial information of a human gene�information that |
| should be used for the betterment of the human race as a whole. |
|
| By the 1970s, the public�s perception of DNA had reached its nadir. Far |
| from being viewed as the vindicator of the wrongfully accused�as the public sees |
| it today�recombinant DNA technology was considered by many to be inherently |
| dangerous. Indeed, various interest groups wanted to ban recombinant DNA |
| research.4 Ironically, this hysteria seemed to begin after I participated in the first |
| scientific discussions exploring whether proposed regulations on DNA research |
| were necessary (at the Gordon Research Conference of Nucleic Acids in June |
| 1973). Unfortunately, the initial ruminations mutated into full-fledged proposed |
| restrictions, issued from the Asilomar Conference in February 1974. Later, as the |
| hysteria increased, the National Institutes of Health (�NIH�) enacted regulations |
| governing recombinant DNA technology. The public discourse reached such a |
| fevered pitch that, in the summer of 1976, the Cambridge City Council declared a |
| three-month moratorium on recombinant DNA research in the city of Cambridge� |
| and therefore at Harvard University and the Massachusetts Institute of Technology. |
|
| 4 I describe much of this history in one of my books. See James D. Watson & John |
| Tooze, The DNA Story: A Documentary History of Gene Cloning (1981). |
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| -7 - |
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| I, of course, did not favor these restrictions. At one point, I had to defend |
| recombinant DNA research from the attacks of the actor Robert Redford, who, |
| along with the Environmental Defense Fund, raised money to stop experiments |
| with recombinant DNA. See James D. Watson, The Nobelist vs. The Film Star: |
| DNA Restrictions Attacked, Washington Post, May 14, 1978, at D1. Eventually, |
| reason and objectivity prevailed, and scientists were free to conduct their |
| recombinant DNA research without absurd regulations. |
|
| My point with this overly brief and incomplete history of recombinant DNA |
| research is to illustrate how the major controversies associated with human genes |
| have arisen because human genes are much more than chemical compounds. The |
| myopic viewpoint thinks of a human gene as merely another chemical compound, |
| composed of various bases and sugars. But history and science teach us otherwise. |
| A human gene, which is a product of nature, is useful because it conveys vital |
| information. The human genome�s ability to be our instruction book on life |
| distinguishes it from other chemicals covered by the patent laws. No other |
| molecule carries the information to instruct a human zygote to become a boy or a |
| girl, a blonde or brunette, an Asian, African, or Caucasian. |
|
| II. |
| THE HUMAN GENOME PROJECT WAS INTENDED TO BENEFIT |
| ALL, NOT JUST SELECT COMPANIES |
| In addition to understanding the uniqueness of human DNA, I hope that an |
| awareness of the Human Genome Project�s history will guide the Court to the |
|
| -8 - |
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|
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| correct decision that human genes, as products of nature, should not be patented. |
| The Human Genome Project was started not to increase the profits of select |
| companies but to expand the our understanding of the human genome and make |
| this information available to all scientists. |
|
| The genesis of the Human Genome Project dates to the mid-1980s, when the |
| dual technological advances of recombinant DNA and computers opened the door |
| to deciphering the human genome. In June 1986, I organized a special session at |
| Cold Spring Harbor Laboratory to discuss the beginnings of what would become |
| the Human Genome Project. At that time, the U.S. Department of Energy had also |
| begun to focus on sequencing the genome. Other eminent scientists joined the |
| early effort, including Bruce Alberts, Sydney Brenner, and David Botstein. |
| Eventually, we published our report (from the National Academy of Sciences) |
| making the case for sequencing the human genome. With the support of James |
| Wyngaarden, then-head of NIH, and many others, the Human Genome Project |
| became reality. |
|
| In May 1988, I was appointed Associate Director for Human Genome |
| Research of NIH (and later, in 1989, became NIH�s Director of the National Center |
| for Human Genome Research). In these positions, my role was to oversee a |
| multimillion dollar budget and to organize what had become an international effort |
| to map the human genome. The United States was directing the project and carried |
