IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`BEFORE THE PATENT AND TRIAL APPEAL BOARD
`
`
`
`
`
`
`INITIATIVE FOR RESPONSIBILITY IN DRUG PRICING, LLC
`Petitioner
`v.
`CELGENE CORPORATION
`Patent Owner
`
`
`
`U.S. Patent No. 6,315,720 to Williams et al.
`Issue Date: November 13, 2001
`Title: Methods For Delivering A Drug To A Patient While Avoiding The
`Occurrence Of An Adverse Side Effect Known Or Suspected
`Of Being Caused By The Drug
`
`
`_____________________
`
`
`
`Inter Partes Review No. Unassigned
`
`_____________________
`
`
`
`Petition For Inter Partes Review Of U.S. Patent No. 6,315,720
`Under 35 Usc §§ 311-319 And 37 Cfr §42.100 Et Seq.
`
`
`
`Mail Stop "PATENT BOARD"
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`Page 1 of 51
`
`CELGENE EXHIBIT 2047
`Coalition for Affordable Drugs VI LLC (Petitioner) v. Celgene Corporation (Patent Owner)
`Case IPR2015-01102
`
`

`
`TABLE OF CONTENTS
`
`I. INTRODUCTION .............................................................................................. 1
`
`II. OVERVIEW ....................................................................................................... 1
`
`III. GROUNDS FOR STANDING (37 C.F.R. § 42.104(a)); PROCEDURAL
`STATEMENTS .................................................................................................. 6
`
`IV. MANDATORY NOTICES (37 C.F.R. § 42.8(a)(1)) ........................................ 6
`
`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. 6,315,720 ............................................10
`
`VII. PROSECUTION HISTORY .........................................................................16
`
`VIII. CLAIM TERMS REQUIRING CONSTRUCTION ................................20
`
`IX. IDENTIFICATION OF THE GROUNDS FOR CHALLENGE (37 C.F.R.
`§ 42.104(b)) .......................................................................................................30
`
`A. The Petition Establishes a Reasonable Likelihood that at Least One
`Challenged Claim is Anticipated ................................................................30
`
`(i) Challenge 1: Claims 1-32 ..........................................................................30
`
`X. CONCLUSION .................................................................................................44
`
`CERTIFICATE OF SERVICE ............................................................................45
`
`
`
`ii
`
`
`
`
`
`Page 2 of 51
`
`

`
`Table of Authorities
`
`Cases
`
`Akzo N.V. v. U.S. Int’l Trade Comm’n,
`808 F.2d 1471, 1479 (Fed. Cir. 1986) ..................................................................28
`
`Amgen Inc. v. Hoechst Marion Roussel, Inc.,
`314 F.3d 1313 (Fed. Cir. 2003) ............................................................................28
`
`Corning Glass Works v. Sumitomo Elec. U.S.A., Inc.,
`868 F.2d 1251, 1257 (Fed. Cir. 1989) ..................................................................30
`
`Elan Pharms. Inc. v. Mayo Found.,
`346 F.3d 1051, 1057 (Fed. Cir. 2003) ..................................................................28
`
`Helifix, Ltd. v. Blok-Lok, Ltd.,
`208 F.3d 1339, 1346 (Fed. Cir. 2000) ..................................................................28
`
`In re Am. Acad. of Sci. Tech. Ctr.,
`367 F.3d 1359, 1364 (Fed. Cir. 2004) ..................................................................19
`
`In re Baxter Travenol Labs,
`952 F.2d 388, 390 (Fed. Cir. 1991) ........................................................... 1, 29, 30
`
`In re Slayter, 276 F.2d 408, 411 (CCPA 1960) .......................................................28
`
`Innova/Pure Water, Inc. v. Safari Water Filtration Systems, Inc.,
`381 F.3d 1111, 1116 (Fed. Cir. 2004) ..................................................................19
`
`Multiform Desiccants, Inc. v. Medzam, Ltd.,
`133 F.3d 1473, 1477 (Fed. Cir. 1998) ..................................................................19
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) ............................................................................19
`
`Richardson v. Suzuki Motor Co.,
`868 F.2d 1226, 1236 (Fed. Cir. 1989) ..................................................................28
`
`Scripps Clinic & Research Found. V. Genentech, Inc.,
`927 F.2d 1565, 1576 (Fed. Cir. 1991) ..................................................................28
`
`
`
`iii
`
`Page 3 of 51
`
`

