`PRIVILEGED AND CONFIDENTIAL
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT AND TRIAL APPEAL BOARD
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`[INSERT NAME OF PETITIONER]
`Petitioner
`v.
`CELGENE
`Patent Owner
`____________
`Case IPR2013-
`Patent 6,045,501
`____________
`
`
`
`
`PETITION FOR INTER PARTES REVIEW OF
`U.S. PATENT NO. 6,045,501
`UNDER 35 USC §§ 311-319 AND 37 CFR §42.100 ET SEQ.
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`Page 1 of 60
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`CELGENE EXHIBIT 2035
`Coalition for Affordable Drugs VI LLC (Petitioner) v. Celgene Corporation (Patent Owner)
`Case IPR2015-01102
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`
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`Contents
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`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
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`I.
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`INTRODUCTION ........................................................................................... 1
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`II. OVERVIEW ..................................................................................................... 1
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`III. GROUNDS FOR STANDING (37 C.F.R. § 42.104(a)); PROCEDURAL
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`STATEMENTS ....................................................................................................... 8
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`IV. MANDATORY NOTICES (37 C.F.R. § 42.8(a)(1)) .................................. 9
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`V. STATEMENT OF THE PRECISE RELIEF REQUESTED AND THE
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`REASONS THEREFOR (37 C.F.R. §42.22(a)) ................................................. 10
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`VI. OVERVIEW OF U.S. PATENT NO. 6,045,501 ...................................... 10
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`VII. PROSECUTION HISTORY ..................................................................... 17
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`VIII. CLAIM TERMS REQUIRING CONSTRUCTION ........................... 19
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`IX.
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`IDENTIFICATION OF THE GROUNDS FOR CHALLENGE (37
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`C.F.R. § 42.104(b)) ................................................................................................ 27
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`A.
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`The Petition Establishes a Reasonable Likelihood that at Least One
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`Challenged Claim is Obvious and/or Anticipated. ............................................ 27
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`(i)
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`(ii)
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`Challenge 1: Claims 1-10 ........................................................................ 30
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`Challenge 2: Claims 1-10 ........................................................................ 39
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`X. CONCLUSION .............................................................................................. 52
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`CERTIFICATE OF SERVICE ........................................................................... 53
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`DRAFT – ATTORNEY-CLIENT
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`iii
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`Cases
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`DRAFT – ATTORNEY-CLIENT
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`Table of Authorities
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`Al-Site Corp. v. VSI Int’l, Inc., 174 F.3d 1308, 1323-24 (Fed. Cir. 1999) ................. 31
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`Graham v. John Deere Co., 383 U.S. 1 (1966) ......................................................... 32
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`In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004) ................ 21
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`In re GPAC Inc., 57 F.3d 1573, 1578 (Fed. Cir. 1995) ............................................. 30
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`Innova/Pure Water, Inc. v. Safari Water Filtration Systems, Inc., 381 F.3d 1111,
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`1116 (Fed. Cir. 2004) ............................................................................................. 21
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`KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007) ............................................. 31, 32
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`Multiform Desiccants, Inc. v. Medzam, Ltd., 133 F.3d 1473, 1477 (Fed. Cir. 1998) 21
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`Nat’l Steel Car, Ltd. v. Canadian Pac. Ry., Ltd., 357 F.3d 1319, 1334 (Fed. Cir.
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`2004) ....................................................................................................................... 29
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`Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005 ............................................. 21
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`State Contracting & Eng. Corp. v. Condotte America Inc., 346 F.3d 1057, 1069 (Fed.
