1. Patenting Human DNA, Embryos and
Organs: Recent Case Law Developments
in the United States
CASRIP 2012
High Technology Protection Summit
Gary M. Myles, Ph.D.
July 28, 2012
2. Topics Covered
• Why is Strong Patent Protection Essential
to the Biotechnology Industry?
• Historical Context for Broad Patent
Eligibility for Biotechnology Inventions
under 35 U.S.C. § 101
• Patent Eligibility of DNA
• Patent Eligibility of Embryos and Stem
Cells
4. Very Expensive and Time Consuming
to Get a Biotech Product on the
Market
• Average Cost to Develop a New
Biotechnology Product is $1.2 Billion,
According to the Tufts Center for the
Study of Drug Development (November
09, 2006)
5. Role of Patents
• PRO
– Patents provide a limited monopoly
• Competitors are excluded from the market for a
limited period of time
• Provides the incentive for companies to invest in
product R&D
• CON
– Too much protection can stifle innovation
and inhibit patient access to needed
therapeutics and diagnostics
6. 35 U.S.C. 101
Patentable Eligibility
Whoever invents or discovers any new and
useful process, machine, manufacture,
or composition of matter, or any new
and useful improvement thereof, may
obtain a patent therefor, subject to the
conditions and requirements of this title
7. Patentable Subject Matter:
Fundamental Principles
• Funk Bros. v. Kalo (S.Ct. 1948)
– Mixed culture of root-nodule bacteria for
inoculating seeds of leguminous plants
• No patentable subject matter
– Each species infects same group of plants
– No species acquires a different use
– No change in the individual bacteria
– No change in their individual utilities
– Use in combination does not improve
natural functioning
8. Patentable Subject Matter:
Fundamental Principles
• Funk Bros. v. Kalo (S.Ct. 1948)
– “Manifestations of nature are free to all men and
reserved exclusively to none”
• Laws of nature
– E = mc2
– Law of gravity
• Physical phenomena
• Principles
• Abstract ideas
• Products of nature
9. Patentable Subject Matter:
Fundamental Principles
• Diamond v. Chakrabarty (S.Ct.
1980)
– Dr. Chakrabarty
• Created oil-eating bacterium
• Claimed “a bacterium from
the genus Pseudomonas
containing therein at least
two stable energy-
generating plasmids, each of
said plasmids providing a
separate hydrocarbon
degradative pathway.”
10. Patentable Subject Matter:
Fundamental Principles
• Diamond v. Chakrabarty (S.Ct. 1980), cont.
– USPTO
• Rejected claim because a bacterium is
– A “product of nature”
– A living thing
– Supreme Court
• Upholds validity of Chakrabarty’s claim
– “Anything under the sun that is made by
man”
14. Patentability of DNA
• Federal Circuit
– Amgen v. Chugai (CAFC 1991)
• Court upholds validity of claims directed to “*a+ purified
and isolated DNA sequence consisting essentially of a
DNA sequence encoding human erythropoietin.”
– In re Kubin (CAFC 2009)
• “The isolation and sequencing of a human gene that
encodes a particular domain of a protein” is “a classic
biotechnology invention”
• USPTO
– Utility Examination Guidelines, 66 Fed. Reg. 1092 (2001)
• “A patent on a gene covers the isolated and purified gene
but does not cover the gene as it occurs in nature.”
– Issued >2,000 patents to isolated and purified DNA
15. Myriad v. ACLU (NY FDC 2010)
• In May 2009, the ACLU filed a lawsuit against
the USPTO, Myriad Genetics, and the
University of Utah Research Foundation
• Challenged patents claiming, inter alia:
• An isolated DNA coding for a BRCA1 polypeptide, said
polypeptide having the amino acid sequence set forth in SEQ
ID NO: 2.
16. Myriad v. ACLU (NY FDC 2010)
• March 29, 2010, Judge Sweet granted
Summary Judgment in favor of the ACLU
– Human genetic sequences are not patentable
• constitutes a natural phenomena, a law of
nature, and abstract ideas
17. Myriad v. ACLU
• Decision appealed to the Federal Circuit
– Myriad Amicus Brief
• Composition of matter claims directed towards
isolated DNA molecules are patent eligible, in
part, because they have “markedly different
characteristics” than their naturally occurring
counterparts
18. Myriad v. ACLU
• Department of Justice Amicus Brief
– Genomic DNA that has merely been isolated from
the human body, without further alteration or
manipulation, is not patent-eligible.