`
`Teleflex, Inc. v. Ficosa North America Corp,
`299 F. 3d 1313, 1325 (Fed. Cir. 2001) .................................................................19
`
`Verdegaal Bros. v. Union Oil Co. of California,
`814 F.2d 628, 631 (Fed. Cir. 1987) ..................................................... 1, 27, 30, 41
`
`
`Statutes
`
`35 U.S.C. § 102(b) ...............................................................................................2, 29
`
`35 U.S.C. § 314 .......................................................................................................... 1
`
`35 U.S.C. §§311-319.................................................................................................. 1
`
`
`Other Authorities
`
`M.P.E.P. § 2111.01 (IV) ..........................................................................................20
`
`M.P.E.P. § 2111.02 ..................................................................................................30
`
`MPEP § 2131.02 ..................................................................................................1, 27
`
`Office Patent Trial Practice Guide, 77 Fed. Reg. 48756, 48766 (Aug. 14, 2012) ..18
`
`
`Rules
`
`37 C . F .R . § 42.10(b) .............................................................................................. 5
`
`37 C.F.R. § 42.104(a) ................................................................................................. 5
`
`37 C.F.R. § 42.108(c) ................................................................................................. 1
`
`37 C.F.R. § 42.6(d) ..................................................................................................29
`
`37 C.F.R. § 42.8(a)(1) ................................................................................................ 6
`
`37 C.F.R. § 42.8(b)(1) ................................................................................................ 6
`
`37 C.F.R. § 42.8(b)(3) ................................................................................................ 6
`
`37 C.F.R. §42.22(a) .................................................................................................... 7
`
`
`
`iv
`
`Page 4 of 51
`
`

`
`37 CFR § 42.106(a) .................................................................................................. 5
`
`
`
`
`
`v
`
`Page 5 of 51
`
`

`
`
`Exhibit 1001 - U.S. Patent No. 6,315,720
`
`Exhibits
`
`Exhibit 1002 - “Thalomid Capsules (Celgene) 07/16/1998 Approval [Erythema
`Nodosum Leprosum: Approval Letter; Final Labeling; Supervisory
`Review” dated July 17, 1998 (“Thalomid PI” or “PI”)
`
`Exhibit 1003 - Office Action, U.S. Patent Application Serial No. 09/694,217,
`January 18, 2001, Paper 2
`
`Exhibit 1004 - Amendment, U.S. Patent Application Serial No. 09/694,217, March
`23, 2001
`
`Exhibit 1005 - Amendment, U.S. Patent Application Serial No. 09/694,217, June
`25, 2001
`
`Exhibit 1006 - Keravich, et al., Am. J. Health-Syst. Pharm., 56: 1721 (1999)
`
`Exhibit 1007 - Declaration of Matthew W. Davis M.D. RhP.
`
`
`
`
`
`
`
`vi
`
`Page 6 of 51
`
`

`
`I.
`
`INTRODUCTION
`
`The Initiative for Responsibility in Drug Pricing, LLC (the
`
`“Petitioner” or “IRDP”) hereby petitions for Inter Partes Review (“IPR”)
`
`(the “Petition”) under 35 U.S.C. §§311-319 seeking cancellation of claims 1-
`
`32 of U.S. Patent No. 6,315,720 (the “‘720 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
`
`“A claim is anticipated only if each and every element as set forth in
`
`the claim is found, either expressly or inherently described, in a single prior
`
`art reference.” Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d 628,
`
`631 (Fed. Cir. 1987), see also MPEP § 2131.02. “[E]xtrinsic evidence may
`
`be considered to explain, but not expand on, the meaning of an anticipatory
`
`reference.” In re Baxter Travenol Labs, 952 F.2d 388, 390 (Fed. Cir. 1991).
`
`The ‘720 patent issued on November 13, 2001, and has an effective
`
`filing date of October 23, 2000. Each and every element of the ‘720 patent
`
`claims is found in the THALOMIDTM (thalidomide) Capsules Revised
`
`
`
`1
`
`Page 7 of 51
`
`