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`Cir. 2003) ................................................................................................................ 30
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`iv
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`Teleflex, Inc. v. Ficosa North America Corp, 299 F. 3d 1313, 1325 (Fed. Cir. 2001)
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`DRAFT – ATTORNEY-CLIENT
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` ................................................................................................................................ 22
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`
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`Rules
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`37 C.F.R. § 42.10(b) and § 42.63(e) ....................................................................... 9
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`37 C.F.R. § 42.6(d) .................................................................................................... 33
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`37 C.F.R. § 42.8(a)(1) .................................................................................................. 9
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`37 C.F.R. § 42.8(b)(1) .................................................................................................. 9
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`37 C.F.R. § 42.8(b)(3) .................................................................................................. 9
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`37 CFR § 42.106(a) .................................................................................................... 9
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`Statutes
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`35 U.S.C. § 102(b) ............................................................................................... 33, 42
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`35 U.S.C. § 103(a) ..................................................................................................... 29
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`35 U.S.C. § 314 ............................................................................................................ 1
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`35 U.S.C. §§311-319 ................................................................................................... 1
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`37 C.F.R. § 42.108(c) ................................................................................................... 1
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`Other Authorities
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`M.P.E.P. § 2141 ......................................................................................................... 32
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`M.P.E.P. §2143 ...................................................................................................... 2, 33
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`Office Patent Trial Practice Guide, 77 Fed. Reg. 48756, 48766 (Aug. 14, 2012) ..... 20
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`I.
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`INTRODUCTION
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`DRAFT – ATTORNEY-CLIENT
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`[INSERT NAME OF PARTY] (the “Petitioner”) hereby petitions for
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`Inter Partes Review (“IPR”) (the “Petition”) under 35 U.S.C. §§311-319
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`seeking cancellation of claims 1-10 of U.S. Patent No. 6,045,501 (the “ ‘501
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`Patent”, Exhibit 1001). Based on the evidence presented in this Petition, the
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`Patent Trial and Appeal Board (the “Board”) should institute an IPR because
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`there is a reasonable likelihood that at least one of the claims challenged in
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`the petition is unpatentable. 37 C.F.R. § 42.108(c).
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`II. OVERVIEW
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`In order to support a conclusion of obviousness based on the rationale
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`of "combining prior art elements according to known methods to yield
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`predictable results", one must articulate the following: (1) a finding that the
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`prior art included each element claimed, although not necessarily in a single
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`prior art reference, with the only difference between the claimed invention
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`and the prior art being the lack of actual combination of the elements in a
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`single prior art reference; (2) a finding that one of ordinary skill in the art
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`could have combined the elements as claimed by known methods, and that
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`in combination, each element merely performs the same function as it does
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`separately; and, (3) a finding that one of ordinary skill in the art would have
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`recognized that the results of the combination were predictable. M.P.E.P.
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`DRAFT – ATTORNEY-CLIENT
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`§2143.
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`Each and every element set forth in the M.P.E.P. is found in the prior
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`art, none of which was cited in the prosecution of the ‘501 patent, as well as
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`in statements made by numerous experts, including the inventors
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`themselves, at meetings held by the Food and Drug Administration and the
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`Centers for Disease Control. Moreover, it was overwhelming clear from
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`these meetings that everyone, physicians, patients, regulatory agencies,
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`pharmacies and pharmaceutical companies, was motivated to prevent the
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`horrific tragedy that occurred when thalidomide was administered in the
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`1960s in an unregulated manner to pregnant women by putting in-place a
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`system that would tightly control distribution of the drug.
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`A brief overview of claim 1 from the ‘501 patent, which has an
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`effective filing date of August 28, 1998, clearly illustrates why this claim is
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`obvious in view of the prior art. For clarity, the claim is shown in italics
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`below.
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`1. A method for delivering a teratogenic drug to patients in need of the drug
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`while avoiding the delivery of said drug to a foetus comprising:
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`2
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`Comment – Mitchell (Mitchell et al. (New England J. Med. 333(2):101
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`(1995) (“Mitchell”)) lays-out the details of a pregnancy prevention program
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`designed to decrease the risk of exposure of a fetus to teratogenic drugs.
