Transcript 1. Function or use

Antibody Patents in the United States
Dan Altman
Knobbe Martens Olsen & Bear, LLP
Issuance of US Antibody Patents by Year
Since 1975…
 3,720 total antibody patents issued in the US1
 211 for monoclonal antibodies
400
Number of Patents
350
300
250
"Antibody"
200
Monoclonal
Antibody
150
100
50
0
2
Year
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Three types of antibody claims considered
1. Novel or known target defined by
function or use
2. Known target
3. Structural definition
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1. Function or use
At least three ways to claim antibodies by
function or use:
(a) Statement of intended use
(b) Antibody “capable of”a function
(c)“Method of use” claim
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1. Function or use
(a) Statement of intended use:
1. A monoclonal antibody for treating a patient
suffering from Disease X.
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1. Function or use
(a) Statement of intended use:
Statement Limits Claim
Statement Does Not Limit
Claim
Preamble that gives life and
meaning to the claim
Intended use alone
Statement of the intentional
purpose for which the method
must be performed
Statement of effect that may or
may not be desired or
appreciated
1Jansen
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v. Rexall Sundown, Inc., 342 F.3d 1329, 1333 (Fed. Cir. 2003)
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1. Function or use
(a) Statement of intended use:
1. A monoclonal antibody for treating a patient
suffering from Disease X.
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1. Function or use
(a) Statement of intended use [as a claim
limitation]:
1. A method of treating or preventing macrocyticmegaloblastic anemia in humans which anemia
is caused by either folic acid deficiency or by
vitamin B12 deficiency which comprises
administering [compound] to a human in need
thereof.
US Patent # 4,945,083, Jansen et al (Feb 1, 1989)
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1. Function or use
(b) Antibodies “capable of” a function
1. A monoclonal antibody capable of
neutralizing the DISEASE_X protein.
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1. Function or use
(b) Antibodies “capable of” a function
 If antibody is in prior art, burden shifts to
applicant to show prior art was not capable of
that function
See In re Fitzgerald, 619 F.2d 67, 70 (CCPA 1980)
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1. Function or use
(b) Antibodies “capable of” a function:
Disclosure of structures may be required
 [For] “genus claims that use functional language
to define the boundaries of a claimed genus…
the specification must demonstrate that the
applicant has made a generic invention that
achieves the claimed result and do so by
showing that the applicant has invented species
sufficient to support a claim to the functionallydefined genus.
Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349 (Fed. Cir. 2010)
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1. Function or use
(b) Antibodies “capable of” a function
[claim allowed]:
1. An isolated monoclonal antibody that specifically
binds an epitope within a polyproline region of the
huntingtin protein comprising greater than 5
consecutive proline residues; wherein said antibody is
capable of inhibiting aggregation of the huntingtin
protein; wherein said monoclonal antibody is a singlechain variant fragment encoded by a nucleotide
sequence comprising SEQ ID NO: 5.
US Patent # 7375194 Khoshnan et al (Dec 18, 2003)
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1. Function or use
(c) “Method of use” claim:
1. A method of treating Disease X, the method
comprising administering to the patient a
therapeutically effective amount of monoclonal
Antibody A
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1. Function or use
(c) “Method of use” claim:
 Claiming a new use of a known antibody:
 Product claim will be anticipated
 But possible “method of use” claim
See Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347 (Fed. Cir. 1999).
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1. Function or use
(c) “Method of use” claim:
 Identifying new properties or results of a known
method of using an antibody:
 Method claim will be anticipated
 Prior art contains “natural and inherent results in
that method.”
Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1378 (Fed. Cir. 2005)
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1. Function or use
(c) “Method of use” [claim allowed]:
26. A method of treating a patient suffering from
arteriosclerosis, comprising administering to the patient
an effective amount of an isolated neutralizing
monoclonal antibody, or binding fragment thereof,
specific for human oxidized low density lipoprotein
receptor (LOX-1).
US Patent # 7993643. Kobiyashi et al. August 9, 2011
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Disclosure req’s per US Statute (35 USC 112)
 Written description: Specification must prove
inventor was in possession of the invention
 Enablement: Specification must teach a skilled
artisan how to make and use the invention
 Best mode: Inventor can’t conceal her
contemplated best mode of practicing invention
35 U.S.C. 112
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2. Known target
Claim for an antibody directed against a known
target:
1. A monoclonal antibody that specifically binds to
the DISEASE_X protein
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2. Known target
“Antibody exception”: Disclosure of a wellcharacterized protein generally satisfies the written
description requirement (possession)
Inject protein into host animal  raise antibodies
Exception may not apply to human antibodies1
 Ethical issues
 Efficacy problems
1Centocor
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Ortho Biotech, Inc. v. Abbott Laboratories, 636 F.3d 1341, 1352 (Fed. Cir. 2011)
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2. Known target
Disclosure of known target can only support
claims if:
(1) Applicant fully discloses the novel protein; and
(2) Generating the claimed antibody is “so routine
that possessing the protein places the applicant in
possession of an antibody”1
1Centocor
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Ortho Biotech, Inc. v. Abbott Laboratories, 636 F.3d 1341, 1352 (Fed. Cir. 2011)
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2. Known target
 Adequate disclosure of target: structure, formula,
chemical name, physical properties, or depositing
protein in a public depository.1
 Inadequate disclosures:
Claim
Disclosure
Human CD40CR antibody1
Mouse antigen only
Genus of monoclonal antibodies that Molecular weight of a single
bind to neurofibrosarcoma (tumor)
mouse antigen
cells2
1
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Noelle v. Lederman, 355 F.3d 1343, 1349 (Fed. Cir. 2004)
2 In re Alonso, 545 F.3d 1015, 1021 (Fed. Cir. 2008)
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2. Known target
 Known antigen  Monoclonal antibody is prima
facie obvious
Ex Parte Erlich, 22 U.S.P.Q.2d 1463 (Bd. Pat. App. & Interf. Jan. 16, 1992)
 Prima facie showing of obviousness is
rebuttable
 Inventive process used to make antibody1
 Antibodies exhibit novel specificity for a particular
antigen2
1e.g.
U.S. Patent No. 5,109,115
2e.g. U.S. Patent No. 5,134,075
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2. Known target
Sample Claim [Allowed]:
1. An isolated antibody or fragment thereof that
specifically binds to the polypeptide of SEQ ID NO:144.
United States Patent # 7,427,664. Goddard, et al. September 23, 2008
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3. Structural claims
Claim directed to the antibody structure:
1. A monoclonal antibody comprising an amino
acid sequence as set out in SEQ ID 1.
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3. Structural claims
Disclosure must prove that every claimed
structural element was in inventor’s
possession
 “The specification at best describes a plan for
making fully-human antibodies and then
identifying those that satisfy the claim limitations.
But a “mere wish or plan” for obtaining the
claimed invention is not sufficient.”1
1Centocor
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Ortho Biotech, Inc. v. Abbott Laboratories, 636 F.3d 1341, 1351 (Fed. Cir. 2011)
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3. Structural claims
Example of insufficient disclosure:
Claimed Structure
Disclosed Structure
(1) Human Constant Region
Human constant region