|
| -9 - |
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|
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| out half of the work, while the rest was done mainly in the United Kingdom, |
| France, Germany, and Japan. |
|
| Even at the early stages of the project, we were concerned about the issue of |
| patenting human genes. Most, although not all, eminent scientists recognized that |
| human genes should not be monopolized by patents. I believed at the time�and |
| continue to believe�that the issue of patenting human genes went to the very crux |
| of whether the information encoded by human DNA should be freely available to |
| the scientific community. Some twenty years ago, I explained that patenting |
| human genes was lunacy, and I was not a lone voice. |
|
| Sadly, and to the detriment of scientific research, my view did not control |
| the policy decisions of NIH, which had filed for numerous patents covering human |
| genes. Even more egregious were the types of patents being filed on human genes. |
| Many of NIH�s patents described only small portions of a gene. For example, in |
| June 1991, an NIH official had urged Craig Venter, who at the time was working at |
| NIH, to file patent applications on several hundred new DNA sequences, even |
| though, in many instances, neither Venter nor NIH had any inkling of what those |
| sequences did. The following year, Venter listed over 2,000 more sequences in his |
| patent applications, still having no clue about the function of those sequences. |
|
| I expressed my objections to NIH management, but to no avail. To me, it |
| was clear that the goal of the Human Genome Project was to map and publish the |
|
| -10 - |
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|
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| human genome sequence for the scientific community. As the then-leader of the |
| project, I felt a particular obligation to do what I could. In my view, |
|
| [t]he Human Genome Project is much more than a vast roll call of As, |
|
| Ts, Gs, and Cs: it is as precious a body of knowledge as humankind |
|
| will ever acquire, with a potential to speak to our most basic |
|
| philosophical questions about human nature, for purposes of good and |
|
| mischief alike. |
| James D. Watson, DNA: The Secret of Life 172 (2003). In 1992, I publicly |
| opposed NIH�s decision to patent human genes. As a result, I was left with no |
| choice and was forced to resign from NIH that year. Patenting human genes was |
| not necessary to complete the Human Genome Project. Indeed, the international |
| effort was proceeding on schedule without any need to file patent applications on |
| human genes. |
|
| Less than fifteen years after its start, the Human Genome Project, along with |
| Celera Genomics, achieved success. On June 26, 2000, President Bill Clinton and |
| Prime Minister Tony Blair announced that the two groups had finished a working |
| draft, which was published for the public in February 2001. Gaps in the rough |
| draft were filled in by 2003�fifty years after Crick and I published the structure of |
| DNA. Scientists have used the data to estimate that humans have about 22,000 |
| genes�in some sense a surprisingly small number compared to other organisms. |
|
| The Human Genome Project was a multi-agency, international effort. It was |
| funded in large part by taxpayer money, and the primary expectation was that the |
|
| -11 - |
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|
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| information derived from the sequenced human genes would be available for all |
| scientists to use. Unfortunately, a decade later, private companies are still trying to |
| unnecessarily restrict access to human genes and the information encoded in those |
| genes. This situation burdens all of society. Other scientists involved in the |
| Human Genome Project continue to warn about the harms caused by patenting |
| human genes. For instance, John Sulston, who received the 2002 Nobel Prize in |
| Physiology or Medicine, headed the British effort of the Human Genome Project. |
| He has explained that �many human genes have patent rights on them and this is |
| going to get in the way of treatment unless you have a lot of money.�5 |
|
| III. |
| PATENTS ON HUMAN GENES ARE NOT NECESSARY, BUT IF |
| THEY ARE GRANTED, COMPULSORY LICENSES SHOULD BE |
| REQUIRED TO ENSURE FAIR ACCESS |
| As a third point, lawyers and judges misunderstand scientific research when |
| they contend that patent protection is necessary to encourage scientists to discover |
| human genes. A scientist does not�and should not�expect to obtain a legal |