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`The program was targeted at prescribers and patients and involved
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`guidelines for physicians, obtaining negative pregnancy tests, a patient-
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`qualification checklist and contraceptive information. The Centers for
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`Disease Control Meeting (CDC Meeting, Centers for Disease Control,
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`Preventing Birth Defects, March 26, 1997 (the “CDC Meeting”)) discussed
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`the need for such programs that would include an accounting of all usage of
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`thalidomide, an informed consent document to be signed by all subjects
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`who receive thalidomide, distribution of an informational patient
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`brochure and a database of all patients who take thalidomide and
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`specifically looked to programs developed for drugs such as clozapine
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`and isotretinoin for guidance on how to develop such a program for
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`thalidomide.
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`Clozapine was made available only through registered
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`treatment centers via the Clozapine national registry. All patients must be
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`cleared through the Clozapine national registry. Pharmacists were cleared
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`via the Clozapine national registry. Based on various clinical criteria,
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`retreatment with clozapine may be denied. Dishman and Bastani disclose
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`computerized programs for registering prescribers such as physicians,
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`pharmacies and patients, which in the case of the Veterans Administration
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`ties the hospital’s laboratory database to the outpatient pharmacy dispensing
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`software and only allows clozapine prescriptions to be processed when
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`certain clinical criteria are met (steps (a), (b) and (c)). Dishman et al. (Am.
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`J. Hosp. Pharm 51: 899 (1994) (“Dishman”) and Bastani et al.
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`(Psychopharmacology 99:S122 (1989) (“Bastani”)).
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`Powell clearly sets forth methods for delivering thalidomide to
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`patients in need of the drug while avoiding exposure of the foetus to the drug
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`Powell lays out explicit guidelines for identification of women of
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`childbearing potential.
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`a. registering in a computer readable storage medium prescribers who are
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`qualified to prescribe said drug;
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`Comment – Honigfeld discloses the development of a clozapine national
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`registry. (Honigfeld (Psychiatric Services 47:52 (1996) (“Honigfeld”)). The
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`computerized database, the clozapine national registry, maintains records on
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`physicians, pharmacies and patients. Id. “All data coming into the
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`Clozapine national registry are entered into an integrated, computerized
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`database maintained by the manufacturer” Id.. The CDC Meeting discussed
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`that the “FDA is also looking at various methods of helping to ensure the
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`safe use of thalidomide by reviewing the ways other drugs with important
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`side effects are handled” and specifically referenced a potential lethal
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`drug, clozapine.
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`b. registering in said medium pharmacies to fill prescriptions for said drug;
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`Comment - The clozapine national registry provides for the responsibilities
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`of physicians, pharmacies, patients and distributors. The computerized
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`database, the clozapine national registry, maintains records on physicians,
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`pharmacies and patients. Honigfeld.
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`c. registering said patients in said medium, including information
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`concerning the ability of female patients to become pregnant and the ability
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`of male patients to impregnate females;
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`Comment – Powell (Powell et al. Postgrad. Med. J. 70:901 (1994)
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`(“Powell”)) provides guidelines for the clinical use and dispensing of
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`thalidomide. Before instituting therapy with thalidomide, pregnancy should
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`be excluded by confirming a negative pregnancy test two weeks prior to
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`starting therapy. Id.
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`d. retrieving from said medium information identifying a subpopulation of
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`said female patients who are capable of becoming pregnant and male
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`patients who are capable of impregnating females;
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`Comment - Powell lays out explicit guidelines for identification of women
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`5
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`of childbearing potential.
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`e. providing to the subpopulation, counseling information concerning the
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`risks attendant to fetal exposure to said drug;
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`Comment - Powell provides specific guidelines for counseling patients
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`concerning the risks attendant to fetal exposure to said drug and states that
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`before treatment the patient must have a negative pregnancy test (steps (e)
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`and (f)). Powell ; see also, the CDC Meeting.
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`Dishman, Bastani and Powell all disclose the use of comprehensive
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`counseling to the patients both before, after and during treatment (step (e)).
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`Powell provides specific guidelines for counseling patients concerning the
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`risks attendant to fetal exposure to said drug and states that before treatment
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`the patient must have a negative pregnancy test (steps (e) and (f)).
