Transcript Drafting Patent Claims for Filing in the United States

Drafting Biotech/Pharma Patent Claims
J. Timothy Meigs
Senior Intellectual Property Counsel
BD Technologies
Research Triangle Park, NC
AIPLA Patent Prosecution Basic Training Seminar
August 26, 2010
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Overview
• Prominent Issues When Claiming
Biotech/Pharma Inventions
– Utility
– Written Description
– Enablement
– Others
• Categories of Biotech/Pharma Claims
• Biotech/Pharma Claim Examples
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Utility
• 35 U.S.C. § 101 - 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 therefore, subject to the
conditions and requirements of this title.
• U.S. Sup. Ct. - Substantial utility: specific benefit
exists in currently available form. Brenner v. Manson
(1966)
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PTO Utility Examination Guidelines
• Technology-neutral, but frequently applied
in biotech/pharma cases.
• Three-pronged test for utility:
– Specific to the subject matter claimed
– Substantial (a.k.a. “practical utility” - defines
a "real world" use)
– Credible (reliability based on logic and facts)
• Or well-established to one skilled in the art.
• See, In re Fisher (Fed. Cir. 2005)
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Written Description/Enablement
• 35 U.S.C. § 112, ¶ 1 - 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, and shall set forth
the best mode contemplated by the inventor
of carrying out his invention.
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Written Description – “Possession”
• The purpose of the "written description"
requirement is broader than to merely
explain how to "make and use"; the
applicant must also convey with
reasonable clarity to those skilled in the art
that, as of the filing date sought, he or she
was in possession of the invention. VasCath v. Mahurkar
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Written Description – Biotech Cases
• An adequate written description of a DNA
requires more than a mere statement that it is
part of the invention and reference to a potential
method for isolating it; what is required is a
description of the DNA itself. Fiers v. Revel
• For inventions in an unpredictable art, adequate
written description of a genus which embraces
widely variant species cannot be achieved by
disclosing only one species within the genus. Eli
Lilly
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Enablement – Case Law
• The specification must teach those skilled
in the art how to make and use the full
scope of the claimed invention without
‘undue experimentation.’ In re Wright
• Many factors to be considered when
determining whether experimentation is
‘undue.’ In re Wands
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Enablement – Wands Factors
• Breadth of Claims
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Nature of the Invention
State of the Prior Art
Level of Skill in the Art
Level of Predictability
• Amount of Direction/Guidance
• Presence/Absence of Working Examples
• Quantity of Experimentation
In re Wands
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35 U.S.C. § 112, ¶ 2
• The specification shall conclude with one or more
claims particularly pointing out and distinctly
claiming the subject matter which the applicant
regards as his invention.
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35 U.S.C. § 112, ¶ 2
Potentially Indefinite Claim Terms
•
•
•
•
•
•
•
“metabolite”
“residue”
“analogue”
“derivative”
“prodrug”
“precursor”
“such as” / “preferably” / “for example”
Source: Brian Stanton, NIH
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35 U.S.C. § 112, ¶ 4
• Subject to the following paragraph [concerning
multiple dependent claims], a claim in dependent
form shall contain a reference to a claim
previously set forth and then specify a further
limitation of the subject matter claimed. A claim in
dependent form shall be construed to incorporate
by reference all the limitations of the claim to
which it refers.
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35 U.S.C. § 112, ¶ 4
Pfizer v. Ranbaxy (Fed. Cir. 2006)
• ANDA litigation re: Lipitor (world’s best
selling drug).
• Pfizer’s ‘995 patent claimed:
Claim 1. (1) Atorvastatin acid; (2) atorvastatin
lactone; or (3) pharmaceutically acceptable
salts thereof.
Claim 2. The compound of claim 1, which is
atorvastatin acid.
Claim 6. The hemicalcium salt of the compound
of claim 2.
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Common Categories of Biotech/Pharma
“Composition of Matter” Claims
• Nucleic Acids
• Single Nucleotide
Polymorphisms
• Vectors
• Cells
• Antisense
• Interfering RNA
• Ribozymes
• Proteins/Peptides
• Antibodies
•
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•
•
•
•
•
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Vaccines
Transgenic Organisms
Viruses
Kits
Combinatorial Libraries
Microarrays
New Chemical Entities
Pharmaceutical
Formulations
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Common Categories of Biotech/Pharma
“Process” Claims
•
•
•
•
•
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Methods of Making Compositions
Methods of Using Compositions
Screening Assays
Diagnostic Methods
Gene Therapy
Methods of Treatment
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Typical Nucleic Acid Claims
• An isolated polynucleotide consisting of SEQ ID
NO:1.
• A probe consisting essentially of SEQ ID NO:1.