`
`Package Insert (15 July 1998), as appended to the “Thalomid Capsules
`
`(Celgene) 07/16/1998 Approval [Erythema Nodosum Leprosum: Approval
`
`Letter; Final Labeling; Supervisory Review” dated July 17, 1998
`
`(“Thalomid PI” or “PI”, Exhibit 1002). Because it was available more than
`
`one year before October 23, 2000, the PI constitutes 35 U.S.C. § 102(b) pre-
`
`AIA prior art to the ‘720 patent.
`
`A brief overview of claim 1 of the ‘720 patent clearly illustrates why
`
`the claim is anticipated by the PI. For clarity, the claim language is shown
`
`in italics.
`
`
`
`1. In a method for delivering a drug to a patient in need of the drug, while
`
`avoiding the occurrence of an adverse side effect known or suspected of
`
`being caused by said drug, wherein said method is of the type in which
`
`prescriptions for said drug are filled only after a computer readable
`
`storage medium has been consulted to assure that the prescriber is
`
`registered in said medium and qualified to prescribe said drug, that the
`
`pharmacy is registered in said medium and qualified to fill the
`
`prescription for said drug, and the patient is registered in said medium
`
`and approved to receive said drug, the improvement comprising:
`
`
`
`2
`
`Page 8 of 51
`
`

`
`Comment - The Thalomid PI is designed to provide a method for
`
`delivering a drug, thalidomide, to a patient in need, while avoiding the
`
`occurrence of an adverse side effect known or suspected of being caused by
`
`the drug. Exhibit 1002 at 18. It provides that all prescribers (physicians) and
`
`pharmacists must be registered with the “S.T.E.P.S.” Program, the restricted
`
`distribution program for the product, and that all patients must agree to
`
`comply with requirements of the program Id. at 1, 3, 4, 21. The S.T.E.P.S.
`
`program was designed by Celgene, the manufacturer of Thalomid, and is
`
`considered part of the Thalomid product label, or package insert. See
`
`Keravich, et al., Am. J. Health-Syst. Pharm., 56: 1721 (1999) (“Keravich”),
`
`Exhibit 1006 at 1 (describing aspects of the S.T.E.P.S. program, including
`
`the computerized database maintained by Celgene’s customer service
`
`division, that includes prescriber (physician) registration, pharmacy
`
`registration, and patient registration), 2; see also, Declaration of Matthew W.
`
`Davis M.D. RhP, Exhibit 1007 at ¶¶ 7-8 (providing a further explanation of
`
`aspects of the S.T.E.P.S. program).1
`
`
`1 Keravich and the Davis Declaration are referenced in order to explain the
`
`meaning of the PI around the S.T.E.P.S. program and are not cited to either
`
`expand on or fill in any gaps in the PI.
`
`
`
`3
`
`Page 9 of 51
`
`

`
`
`
`a. defining a plurality of patient risk groups based upon a predefined set
`
`of risk parameters for said drug;
`
`Comment - The PI defines a plurality of patient risk groups based on a
`
`predefined set of risk parameters, e.g. women of childbearing potential, men
`
`capable of impregnating women. Exhibit 1002 at 3-4.
`
`
`
`b. defining a set of information to be obtained from said patient, which
`
`information is probative of the risk that said adverse side effect is
`
`likely to occur if said drug is taken by said patient;
`
`Comment - The PI lays-out a set of information (as part of a consent form)
`
`to be obtained from the patient that is probative of the risk of the drug’s
`
`potential side effects, e.g., a signed informed consent form and pregnancy
`
`test; Id. at 20-21.
`
`
`
`c. in response to said information set, assigning said patient to at least
`
`one of said risk groups and entering said risk group assignment in
`
`said medium;
`
`Comment - The PI assigns the patient to one of the risk groups, which
`
`information is entered into the S.T.E.P.S. database; Id. (consent forms
`
`
`
`4
`
`Page 10 of 51
`
`