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`f. determining whether patients comprising said subpopulation are
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`pregnant; and
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`Comment - Pregnancy should be excluded before instituting therapy with
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`thalidomide by a negative pregnancy test within 2 weeks prior to starting
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`therapy. Mitchell. Mitchell also discusses that a negative pregnancy test
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`should be obtained before starting therapy and delay the start of therapy until
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`the second or third day of the next normal menstruation.
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`g. in response to a determination of non-pregnancy for said patients,
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`authorizing said registered pharmacies to fill prescriptions from said
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`registered prescribers for said non-pregnant registered patients.
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`Comment - As noted above, the CDC Meeting discussed the need for such
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`programs that would include an accounting of all usage of thalidomide, an
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`informed consent document to be signed by all subjects who receive
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`thalidomide, distribution of an informational patient brochure and a
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`database of all patients who take thalidomide. Notably, the CDC
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`Meeting looked to programs developed for drugs such as clozapine and
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`isotretinoin for guidance on how to develop such a program for
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`thalidomide.
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`Finally, with regards to step (g), “in response to a determination of
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`non-pregnancy for said patients, authorizing said registered pharmacies to
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`fill prescriptions from said registered prescribers for said non-pregnant
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`registered patients”, Dishman and Bastani disclose both registered
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`pharmacies and prescribers who require authorization in order to dispense
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`the drug. Powell makes it clear that thalidomide should only be dispensed to
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`a patient who is not pregnant.
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`In summary, each and every element of claim 1 is set forth in the prior
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`art references cited in the Petition. The Petition is accompanied by a
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`declaration of a technical expert, Dr. Matthew W. Davis (Exhibit 1007). Dr.
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`Davis lays out why a physician, pharmacist or medical director would have
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`DRAFT – ATTORNEY-CLIENT
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`clearly combined the prior art together. Davis Declaration, Exhibit 1007.
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`Moreover, there would have been a clear motivation and a compelling need
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`to create such a system given the disaster with thalidomide in the early
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`1960s. Finally, the combination of the computerized drug monitoring and
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`registration systems disclosed in the prior art with the guidelines for
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`dispensing thalidomide would have resulted in the establishment of a
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`completely predictable monitoring and registration system for thalidomide.
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`The remaining dependent claims, 2-10 add nothing patentable and are
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`discussed in greater detail below in both the Petition and Declaration.
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`
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`III. GROUNDS FOR STANDING (37 C.F.R. § 42.104(a));
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`PROCEDURAL STATEMENTS
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`Petitioner certifies that the ‘501 patent is available for IPR and
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`that the Petitioner is not barred or estopped from requesting an IPR of any
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`claim of the ‘501 patent on the grounds identified herein. This Petition is
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`filed in accordance with 37 CFR § 42.106(a). P owers of Attorney are
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`filed concurrently , as well as an Exhibit List per 37 C.F.R. § 42.10(b)
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`and § 42.63(e), respectively. The required fee is paid via online credit
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`card payment. The Office is authorized to charge fee deficiencies and
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`credit overpayments to Deposit Acct. No. __________ (Customer ID No.
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`___________).
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`IV. MANDATORY NOTICES (37 C.F.R. § 42.8(a)(1))
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`The Real Parties-In-Interest (37 C.F.R. § 42.8(b)(1)) are:
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`[INSERT PARTY] (the “Petitioner.”)
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`Designation of Lead and Back-Up Counsel (37 C.F.R. § 42.8(b)(3)):
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`
`
`
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`Back-Up Counsel
`Tarek N. Fahmi, Esq.
`
` D
`
` +1 408 389 3537
`T +1 866 877 4883
`F +1 408 773 6177
`
`tarek.fahmi@fseip.com
`
`Fahmi, Sellers, Embert & Davitz
`84 W. Santa Clara St.
`Suite 550
`San Jose, CA 95113-1812
`1-866-877-4888
`
`Lead Counsel
`Michael A. Davitz M.D. J.D.
