Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
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 © 2011 Knobbe Martens Olson & Bear LLP Three types of antibody claims considered 1. Novel or known target defined by function or use 2. Known target 3. Structural definition 3 © 2011 Knobbe Martens Olson & Bear LLP 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 4 © 2011 Knobbe Martens Olson & Bear LLP 1. Function or use (a) Statement of intended use: 1. A monoclonal antibody for treating a patient suffering from Disease X. 5 © 2011 Knobbe Martens Olson & Bear LLP 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 6 v. Rexall Sundown, Inc., 342 F.3d 1329, 1333 (Fed. Cir. 2003) © 2011 Knobbe Martens Olson & Bear LLP 1. Function or use (a) Statement of intended use: 1. A monoclonal antibody for treating a patient suffering from Disease X. 7 © 2011 Knobbe Martens Olson & Bear LLP 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) 8 © 2011 Knobbe Martens Olson & Bear LLP 1. Function or use (b) Antibodies “capable of” a function 1. A monoclonal antibody capable of neutralizing the DISEASE_X protein. 9 © 2011 Knobbe Martens Olson & Bear LLP 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) 10 © 2011 Knobbe Martens Olson & Bear LLP 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) 11 © 2011 Knobbe Martens Olson & Bear LLP 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) 12 © 2011 Knobbe Martens Olson & Bear LLP 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 13 © 2011 Knobbe Martens Olson & Bear LLP 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). 14 © 2011 Knobbe Martens Olson & Bear LLP 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) 15 © 2011 Knobbe Martens Olson & Bear LLP 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 16 © 2011 Knobbe Martens Olson & Bear LLP 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 17 © 2011 Knobbe Martens Olson & Bear LLP 2. Known target Claim for an antibody directed against a known target: 1. A monoclonal antibody that specifically binds to the DISEASE_X protein 18 © 2011 Knobbe Martens Olson & Bear LLP 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 19 Ortho Biotech, Inc. v. Abbott Laboratories, 636 F.3d 1341, 1352 (Fed. Cir. 2011) © 2011 Knobbe Martens Olson & Bear LLP 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 20 Ortho Biotech, Inc. v. Abbott Laboratories, 636 F.3d 1341, 1352 (Fed. Cir. 2011) © 2011 Knobbe Martens Olson & Bear LLP 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 21 Noelle v. Lederman, 355 F.3d 1343, 1349 (Fed. Cir. 2004) 2 In re Alonso, 545 F.3d 1015, 1021 (Fed. Cir. 2008) © 2011 Knobbe Martens Olson & Bear LLP 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 22 © 2011 Knobbe Martens Olson & Bear LLP 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 23 © 2011 Knobbe Martens Olson & Bear LLP 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. 24 © 2011 Knobbe Martens Olson & Bear LLP 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 25 Ortho Biotech, Inc. v. Abbott Laboratories, 636 F.3d 1341, 1351 (Fed. Cir. 2011) © 2011 Knobbe Martens Olson & Bear LLP 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 26 Ortho Biotech, Inc. v. Abbott Laboratories, 636 F.3d 1341, 1351 (Fed. Cir. 2011) © 2011 Knobbe Martens Olson & Bear LLP 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 27 © 2011 Knobbe Martens Olson & Bear LLP 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. 28 © 2011 Knobbe Martens Olson & Bear LLP 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) 29 © 2011 Knobbe Martens Olson & Bear LLP 3. Structural claims Deposit may satisfy written description requirement1 Deposit + accession number in specification = possible proof of possession 1 Enzo 30 Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 970 (Fed. Cir. 2002) © 2011 Knobbe Martens Olson & Bear LLP 3. Structural claims Deposit usually sufficient to satisfy enablement requirement1 Deposit not always necessary to satisfy enablement requirement2 1 Enzo 2 31 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 © 2011 Knobbe Martens Olson & Bear LLP 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) 32 © 2011 Knobbe Martens Olson & Bear LLP 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) 33 © 2011 Knobbe Martens Olson & Bear LLP 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 34 Harrison, et al. February 5, 2008 © 2011 Knobbe Martens Olson & Bear LLP Daniel E. Altman 2040 Main Street • 14th Floor • Irvine, CA 92614 Phone 949-760-0404 Fax 949-760-9502 Other offices in Los Angeles, Palo Alto, Riverside, San Diego, San Francisco, Seattle, & Washington D.C kmob.com