Paper No. ______
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`Filed: April 23, 2015
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
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`
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`COALITION FOR AFFORDABLE DRUGS VI LLC
`
`PETITIONER
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`V.
`
`CELGENE
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`PATENT OWNER
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`___________________
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`CASE NO.: UNASSIGNED
`PATENT NO. 6,315,720
`FILED: OCTOBER 23, 2000
`ISSUED: NOVEMBER 13, 2001
`INVENTORS: BRUCE A. WILLIAMS AND JOSEPH K. KAMINSKI
`
`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
`___________________
`
`
`PETITION FOR INTER PARTES REVIEW
`OF U.S. PATENT NO. 6,315,720
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`Patent No. 6,315,720
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`TABLE OF CONTENTS
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`I.
`INTRODUCTION ..................................................................................................... 1
`II. GROUNDS FOR STANDING (37 C.F.R. § 42.104(a)) ........................................ 1
`III. MANDATORY NOTICES (37 C.F.R. § 42.8) ........................................................ 1
`A. Real Parties-in-Interest (37 C.F.R. § 42.8(b)(1)) .................................................... 1
`B. Related Judicial and Administrative Matters (37 C.F.R. § 42.8(b)(2)) ................. 2
`C. Lead and Back-Up Counsel (37 C.F.R. § 42.8(b)(3)) and Service
`Information (37 C.F.R. § 42.8(b)(4)) ....................................................................... 3
`IV. PAYMENT OF FEES (37 C.F.R. § 42.15(a) and § 42.103) ................................... 3
`V.
`IDENTIFICATION OF CHALLENGE ................................................................ 3
`A. Overview of U.S. Patent No. 6,315,720 ................................................................. 3
` The ’720 Patent Specification ............................................................................. 4 1.
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` The ’720 Claims .................................................................................................... 5 2.
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` The ’720 Prosecution History ............................................................................. 6 3.
`B. Claim Construction of Challenged Claims ............................................................. 9
`1.
`“Consulted” ......................................................................................................... 10
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`2.
`“Teratogenic effect” ........................................................................................... 10
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`3.
`“Adverse side effect” ......................................................................................... 11
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`C. Statement of Precise Relief Requested for Each Claim Challenged ................. 11
` Claims for Which Review is Requested ........................................................... 11 1.
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`Statutory Grounds of Challenge ....................................................................... 11
`2.
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`D. Overview of the State of the Art ........................................................................... 12
`VI. DETAILED EXPLANATION OF THE CHALLENGE ................................. 14
`A. Ground 1: THALOMID™ (thalidomide) Capsules Revised
`Package Insert anticipates Claims 1–32 of U.S. Patent No.
`6,315,720 under 35 U.S.C. § 102(b). ...................................................................... 14
` Thalomid PI anticipates Claim 1. ........................................................................ 17
`1.
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`Patent No. 6,315,720
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` Thalomid PI anticipates Claims 2–6. .................................................................. 22
`2.
` Thalomid PI anticipates Claims 7–10. ................................................................ 25
`3.
` Thalomid PI anticipates Claims 11–14 and 20–25. ........................................... 28
`4.
` Thalomid PI anticipates Claim 15. ...................................................................... 30
`5.
` Thalomid PI anticipates Claims 16–17. .............................................................. 31
`6.
` Thalomid PI anticipates Claims 18–19 and 26–27. ........................................... 33
`7.
` Thalomid PI anticipates Claims 28–32. .............................................................. 34
`8.
`
` Claim chart for Ground 1 showing exemplary citations in 9.
`Thalomid PI. ......................................................................................................... 36
`B. Ground 2: Claims 1–32 of U.S. Patent No. 6,315,720 are obvious
`under 35 U.S.C. § 103(a) over Thalomid PI in view of Cunningham,
`and in further view of the knowledge of one of ordinary skill in the art. ........ 51
` Claims 1(e) and 28(e) are obvious over Thalomid PI in view
`1.
`of Cunningham. .................................................................................................... 52
` Claims 5 and 6 are obvious over Thalomid PI in view of the
`2.
`knowledge of one of ordinary skill in the art. ................................................ 54
` Claims 9 and 10 are obvious over Thalomid PI in view of the
`3.
`knowledge of one of ordinary skill in the art. ................................................ 57
` Claim 17 is obvious over Thalomid PI in view of the knowledge
`4.
`of one of ordinary skill in the art. .................................................................... 59
`
` Claim Chart for Ground 2 showing exemplary citations in 5.
