DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
`
`
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`BEFORE THE PATENT AND TRIAL APPEAL BOARD
`
`
`
`
`
`
`[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.
`
`
`
`
`
`
`
`Page 1 of 60
`
`CELGENE EXHIBIT 2035
`Coalition for Affordable Drugs VI LLC (Petitioner) v. Celgene Corporation (Patent Owner)
`Case IPR2015-01103
`
`
`PRIVILEGED AND CONFIDENTIAL
`
`
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`BEFORE THE PATENT AND TRIAL APPEAL BOARD
`
`
`
`
`
`
`[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.
`
`
`
`
`
`
`
`Page 1 of 60
`
`CELGENE EXHIBIT 2035
`Coalition for Affordable Drugs VI LLC (Petitioner) v. Celgene Corporation (Patent Owner)
`Case IPR2015-01103
`
`
`
`
`
`Contents
`
`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
`
`I.
`
`INTRODUCTION ........................................................................................... 1
`
`II. OVERVIEW ..................................................................................................... 1
`
`III. GROUNDS FOR STANDING (37 C.F.R. § 42.104(a)); PROCEDURAL
`
`STATEMENTS ....................................................................................................... 8
`
`IV. MANDATORY NOTICES (37 C.F.R. § 42.8(a)(1)) .................................. 9
`
`V. STATEMENT OF THE PRECISE RELIEF REQUESTED AND THE
`
`REASONS THEREFOR (37 C.F.R. §42.22(a)) ................................................. 10
`
`VI. OVERVIEW OF U.S. PATENT NO. 6,045,501 ...................................... 10
`
`VII. PROSECUTION HISTORY ..................................................................... 17
`
`VIII. CLAIM TERMS REQUIRING CONSTRUCTION ........................... 19
`
`IX.
`
`IDENTIFICATION OF THE GROUNDS FOR CHALLENGE (37
`
`C.F.R. § 42.104(b)) ................................................................................................ 27
`
`A.
`
`The Petition Establishes a Reasonable Likelihood that at Least One
`
`Challenged Claim is Obvious and/or Anticipated. ............................................ 27
`
`(i)
`
`(ii)
`
`Challenge 1: Claims 1-10 ........................................................................ 30
`
`Challenge 2: Claims 1-10 ........................................................................ 39
`
`X. CONCLUSION .............................................................................................. 52
`
`
`
`ii
`
`Page 2 of 60
`
`
`
`
`
`CERTIFICATE OF SERVICE ........................................................................... 53
`
`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
`
`
`
`iii
`
`
`
`
`
`Page 3 of 60
`
`
`
`
`
`Cases
`
`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
`
`Table of Authorities
`
`Al-Site Corp. v. VSI Int’l, Inc., 174 F.3d 1308, 1323-24 (Fed. Cir. 1999) ................. 31
`
`Graham v. John Deere Co., 383 U.S. 1 (1966) ......................................................... 32
`
`In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004) ................ 21
`
`In re GPAC Inc., 57 F.3d 1573, 1578 (Fed. Cir. 1995) ............................................. 30
`
`Innova/Pure Water, Inc. v. Safari Water Filtration Systems, Inc., 381 F.3d 1111,
`
`1116 (Fed. Cir. 2004) ............................................................................................. 21
`
`KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007) ............................................. 31, 32
`
`Multiform Desiccants, Inc. v. Medzam, Ltd., 133 F.3d 1473, 1477 (Fed. Cir. 1998) 21
`
`Nat’l Steel Car, Ltd. v. Canadian Pac. Ry., Ltd., 357 F.3d 1319, 1334 (Fed. Cir.
`
`2004) ....................................................................................................................... 29
`
`Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005 ............................................. 21
`
`State Contracting & Eng. Corp. v. Condotte America Inc., 346 F.3d 1057, 1069 (Fed.