– Define ‘probe’ in the specification as SEQ ID NO:1
with up to 20 additional residues on either/both the 5’
or 3’ end.
• An isolated polynucleotide comprising SEQ ID
NO:1.
• An isolated polynucleotide encoding a protein
comprising SEQ ID NO:2.
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Nucleic Acid Claims
Hybridization + Function
• An isolated DNA molecule comprising a
nucleic acid sequence, the full-length
complement of which hybridizes under
stringent hybridization and wash
conditions to SEQ ID NO:1, wherein said
nucleic acid sequence encodes a protein
with X function.
– Define “stringent hybridization and wash
conditions” in the specification.
See, e.g., U.S. Pat. No. 6,346,655
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Nucleic Acid Claims
Percent Identity + Function
• An isolated nucleic acid molecule comprising a
sequence at least 80% identical to SEQ ID NO:1 and
that encodes a protein having X function.
• An isolated nucleic acid molecule comprising a
sequence that encodes a polypeptide the amino acid
sequence of which is at least 80% identical to SEQ
ID NO:2, wherein said polypeptide has X function.
– Define algorithm or parameters used to calculate %
identity in the specification. See, e.g., U.S. Pat. No. 6,346,655
• But see Ex parte Kubin and Written Description
Guidelines
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Other Nucleic Acid Claims
• Probe claim: An isolated nucleic acid molecule
comprising a fragment of SEQ ID NO:1 at least 10
nucleotides in length.
– Specification must describe target of probe.
• By reference to deposited clone: An isolated nucleic
acid molecule comprising the sequence of the ~2kb
XhoI fragment deposited as ATCC#____.
• Promoter claim: An isolated nucleic acid promoter
comprising SEQ ID NO:1, or a fragment of SEQ ID
NO:1 that retains promoter activity.
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Single Nucleotide Polymorphism
(SNP) Claims
• An isolated nucleic acid molecule
comprising 20 contiguous nucleotides of
SEQ ID NO:1, wherein the T at nucleotide
240 is replaced with C.
• An isolated nucleic acid molecule
comprising a sequence that encodes a
protein comprising SEQ ID NO:2, except
that said protein comprises a serine-toalanine mutation at position 55.
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Chimeric Construct and Vector
Claims
• A chimeric construct comprising a
promoter active in tumor cells operatively
linked to a nucleic acid molecule
according to claim 1.
• An expression vector comprising a
chimeric construct according to claim 2.
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Cell Claims
• A cultured cell comprising a chimeric construct
according to claim 2.
• A cultured cell comprising an expression vector
according to claim 3 or a progeny of said cell,
wherein said cell or said progeny expresses
said protein. (§ 112, ¶ 4 implications?)
• A biologically pure culture of a Bacillus
thuringiensis strain deposited as NRRL B21060.
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Antisense Claims
• An antisense oligonucleotide complementary to
SEQ ID NO:1 that inhibits the expression of a
protein encoded by SEQ ID NO:1.
• An antisense oligonucleotide consisting of the
sequence of SEQ ID NO:1.
• An isolated nucleic acid molecule comprising at
least 10 consecutive nucleotides of the
complement of SEQ ID NO:1.
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RNAi and dsRNA Claims
• An interfering RNA complementary to SEQ ID NO:1
that inhibits the expression of a protein encoded by
SEQ ID NO:1.
• An interfering RNA consisting of the sequence of SEQ
ID NO:1.
• An isolated ribonucleic acid molecule comprising at
least 10 consecutive nucleotides of the complement of
SEQ ID NO:1.
• A double-stranded ribonucleic acid molecule
comprising a first strand identical to 20-25 consecutive
nucleotides of SEQ ID NO:1, and a second strand
complementary to said first strand.
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Protein/Polypeptide Claims
• By source, function and MW: An isolated 50
kDa protein from [source organism] that
[performs X function].
– Define in specification how molecular weight is
determined.
• By % identity + function: An isolated protein
comprising an amino acid sequence at least
90% identical to SEQ ID NO:2 that
[performs X function].
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More Protein/Polypeptide Claims
• By sequence: An isolated protein comprising the
amino acid sequence set forth in SEQ ID NO:2.
• By functional fragment: An isolated protein
comprising the amino acid sequence set forth in
SEQ ID NO:2, or a fragment thereof that retains
[X function].
• By antigenic fragment: An isolated polypeptide
comprising an antigenic fragment of the amino
acid sequence set forth in SEQ ID NO:2.
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Transgenic Animal Claims
• A mouse homozygous for a disrupted
trkB gene, wherein the trkB gene is
disrupted by the insertion of a
selectable marker sequence and
wherein said mouse exhibits a decrease
in the number of neurons which
comprise the facial motor nucleus,
spinal cord, trigeminal ganglia and
dorsal root ganglia.