`Cunningham. ......................................................................................................... 59
`VII. CONCLUSION ......................................................................................................... 60
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`Patent No. 6,315,720
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`TABLE OF AUTHORITIES
`
`Cases
`Abbott Labs v. Andrx Pharms., Inc.,
`452 F.3d 1331 (Fed. Cir. 2006) ....................................................................................... 54
`Atlas Powder Co. v. IRECO, Inc.,
`190 F.3d 1342 (Fed. Cir. 1999) ....................................................................................... 16
`Bayer Schering Pharma AG v. Barr Labs., Inc.,
`575 F.3d 1341 (Fed. Cir. 2009) ....................................................................................... 56
`Continental Can Co. USA, Inc. v. Monsanto Co.,
`948 F.2d 1264 (Fed. Cir. 1991) ................................................................................. 17, 21
`Dow Chem. Co. v. Sumitomo Chem. Co.,
`257 F.3d 1364 (Fed. Cir. 2001) ....................................................................................... 17
`Dystar Textilfarben GmbH v. C.H. Patrick Co.,
`464 F.3d 1356 (Fed. Cir. 2006) ....................................................................................... 54
`In re Am. Acad. of Sci. Tech. Ctr.,
`367 F.3d 1359 (Fed. Cir. 2004) ....................................................................................... 10
`In re Baxter Travenol Labs,
`952 F.2d 388 (Fed. Cir. 1991) ......................................................................................... 17
`In re Cruciferous Sprout Litigation,
`301 F.3d 1343 (Fed. Cir. 2002) ....................................................................................... 27
`In re Cuozzo Speed Techs., LLC,
`778 F.3d 1271 (Fed. Cir. 2015) ......................................................................................... 9
`In re Glatt Air Techniques, Inc.,
`630 F.3d 1026 (Fed. Cir. 2011) ....................................................................................... 18
`In re Graves,
`69 F.3d 1147 (Fed. Cir. 1995) ............................................................................. 21, 25, 27
`In re LeGrice,
`301 F.2d 929 (CCPA 1962) ....................................................................................... 21, 27
`In re Venner,
`262 F.2d 91 (C.C.P.A. 1958) ........................................................................................... 59
`KSR Int'l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) .......................................................................................................... 53
`Pacing Techs., LLC v. Garmin Int’l, Inc.,
`778 F.3d 1021 (Fed. Cir. 2015) ....................................................................................... 10
`
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`Patent No. 6,315,720
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`Pentec, Inc. v. Graphic Controls Corp.,
`776 F.2d 309 (Fed. Cir. 1985) ......................................................................................... 18
`Perfect Web Techs., Inc. v. InfoUSA, Inc.,
`587 F.3d 1324 (Fed. Cir. 2009) ....................................................................................... 56
`Schering Corp. v. Geneva Pharms., Inc.,
`339 F.3d 1373 (Fed. Cir. 2003) .............................................................. 21, 24, 31, 27, 33
`SmithKline Beecham Corp. v. Apotex Corp.,
`403 F.3d 1331 (Fed. Cir. 2005) ....................................................................................... 33
`Titanium Metals Corp. v. Banner,
`778 F.2d 775 (Fed. Cir. 1985) ......................................................................................... 16
`Tyco Healthcare Grp. LP v. Ethicon Endo-Surgery, Inc.,
`774 F.3d 968 (Fed. Cir. 2014) ......................................................................................... 58
`Unigene Labs., Inc. v. Apotex, Inc.,
`655 F.3d 1352 (Fed. Cir. 2011) ....................................................................................... 58
`Verdegaal Bros. v. Union Oil Co. of California,
`814 F.2d 628 (Fed. Cir. 1987) ......................................................................................... 16
`Rules
`37 C.F.R. § 42.103 .................................................................................................................. 3
`37 C.F.R. § 42.15(a) ................................................................................................................ 3
`37 C.F.R. § 42.8(b)(1) ............................................................................................................. 1
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`Patent No. 6,315,720
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`TABLE OF EXHIBITS
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`Exhibit 1006
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`Exhibit 1007
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`Exhibit 1008
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`Description
`Exhibit No.
`Exhibit 1001 U.S. Patent No. 6,315,720 to Bruce A. Williams and Joseph K.