`
`Cir. 2003) ................................................................................................................ 30
`
`
`
`iv
`
`Page 4 of 60
`
`
`
`
`
`Teleflex, Inc. v. Ficosa North America Corp, 299 F. 3d 1313, 1325 (Fed. Cir. 2001)
`
`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
`
` ................................................................................................................................ 22
`
`
`
`Rules
`
`37 C.F.R. § 42.10(b) and § 42.63(e) ....................................................................... 9
`
`37 C.F.R. § 42.6(d) .................................................................................................... 33
`
`37 C.F.R. § 42.8(a)(1) .................................................................................................. 9
`
`37 C.F.R. § 42.8(b)(1) .................................................................................................. 9
`
`37 C.F.R. § 42.8(b)(3) .................................................................................................. 9
`
`37 CFR § 42.106(a) .................................................................................................... 9
`
`
`
`Statutes
`
`35 U.S.C. § 102(b) ............................................................................................... 33, 42
`
`35 U.S.C. § 103(a) ..................................................................................................... 29
`
`35 U.S.C. § 314 ............................................................................................................ 1
`
`
`
`v
`
`Page 5 of 60
`
`
`
`
`
`35 U.S.C. §§311-319 ................................................................................................... 1
`
`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
`
`37 C.F.R. § 42.108(c) ................................................................................................... 1
`
`
`
`Other Authorities
`
`M.P.E.P. § 2141 ......................................................................................................... 32
`
`M.P.E.P. §2143 ...................................................................................................... 2, 33
`
`Office Patent Trial Practice Guide, 77 Fed. Reg. 48756, 48766 (Aug. 14, 2012) ..... 20
`
`
`
`vi
`
`Page 6 of 60
`
`
`
`
`
`I.
`
`INTRODUCTION
`
`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
`
`[INSERT NAME OF PARTY] (the “Petitioner”) hereby petitions for
`
`Inter Partes Review (“IPR”) (the “Petition”) under 35 U.S.C. §§311-319
`
`seeking cancellation of claims 1-10 of U.S. Patent No. 6,045,501 (the “ ‘501
`
`Patent”, Exhibit 1001). Based on the evidence presented in this Petition, the
`
`Patent Trial and Appeal Board (the “Board”) should institute an IPR because
`
`there is a reasonable likelihood that at least one of the claims challenged in
`
`the petition is unpatentable. 37 C.F.R. § 42.108(c).
`
`
`
`II. OVERVIEW
`
`In order to support a conclusion of obviousness based on the rationale
`
`of "combining prior art elements according to known methods to yield
`
`predictable results", one must articulate the following: (1) a finding that the
`
`prior art included each element claimed, although not necessarily in a single
`
`prior art reference, with the only difference between the claimed invention
`
`and the prior art being the lack of actual combination of the elements in a
`
`single prior art reference; (2) a finding that one of ordinary skill in the art
`
`could have combined the elements as claimed by known methods, and that
`
`in combination, each element merely performs the same function as it does
`
`separately; and, (3) a finding that one of ordinary skill in the art would have
`
`
`
`1
`
`Page 7 of 60
`
`
`
`
`
`recognized that the results of the combination were predictable. M.P.E.P.
`
`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
`
`§2143.
`
`Each and every element set forth in the M.P.E.P. is found in the prior
`
`art, none of which was cited in the prosecution of the ‘501 patent, as well as
`
`in statements made by numerous experts, including the inventors
`
`themselves, at meetings held by the Food and Drug Administration and the
`
`Centers for Disease Control. Moreover, it was overwhelming clear from
`
`these meetings that everyone, physicians, patients, regulatory agencies,
`
`pharmacies and pharmaceutical companies, was motivated to prevent the
`
`horrific tragedy that occurred when thalidomide was administered in the
`
`1960s in an unregulated manner to pregnant women by putting in-place a
`
`system that would tightly control distribution of the drug.
`
`A brief overview of claim 1 from the ‘501 patent, which has an
`
`effective filing date of August 28, 1998, clearly illustrates why this claim is
`
`obvious in view of the prior art. For clarity, the claim is shown in italics
`
`below.
`
`
`
`1. A method for delivering a teratogenic drug to patients in need of the drug
`
`while avoiding the delivery of said drug to a foetus comprising:
`
`
`
`2
`
`Page 8 of 60
`
`
`
`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
`
`Comment – Mitchell (Mitchell et al. (New England J. Med. 333(2):101
`
`(1995) (“Mitchell”)) lays-out the details of a pregnancy prevention program
`
`designed to decrease the risk of exposure of a fetus to teratogenic drugs.