(2) Human variable region
Mouse variable region

(3) High affinity for human TNF-α,
High affinity for human TNF-α,

(4) Neutralizing activity
Neutralizing activity

(5) “A2 specificity”
A2 specificity

1Centocor
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Ortho Biotech, Inc. v. Abbott Laboratories, 636 F.3d 1341, 1351 (Fed. Cir. 2011)
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3. Structural claims
[Allowed structural claim]:
1. An antibody comprising a specific binding member
capable of binding an intracellular antigen, wherein
said specific binding member comprises a polypeptide
binding domain comprising an amino acid sequence as
set out as residues 99 to 106 of SEQ ID NO: 2.
United States Patent # 6,827,925 Williams et al. December 7, 2004
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3. Structural claims
Claim based on deposit of biological material:
1. An isolated monoclonal Antibody A,
deposited at Center C on 1 Jan. 2011 and
accorded accession number 123.
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3. Structural claims
Limited circumstances under which deposit
may satisfy disclosure requirements of 112:
 Biological invention
 Invention otherwise meets the requirements for
patent protection
 Providing a description in written form is not
practicable
Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 970 (Fed. Cir. 2002)
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3. Structural claims
 Deposit may satisfy written description
requirement1
 Deposit + accession number in specification =
possible proof of possession
1 Enzo
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Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 970 (Fed. Cir. 2002)
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3. Structural claims
 Deposit usually sufficient to satisfy
enablement requirement1
 Deposit not always necessary to satisfy
enablement requirement2
1 Enzo
2
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Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 965 (Fed. Cir. 2002)
In re Wands, 858 F.2d 731, 736 (Fed. Cir. 1988); See also 37 CFR Part 1
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3. Structural claims
 For genus claims, deposit must represent
scope of claim
Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 967 (Fed. Cir. 2002)
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3. Structural claims
Deposits and best mode
 Best mode requirement: Inventor cannot
conceal subjective “best mode”
 No deposit required when:
“[The invention] can be prepared by one skilled
in the art from known materials using the
description in the specification.”
Amgen, Inc. v. Chugai Pharm. Co., Ltd., 927 F.2d 1200, 1211 (Fed. Cir. 1991)
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3. Structural claims
Claim based on deposit of biological material
[Allowed]:
1. An isolated monoclonal antibody mAb PAB-1,
deposited at ATCC on 24 Jan. 2002 and accorded
accession PTA-4005, which binds to a surface antigen
on nematode L3.
United States Patent # 7,326,774
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Harrison, et al. February 5, 2008
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