Transcript 35 USC §112 Written Description

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Biotechnology Inventions: Genes &
Life Forms and the Impact of
Patenting on Upstream Science
Nancy J. Linck, Ph.D., J.D.
Deputy General Counsel
Intellectual Property & Trade
WIPO Open Forum on the Draft SPLT
Geneva, March 3, 2006
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The United States’ Patent System
• Served our country well for more than 200 years,
despite attacks from time to time and “sky is
falling” warnings
• “Promoted the progress of … the useful arts” as
our constitution charged the U.S. Congress to do
• It is a strong, enduring system that can be
improved but is certainly not “broken”
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Current Issues Under U.S. Law
• Patentable Subject Matter 35 USC § 101
• Utility 35 USC § 101
• Enablement 35 USC § 112
• Written Description 35 USC § 112
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35 USC § 101
Inventions Patentable
• “Whoever invents or discovers any new and
useful process, machine, manufacture, or
composition of matter … may obtain a patent
therefor, subject to the conditions and
requirements of this title.”
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Patentable Subject Matter
Chakrabarty 1980
• Is the claimed invention a process, machine, manufacture,
or composition of matter?
• “As with Fulton’s steamboat ‘folly’ and ‘Bell’s telephone
toy,’ new technolgies have historically encountered
resistance. But if our patent laws are to achieve their
objective, extra-legal efforts to restrict wholly new
technologies to the technological parameters of the past
must be eschewed.” Chakrabarty (CCPA, Markey, J.)
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Patentable Subject Matter
U.S. Supreme Court & Chakrabarty
• Section 101 is couched in “expansive” terms to give
“ingenuity” a liberal encouragement
• Statutory subject matter “include[s] anything under the sun
made by man”
• Ananda Chakrabarty’s bacterium containing genetically
modified plasmids useful to degrade hydrocarbons are
patentable subject matter
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The § 101 Utility Requirement
• Is the claimed invention a useful process,
machine, manufacture, or composition of matter?
• Under the U.S. Patent and Trademark’s guidelines,
the utility must be
(1) specific, (2) substantial, and (3) credible
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An Example of a “Specific” Utility
• Disclosure of a specific biological activity
and a reasonable correlation to a disease
condition
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What is NOT a “Specific” Utility?
• Claim to a polynucleotide useful as a gene probe
or chromosome marker is not specific unless a
specific DNA target is disclosed
• A general statement of diagnostic utility of an
unspecified disease is not specific enough
• Language such as “may prove useful” or a useful
invention “may arise” are especially damaging to
this test
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What is a “Substantial” Utility?
• A “substantial utility” defines a “real world” use
• A therapeutic method of treating a known or
newly discovered disease
• An assay for identifying compounds that have a
“substantial utility”
• An assay that measures the presence of a material
which has a correlation to a predisposition to the
onset of a particular disease condition
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What is NOT a “Substantial” Utility?
• Utilities that require or constitute carrying
out further research to identify or
reasonably confirm a “real world” context
• Basic research such as studying the
properties of the claimed product or its
mechanism of action
• Method of treating an unspecified disease
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The Use Must Be Credible
• A small degree of utility is sufficient—only total
incapacity merits rejection
• Rare basis for rejection—seldom upheld by courts
• Mere identification of pharmacological activity of
a compound relevant to an asserted
pharmacological use provides an “immediate
benefit to the public” Nelson v. Bowler (CCPA
1980)
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Unsuccessful Credibility Challenges
• Synthetic prostaglandins modeled on naturally
occurring, bioactive prostaglandins plus tests
showing relative activity (Nelson v. Bowler)
• Pharmaceutical compositions for treating leukemia
in which active ingredient was structural analog to
known anticancer agent and data showed
comparable activity (In re Jolles 1980)
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Evaluation of Evidence Related to Utility
• Data from animal testing is relevant to
asserted human therapeutic utility if there is
a “satisfactory correlation” between the
effect on animals and humans
• Do not need to prove correlation with
statistical certainty
• If no previous treatment or cure, the PTO
will carefully review for credibility
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In re Fisher
421 F.2d 1365 (Fed. Cir. 2005)
• Test case: Claimed 5 expressed sequence tags
(ESTs) that encode proteins and protein fragments
in maize plants
• Recited 7 utilities: serving as a molecular marker
for gene mapping, measuring level of mRNA to
study gene expression, providing a source for
primers for use in PCR, identification of
polymorphism, isolating promoters, controlling
