AMP v. USPTO The Fate of Gene Patents

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AMP v. USPTOThe Fate of Gene Patents

• carr/ferrell
• February 23, 2011

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• Background
• 1989 It was discovered
• by the Intl Breast Cancer
• Linkage Corsortium that
• a gene (BRCA1) on
• chromosome 17 was
• linked to breast and ovarian
• cancer.

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• 1991 Myriad Genetics was founded
• 1994 Myriad, along with researchers from NIEHS,
  Univ. of
• Utah, McGill University, and Eli Lilly, sequenced
  BRCA1

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• 1995 A second breast cancer gene (BRCA2) was
• 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.

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• BRCA1/2 genes code for tumor suppressor proteins.
  

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• 1998-2008 Myriad charges about 3000 for BRCA1/2
  test.
• In 2008, revenues are 222 million, of which 190
  million
• is profit.
• In contrast, the Ontario regional public health
  plan offering
• BRCA1/2 testing - in disregard of the Myriad
  patents
• charges about 1000/test.

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• 2000-2008 Myriad sends cease-and-desist letters
  and
• 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.

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• Plaintiffs
• Medical/Advocacy Groups
• Association for Molecular Pathology (AMP),
• American College of Medical Genetics (ACMG),
• American Society for Clinical Pathology (ASCP),
• College of American Pathologists (CAP),
• Breast Cancer Action (BCA),
• Boston Womens Health Book Collective (OBOS)

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• Plaintiffs (cont.)
• Geneticists and genetic counselors Dr. Haig
  Kazarian,
• Dr. Arupa Ganguly, Dr. Wendy Chung, Dr. Harry
  Ostrer,
• Dr. David Ledbetter, Dr. Stephen Warren, Ellen
  Matloff,
• Elsa Reich
• Patients Lisbeth Ceriani, Runi Limary, Genae
  Girard,
• Patrice Fortune, Vicky Thomason, Kathleen Raker

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• Amici of Plaintiffs
• 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 Womens 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

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• Defendants
• 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)

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• Amici of Defendants
• 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

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• Patents in Suit
• 15 (out of 179) claims
• across 7 patents
• 5,747,282
• 5,837,492
• 5,693,473
• 5,709,999
• 5,710,001
• 5,753,441
• 6,033,857

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• Two types of claims
• 1. Composition claims
• An isolated DNA coding for a
• BRCA1 polypeptide, said
• polypeptide having the
• amino acid sequence set forth
• in SEQ IDS NO2.

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• 2. Method claims
• 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 NO1.

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• Summary judgment
• 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.

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• 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.

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• Two-step analysis under 101
• Whether the claimed invention is useful
  (utility)
• Whether the claimed invention constitutes a
  process, machine, manufacture, or composition or
  matter, or a new and useful improvement thereof
• (statutory subject matter or patentable
  subject matter)
• Whether the claimed invention is new
  (novelty) is governed
• by 102

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• In 1980, the U.S. Supreme Court specified that 3
  types of
• 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)

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• Examples of patentable subject matter
• Genetically engineered bacteria that had
  markedly different characteristics from any
  bacteria found in nature (Chakrabarty)
• Vitamin B12 active compositions
• 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)

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• Examples that are not patentable subject matter
• Fruit treated with mold-resistant borax (American
  Fruit Growers)
• Cocktail of unmanipulated bacteria (Funk
  Brothers)
• Purified or extracted natural compounds refined
  wood cellulose or purified tungsten (American
  Wood-Paper, General Electric)
• Natural compound manipulated through acid, heat,
  water, or distillation (Cochrane)
• Extracted and treated pine needle fibers (Latimer)

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• Isolated DNA vs. natural DNA
• Similarities
• Convey the same information
• Same nucleotide sequences
• (except for introns)
• Code for same proteins
• Identical pseudogenes
• Differences (from chromatin form of DNA)
• Structurally different
• Chemically different
• Can be used in different ways (as probes, primers)

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• The District Court finds isolated DNA is not
• patentable subject matter.
• DNA (particularly its nucleotide sequence) is a
  physical embodiment of the laws of nature.
  Absence of chromatin proteins is result of mere
  purification.
• The nucleotide sequence of a gene appears in
  natural DNA albeit with introns, but the absence
  of introns is not claimed. Further, the absence
  of introns results from natural splicing.
• It is the nucleotide sequence that it shares with
  natural DNA that gives isolated DNA the ability
  to act as probe, primer, etc.

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• The District Court finds method claims are not
• patentable subject matter.
• Failed the machine or transformation test
  (Bilski), which was later found to be too
  restrictive by the U.S. Supreme Court.
• Recited only steps of analyzing or comparing
  DNA sequences (abstract mental processes).
• Although Myriad argued that obtaining DNA
  sequences requires transformative steps (e.g.,
  isolating, sequencing), those steps were not
  actually claimed in challenged claim and may also
  be considered mere data gathering.

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• The District Court decision in AMP v. USPTO was
  issued on March 29, 2010. Final judgment entered
  April 19, 2010.
• On June 16, 2010, Myriad files a notice of
  appeal to the Federal Circuit.

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• As of February 22, 2011, the issues have been
  fully briefed (including more than 20 amici), and
  the oral arguments scheduled for April 4, 2011.
• The Federal Circuit usually publishes decision
  within 90-120 days of oral arguments.
• The losing party will likely either petition for
  a Federal Circuit rehearing en banc or appeal to
  the U.S. Supreme Court.

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• Myriads arguments on appeal
• Procedural The District Court lacked
  jurisdiction, because Plaintiffs failed to allege
  an affirmative act by Myriad constituting a
  controversy of sufficient immediacy or reality.
• 2. Legal The District Court erred when it
  invalidated claims directed to isolated BRCA1/2
  DNA and methods for detecting.

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• Myriad on Patentable Subject Matter
• Isolated DNA is a composition of matter
• Isolated DNA is not one of the 3 exceptions (law
  of nature, physical phenomena, abstract idea)
• Products of Nature are not categorically
  excluded from constituting patentable subject
  matter

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• Myriad on Products of Nature
• Would not protect valuable/new/useful inventions
  that add to human knowledge
• Would disrespect longstanding PTO practice,
  judicial precedent, and Congress legislative
  role
• Markedly different is a factual standard
  related to novelty legal standard for patentable
  subject matter should be human ingenuity
• Inconsistent and unworkable with statute

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• Myriad on Method Claims
• Relies on precedent that a determining (of
  metabolite levels) step involves a transformation
  where the determination cannot be performed by
  mere inspection
• Analyzing or comparing DNA sequences require
  extraction and processing of human tissue samples
• The District Court erred construing sequence to
  refer to information rather than a physical
  molecule
• Improper characterization of the essence of a
  claim

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• Appellees Response
• Myriads patents preclude examination of any
  and all BRCA1/2 genes
• Each of the claims defines isolated DNA
  according to how DNA functions in the body
• Myriads method claims cover the abstract idea
  of looking at DNA sequences and thinking about
  their significance. Addition of data-gathering
  or postsolution activity does not confer
  patentable subject matter.
• The patents give entire control over a body of
  knowledge and over pure information to the
  patentee. (A BRCA gene cannot be designed around
  new or alternative genes cannot be invented)

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• Department of Justice (DOJ) amicus brief
• proposes a human-made standard
• Distinguishes between man-made constructs (e.g.,
  cDNA, recombinant vectors/plasmids, chimeric
  proteins) and
• isolated, but otherwise unmodified DNA
• Notes that in light of prevailing knowledge,
  cDNAs or simple recombinant vectors may become
  obvious (but that is an issue under 103, not
  101)

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