Antibody Patents in the United States Dan Altman Knobbe Martens Olsen & Bear, LLP Dan Altman...

Antibody Patents in the United StatesAntibody Patents in the United States

Dan Altman

Knobbe Martens Olsen & Bear, LLP

Dan Altman

Knobbe Martens Olsen & Bear, LLP

Issuance of US Antibody Patents by YearSince 1975…

3,720 total antibody patents issued in the US1

211 for monoclonal antibodies

Three types of antibody claims considered

1. Novel or known target defined by function or use

2. Known target

3. Structural definition

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

1. Function or use

(a) Statement of intended use:

1. A monoclonal antibody for treating a patient suffering from Disease X.

1. Function or use

1Jansen v. Rexall Sundown, Inc., 342 F.3d 1329, 1333 (Fed. Cir. 2003)

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

1. Function or use

1. A monoclonal antibody for treating a patient suffering from Disease X.

1. Function or use

(a) Statement of intended use [as a claim limitation]:

1. A method of treating or preventing macrocytic-megaloblastic 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)

(b) Antibodies “capable of” a function

1. A monoclonal antibody capable of neutralizing the DISEASE_X protein.

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)

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 functionally-defined genus.

Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349 (Fed. Cir. 2010)

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 single-chain variant fragment encoded by a nucleotide sequence comprising SEQ ID NO: 5.

US Patent # 7375194 Khoshnan et al (Dec 18, 2003)

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

1. Function or use

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).

1. Function or use

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)

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

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

2. Known target

Claim for an antibody directed against a known target:

1. A monoclonal antibody that specifically binds to the DISEASE_X protein

2. Known target

“Antibody exception”: Disclosure of a well-characterized 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 Ortho Biotech, Inc. v. Abbott Laboratories, 636 F.3d 1341, 1352 (Fed. Cir. 2011)

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

2. Known target

Adequate disclosure of target: structure, formula, chemical name, physical properties, or depositing protein in a public depository.1

Inadequate disclosures:

1 Noelle v. Lederman, 355 F.3d 1343, 1349 (Fed. Cir. 2004)2 In re Alonso, 545 F.3d 1015, 1021 (Fed. Cir. 2008)

Claim Disclosure

Human CD40CR antibody1 Mouse antigen only

Genus of monoclonal antibodies that bind to neurofibrosarcoma (tumor) cells2

Molecular weight of a single mouse antigen

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

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

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.

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

3. Structural claimsExample 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

[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

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.

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)

Deposit may satisfy written description requirement1

Deposit + accession number in specification = possible proof of possession

1 Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 970 (Fed. Cir. 2002)

Deposit usually sufficient to satisfy enablement requirement1

Deposit not always necessary to satisfy enablement requirement2

1 Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 965 (Fed. Cir. 2002)2 In re Wands, 858 F.2d 731, 736 (Fed. Cir. 1988); See also 37 CFR Part 1

For genus claims, deposit must represent scope of claim

Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 967 (Fed. Cir. 2002)

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)

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 Harrison, et al. February 5, 2008

Daniel E. Altman

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