protein expression, and locating genetic molecules
of other plants and organisms
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In re Fisher
The PTO’s Rejection
• No specific and substantial utility but instead
generally applicable to any EST
• No known use for the proteins produced as final
products
• Utilities that require or constitute carrying out
further research to identify or reasonably confirm a
“real world” use are not substantial utilities
• Board of Appeals affirmed and Fisher appealed
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In re Fisher
Basis for Federal Circuit’s Affirmance
• Court equated “practical utility” and “real world utility”
with “substantial utility”—must show “a significant and
presently available benefit to the public” and cannot require
further research to identify or reasonably confirm utility
• Blessed the PTO Guidelines as “comport[ing] with this
court’s interpretation of the utility requirement of § 101”
• No evidence that ESTs had been used for any of the
asserted utilities
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In re Fisher
Basis for Federal Circuit’s Affirmance
• Court analogized this case to earlier ones
• Process for preparing compounds of unknown use (Brenner
v. Manson (S.Ct. 1966))
• New steroidal compounds with two possible utilities (In re
Kirk (CCPA 1967))
• Compounds useful as intermediates in preparing steroids of
no known use but similar in chemical structure to those
with pharmcological activity (In re Joly (CCPA 1967))
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In re Fisher
Majority’s Conclusions
• Granting a patent to Fisher “would amount to a
hunting license because the claimed ESTs can be
used only to gain further information about the
underlying genes and the proteins encoded for by
those genes.”
• The application “does not meet the utility
requirement … because Fisher does not identify
the function for the underlying protein-encoding
genes”
– No “immediate, well-defined real world benefit”
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In re Fisher
Judge Rader’s Dissent
• ESTs are research tools, patentable under § 101
• Similar to a microscope—both supply information
about a molecular structure and advance research
• Research is conducted in small steps, usually
requiring further research
• The Proper tool for assessing contributions of a
claimed advance is 35 U.S.C. § 103, not § 101
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35 USC §112
Specification
• “The specification shall contain a written
description of the invention, and of the
manner and process of making and using it,
in such full, clear, concise, and exact terms
as to enable any person skilled in the art to
which it pertains, or with which it is most
nearly connected, to make and use the same
….”
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35 USC §112
Two Separate and Distinct Requirements
• Written description: Inventor must have had
“possession” of the claimed invention when
the application was filed
• Enablement: The specification must teach
how to make and use the claimed invention
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35 USC §112
Enablement
• If the examiner rejects a claim for lack of
utility, then must also reject it for lack of
enablement (cannot teach how to use if not
useful)
• Typically, enablement is not a significant
issue—focus is on written description
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35 USC §112
Written Description
• Prior to 1997, used to ensure applicants did
not add essential disclosure to later-filed
continuations or new claims (“new matter”)
• In 1997, also used to invalidate a patent for
failure to show “possession” of the claimed
invention (University of California v. Eli
Lilly (Fed. Cir.)
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University of California v. Eli Lilly
119 F.3d 1559 (Fed Cir 1997)
• Relevant patent was filed in 1977
• Key claim required “a nucleotide sequence
having the structure of the reverse transcript
of an mRNA of a [human], which mRNA
encodes insulin”
• Prophetic example using the method used to
obtain rat cDNA along with the amino acid
sequences for human insulin A and B chains
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University of California v. Eli Lilly
(continued)
• Analysis:
– No description of human cDNA (no relevant
structure or physical characteristics)
– Sequence information for rat is not sufficient
– General process for making it plus protein
sequence is not sufficient
• Conclusion: No possession
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University of California v. Eli Lilly
(continued)
• Genus claims to vertebrate and mammalian insulin
cDNA for which rat insulin-encoding cDNA was
sufficiently disclosed (one species)
• Held: Not sufficient to support the broad
genuses—a broad statement such as “mammalian
insulin cDNA” is not equivalent to a generic
chemical claim—just a functional definition
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35 USC §112
Written Description
• The concept of “possession” is a difficult
one: One skilled in the art must
“immediately envisage” what is claimed
from what is disclosed
• Highly fact-based inquiry, so must be
decided on a case-by-case basis (tough to
understand through earlier cases)
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What is Necessary to Show
Possession?