`
`The program was targeted at prescribers and patients and involved
`
`guidelines for physicians, obtaining negative pregnancy tests, a patient-
`
`qualification checklist and contraceptive information. The Centers for
`
`Disease Control Meeting (CDC Meeting, Centers for Disease Control,
`
`Preventing Birth Defects, March 26, 1997 (the “CDC Meeting”)) discussed
`
`the need for such programs that would include an accounting of all usage of
`
`thalidomide, an informed consent document to be signed by all subjects
`
`who receive thalidomide, distribution of an informational patient
`
`brochure and a database of all patients who take thalidomide and
`
`specifically looked to programs developed for drugs such as clozapine
`
`and isotretinoin for guidance on how to develop such a program for
`
`thalidomide.
`
`Clozapine was made available only through registered
`
`treatment centers via the Clozapine national registry. All patients must be
`
`cleared through the Clozapine national registry. Pharmacists were cleared
`
`via the Clozapine national registry. Based on various clinical criteria,
`
`
`
`
`
`retreatment with clozapine may be denied. Dishman and Bastani disclose
`
`3
`
`Page 9 of 60
`
`
`
`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
`
`computerized programs for registering prescribers such as physicians,
`
`pharmacies and patients, which in the case of the Veterans Administration
`
`ties the hospital’s laboratory database to the outpatient pharmacy dispensing
`
`software and only allows clozapine prescriptions to be processed when
`
`certain clinical criteria are met (steps (a), (b) and (c)). Dishman et al. (Am.
`
`J. Hosp. Pharm 51: 899 (1994) (“Dishman”) and Bastani et al.
`
`(Psychopharmacology 99:S122 (1989) (“Bastani”)).
`
`Powell clearly sets forth methods for delivering thalidomide to
`
`patients in need of the drug while avoiding exposure of the foetus to the drug
`
`Powell lays out explicit guidelines for identification of women of
`
`childbearing potential.
`
`a. registering in a computer readable storage medium prescribers who are
`
`qualified to prescribe said drug;
`
`Comment – Honigfeld discloses the development of a clozapine national
`
`registry. (Honigfeld (Psychiatric Services 47:52 (1996) (“Honigfeld”)). The
`
`computerized database, the clozapine national registry, maintains records on
`
`physicians, pharmacies and patients. Id. “All data coming into the
`
`Clozapine national registry are entered into an integrated, computerized
`
`database maintained by the manufacturer” Id.. The CDC Meeting discussed
`
`
`
`
`
`that the “FDA is also looking at various methods of helping to ensure the
`
`4
`
`Page 10 of 60
`
`
`
`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
`
`safe use of thalidomide by reviewing the ways other drugs with important
`
`side effects are handled” and specifically referenced a potential lethal
`
`drug, clozapine.
`
`b. registering in said medium pharmacies to fill prescriptions for said drug;
`
`Comment - The clozapine national registry provides for the responsibilities
`
`of physicians, pharmacies, patients and distributors. The computerized
`
`database, the clozapine national registry, maintains records on physicians,
`
`pharmacies and patients. Honigfeld.
`
`c. registering said patients in said medium, including information
`
`concerning the ability of female patients to become pregnant and the ability
`
`of male patients to impregnate females;
`
`Comment – Powell (Powell et al. Postgrad. Med. J. 70:901 (1994)
`
`(“Powell”)) provides guidelines for the clinical use and dispensing of
`
`thalidomide. Before instituting therapy with thalidomide, pregnancy should
`
`be excluded by confirming a negative pregnancy test two weeks prior to
`
`starting therapy. Id.
`
`d. retrieving from said medium information identifying a subpopulation of
`
`said female patients who are capable of becoming pregnant and male
`
`patients who are capable of impregnating females;
`
`
`
`
`
`Comment - Powell lays out explicit guidelines for identification of women
`
`5
`
`Page 11 of 60
`
`
`
`
`
`of childbearing potential.
`
`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
`
`e. providing to the subpopulation, counseling information concerning the
`
`risks attendant to fetal exposure to said drug;
`
`Comment - Powell provides specific guidelines for counseling patients
`
`concerning the risks attendant to fetal exposure to said drug and states that
`
`before treatment the patient must have a negative pregnancy test (steps (e)
`
`and (f)). Powell ; see also, the CDC Meeting.
`
`
`
`Dishman, Bastani and Powell all disclose the use of comprehensive
`
`counseling to the patients both before, after and during treatment (step (e)).