`
`
`
`T: +1 866-877-4883
`C: +1 914-582-8817
`F: +1 408-773-6177
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`michael.davitz@fseip.com
`
`Fahmi, Sellers, Embert & Davitz
`84 W. Santa Clara St.,
`Suite 550
`San Jose, CA 95113-1812
`1-866-877-4888
`
`
`
`
`
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`Notice of Service Information (37 C.F.R. § 42.8(b)(4)): Please
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`direct all correspondence to lead counsel at the above address. Petitioners
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`consent to email service at: michael.davitz@fseip.com and
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`tarek.fahmi@fseip.com.
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`V.
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`STATEMENT OF THE PRECISE RELIEF REQUESTED AND
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`THE REASONS THEREFOR (37 C.F.R. §42.22(a))
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`
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`Petitioners request IPR and cancellation of claims 1-10 of the ‘501
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`patent. A summary of the reasons for the relief is set forth in §II and in
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`greater detail below.
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`
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`VI. OVERVIEW OF U.S. PATENT NO. 6,045,501
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`
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`The ‘501 patent issued on April 4, 2000 and has an effective filing
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`date of August 28, 1998. The patent describes methods for delivering a drug
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`to a patient, while preventing the exposure of the fetus or other
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`contraindicated individuals to the drug. In various embodiments,
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`prescribers, pharmacies, and patients are registered in a computer database.
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`The registered patients receive counseling regarding the risks related to fetal
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`exposure to the drug. Under certain circumstances male patients, and female
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`patients who are not pregnant, can receive the drug. Exhibit 1001 at
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`Abstract.
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`10
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`There are 10 claims with a single independent claim which is
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`reproduced below.
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`1. A method for delivering a teratogenic drug to patients in need of the
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`drug while avoiding the delivery of said drug to a foetus comprising:
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`a. registering in a computer readable storage medium prescribers who
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`are qualified to prescribe said drug;
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`b. registering in said medium pharmacies to fill prescriptions for said
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`drug;
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`c. registering said patients in said medium, including information
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`concerning the ability of female patients to become pregnant and the
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`ability of male patients to impregnate females;
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`d. retrieving from said medium information identifying a
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`subpopulation of said female patients who are capable of becoming
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`pregnant and male patients who are capable of impregnating females;
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`e. providing to the subpopulation, counseling information concerning
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`the risks attendant to fetal exposure to said drug;
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`f. determining whether patients comprising said subpopulation are
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`pregnant; and
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`g. in response to a determination of non-pregnancy for said patients,
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`authorizing said registered pharmacies to fill prescriptions from said
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`registered prescribers for said non-pregnant registered patients.
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`The dependent claims, claims 2-10, recite the following limitations:
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`(i) claim 2, the method of claim 1 wherein said drug is thalidomide; (ii)
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`claim 3, the method of claim 1 further comprising including in said
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`registering information concerning male patients who are capable of
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`impregnating females and including said males within said subpopulation;
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`(iii) claim 4, the method of claim 1 wherein said determination comprises
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`pregnancy testing; (iv) claim 5, the method of claim 1 wherein the issuance
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`and fulfillment of said prescriptions are recorded in said computer readable
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`storage medium; (v) claim 6, the method of claim 1 wherein refilling of said
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`prescriptions is authorizable only in response to information contained on
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`said computer readable storage medium; (vi) claim 7, the method of claim 1
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`wherein said prescriptions are filled for no more than about 28 days; (vii)
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`claim 8, the method of claim 1 wherein said prescriptions are filled together
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`with distribution of literature warning of the effects of said drug upon
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`fetuses; (viii) claim 9, the method of claim 1 further comprising providing
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`said patients with contraception counseling; and, (ix) claim 10, the method
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`of claim 1 further comprising: h. providing to said patients who are capable
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`of becoming pregnant a contraceptive device or formulation.
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`The drug delivery methods described involve first registering
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`prescribers, who are qualified to prescribe a teratogenic drug, in a computer
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`readable storage medium. Exhibit 1001 at 4:10-15. Prescribers are “any
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`individual who are capable of prescribing drugs, including, for example,
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`medical doctors.” Id. at 3:30-33. In order to become registered, the
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`prescriber may be required to provide patient counseling and education. Id.