`Kaminski, filed on Oct. 23, 2003, and issued on Nov. 13, 2001 (the
`“’720 Patent”)
`Exhibit 1002 U.S. Patent No. 6,315,720 Prosecution History (“’720 prosecution
`history”)
`Exhibit 1003 U.S. Patent No. 6,045,501 to Marc Elsayed and Bruce Williams, filed
`on Aug. 28, 1998, and issued on Apr. 4, 2000 (“Elsayed”)
`Exhibit 1004 U.S. Patent No. 6,063,026 to Mark A. Schauss and Patricia Kane,
`filed on Mar. 22, 1996, and issued on May 16, 2000 (“Schauss”)
`Exhibit 1005 U.S. Patent No. 6,202,923 to Joseph H. Boyer et al., filed on Aug. 23,
`1999, and issued on Mar. 20, 2001 (“Boyer”)
`“THALOMID™ (thalidomide) Capsules Revised Package Insert”
`(Jul. 15, 1998) (“Thalomid PI”)
`“Guideline for the clinical use and dispensing of thalidomide,” R.J.
`Powell and J.M.M Gardner-Medwin, Postgrad Med. J. (1994) 79,
`901–904 (“Powell”)
`“Pharmacists’ role in clozapine therapy at a Veterans Affairs medical
`center,” Benjamin R. Dishman et al., Am. J. Hosp. Pharm. (Apr. 1,
`1994) 51, 899–901 (“Dishman”)
`Exhibit 1009 U.S. Patent No. 5,832,449 to David W. Cunningham, filed on Nov.
`13, 1995, and issued on Nov. 3, 1998 (“Cunningham”)
`Exhibit 1010 U.S. Patent No. 6,055,507 to David W. Cunningham, filed on Aug.
`20, 1998, and issued on Apr. 25, 2000 (“Cunningham Divisional”)
`“A Pregnancy-Prevention Program in Women of Childbearing Age
`Receiving Isotretinoin,” Allen A. Mitchell et al., New Eng. J. Med.
`(Jul. 13, 1995) 333:2, 101–06 (“Mitchell”)
`“S.T.E.P.S.TM: A Comprehensive Program for Controlling and
`Monitoring Access to Thalidomide,” Jerome B. Zeldis et al., Clinical
`Therapeutics (1999) 21:2, 319–30 (“Zeldis”)
`Exhibit 1013 Transcript of the FDA’s “Forty-Seventh Meeting of the
`Dermatologic and Opthalmic Drugs Advisory Committee,” Sept. 4,
`1997 (“FDA Meeting Part 1”)
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`Exhibit 1011
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`Exhibit 1012
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`Patent No. 6,315,720
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`Exhibit 1015
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`Exhibit 1016
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`Exhibit 1017
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`Exhibit 1018
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`Exhibit 1019
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`Description
`Exhibit No.
`Exhibit 1014 Transcript of the FDA’s “Forty-Seventh Meeting of the
`Dermatologic and Opthalmic Drugs Advisory Committee,” Sept. 5,
`1997 (“FDA Meeting Part 2”)
`“CDC Meeting: 03/26/1997 Minutes and Agenda Regarding
`Thalidomide” (“CDC Meeting”)
`“Assessing the Effectiveness of a Computerized Pharmacy System,”
`Reed M. Gardner et al., Decision Support Systems in Critical Care,
`1994, M.M. Schabot et al., eds. (“Gardner”)
`“Review of computer applications in institutional pharmacy—1975–
`1981,” Ken W. Burleson, Am. J. Hosp. Pharm. (1982) 39:53–70
`(“Burleson”)
`“Challenges of thalidomide distribution in a hospital setting,” Daniel
`P. Keravich and Charles E. Daniels, Am. J. Health-Syst. Pharm.
`(Sept. 1, 1999) 56:1721–75 (“Keravich”)
`“The Assessment of Refill Compliance Using Pharmacy Records:
`Methods, Validity, and Applications,” John F. Steiner and Allan V.
`Prochazka, J. Clin. Epidemiol. (1997) 50:1, 105–16 (“Steiner”)
`“Therapeutic Antibiotic Monitoring: Surveillance Using a
`Computerized Expert System,” Stanley L. Pestotnik et al., Am. J.
`Med. (Jan. 1990) 88:43–48 (“Pestotnik”)
`Exhibit 1021 Declaration of Jeffrey Fudin, R.Ph., B.S., Pharm.D., DAAPM, FCCP,
`FASHP (“Fudin Decl.”)
`Exhibit 1022 Curriculum Vitae for Jeffrey Fudin, R.Ph., B.S., Pharm.D., DAAPM,
`FCCP, FASHP (“Fudin CV”)
`“Joint Claim Construction and Prehearing Statement,” Celgene Corp. v.