U. S. Patent No. 5,625,121
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Transgenic Plant Claims
• A plant, plant tissue or plant seed having
altered protoporphyrinogen oxidase (protox)
activity, wherein said altered protox activity is
conferred by expression of a DNA molecule
encoding a herbicide tolerant protox enzyme,
wherein said altered protox activity confers
upon said plant tolerance to a herbicide in
amounts which inhibit naturally occurring
protox activity.
U.S. Patent No. 6,307,129
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Virus Claims
• A tissue-specific replication-conditional
adenoviral virion comprising a heterologous
tissue-specific transcriptional regulatory
sequence operably linked to the coding region of
a gene that is essential for replication of said
virion. U.S. Pat. No. 6,551,587
• A mutant rabies virus comprising a rabies virus N
protein, wherein said N protein is not
phosphorylated. U.S. Pat. No. 6,706,523
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Diagnostic Claims
• A method for the detection of organism X, comprising the
steps of:
(a) isolating DNA from an organism to be characterized;
(b) subjecting said DNA to PCR amplification using at
least one PCR primer having sequence identity with at
least 10 consecutive nucleotides of SEQ ID NO:1; and
(c) visualizing the product or products of said
polymerase chain reaction amplification, whereby
detection of the product or products of said polymerase
chain reaction amplification indicates that the organism
to be characterized is X.
U.S. Patent No. 5,800,997.
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New Chemical Entity (NCE) Claims
1. N-[1-(Cyanomethyl-carbamoyl)cyclohexyl]-4-[4-(1-propyl)-piperazin-1yl]-b enzamide, or a pharmaceutically
acceptable salt thereof.
2. A pharmaceutical composition
comprising a compound according to
claim 1 as an active ingredient.
U.S. Pat. No. 6,642,239
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Pharmaceutical Formulation
Claims
• A pharmaceutical dry powder composition
comprising a TGF-β in a water soluble salt
chosen from calcium chloride, calcium
phosphate, potassium acetate, lithium
acetate, ammonium acetate and ammonium
bicarbonate.
U.S. Pat. No. 6,649,168
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Method of Treatment Claims
• Claim to ultimate use: A method of treating
disease Y comprising the administration, to a
human in need of such treatment, of an
effective dose of compound X.
• Claim to underlying activity: A method of
inhibiting the growth of a tumor cell, comprising
contacting the tumor cell with compound X.
U.S. Pat. No. 6,677,366
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Screening Assay Claims
•
A method for screening a chemical for the ability to inhibit X enzyme
activity, comprising:
(a) combining an enzyme according to claim 1 in a first reaction
mixture with [the enzyme’s substrate(s)] under conditions in which the
enzyme is capable of catalyzing the synthesis of [product];
(b) combining the chemical and the enzyme in a second reaction
mixture with [the enzyme’s substrate(s)] under the same conditions as
in the first reaction mixture;
(c) determining the amounts of [product] produced in the first and
second reaction mixtures; and
(d) comparing the amounts of [product] produced in the first and
second reaction mixtures;
wherein the chemical is capable of inhibiting X enzyme activity if the
amount of [product] produced in the second reaction mixture is
significantly less than the amount of [product] produced in the first
reaction mixture.
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Diagnostic Claims
• A method for the detection of organism X, comprising the
steps of:
(a) isolating DNA from an organism to be characterized;
(b) subjecting said DNA to PCR amplification using at
least one PCR primer having sequence identity with at
least 10 consecutive nucleotides of SEQ ID NO:1; and
(c) visualizing the product or products of said
polymerase chain reaction amplification, whereby
detection of the product or products of said polymerase
chain reaction amplification indicates that the organism
to be characterized is X.
U.S. Patent No. 5,800,997.
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Method of Treatment Claims
• Claim to ultimate use: A method of treating
disease Y comprising the administration, to a
human in need of such treatment, of an
effective dose of compound X.
• Claim to underlying activity: A method of
inhibiting the growth of a tumor cell,
comprising contacting the tumor cell with
compound X.
U.S. Pat. No. 6,677,366
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Method of Treatment Claims
• A method for reducing or preventing the effects of inflammation
arising from injured tissue, which method comprises the steps
of:
a. contacting the injured tissue with a green porphyrin
photosensitizing agent capable of penetrating into the injured
tissue and causing the desired pharmacological effect in less
than one hour; and
b. exposing the contacted injured tissue to light having a
wavelength absorbed by the photosensitizing agent for a time
sufficient to reduce or prevent inflammation in the exposed
tissue, but not so long as to cause necrosis or erythema of the
exposed injured tissue. U.S. Pat. No. 6,677,366
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Thank You!
J. Timothy Meigs
[email protected]
919-597-6276
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