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`at 4:19-21. Registration can be achieved by mail, facsimile or on-line
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`transmission and the prescriber may be asked to provide certain information
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`as part of the registration, including, name, address and health care
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`institution affiliation. Id. at 4:35-40. A pharmacy that can fill the
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`prescription for the drug can become registered in a computer readable
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`medium in a similar manner. Id. at 5:1-23.
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`The patient must also be registered in a computer readable medium.
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`In order to be registered in the computer readable medium, the patient needs
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`to comply with various requirements. For example, the patient needs to
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`supply her/his name, mailing address and date of birth. Id. at 5:43-45. In
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`addition, other information is also entered into the computer readable storage
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`medium allowing the prescriber or distributor of the drug to “glean
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`therefrom information regarding the level of risk associated with the
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`administration of the involved drug to various patient.” Id. at 8:28-32.
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`The types of information can include a patient survey conducted
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`before, during and after treatment with the drug. Id. at 8:10-12. “The
`patient survey provides information, for example, to the prescriber,
`manufacturer and/or distributor of the drug, as well as to any group or
`body which may be established to generally provide oversight on the
`distribution of the drug, on information regarding the general lifestyle of
`the patient, including detailed information on the patient's sexual
`behavior.” Id. at 8:15-20. The patient may also be required to receive
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`counseling on birth control and fill-out an informed consent. Id. at 7:33-38.
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`The information can then be used to identify various subpopulations.
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`Specifically, “[o]nce entered into the computer readable storage medium, the
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`prescriber, manufacturer and/or distributor of the drug may be able to glean
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`therefrom information regarding the level of risk associated with the
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`administration of the involved drug to the various patients. Accordingly, it
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`may be possible to identify, from among the entire population of registered
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`patients, one or more subpopulations of patients for which the involved drug
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`may be more likely to be contraindicated. For example, it may be possible to
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`identify a subpopulation of female patients who are capable of becoming
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`pregnant and/or a subpopulation of male patients who are capable of
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`impregnating female patients. Preferably, the counseling information
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`discussed above relating to exposure of a foetus to a teratogenic drug may
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`then be addressed primarily to this subpopulation of patients.” Id. at 8:28-
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`42.
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`Counseling is provided to both male and female patients. Extensive
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`details on the nature of the counseling are set forth in the specification. The
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`counseling may be provided verbally, in written form or through
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`instructional videos. Id. at 6:15-20. Excerpts from the patent are provided
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`below.
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`Female Patients - “[T]he prescriber preferably counsels female patients that
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`such drugs must never be used by pregnant women. If the patient is a female
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`of child-bearing potential (i.e., a woman who is capable of becoming
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`pregnant), the prescriber preferably counsels the patient that even a single
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`dosage of certain teratogenic drugs, such as thalidomide, may cause birth
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`defects. Accordingly, the patient is preferably counseled to avoid sexual
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`intercourse entirely, or if sexually active, to use appropriate forms of
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`contraception or birth control. For both male and female patients, the
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`prescriber preferably provides counsel on the importance of using at least
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`two forms of effective birth control methods, with one form preferably being
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`a highly effective hormonal method, and the other form preferably being an
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`effective barrier method. The patients are preferably counseled to use the
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`birth control methods for a period of time prior to and during treatment with
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`the teratogenic drug, as well as for a period of time after treatment with the
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`drug has been terminated.” Id. at 6:27-46.
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`Male Patients - “Male patients who are being prescribed a teratogenic drug
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`are preferably counseled to use condoms every time they engage in sexual
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`relations, since many teratogenic drugs may be found in semen. Male
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`patients are also preferably counseled to contact their prescriber if they have
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`sexual intercourse without a condom, and/or if it is believed that they may
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`have caused a pregnancy.” Id. at 6:54-60.