| monopoly controlling the information encoded by human genes. And the average |
| scientist should not expect a windfall simply for revealing the sequence of DNA |
| bases that encode various genes. Research on human genes is one of those rare |
| endeavors which should be�and is done�with the understanding that, although |
|
| 5 See Alok Jha, Human Genome Project Leader Warns Against Attempts to Patent |
| Genes, The Guardian, June 24, 2010, at http://www.guardian.co.uk/science/2010/ |
| jun/24/human-genome-project-patent-genes. |
|
| -12 - |
|
|
|
| inventions based on those genes may later be commercialized, the genes |
| themselves are to be employed for the maximum benefits of humankind. |
|
| Consider also whether a biotechnology or pharmaceutical company derives |
| major revenue of human genes. From what I have seen, the answer is generally no. |
| Most biotechnology and pharmaceutical companies do not derive substantial |
| revenue from selling or licensing human genes. Rather, their primary revenue |
| source is much more likely their selling pharmaceuticals or actual research tools. |
| We should not be overly concerned that banning patents on human genes will |
| cause a detrimental loss of revenue. |
|
| Additionally, researchers are developing new medical diagnostic tools which |
| often rely on the use of multiple genes. For instance, investigators at the |
| University of Washington have developed parallel gene sequencing methods for |
| identifying of inherited mutations in breast and ovarian cancer genes. See Tom |
| Walsh, et al., Detection of Inherited Mutations for Breast and Ovarian Cancer |
| Using Genomic Capture and Massively Parallel Sequencing, 107 Proceedings of |
| the National Academy of Science USA 12,629 (2010). This group�s approach uses |
| multiple genes, not just the specific BRCA1 and BRCA2 genes in the Myriad |
| patents, to estimate cancer risk. |
|
| If each of the human genes used in a new multi-gene assay are subject to |
| patents, I fear that useful tests requiring multiple human genes will be |
|
| -13 - |
|
|
|
| unnecessarily delayed, become prohibitively expensive, or, worse yet, never be |
| made available to patients at all. For a new assay using hundreds of human genes, |
| the sea of patents and patent applications would create hundreds, if not thousands, |
| of individual obstacles to developing and commercializing the assay. The best |
| way, in my view, to resolve this problem is to eliminate the unnecessary patenting |
| of human genes. |
|
| If, for some reason, patents on human genes are deemed necessary, the next |
| best, albeit imperfect, solution is to require those patent holders to license the |
| patents to other researchers so that scientific progress is not obstructed. This is |
| often called a �compulsory license.� In my view, a compulsory license can |
| establish reasonable access to human genes and genetic information�which is |
| what scientists in general want, had the lawyers and courts not complicated |
| matters. Reasonable access facilitates scientific and social progress. |
|
| Compulsory licensing ensures that scientists and researchers will have |
| reasonable access to human genes and genetic information. Compulsory licensing |
| will attenuate the negative consequences of the genetic monopolies created by |
| patents. Implementing a compulsory license protocol will also reduce the risk that |
| a patient is denied access to life-saving medicines and technologies using human |
| genes and the information encoded in the genes. |
|
| -14 - |
|
|
|
| CERTIFICATE OF SERVICE |
|
| I hereby certify that on this day, June 15, 2012, two copies of the foregoing |
| BRIEF OF AMICUS CURIAE JAMES D. WATSON IN SUPPORT OF |
| NEITHER PARTY were served via first class mail on the following counsel for |
|
| the parties: |
|
| Gregory A. Castanias |
| Jones Day |
| 51 Louisiana Avenue, N.W. |
| Washington, D.C. 20001 |
|
| Counsel for Defendants-Appellants |
|
| Bruce Vignery |
| AARP Foundation Litigation |
| 601 E Street, NW |
| Washington, DC 20049 |
|
| Counsel for Amicus AARP |
|
| Barbara R. Rudolph |
| Finnegan, Henderson, Farabow, |
| Garrett & Dunner |
| 901 New York Avenue, N.W. |
| Suite 1100 |
| Washington, DC 20001-4413 |
|
| Counsel for Amicus American |
| Intellectual Property Law |
| Association |
|
| Seth P. Waxman |
| Wilmer Hale |
| 1875 Pennsylvania Avenue, N.W. |
| Washington, DC 20006 |
|
| Counsel for Amici Biotech Industry |
| Organization et al. |
|
| Christopher A. Hansen |
| American Civil Liberties Union |
| 125 Broad Street, 18th Floor |
| New York, New York 10004 |
|
| Counsel for Plaintiffs-Appellees |
|
| Stephen B. Maebius |
| Foley and Lardner |
| 3000 K Street, N.W., Suite 500 |
