|
FRIDAY, NOVEMBER 30, 2012 CERTIORARI GRANTED
|
|
|
12-142
|
MUTUAL PHARMACEUTICAL CO. V. BARTLETT, KAREN L.
|
|
The petition for a writ of certiorari is granted.
|
|
|
12-398
|
ASSOC. FOR MOLECULAR PATHOLOGY V. MYRIAD GENETICS, INC., ET AL.
|
|
The petition for a writ of certiorari is granted limited to
|
|
|
Question 1 presented by the petition.
See also the SCOTUS blog page:
|
| ||||||||||||||||||||||||||||||||||||||||||||
| |||||||||||||||||||||||||||||||||||||||||
| REP. BECERRA APPLAUDS COURT DECISION ON GENE PATENTING |  |  |
WASHINGTON, D.C.— Representative Xavier Becerra (CA-31), Vice Chair of the House Democratic Caucus and a member of the House Ways and Means and Budget Committees, today applauded a U.S. District Court of New York.decision in the case Association for Molecular Pathology v. U.S. Patent and Trademark Office, which invalidates patents on genes linked to hereditary breast and ovarian cancer. The ruling is the result of a lawsuit brought by a group of patients, physicians and scientists.
Although this court decision represents significant progress, it does not prevent the U.S. Patent and Trade Office from issuing future patents.
This decision is also subject to appeal and, therefore, is not yet final.This decision is consistent with gene patent legislation Rep. Becerra has authored and will reintroduce. Rep. Becerra’s bill affirms that products of nature, such as the human genome, cannot be patented.
|
| UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT |
| 2010-1406 |
| 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, |
| Plaintiffs-Appellees, |
| v. |
| UNITED STATES PATENT AND TRADEMARK OFFICE, |
| Defendant, |
| and |
| MYRIAD GENETICS, INC., |
| Defendant-Appellant, |
| and |
| 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, |
| Defendants-Appellants. |
| 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 |
| (202) 719-7000 |
| Attorneys for Amicus Curiae James D. Watson |
| TABLE OF CONTENTS |
| Page |
| INTEREST OF AMICUS CURIAE JAMES D. WATSON .....................................1 |
| ARGUMENT .............................................................................................................2 |
| 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 |
| TABLE OF AUTHORITIES |
| Page |
| 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 |
| James D. Watson, DNA: The Secret of Life (2003)..........................................11, 15 |
| 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 |
| -ii - |
| INTEREST OF AMICUS CURIAE JAMES D. WATSON |
| 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. |
| -1 - |
| ARGUMENT |
| 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. |
| -2 - |
| 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. |
| -3 - |
| 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. |
| -4 - |
| 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 |
| -5 - |
| 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. |
| -6 - |
| 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). |
| -7 - |
| 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 - |
| 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 - |
| 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 - |
| 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 - |
| 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 |
