AMP v. USPTO The Fate of Gene Patents. carr/ferrell February 23, 2011. Background 1989: It was discovered by the Int’l Breast Cancer Linkage Corsortium that a gene (BRCA1) on chromosome 17 was linked to breast and ovarian cancer. 1991: Myriad Genetics was founded
February 23, 2011
1989: It was discovered
by the Int’l Breast Cancer
Linkage Corsortium that
a gene (BRCA1) on
chromosome 17 was
linked to breast and ovarian
1994: Myriad, along with researchers from NIEHS, Univ. of
Utah, McGill University, and Eli Lilly, sequenced BRCA1
discovered and sequenced.
1995-2000: The 7 patents-in-suit
(for BRCA1/2) were submitted
and issued. Six of the patents
expire in 2015; one expires in 2017.
In 2008, revenues are $222 million, of which $190 million
In contrast, the Ontario regional public health plan offering
BRCA1/2 testing - in disregard of the Myriad patents –
charges about $1000/test.
sues to enforce patents against various clinical testing and
research centers. Licenses restrict licensees’ ability to
perform full screenings and/or to tell patients the results.
2009: Lawsuit to invalidate BRCA1/2
patents is filed.
Geneticists and genetic counselors: Dr. Haig Kazarian,
Dr. Arupa Ganguly, Dr. Wendy Chung, Dr. Harry Ostrer,
Dr. David Ledbetter, Dr. Stephen Warren, Ellen Matloff,
Patients: Lisbeth Ceriani, Runi Limary, Genae Girard,
Patrice Fortune, Vicky Thomason, Kathleen Raker
American Medical Association (AMA), American Society of Human Genetics,
American College of Obstetricians and Gynecologists, American College of
Embryology, and The Medical Society of the State of New York, March of
Dimes Foundation, Canavan Foundation, Claire Altman Heine Foundation,
Breast Cancer Coalition, Massachusetts Breast Cancer Coalition, National
Organization for Rare Disorders, National Tay-Sachs & Allied Diseases
Association, National Women’s Health Network, Asian Communities for
Reproductive Justice, Center for Genetics and Society, Generations Ahead,
Pro-Choice Alliance for Responsible Research, The International Center for
Technology Assessment, Indigenous People Council on Biocolonialism,
Greenpeace, Inc., Council for Responsible Genetics
United States Patent and Trademark Office (USPTO),
University of Utah Research Foundation (co-owner),
Myriad Genetics (co-owner and sole provider of
comprehensive BRCA1/2 screening)
Biotechnology Industry Organization (BIO), Boston Patent
Law Association, Rosetta Genomics, Inc., George Mason
University, BayBio, Celera Corporation, The Coalition for
21st Century Medicine, Genomic Health, Inc., Qiagen,
N.V., Target Discover, Inc., xDx, Inc., Prof. Kenneth
Chahine, Dr. Kevin Noonan
15 (out of 179) claims
across 7 patents
1. Composition claims:
An isolated DNA coding for a
BRCA1 polypeptide, said
polypeptide having the
amino acid sequence set forth
in SEQ IDS NO:2.
A method for detecting a germline alteration in a BRCA1 gene, said
alteration selected from a group consisting of the alterations set forth
in Tables 12A, 14, 18, or 19 in a human which comprises
analyzing a sequence of a BRCA1 gene or BRCA1 RNA from
a human sample or
analyzing a sequence of BRCA1 cDNA made from mRNA
from said human sample with the proviso that said germline alteration
is not a deletion of 4 nucleotides corresponding to base numbers
4184-4187 of SEQ IDS NO:1.
The Plaintiffs move for
summary judgment to declare
the 15 claims in suit invalid
under 35 U.S.C. § 101 and
unconstitutional under Article I,
Section 8 of the Constitution
and 1st and 14th Amendments.
35 U.S.C. § 101
Whoever invents or discovers any new and useful process, machine, manufacture, or composition or matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.
Two-step analysis under § 101
(“statutory subject matter” or “patentable subject matter”)
* Whether the claimed invention is new (“novelty”) is governed
by § 102
subject matter are categorically not patentable under § 101
(Diamond v. Chakrabarty (1980)):
1. Laws of nature (algorithms)
2. Physical phenomena
3. Abstract ideas (mental processes)
from bacterial fermentates “that
did not exist in nature in the form
in which the patentees produced
it,” in contrast to crystalline form of
vitamin B12 (Merck)
(except for introns)
Differences (from chromatin form of DNA):
patentable subject matter.
patentable subject matter.
Myriad’s arguments on appeal (including more than 20 amici), and the oral arguments scheduled for April 4, 2011.
2. Legal: The District Court erred when it invalidated claims directed to isolated BRCA1/2 DNA and methods for detecting.
Myriad on Patentable Subject Matter (including more than 20 amici), and the oral arguments scheduled for April 4, 2011.
Myriad on “Products of Nature” (including more than 20 amici), and the oral arguments scheduled for April 4, 2011.
Myriad on Method Claims (including more than 20 amici), and the oral arguments scheduled for April 4, 2011.
Appellees’ Response (including more than 20 amici), and the oral arguments scheduled for April 4, 2011.
Department of Justice (DOJ) amicus brief (including more than 20 amici), and the oral arguments scheduled for April 4, 2011.
proposes a “human-made” standard
isolated, but otherwise unmodified DNA