| Washington, DC 20007 |
|
| Counsel for Amicus Alnylam |
| Pharmaceuticals |
|
| Lori B. Andrews |
| Chicago-Kent College of Law |
| Illinois Institute of Technology |
| College of Law |
| 565 West Adams Street |
| Chicago, IL 60661 |
|
| Counsel for Amici American |
| Medical Association et al. |
|
| Erik P. Belt |
| McCarter & English |
| 265 Franklin Street |
| Boston, MA 02110 |
|
| Counsel for Amicus Boston Patent |
| Law Association |
|
|
| John L. Hendricks |
| Hitchcock Evert LLP |
| 750 North St. Paul Street |
| Suite 1110 |
| Dallas, Texas 75201 |
|
| Counsel for Amici Canavan |
| Foundation et al. |
|
| Christopher M. Holman |
| 5100 Rockhill Road |
| Kansas City, MO 64110 |
|
| Counsel for Amici Christopher |
| Holman et al. |
|
| E. Richard Gold |
| Faculty of Law, McGill University |
| 3664 Peel Street |
| Montreal, Quebec H3A 1W9 |
| Counsel for Amici E. Richard Gold |
| et al. |
|
| Erika R. George |
| Loyola University Chicago School |
| of Law |
| 25 E. Pearson |
| Chicago, IL 60611 |
|
| Counsel for Amici Erika R. George and |
| Kali N. Murray |
|
| David S. Forman |
| Finnegan, Henderson, Farabow, |
| Garrett & Dunner |
| 901 New York Avenue, N.W. |
| Washington, DC 20001-4413 |
|
| Counsel for Amicus Genetic |
| Alliance |
|
| Larry Frierson |
| The Law Offices of Larry Frierson |
| 3265 Lake County Highway |
| Calistoga, CA 94515 |
|
| Counsel for Amici Cancer Council |
| Australia and Luigi Palombi |
|
| Jennifer Gordon |
| Baker Botts |
| 30 Rockefeller Center |
| New York, NY 10112 |
|
| Counsel for Amicus Croplife |
| International |
|
| Eileen M. Kane |
| Penn State Dickinson School of Law |
| 328 Katz Building |
| University Park, PA 16802 |
|
| Counsel for Amicus Professor |
| Eileen N. Kane |
|
| Maxim H. Waldbaum |
| Schiff Hardin |
| 900 Third Avenue, 23rd Floor |
| New York, NY 10022 |
|
| Counsel for Amicus Fホdホration |
| Internationale des Conseils en |
| Propriホtホ Industrielle (FICPI) |
|
| William G. Gaede, III |
| McDermott, Will & Emery |
| 275 Middlefield Rd., Suite 100 |
| Menlo Park, CA 94025 |
|
| Counsel for Amici Genomic Health |
| et al. |
|
|
| J. Timothy Keane |
| Harness, Dickey & Pierce |
| 7700 Bonhomme Avenue, Suite 400 |
| St. Louis, MO 63105 |
| Counsel for Amici Gilead Sciences |
| et al. |
|
| George Kimbrell |
| International Center for |
| Technology Assessment |
| 660 Pennsylvania Ave., Suite 302 |
| Washington, D.C. 20003 |
|
| Counsel for Amici International |
| Center for Technology Assessment |
| et al. |
|
| Judy Deleon Jarecki-Black |
| Merial Limited |
| 3239 Satellite Blvd. |
| Duluth, GA 30096 |
|
| Counsel for Amicus Merial Limited |
|
| Debra L. Greenfield |
| UCLA Center for Society and |
| Genetics |
| Box 957221, 1323 Rolfe Hall |
| Los Angeles, CA 90095 |
|
| Counsel for Amici National |
| Women�s Health Network et al. |
|
| Kurt G. Calia |
| Covington & Burling |
| 1201 Pennsylvania Avenue, N.W. |
| Washington, DC 20004-2401 |
|
| Counsel for Amicus Pharmaceutical |
| Research and Manufacturers of |
| America |
|
| Herbert C. Wamsley |
| Intellectual Property Owners |
| 1501 M Street |
| Suite 1150 |
| Washington, D.C. 20005 |
|
| Counsel for Amicus Intellectual |
| Property Owners Association |
|
| Jacqueline Wright-Bonilla |
| Foley & Lardner LLP |
| 3000 K Street, NW |
| Suite 500 |
| Washington, D.C. 20007 |
|
| Counsel for Amici Rosetta Genomics, |
| Inc. et al. |
|
| Kent D. McClure |
| Animal Health Institute |
| 1325 G Street, NW, Suite 700 |
| Washington, DC 20005 |
|
| Counsel for Amicus Animal Health |
| Institute |
|
| Aaron Stiefel |
| Kaye Scholer |
| 425 Park Avenue |
| New York, NY 10022 |
|
| Counsel for Amicus Novartis Corp. |
|
| Mark R. Freeman |
|
| U.S. Department of Justice |
| 950 Pennsylvania Avenue, N.W. |
| Room 7646 |
| Washington, D.C. 20530 |
| Counsel for Amicus Curiae United |
| States |
|
|
| Krista L. Cox Ann M. McCrackin |
| Universities Allied for Essential University of New Hampshire |
| Medicines 2 White Street |
| 2625 Alcatraz Avenue Concord, NH 03301 |
| No. 180 Counsel for Amicus University of New |
| Berkeley, CA 94705 Hampshire School of Law |
| Counsel for Amicus Universities Allied |
| for Essential Medicines |
|
| James J. Kelley Andrew Chin |
| Eli Lilly & Co. University of North Carolina School of |
| 940 S. East Street Law |
| Dock 88 160 Ridge Road CB# 3380 |
| Lilly Corp. Center � Drop Code 1104 Chapel Hill, NC 27599 |
| Indianapolis, IN 46225 Counsel for Amici University of North |
| Counsel for Amicus Eli Lilly & Co. Carolina School of Law et al. |
|
| Francis Pizzulli |
| 718 Wilshire Blvd. |
| Santa Monica, CA 90401 |
|
| Counsel for Amicus The Southern |
| Baptist Convention |
|
| ____________________ |
| Matthew J. Dowd |
|
| Dated: June 15, 2012 |
|
|