`
`indicating agreement to participate in surveys and patient registries); (see
`
`also, Exhibit 1006 at 2-3 (describing that patients are registered into
`
`Celgene’s S.T.E.P.S. database based on their signed informed consent form).
`
`
`
`d. based upon said information and said risk group assignment,
`
`determining whether the risk that said adverse side effect is likely to
`
`occur is acceptable;
`
`Comment – The PI permits dispensing based only on the terms of the
`
`S.T.E.P.S. program. Id. at 19.
`
`
`
`e. upon a determination that said risk is acceptable, generating a
`
`prescription approval code to be retrieved by said pharmacy before
`
`said prescription is filled.
`
`Comment –– The PI permits prescription and dispensing based only
`
`on the terms of the S.T.E.P.S. program. Id.
`
`
`
`In summary, each and every element of claim 1 is set forth in the
`
`Thalomid PI, which incorporates the S.T.E.P.S. program, and the claim is
`
`therefore, anticipated. A similar rationale applies for claims 2-32 as
`
`discussed in greater detail below.
`
`
`
`5
`
`Page 11 of 51
`
`

`
`III. GROUNDS FOR STANDING (37 C.F.R. § 42.104(a));
`
`PROCEDURAL STATEMENTS
`
`Petitioner certifies that the ‘720 patent is available for IPR and
`
`that the Petitioner is not barred or estopped from requesting an IPR of any
`
`claim of the ‘720 patent on the grounds identified herein. This Petition is
`
`filed in accordance with 37 CFR § 42.106(a). Powers of Attorney are
`
`filed concurrently, as well as an Exhibit List per 3 7 C . F . R . § 42.10(b)
`
`and § 42.63(e), respectively. The required fee is being submitted
`
`concurrently via online payment.
`
`IV. MANDATORY NOTICES (37 C.F.R. § 42.8(a)(1))
`
`
`
`
`
`The Real Party-In-Interest (37 C.F.R. § 42.8(b)(1)) is: Initiative
`
`for Responsibility in Drug Pricing, LLC (“Petitioner” or “IRDP”), 1020
`
`Shark Reef Road, Lopez Island Washington 98261. IRDP seeks to
`
`improve Americans’ access to low-cost generic pharmaceuticals by
`
`invalidating patents that are unjustifiably delaying generic competition.
`
`IRDP is not affiliated with any pharmaceutical company, and is therefore
`
`not susceptible to the considerations that often result in settlements
`
`between brand-name and generic pharmaceutical companies that, in
`
`IRDP’s view, do not serve the public interest.
`
`6
`
`Page 12 of 51
`
`

`
`The Founder and President of the Initiative for Responsibility in
`
`Drug Pricing, LLC is Dr. Albert Berger. Professor Berger is the former
`
`Vice-Dean of the University of Washington Medical School and former
`
`Chair of the Department of Physiology & Graduate Education at the
`
`University of Washington. He holds grants and awards including the Ford
`
`Fellowship Foundation, Guggenheim Foundation Fellowship, Fogarty
`
`Fellowship, and two Javits Awards from the National Institutes of Health.
`
`Professor Berger holds PhDs in Chemical Engineering and Physiology
`
`from Princeton University and University of California – San Francisco.
`
`Professor Berger is the author of more than 125 medical research papers.
`
`Notice of Related Matters (37 C.F.R. § 42.8(b)(2)):
`
`Judicial matters: The ‘720 patent (Exh. 1001) is the subject of five
`
`court cases. Celgene Corporation v. Natco Pharma Limited, 2-10-cv-
`
`05197 (D.N.J.); Celgene Corporation et al. v. Barr Laboratories, Inc. et
`
`al., 2-08-cv-03357 (D.N.J.); Celgene Corporation v. Barr Laboratories,
`
`Inc. et al., 2-07-cv-05485 (D.N.J.); Celgene Corporation v. Barr
`
`Laboratories, Inc. et al., 2-07-cv-04050 (D.N.J.); Celgene Corporation v.
`
`Barr Laboratories, Inc. et al., 2-07-cv-00286 (D.N.J.). Petitioner is not a
`
`party to any of the above referenced matters.
`
`
`
`7
`
`Page 13 of 51
`
`