• Description of an actual reduction to practice
• A showing that the invention was ready for
patenting such as by disclosure of drawings
or structural chemical formulae
• Specific identification of a deposit of a
biological material
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Examples from Guidelines
Assume:
– The utility requirement is satisfied
– The claimed invention is novel and
nonobvious
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Lack of Written Description
• A claimed biomolecule sequence
characterized only by a function without any
known correlation between function and
structure, even when it’s accompanied by a
method for making the biomolecule
sequence
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Lack of Written Description
Genes
• A claim to “A gene comprising SEQ ID
NO:1” where there is insufficient description
of specific structures such as promoters,
enhancers, coding regions, and other
regulatory elements, and these structures are
required in the description of the gene
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Lack of Written Description
ESTs
• Claim: An isolated DNA comprising SEQ ID NO:
16. (A genus claim)
• Reduction to practice of SEQ ID NO: 16 but
substantial variability among the DNAs
• Conclusion: No possession of the genus
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DNA Fragment Encoding a Full Open
Reading Frame (ORF)
• Claim: An isolated and purified nucleic acid
comprising SEQ ID NO: 2.
• 5000 members of cDNA library were sequenced
and open reading frames identified
• One member having SEQ ID NO: 2 has a high
level of homology to a DNA ligase
• Conclusion: In possession of the genus
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Hybridization
• Claim: An isolated nucleic acid that
specifically hybridizes under highly stringent
conditions to the complement of the
sequence set forth in SEQ ID NO: 1, wherein
said nucleic acid encodes a protein that binds
to a dopamine receptor and stimulates
adenylate cyclase activity.
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Hybridization (con’t)
• Hybridization techniques using a known
DNA probe under highly stringent conditions
were conventional in the art at filing
• SEQ ID NO: 1 is disclosed and there’s an
actual reduction to practice of it
• Would not expect substantial variation within
the genus
Conclusion: Adequately described
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Allelic Variants
• Claim: An isolated allele of an isolated DNA
that encodes protein X (SEQ ID NO: 2).
• Genus of DNAs that encodes protein X can
be envisioned from one species by using a
genetic code table but the genus of alleles
cannot be due to lack of knowledge in the art.
• Conclusion: Not adequately described
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Protein Variants
• Claim: An isolated variant of an isolated
protein having SEQ ID NO: 3.
• One member of the genus SEQ IDNO: 3 is
described by a complete structure
• No limitations are put on substitutions,
deletions, insertions and/or additions and no
common features are described
• Conclusion: No “possession”
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Product by Function
• Claim: A protein comprising SEQ ID NO: 3
and variants thereof that are at least 95%
identical to SEQ ID NO: 3 and catalyze the
reaction of A to B
• Procedures for making variants are routine
and an assay is described to identify which
proteins will have claimed catalytic activity
• A single species is reduced to practice
• Conclusion: “Possession” established
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Other Examples
• www.uspto.gov: Synopsis of Application of
Written Description Guidelines
• See also Revised Interim Utility Guidelines
Training Materials for more examples
relating to the utility requirement
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Biotech Inventions:
General Conclusions
• The line between what is sufficient and what
is not is subjective and will change as the
level of knowledge and skill in the art
increases
• Broad claims will come under more scrutiny
that narrow ones
• More detail about the claimed invention
helps but may limit the value of the claim
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Impact of Patenting on Upstream
Science
• Focus’s basic research
• Fosters discoveries that will serve the public
such as cures and treatments for diseases
• Through partnerships under Bayh-Dole,
promotes the development of such useful
discoveries
• No negative impact shown—NRC data does
not support their expressed concerns
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Thank you
• Any questions or requests for slides, write me
at [email protected]
• For information about the Biotechnology
Industry Organization (BIO), visit our
website: www.bio.org
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