`
`Powell provides specific guidelines for counseling patients concerning the
`
`risks attendant to fetal exposure to said drug and states that before treatment
`
`the patient must have a negative pregnancy test (steps (e) and (f)).
`
`f. determining whether patients comprising said subpopulation are
`
`pregnant; and
`
`Comment - Pregnancy should be excluded before instituting therapy with
`
`thalidomide by a negative pregnancy test within 2 weeks prior to starting
`
`therapy. Mitchell. Mitchell also discusses that a negative pregnancy test
`
`should be obtained before starting therapy and delay the start of therapy until
`
`the second or third day of the next normal menstruation.
`
`g. in response to a determination of non-pregnancy for said patients,
`
`
`
`6
`
`Page 12 of 60
`
`
`
`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
`
`authorizing said registered pharmacies to fill prescriptions from said
`
`registered prescribers for said non-pregnant registered patients.
`
`Comment - As noted above, the CDC Meeting discussed the need for such
`
`programs that would include an accounting of all usage of thalidomide, an
`
`informed consent document to be signed by all subjects who receive
`
`thalidomide, distribution of an informational patient brochure and a
`
`database of all patients who take thalidomide. Notably, the CDC
`
`Meeting looked to programs developed for drugs such as clozapine and
`
`isotretinoin for guidance on how to develop such a program for
`
`thalidomide.
`
`Finally, with regards to step (g), “in response to a determination of
`
`non-pregnancy for said patients, authorizing said registered pharmacies to
`
`fill prescriptions from said registered prescribers for said non-pregnant
`
`registered patients”, Dishman and Bastani disclose both registered
`
`pharmacies and prescribers who require authorization in order to dispense
`
`the drug. Powell makes it clear that thalidomide should only be dispensed to
`
`a patient who is not pregnant.
`
`In summary, each and every element of claim 1 is set forth in the prior
`
`art references cited in the Petition. The Petition is accompanied by a
`
`
`
`
`
`declaration of a technical expert, Dr. Matthew W. Davis (Exhibit 1007). Dr.
`
`7
`
`Page 13 of 60
`
`
`
`
`
`Davis lays out why a physician, pharmacist or medical director would have
`
`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
`
`clearly combined the prior art together. Davis Declaration, Exhibit 1007.
`
`Moreover, there would have been a clear motivation and a compelling need
`
`to create such a system given the disaster with thalidomide in the early
`
`1960s. Finally, the combination of the computerized drug monitoring and
`
`registration systems disclosed in the prior art with the guidelines for
`
`dispensing thalidomide would have resulted in the establishment of a
`
`completely predictable monitoring and registration system for thalidomide.
`
`The remaining dependent claims, 2-10 add nothing patentable and are
`
`discussed in greater detail below in both the Petition and Declaration.
`
`
`
`III. GROUNDS FOR STANDING (37 C.F.R. § 42.104(a));
`
`PROCEDURAL STATEMENTS
`
`Petitioner certifies that the ‘501 patent is available for IPR and
`
`that the Petitioner is not barred or estopped from requesting an IPR of any
`
`claim of the ‘501 patent on the grounds identified herein. This Petition is
`
`filed in accordance with 37 CFR § 42.106(a). P owers of Attorney are
`
`filed concurrently , as well as an Exhibit List per 37 C.F.R. § 42.10(b)
`
`and § 42.63(e), respectively. The required fee is paid via online credit
`
`card payment. The Office is authorized to charge fee deficiencies and
`
`
`
`8
`
`Page 14 of 60
`
`
`
`
`
`
`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
`
`credit overpayments to Deposit Acct. No. __________ (Customer ID No.
`
`___________).
`
`IV. MANDATORY NOTICES (37 C.F.R. § 42.8(a)(1))
`
`
`The Real Parties-In-Interest (37 C.F.R. § 42.8(b)(1)) are:
`
`[INSERT PARTY] (the “Petitioner.”)
`
`Designation of Lead and Back-Up Counsel (37 C.F.R. § 42.8(b)(3)):
`
`
`
`
`
`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
`
`michael.davitz@fseip.com
`
`Fahmi, Sellers, Embert & Davitz
`84 W. Santa Clara St.,
`Suite 550
`San Jose, CA 95113-1812
`1-866-877-4888
`
`
`
`
`
`
`Notice of Service Information (37 C.F.R. § 42.8(b)(4)): Please
`
`direct all correspondence to lead counsel at the above address. Petitioners
`
`
`9
`
`Page 15 of 60
`
`
`
`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
`
`consent to email service at: michael.davitz@fseip.com and
`
`tarek.fahmi@fseip.com.