`Natco Pharma Ltd., NJD-2-10-cv-05197, Jul. 18, 2011 (“Celgene Claim
`Construction Brief”)
`“Interactive Voice Response Systems in Clinical Research and
`Treatment,” James C. Mundt, Psychiatric Services (May 1997) 48:5,
`611–12, 623 (“Mundt”)
`“Center for Drug Evaluation and Research Approval Package for:
`Application Number NDA 20-785 Approval Letter(s),” Sept. 19,
`1997, and Jul. 16, 1998 (“FDA Thalomid Approval Letters”)
`
`
`Exhibit 1020
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`Exhibit 1023
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`Exhibit 1024
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`Exhibit 1025
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`I.
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`Patent No. 6,315,720
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`INTRODUCTION
`Petitioner Coalition For Affordable Drugs VI LLC (“CFAD”), requests an Inter
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`Partes Review (“IPR”) of Claims 1–32 (collectively, the “Challenged Claims”) of U.S.
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`Patent No. 6,315,720 (the “’720 Patent”) (Ex. 1001) in accordance with 35 U.S.C.
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`§§ 311–19 and 37 C.F.R. §§ 42.100 et seq.
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`II. GROUNDS FOR STANDING (37 C.F.R. § 42.104(A))
`Pursuant to 37 C.F.R. § 42.104(a), Petitioner certifies that the ’720 patent is
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`available for IPR and that Petitioner is not barred or estopped from requesting IPR
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`challenging the claims of the ’720 patent on the grounds identified in this Petition.
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`III. MANDATORY NOTICES (37 C.F.R. § 42.8)
`A. Real Parties-in-Interest (37 C.F.R. § 42.8(b)(1))
`Pursuant to 37 C.F.R. § 42.8(b)(1), Petitioner certifies that Coalition For
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`Affordable Drugs VI LLC (“CFAD VI”), Hayman Credes Master Fund, L.P.
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`(“Credes”), Hayman Orange Fund SPC – Portfolio A (“HOF”), Hayman Capital
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`Master Fund, L.P. (“HCMF”), Hayman Capital Management, L.P. (“HCM”), Hayman
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`Offshore Management, Inc. (“HOM”), Hayman Investments, L.L.C. (“HI”), nXn
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`Partners, LLC (“nXnP”), IP Navigation Group, LLC (“IPNav”), J. Kyle Bass, and
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`Erich Spangenberg are the real parties in interest (collectively, “RPI”). The RPI
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`hereby certify the following information: CFAD VI is a wholly owned subsidiary of
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`Credes. Credes is a limited partnership. HOF is a segregated portfolio company.
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`HCMF is a limited partnership. HCM is the general partner and investment manager
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`of Credes and HCMF. HCM is the investment manager of HOF. HOM is the
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`administrative general partner of Credes and HCMF. HI is the general partner of
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`HCM. J. Kyle Bass is the sole member of HI and sole shareholder of HOM. CFAD
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`VI, Credes, HOF and HCMF act, directly or indirectly, through HCM as the general
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`partner and/or investment manager of Credes, HOF and HCMF. nXnP is a paid
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`consultant to HCM. Erich Spangenberg is the 98.5% member of nXnP. IPNav is a
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`paid consultant to nXnP. Erich Spangenberg is the 98.5% member of IPNav. Other
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`than HCM and J. Kyle Bass in his capacity as the Chief Investment Officer of HCM
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`and nXnP and Erich Spangenberg in his capacity as the Manager/CEO of nXnP, no
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`other person (including any investor, limited partner, or member or any other person
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`in any of CFAD VI, Credes, HOF, HCMF, HCM, HOM, HI, nXnP or IPNav) has
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`authority to direct or control (i) the timing of, filing of, content of, or any decisions or
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`other activities relating to this Petition or (ii) any timing, future filings, content of, or
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`any decisions or other activities relating to the future proceedings related to this
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`Petition. All of the costs associated with this Petition will be borne by HCM, CFAD
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`VI, Credes, HOF and/or HCMF.