`
`The ‘720 patent is an Orange Book listed patent for Celgene’s
`
`branded pharmaceutical drugs Thalomid and Revlimid. In Mylan
`
`Pharmaceuticals, Inc. v. Celgene Corporation, 14-cv-2094 (D.N.J.),
`
`generic drug maker Mylan alleges that Celgene unlawfully maintains
`
`monopolies over its two “lead” products—Thalomid and Revlimid—by
`
`preventing lower-priced generic competition from entering the market.
`
`Mylan alleges Celgene prevents generic manufactures from obtaining
`
`product samples for Thalomid and Revlimid, thus preventing a generic
`
`drug maker from demonstrating bioequivalence as required in an
`
`Abbreviated New Drug Application (“ANDA”). The Federal Trade
`
`Commission (“FTC”) filed an amicus brief expressing its disapproval of
`
`Celgene’s conduct. IRDP is not a party to this matter.
`
`Administrative matters: (1) In a petition filed concurrently herewith,
`
`Petitioner seeks IPR of the ‘720 patent on obviousness grounds and (2) in
`
`a petition filed concurrently herewith, Petitioner seeks IPR of U.S. Pat.
`
`No. 6,045,501, which is against the same Patent Owner.
`
`
`
`
`
`8
`
`Page 14 of 51
`
`

`
`
`
`Designation of Lead and Back-Up Counsel (37 C.F.R. § 42.8(b)(3)):
`
`Lead Counsel
`
`Back-Up Counsel
`
`Michael A. Davitz M.D. J.D.
`USPTO Reg. No. 47,519
`
`Tarek N. Fahmi
`USPTO Reg. No. 41,402
`
` D
`
` +1 408 389 3537
`T +1 866 877 4883
`F +1 408 773 6177
`
`tarek.fahmi@ascendalaw.com
`
`Ascenda Law Group, PC
`84 W. Santa Clara St.
`Suite 550
`San Jose, CA 95113-1812
`
`
`
`D: +1 914-582-8817
`T: +1 866-877-4883
`F: +1 408-773-6177
`
`michael.davitz@ascendalaw.com
`
`Ascenda Law Group, PC
`84 W. Santa Clara St.
`Suite 550

`San Jose, CA 95113-1812
`
`
`
`
`
`
`Notice of Service Information (37 C.F.R. § 42.8(b)(4)): Please direct
`
`all correspondence to lead counsel at the above address. Petitioners
`
`
`consent to email service: michael.davitz@ascendalaw.com and
`
`tarek.fahmi@ascendalaw.com.
`
`9
`
`
`
`
`
`
`
`Page 15 of 51
`
`

`
`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 1-32 of the ‘720
`
`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. 6,315,720
`
`
`
`The ‘720 patent issued on November 13, 2001 and has an effective
`
`filing date of October 23, 2000. The patent describes methods for delivering
`
`a drug to a patient, while avoiding the occurrence of adverse side effects.
`
`Prescriptions are only filled after a computer readable storage medium has
`
`been consulted to confirm that the prescribers, pharmacies, and patients are
`
`registered in a computer database. Patients may be assigned to risk groups
`
`based on the degree of risk that taking the drug will lead to a side effect.
`
`Periodic surveys as well as diagnostics tests can also be obtained prior to
`
`approving dispensing the drug. Exhibit 1001 at Abstract.
`
`There are 32 claims with two independent claims. Claim 1 is
`
`representative and is reproduced below.
`
`1. In a method for delivering a drug to a patient in need of the
`
`drug, while avoiding the occurrence of an adverse side effect
`
`known or suspected of being caused by said drug, wherein said
`
`method is of the type in which prescriptions for said drug are
`
`
`
`10
`
`Page 16 of 51
`
`