`
`
`
`
`
`V.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED AND
`
`THE REASONS THEREFOR (37 C.F.R. §42.22(a))
`
`
`
`Petitioners request IPR and cancellation of claims 1-10 of the ‘501
`
`patent. A summary of the reasons for the relief is set forth in §II and in
`
`greater detail below.
`
`
`
`VI. OVERVIEW OF U.S. PATENT NO. 6,045,501
`
`
`
`The ‘501 patent issued on April 4, 2000 and has an effective filing
`
`date of August 28, 1998. The patent describes methods for delivering a drug
`
`to a patient, while preventing the exposure of the fetus or other
`
`contraindicated individuals to the drug. In various embodiments,
`
`prescribers, pharmacies, and patients are registered in a computer database.
`
`The registered patients receive counseling regarding the risks related to fetal
`
`exposure to the drug. Under certain circumstances male patients, and female
`
`patients who are not pregnant, can receive the drug. Exhibit 1001 at
`
`Abstract.
`
`
`
`10
`
`Page 16 of 60
`
`
`
`
`
`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
`
`There are 10 claims with a single independent claim which is
`
`reproduced below.
`
`1. A method for delivering a teratogenic drug to patients in need of the
`
`drug while avoiding the delivery of said drug to a foetus comprising:
`
`a. registering in a computer readable storage medium prescribers who
`
`are qualified to prescribe said drug;
`
`b. registering in said medium pharmacies to fill prescriptions for said
`
`drug;
`
`c. registering said patients in said medium, including information
`
`concerning the ability of female patients to become pregnant and the
`
`ability of male patients to impregnate females;
`
`d. retrieving from said medium information identifying a
`
`subpopulation of said female patients who are capable of becoming
`
`pregnant and male patients who are capable of impregnating females;
`
`e. providing to the subpopulation, counseling information concerning
`
`the risks attendant to fetal exposure to said drug;
`
`
`
`11
`
`Page 17 of 60
`
`
`
`
`
`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
`
`f. determining whether patients comprising said subpopulation are
`
`pregnant; and
`
`g. in response to a determination of non-pregnancy for said patients,
`
`authorizing said registered pharmacies to fill prescriptions from said
`
`registered prescribers for said non-pregnant registered patients.
`
`The dependent claims, claims 2-10, recite the following limitations:
`
`(i) claim 2, the method of claim 1 wherein said drug is thalidomide; (ii)
`
`claim 3, the method of claim 1 further comprising including in said
`
`registering information concerning male patients who are capable of
`
`impregnating females and including said males within said subpopulation;
`
`(iii) claim 4, the method of claim 1 wherein said determination comprises
`
`pregnancy testing; (iv) claim 5, the method of claim 1 wherein the issuance
`
`and fulfillment of said prescriptions are recorded in said computer readable
`
`storage medium; (v) claim 6, the method of claim 1 wherein refilling of said
`
`prescriptions is authorizable only in response to information contained on
`
`said computer readable storage medium; (vi) claim 7, the method of claim 1
`
`wherein said prescriptions are filled for no more than about 28 days; (vii)
`
`claim 8, the method of claim 1 wherein said prescriptions are filled together
`
`with distribution of literature warning of the effects of said drug upon
`
`
`
`12
`
`Page 18 of 60
`
`
`
`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
`
`fetuses; (viii) claim 9, the method of claim 1 further comprising providing
`
`said patients with contraception counseling; and, (ix) claim 10, the method
`
`of claim 1 further comprising: h. providing to said patients who are capable
`
`of becoming pregnant a contraceptive device or formulation.
`
`The drug delivery methods described involve first registering
`
`prescribers, who are qualified to prescribe a teratogenic drug, in a computer
`
`readable storage medium. Exhibit 1001 at 4:10-15. Prescribers are “any
`
`individual who are capable of prescribing drugs, including, for example,
`
`medical doctors.” Id. at 3:30-33. In order to become registered, the
`
`prescriber may be required to provide patient counseling and education. Id.