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`Prescriber – The prescriber may also “advise the patient to not share the drug
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`with anyone else, and particularly that the drug should be kept out of the reach
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`of children as well as women of child-bearing potential. In the case of female
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`patients, particularly female patients of child-bearing potential, the prescriber
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`should give the patient a pregnancy test, preferably a serum pregnancy test,
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`prior to and during treatment with the teratogenic drug. To begin receiving the
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`teratogenic drug and to continue taking the drug, female patients of child-
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`bearing potential should continue to have negative pregnancy tests.” Id. at
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`7:12-24.
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`Before filling and dispensing the prescription, the registered
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`pharmacy, the patient has filled-out the registration form and is registered in
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`the computer readable storage medium. Id. at 9:14-18. The pharmacy can
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`then dispense the drug. Id. at 9:19-20.
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` Registration in a computer readable storage medium of the prescriber,
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`pharmacy and patient provides a means to monitor and authorize distribution
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`of contraindicated drugs such as teratogenic drugs. Id. at 10:13-17. The
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`computer readable storage medium may also act to deny access, dispension
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`or prescription of such teratogenic drugs to patients, pharmacies or
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`prescribers who fail to comply with the methods set forth in the ‘501 patent.
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`VII. PROSECUTION HISTORY
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`The ‘501 patent was filed August 28, 1998 (U.S. Patent Application
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`Serial No. 09/143,569 (the “‘569 application”)). There are two named
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`inventors, Marc Elsayed and Bruce Williams. There were 11 claims as filed,
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`including the claims as issued as well as a second independent claim, claim
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`11. On October 7, 1999, the USPTO issued a rejection under 35 U.S.C.
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`103(a) of claims 1 and 4-11 as being unpatentable over Sloan, U.S. Patent
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`No. 5,619,991 (the “‘991 patent”). It was the Examiner’s position that
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`Sloan discloses a “method for delivery drugs to patients in need of a drug
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`while avoiding delivery of said drug to a foetus comprising registering
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`qualified prescriber …in a computer readable storage medium, registering
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`pharmacies to fill prescriptions, registering patients and patient data,
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`providing counseling information to a patient…determining whether the
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`patient is pregnant… and authorization of prescriptions to be filled.” Exhibit
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`1002.
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`The Examiner stated that claims 2-3 would be allowable if rewritten
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`in an independent form. Id. Of note, claim 2 as filed recited a specific drug,
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`namely, thalidomide, while claim 3 recited “registering information
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`concerning male patients who are capable of impregnating females and
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`including said males within said subpopulation.”
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`In response, the Applicants argued that claim 1 distinguished itself
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`over Sloane by defining “methods for the delivery of a teratogenic drug to
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`patients in need of the drug while avoiding the delivery of the drug to a
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`foetus…[while] claim 11 distinguishes over Sloan by defining methods for
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`delivery a potentially hazardous drug to patients in need of the drug while
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`avoiding the delivery of the drug to persons for whom the drug is
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`contraindicated.” Exhibit 1003, Amendment ‘569 Application, page 3,
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`November 10, 1999. The Applicants argued that Sloan was “utterly silent
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`regarding the use of computer readable storage media to deliver to
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`patients…teratogenic drugs, while at the same time avoiding their delivery
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`to… fetuses.” Id. Although the Applicants acknowledged that Sloan’s “e-
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`doc” contained patient data, Sloan does not show procedures for identifying
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`an at-risk subpopulation and then prescribing a drug to patients while
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`avoiding the at-risk subpopulation. Id. The Applicants also argued that
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`Sloan does not teach how its methods could be used to provide any checks
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`and balances to insure that only registered prescribers or pharmacies are
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`permitted access.
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`The Applicants acknowledge that the “present invention [has] been
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`approved by the U.S. Food and Drug (FDA) for use in delivering the
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`teratogen thalidomide to patients while avoiding feoetal delivery” Id. The
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`USPTO issued a Notice of Allowance for claims 1-10 on February 22, 2000
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`and the patent issued on April 4, 2000.
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`VIII. CLAIM TERMS REQUIRING CONSTRUCTION
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`Consistent with the statute and legislative history of the America
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`Invents Act, when considering whether to institute a patent trial the Board
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`has indicated that it will interpret the clai