`
`filled only after a computer readable storage medium has been
`
`consulted to assure that the prescriber is registered in said
`
`medium and qualified to prescribe said drug, that the pharmacy
`
`is registered in said medium and qualified to fill the
`
`prescription for said drug, and the patient is registered in said
`
`medium and approved to receive said drug, the improvement
`
`comprising:
`
`a. defining a plurality of patient risk groups based upon a
`
`predefined set of risk parameters for said drug;
`
`b. defining a set of information to be obtained from said
`
`patient, which information is probative of the risk that said
`
`adverse side effect is likely to occur if said drug is taken by said
`
`patient;
`
`c. in response to said information set, assigning said
`
`patient to at least one of said risk groups and entering said risk
`
`group assignment in said medium;
`
`d. based upon said information and said risk group
`
`assignment, determining whether the risk that said adverse side
`
`effect is likely to occur is acceptable; and
`
`e. upon a determination that said risk is acceptable,
`
`generating a prescription approval code to be retrieved by said
`
`pharmacy before said prescription is filled.
`
` The dependent claims, claims 2-27, recite the following limitations:
`
`Claim 2 adds the limitation of “in response to said risk group assignment,
`
`said patient is counseled as to the risks of taking said drug and advised as to
`
`
`
`11
`
`Page 17 of 51
`
`

`
`risk avoidance measures” to claim 1. Claim 3 adds “wherein said counseling
`
`comprises full disclosure of said risks” to claim 2. Claim 4 adds “wherein
`
`said prescription is filled only following said full disclosure and informed
`
`consent of said patient” to claim 3. Claim 5 adds “wherein said risk group
`
`assignment and said informed consent is verified by said prescriber at the
`
`time that said patient is registered in said computer readable storage
`
`medium” to claim4. Claim 6 adds “wherein said risk group assignment and
`
`said informed consent is transmitted to said computer readable storage
`
`medium by facsimile and interpreted by optical character recognition
`
`software” to claim 7. Claim 7 adds “wherein said set of information
`
`includes the results of diagnostic testing” to claim 1. Claim 8 adds “wherein
`
`said diagnostic testing is probative of the onset of said adverse side effect” to
`
`claim 7. Claim 9 adds “wherein said diagnostic testing is probative of the
`
`concentration of said drug in a tissue of said patient” to claim 7. Claim 10
`
`adds “wherein said diagnostic testing comprises genetic testing” to claim 7.
`
`Claim 11 adds “wherein said side effect is likely to arise in said patient” to
`
`claim 1. Claim 12 adds “wherein said side effect is likely to arise in a foetus
`
`carried by said patient” to claim 1. Claim 13 adds “wherein said side effect
`
`is likely to arise in a recipient or a foetus carried by a recipient of the bodily
`
`fluid of said patient” to claim 1. Claim 14 adds “wherein said recipient is a
`
`
`
`12
`
`Page 18 of 51
`
`

`
`sexual partner of said patient” to claim 13. Claim 15 adds “[t]he method of
`
`claim 1 further comprising: f. defining for each said risk group a second set
`
`of information to be collected from said patient on a periodic basis; g.
`
`obtaining said second set of information from said patient; and h. entering
`
`said second set of information in said medium before said patient is
`
`approved to receive said drug” to claim 1. Claim 16 adds “wherein said
`
`second set of information comprises a survey regarding said patient's
`
`behavior and compliance with said risk avoidance measures” to claim 15.
`
`Claim 17 adds “wherein said survey is conducted telephonically using an
`
`integrated voice response system” to claim 16. Claim 18 adds “wherein said
`
`patient is a female of childbearing potential and said second set of
`
`information comprises the results of a pregnancy test” to claim 16.
`
`Claim 19 adds “wherein said periodic interval comprises about 28 days” to
`
`claim 18. Claim 20 adds “further comprising providing said patient with a
`
`contraceptive device or formulation” to claim 1. Claim 21 adds “wherein
`
`said adverse side effect comprises a teratogenic effect” to claim 1. Claim 22
`
`adds “wherein said drug is thalidomide” to claim 1. Claim 23 adds “wherein
`
`said teratogenic effect is likely to arise in a foetus carried by said patient” to
`
`claim 21. Claim 24 adds “wherein said teratogenic effect is likely to arise in
`
`a foetus carried by a recipient of the bodily fluid of said patient” to claim 21.
`
`
`
`13
`
`Page 19 of 51
`
`