`
`at 4:19-21. Registration can be achieved by mail, facsimile or on-line
`
`transmission and the prescriber may be asked to provide certain information
`
`as part of the registration, including, name, address and health care
`
`institution affiliation. Id. at 4:35-40. A pharmacy that can fill the
`
`prescription for the drug can become registered in a computer readable
`
`medium in a similar manner. Id. at 5:1-23.
`
`The patient must also be registered in a computer readable medium.
`
`In order to be registered in the computer readable medium, the patient needs
`
`to comply with various requirements. For example, the patient needs to
`
`
`
`
`
`supply her/his name, mailing address and date of birth. Id. at 5:43-45. In
`
`13
`
`Page 19 of 60
`
`
`
`
`
`addition, other information is also entered into the computer readable storage
`
`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
`
`medium allowing the prescriber or distributor of the drug to “glean
`
`therefrom information regarding the level of risk associated with the
`
`administration of the involved drug to various patient.” Id. at 8:28-32.
`
`The types of information can include a patient survey conducted
`
`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
`
`counseling on birth control and fill-out an informed consent. Id. at 7:33-38.
`
`The information can then be used to identify various subpopulations.
`
`Specifically, “[o]nce entered into the computer readable storage medium, the
`
`prescriber, manufacturer and/or distributor of the drug may be able to glean
`
`therefrom information regarding the level of risk associated with the
`
`administration of the involved drug to the various patients. Accordingly, it
`
`may be possible to identify, from among the entire population of registered
`
`patients, one or more subpopulations of patients for which the involved drug
`
`
`
`14
`
`Page 20 of 60
`
`
`
`
`
`may be more likely to be contraindicated. For example, it may be possible to
`
`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
`
`identify a subpopulation of female patients who are capable of becoming
`
`pregnant and/or a subpopulation of male patients who are capable of
`
`impregnating female patients. Preferably, the counseling information
`
`discussed above relating to exposure of a foetus to a teratogenic drug may
`
`then be addressed primarily to this subpopulation of patients.” Id. at 8:28-
`
`42.
`
`Counseling is provided to both male and female patients. Extensive
`
`details on the nature of the counseling are set forth in the specification. The
`
`counseling may be provided verbally, in written form or through
`
`instructional videos. Id. at 6:15-20. Excerpts from the patent are provided
`
`below.
`
`Female Patients - “[T]he prescriber preferably counsels female patients that
`
`such drugs must never be used by pregnant women. If the patient is a female
`
`of child-bearing potential (i.e., a woman who is capable of becoming
`
`pregnant), the prescriber preferably counsels the patient that even a single
`
`dosage of certain teratogenic drugs, such as thalidomide, may cause birth
`
`defects. Accordingly, the patient is preferably counseled to avoid sexual
`
`intercourse entirely, or if sexually active, to use appropriate forms of
`
`contraception or birth control. For both male and female patients, the
`
`
`
`15
`
`Page 21 of 60
`
`
`
`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
`
`prescriber preferably provides counsel on the importance of using at least
`
`two forms of effective birth control methods, with one form preferably being
`
`a highly effective hormonal method, and the other form preferably being an
`
`effective barrier method. The patients are preferably counseled to use the
`
`birth control methods for a period of time prior to and during treatment with
`
`the teratogenic drug, as well as for a period of time after treatment with the
`
`drug has been terminated.” Id. at 6:27-46.
`
`Male Patients - “Male patients who are being prescribed a teratogenic drug
`
`are preferably counseled to use condoms every time they engage in sexual
`
`relations, since many teratogenic drugs may be found in semen. Male
`
`patients are also preferably counseled to contact their prescriber if they have
`
`sexual intercourse without a condom, and/or if it is believed that they may
`
`have caused a pregnancy.” Id. at 6:54-60.
`
`Prescriber – The prescriber may also “advise the patient to not share the drug
`
`with anyone else, and particularly that the drug should be kept out of the reach
`
`of children as well as women of child-bearing potential. In the case of female
`
`patients, particularly female patients of child-bearing potential, the prescriber
`
`should give the patient a pregnancy test, preferably a serum pregnancy test,
`
`prior to and during treatment with the teratogenic drug. To begin receiving the
`
`
`
`
`
`teratogenic drug and to continue taking the drug, female patients of child-
`
`16
`
`Page 22 of 60
`
`
`
`
`
`bearing potential should continue to have negative pregnancy tests.” Id. at
`
`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
`
`7:12-24.