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`B. Related Judicial and Administrative Matters (37 C.F.R. § 42.8(b)(2))
`Pursuant to 37 C.F.R. § 42.8(b)(2), Petitioner states that the ’720 Patent has
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`been the subject of the following lawsuits: Celgene Corp. et al. v. Lannett Holdings, Inc. et
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`al., NJD-2-15-00697 (filed Jan. 30, 2015); Celgene Corp. v. Natco Pharma Ltd., NJD-2-10-
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`cv-05197 (filed Oct. 8, 2010); Celgene Corp. et al. v. Barr Laboratories, Inc. et al., NJD-2-
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`08-cv-03357 (filed July 3, 2008); Celgene Corp. et al. v. Barr Laboratories, Inc. et al., NJD-2-
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`07-cv-05485 (filed Nov. 14, 2007); Celgene Corp. et al. v. Barr Laboratories, Inc. et al., NJD-
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`2-07-cv-04050 (filed Aug. 23, 2007); Celgene Corp. et al. v. Barr Laboratories, Inc. et al.,
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`NJD-2-07-cv-00286 (filed Jan. 18, 2007).
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`C.
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`Lead and Back-Up Counsel (37 C.F.R. § 42.8(b)(3)) and Service
`Information (37 C.F.R. § 42.8(b)(4))
`Lead counsel is Sarah E. Spires, Reg. No. 61,501,
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`sarah.spires@skiermontpuckett.com. Back-up counsel are Ki O, Reg. No. 68,952,
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`ki.o@skiermontpuckett.com; Dr. Parvathi Kota, Reg. No. 65,122,
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`parvathi.kota@skiermontpuckett.com; and Paul J. Skiermont (pro hac vice requested),
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`paul.skiermont@skiermontpuckett.com—all of Skiermont Puckett LLP, 2200 Ross
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`Ave. Ste. 4800W, Dallas, Texas 75201, P: 214-978-6600/F: 214-978-6601. Petitioner
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`consents to electronic service.
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`IV. PAYMENT OF FEES (37 C.F.R. § 42.15(A) AND § 42.103)
`The required fees are submitted herewith in accordance with 37 C.F.R.
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`§§ 42.103(a) and 42.15(a). If any additional fees are due during this proceeding, the
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`Office is authorized to charge such fees to Deposit Account No. 506293. Any
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`overpayment or refund of fees may also be deposited in this Deposit Account.
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`V.
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`IDENTIFICATION OF CHALLENGE
`A. Overview of U.S. Patent No. 6,315,720
`The ’720 Patent is titled “Methods for Delivering a Drug To A Patient While
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`Avoiding The Occurrence Of An Adverse Side Effect Known Or Suspected Of Being
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`Patent No. 6,315,720
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`Caused By The Drug.” (Ex. 1001 at Front Cover.) The underlying application, U.S.
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`Patent Application Serial No. 09/694,217, was filed on October 23, 2000. The ’720
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`Patent issued to Bruce Williams and Joseph K. Kaminski on November 13, 2001. (Id.)
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`1.
`The ’720 Patent Specification
`The ’720 Patent claims methods for delivering a drug to a patient, while
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`avoiding the occurrence of adverse side effects. (Id. at Abstract.) The ’720 Patent
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`generally describes methods for “the distribution to patients of drugs, particularly
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`teratogenic drugs, in ways wherein such distribution can be carefully monitored and
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`controlled.” (Id. at 1:13–16.) A teratogenic drug can cause severe birth defects when
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`administered to a pregnant woman. (Id. at 1:27–29.) The ’720 specification
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`acknowledges that prior “[m]ethods for monitoring and educating patients to whom a
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`drug is distributed have been developed in connection with” a known teratogenic
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`drug (isotretinoin), including a “pregnancy prevention program.” (Id. at 2:13–20.)
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`The invention of the ’720 Patent was allegedly conceived in the context of the
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`FDA approval of thalidomide—a teratogenic drug effective in treating a variety of
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`diseases—when the inventors were seeking methods “to control the distribution of
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`[thalidomide] so as to preclude administration to foetuses.” (Id. at 1:46–64.)
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`The ’720 Patent’s invention can be summarized as: (1) filling prescriptions only
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`after consulting a computer readable storage medium to confirm that the prescribers,
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`pharmacies, and patients are registered in a computer database; (2) assigning patients
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`to risk groups based on the risk that the drug will cause adverse side effects and
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`entering the risk group assignment in the storage medium; (3) determining the
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`acceptability of the likely adverse effect; and (4) “generating a prescription approval
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`code to … said pharmacy before said prescription is filled.” (Id. at 2:49–3:4.) The ’720
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`Patent specification also teaches that “[t]he invention is not limited to the distribution
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`of teratogenic drugs; other potentially hazardous drugs may also be distributed in
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`accordance with embodiments of this invention … in such a fashion that persons for
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`whom such drugs are contraindicated will not receive them.” (Id. at 3:21–26.)