`
`Claim 25 adds “wherein said recipient of the bodily fluid of said patient is a
`
`sexual partner of said patient” to claim 24. Claim 26 adds “wherein said set
`
`of information includes the results of a pregnancy test” to claim 21. Claim
`
`27 adds “wherein said prescription is filled for no more than about 28 days”
`
`to claim 26.
`
`The other independent claim, 28, is identical to claim 1 with the
`
`following limitation: “wherein said adverse side effect is likely to arise in
`
`patients who take said drug in combination with at least one other drug.”
`
`The claims which depend from claim 28 recite the following
`
`limitations: claim 29 adds “wherein said set of information is also probative
`
`of the likelihood that said patient may take said drug and said other drug in
`
`combination” to claim 28. Claim 30 adds “wherein said set of information
`
`includes the results of diagnostic testing” to claim 28. Claim 31 adds
`
`“wherein said diagnostic testing comprises testing for evidence of the use of
`
`said other drug” to claim 30. Claim 32 adds “wherein said diagnostic testing
`
`comprises testing for evidence which is indicative of the onset of said
`
`adverse side effect” to claim 30.
`
`The drug delivery methods described are generally to “methods for
`
`delivering drugs known or suspected of causing an adverse side effect,
`
`especially teratogenic drugs, to patients.” Exhibit 1001 at 3:31-34.
`
`
`
`14
`
`Page 20 of 51
`
`

`
`According to the specification, the methods of the present invention
`
`may be “advantageously employed” in order to avoid taking drugs that can
`
`cause adverse side effects in patients “for whom the drug is
`
`contraindicated”. Id. at 4: 1- 5.
`
`The prescriber must be registered in a computer readable medium. In
`
`order to be registered in the computer readable medium, prescribers may be
`
`required to comply with various requirements, including, providing patient
`
`counseling and education. Id. at 4: 49-54. 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 4:54-59; Id. at 5:1-5. A
`
`pharmacy that can fill the prescription for the drug can also become
`
`registered in a computer readable medium in a similar manner. Id. at 5:17-
`
`60.
`
`Patients are also registered in the computer readable storage medium.
`
`Id. at 5: 61-63. Registration of the patient can take place at a registered
`
`pharmacy. Id. at 6: 3-7. Registration will involve filling in a registration
`
`card of form and providing information such as name, sex, mailing address,
`
`date of birth, etc. Id. at 6:11-14. Information that is probative of the risk of
`
`known side effects will also be collected. Id. at 6:30-33. Once collected this
`
`
`
`15
`
`Page 21 of 51
`
`

`
`information can then be compared with a predefined set of risk parameters
`
`for the drug which allows for assignment of the patient to particular risk
`
`group. Id. at 6:33-36.
`
`VII. PROSECUTION HISTORY
`
`The ‘720 patent was filed October 23, 2000 (U.S. Patent Application
`
`Serial No. 09/694,217 (the “‘217 application”)), with two named inventors:
`
`Bruce Williams and Joseph K. Kaminiski. There were 32 claims as filed,
`
`including two independent claims. Claim 1 as originally filed read:
`
`1.
`
`In a method for delivering a drug to a patient in
`
`need of the drug, while avoiding the occurrence of an adverse
`
`side effect known or suspected of being caused by said drug,
`
`wherein said method is of the type which prescriptions for said
`
`drug are filled only after a computer readable storage medium
`
`has been consulted to assure that the prescriber is registered in
`
`said medium and qualified to prescribe said drug, that the
`
`pharmacy registered in said medium and qualified to fill the
`
`prescription for said drug, and the patient is registered in said
`
`medium and approved to receive said drug, the improvement
`
`comprising:
`
`(a) defining a plurality of patient risk groups based upon
`
`a predefined set of risk parameters for said drug;
`
`(b) defining a set of information to be obtained from said
`
`patient, which information is probative of the risk that said
`
`
`
`16
`
`Page 22 of 51
`
`