`
`
`
`Before filling and dispensing the prescription, the registered
`
`pharmacy, the patient has filled-out the registration form and is registered in
`
`the computer readable storage medium. Id. at 9:14-18. The pharmacy can
`
`then dispense the drug. Id. at 9:19-20.
`
`
`
` Registration in a computer readable storage medium of the prescriber,
`
`pharmacy and patient provides a means to monitor and authorize distribution
`
`of contraindicated drugs such as teratogenic drugs. Id. at 10:13-17. The
`
`computer readable storage medium may also act to deny access, dispension
`
`or prescription of such teratogenic drugs to patients, pharmacies or
`
`prescribers who fail to comply with the methods set forth in the ‘501 patent.
`
`
`
`VII. PROSECUTION HISTORY
`
`The ‘501 patent was filed August 28, 1998 (U.S. Patent Application
`
`Serial No. 09/143,569 (the “‘569 application”)). There are two named
`
`inventors, Marc Elsayed and Bruce Williams. There were 11 claims as filed,
`
`including the claims as issued as well as a second independent claim, claim
`
`11. On October 7, 1999, the USPTO issued a rejection under 35 U.S.C.
`
`103(a) of claims 1 and 4-11 as being unpatentable over Sloan, U.S. Patent
`
`
`
`17
`
`Page 23 of 60
`
`
`
`
`
`No. 5,619,991 (the “‘991 patent”). It was the Examiner’s position that
`
`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
`
`Sloan discloses a “method for delivery drugs to patients in need of a drug
`
`while avoiding delivery of said drug to a foetus comprising registering
`
`qualified prescriber …in a computer readable storage medium, registering
`
`pharmacies to fill prescriptions, registering patients and patient data,
`
`providing counseling information to a patient…determining whether the
`
`patient is pregnant… and authorization of prescriptions to be filled.” Exhibit
`
`1002.
`
`The Examiner stated that claims 2-3 would be allowable if rewritten
`
`in an independent form. Id. Of note, claim 2 as filed recited a specific drug,
`
`namely, thalidomide, while claim 3 recited “registering information
`
`concerning male patients who are capable of impregnating females and
`
`including said males within said subpopulation.”
`
`In response, the Applicants argued that claim 1 distinguished itself
`
`over Sloane by defining “methods for the delivery of a teratogenic drug to
`
`patients in need of the drug while avoiding the delivery of the drug to a
`
`foetus…[while] claim 11 distinguishes over Sloan by defining methods for
`
`delivery a potentially hazardous drug to patients in need of the drug while
`
`avoiding the delivery of the drug to persons for whom the drug is
`
`contraindicated.” Exhibit 1003, Amendment ‘569 Application, page 3,
`
`
`
`18
`
`Page 24 of 60
`
`
`
`
`
`November 10, 1999. The Applicants argued that Sloan was “utterly silent
`
`DRAFT – ATTORNEY-CLIENT
`PRIVILEGED AND CONFIDENTIAL
`
`regarding the use of computer readable storage media to deliver to
`
`patients…teratogenic drugs, while at the same time avoiding their delivery
`
`to… fetuses.” Id. Although the Applicants acknowledged that Sloan’s “e-
`
`doc” contained patient data, Sloan does not show procedures for identifying
`
`an at-risk subpopulation and then prescribing a drug to patients while
`
`avoiding the at-risk subpopulation. Id. The Applicants also argued that
`
`Sloan does not teach how its methods could be used to provide any checks
`
`and balances to insure that only registered prescribers or pharmacies are
`
`permitted access.
`
`The Applicants acknowledge that the “present invention [has] been
`
`approved by the U.S. Food and Drug (FDA) for use in delivering the
`
`teratogen thalidomide to patients while avoiding feoetal delivery” Id. The
`
`USPTO issued a Notice of Allowance for claims 1-10 on February 22, 2000
`
`and the patent issued on April 4, 2000.
`
`
`
`VIII. CLAIM TERMS REQUIRING CONSTRUCTION
`
`
`
`Consistent with the statute and legislative history of the America
`
`Invents Act, when considering whether to institute a patent trial the Board
`
`has indicated that it will interpret the clai
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