– The unique chain of chemical base pairs that
induces a human cell to express a cancer protein is
not a 'human-made invention.'
19. Myriad v. ACLU (CAFC 2011)
• July 29, 2011, Federal Circuit
– Reverses NY District Court
• Composition claims to “isolated” DNA are patent eligible
since the molecules as claimed do not exist in nature
20. Myriad v. ACLU (CAFC 2011)
• CAFC Distinguishes “Isolated” and “Purified”
– Isolated = Patent Eligible?
• The claimed “isolated” molecule has “a markedly
different chemical structure” or “a distinctive chemical
identity and nature” from a molecule that exists in nature
• “Isolated” molecules are “manipulated chemically” …
“chemically cleaved from their chemical combination with
other *+ materials” as exists in nature … differences “are
directly related to the change in chemical bonds.”
– Purified = Patent Ineligible?
• “Purification makes pure what was the same material, but
was previously impure”
• “Mere purification of a naturally occurring element is
typically insufficient to make it patentable subject
matter”
21. Myriad v. ACLU (S.Ct.)
• December 7, 2011: Petition for writ of
certiorari filed with U.S. Supreme Court
• March 26, 2012: Petition granted,
judgment vacated, case remanded to
CAFC for decision in light of Mayo v.
Prometheus
• July 20, 2012: CAFC heard oral
arguments
22. Practice Tips
• Product Claims
– Draft claims to “isolated” rather than “purified” products
• Describe in specification how “isolated” product is
structurally and chemically distinct from what is found in
nature
• Describe in specification new uses or functions for the
claimed product as compared to a natural product in its
natural environment.
– Draft claims to commercial embodiments
• Compositions and /or kits comprising “isolated” or
“purified” products
• Hybrid and fusion molecules
• Vectors
• Recombinant cells
25. Sherley v. Sebelius, (CA Dist. Col.)
• Lawsuit, filed in 2009, challenges the
legality of the funding by the National
Institutes of Health of hESC research
• 1996 Dickey-Wicker amendment bars US
from supporting research in which a
human embryo is “destroyed, discarded,
or knowingly subjected to risk of injury
or death.”
• Oral arguments heard April 23, 2012
26. Patenting of Embryonic Stem Cells
• 1998: James Thompson at University of
Wisconsin developed technique to
isolate and grow human embryonic stem
cells in culture
• USPTO Issued the following patents,
assigned to WARF:
– US 5,843,780 “Primate Embryonic Stem Cells”
– US 6,200,806 “Primate Embryonic Stem Cells”
– US 7,029,913 “Primate Embryonic Stem Cells”
27. America Invents Act
(September 16, 2011)
– Weldon Amendment
• “*N+o patent may issue on a claim directed to or
encompassing a human organism” Pub.L. 112-
29, H.R. 1249, Section 33(a)
• Controversy over whether “directed to” a
human organism may be construed to exclude
patents for DNA, stem cells, or other
technologies
28. AIA Legislative History
• Representative Lamar Smith (157 Cong. Rec. E1182-85, June 23, 2011)
– Nothing in this section should be construed to limit the ability
of the USPTO to issue a patent containing claims directed to:
• Chemical compounds whether obtained from
animal/human or produced synthetically … including
nucleic acids, polypeptides, proteins, antibodies and
hormones
• Cells, tissue, organs or other bodily components
produced through human intervention … including stem
cells, stem cell derived tissues … synthetic organs
• Methods for creating, modifying, or treating human
organisms including … methods for creating embryos …
• Nonhuman organism incorporating genes from human
29. USPTO
• September 20, 2011, Robert Bahr, Senior Patent
Counsel
• Claims Directed to or Encompassing a Human
Organism
– Section 33(a) of the AIA “does not change existing
law or longstanding USPTO policy that a claim
encompassing a human being is not patentable”