`
`adverse side effect is likely to occur if said drug is taken by said
`
`patient;
`
`(c) in response to said information set, assigning said
`
`patient to at least one of said risk groups; and
`
`(d) entering said risk group assignment in said medium
`
`before said patient is approved to receive said drug.
`
`On January 18, 2001, the USPTO issued an Office Action, rejecting
`
`claims 1-27 as obvious. Exhibit 1003 at 3-4. The USPTO file copy of the
`
`Office Action is unreadable at some portions, however, in the readable
`
`portions the Examiner stated that Elsayed et al. (U.S. Patent No. 6,045,501,
`
`hereinafter, Elsayed) suggests the “use of the information to evaluate the risk
`
`levels, but do not teach the specific implementation of this procedure.” Id.
`
`at 4. The Examiner also stated that Schauss et al. (U.S. Patent No.
`
`6,063,026, hereinafter, Schauss) teaches a medical diagnostic analysis
`
`system that evaluates patient data obtained from medical testing or patient
`
`questioning for drugs contraindications. Id. According to the Examiner, “it
`
`would have been obvious to one of ordinary skill in the art at the time of the
`
`invention to implement the screen for drug contraindications suggested in
`
`Elsayed et al, with the method of Schauss et al., since Schauss et al. teach
`
`the particular steps for performing the analysis.” Id. Claims 28-32 were
`
`
`
`17
`
`Page 23 of 51
`
`

`
`objected to, but were indicated as being allowable if rewritten in
`
`independent form. Id. at 5.
`
`On March 23, 2001, the Applicants responded by amending claim 1
`
`and arguing that, “Elsayed, although teaching a method which contains
`
`many of the steps of the present invention, contains no disclosure of the
`
`generation of a prescription approval code as recited in amended Claim 1.
`
`Nor is there any explicit description in Elsayed of the benefits and attributes
`
`which flow from the inclusion of this step…the inventors have found that
`
`improved compliance with the drug delivery methods of the present
`
`invention may be achieved when the patient’s risk group assignment and all
`
`required information is entered in the computer readable storage medium,
`
`and it is determined that the risk is acceptable, prior to generation of the
`
`prescription approval code.” Exhibit 1004 at 4.
`
`
`
`The amendments to claim 1 concered steps (c) and (d), and a new step
`
`(e) to claim 1 as follows:
`
` (c) in response to said information set, assigning said
`
`patient to at least one of said risk groups and entering said risk
`
`group assignment in said medium; [and]
`
`(d) [entering said risk group assignment in said medium
`
`before said patient is approved to receive said drug] based upon
`
`said information and said risk group assignment, determining
`
`
`
`18
`
`Page 24 of 51
`
`

`
`whether the risk that said adverse side effect is likely to occur is
`
`acceptable [.] and
`
`(e) upon a determination that said risk is acceptable,
`
`generating a prescription approval code to be retrieved by said
`
`pharmacy before said prescription is filled.
`
`Id. at 2, 6 (the latter showing marked changes except for (e), which is
`
`unreadable).
`
`
`
`On April 12, 2001, the Examiner issued a final Office Action
`
`maintaining the rejections of the claims over Elsayed and Schauss et al. The
`
`Examiner also cited Boyer et al., U.S. Patent No. 6,202,923, as teaching the
`
`step for generating a prescription approval number or code associated with
`
`said prescription by a computer workstation. In June 2001, the Applicants
`
`responded stating that, “[a]s the Examiner has not maintained the previous
`
`rejection of Claims 1 to 27 over the combination of Elsayed and Schauss et
`
`al, it is apparently the Examiner’s position that the amendment submitted on
`
`March 23, 2001 was sufficient to overcome the rejection, but that Boyer
`
`contains disclosure that teaches or suggest the additional claim elements
`
`added by Applicants in that amendment… Applicants respectfully disagree.
`
`Claim 1 defines an improved method fo