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`The patent also discloses that when a patient is registered in the computer
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`readable storage medium, information probative of the risk of a drug’s side effects is
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`also collected from the patient. (Id. at 6:30–33.) This information can then be
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`compared with a defined set of risk parameters for the drug, allowing for assignment
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`of the patient to a particular risk group. (Id. at 6:33–36.) If the risk of adverse side
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`effects is deemed acceptable, the patient may receive the drug from a registered
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`pharmacy, subject to conditions such as a negative pregnancy test, but may not receive
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`refills without a renewal prescription from the prescriber. (Id. at 11:62–12:8.)
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`The ’720 Claims
`2.
`The ’720 Patent has two independent claims and 30 dependent claims. Claim 1
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`is representative and is reproduced below.
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`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
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`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:
`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.
`(Ex. 1001 at 18:17–42.) All other claim limitations are listed within Ground 1 below.
`
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`The ’720 Prosecution History
`3.
`During prosecution of U.S. Patent Application No. 09/694,217 (filed October
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`23, 2000), which led to the ’720 Patent, the Examiner initially rejected Claims 1–27 as
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`obvious under 35 U.S.C. § 103(a) over U.S. Patent No. 6,045,501 (Ex. 1003, “Elsayed”)
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`Patent No. 6,315,720
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`in view of U.S. Patent No. 6,063,026 (Ex. 1004, “Schauss”). (See Ex. 1002 at 57–58.1)
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`At this time, Claims 1–32 were pending. (Id. at 56.) Claim 1, the only independent
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`claim, recited “a method for delivering a drug to a patient in need of the drug while
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`avoiding the occurrence of an adverse side effect known or suspected of being caused
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`by said drug.” (Id. at 44.)
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`The Examiner rejected Claims 1–27, stating that Elsayed suggested the “use of
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`the information to evaluate risk levels,” while Schauss taught “a medical diagnostic
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`analysis system that evaluates patient data obtained from medical testing or patient
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`questioning for drugs contraindications.” (Id. at 58.) The Examiner concluded that “it
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`would have been obvious to one of ordinary skill in the art at the time of the invention
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`to implement the screening for drug contraindications suggested in Elsayed et al. with
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`the method of Schauss et al., since Schauss et al. teach the particular steps for
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`performing the analysis.” (Id. at 58.) Regarding Claim 6, the Examiner stated that
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`although Elsayed “does not specifically teach that data received by facsimile
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`transmission is entered by an OCR software, it is inherent that this data must be
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`entered into database.” (Id. at 58.) The Examiner objected to Claims 28–32 “as being
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`dependent upon a rejected base claim, but would be allowable if rewritten in
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`independent form.” (Id. at 59.)
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`1 Except for the prosecution history, exhibit cites herein are directed to the internal
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`page numbers of the exhibit, rather than to the Exhibit’s Bates numbers.
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`In response, applicants amended Claim 1 by adding, among other limitations,
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`“upon a determination that said risk is acceptable, generating a prescription approval
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`code to be retrieved by said pharmacy before said prescription is filled.” (Id. at 87.)
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`Based on this amendment, applicants argued that “Elsayed, although teaching a
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`method which contains many of the steps of the present invention, contains no
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`disclosure of the generation of a prescription approval code as recited in amended
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`Claim 1.” (Id. at 85.) Applicants further argued that “[a]lthough Schauss may describe
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`a medical diagnostic analysis system that evaluates patient data obtained from
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`questioning a patient or medical testing, Schauss contains no disclosure remotely
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`related to the generation of a prescription approval code, this being the subject of
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`Applicants’ claims.” (Id. at 86.)
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`In response, the Examiner rejected the claims as obvious over Elsayed in view of
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`Schauss and Boyer, U.S. Patent No. 6,202,923 (Ex. 1005, “Boyer”), which “includes a step
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`for generating a prescription number or code associated with said prescription by a
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`computer workstation.” (Id. at 91–92.)
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`In response, applicants argued:
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`As amended on March 23, 2001, Claim 1 further requires an assessment,
`based upon the risk group assignment and the information collected
`from the patient, as to whether the risk of the side effect occurring is
`acceptable. Upon a determination that the risk is acceptable, and only upon
`such a determination, a prescription approval code is generated, which must
`be retrieved by the pharmacy before the prescription may be filled. Thus,
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`Patent No. 6,315,720
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`the prescription approval code is not merely a number that is associated
`with the prescription, but instead represents the fact that a determination
`has been made that the risk of the side effect occurring is acceptable, and
`that approval—an affirmative decision—has been made for the
`prescription to be filled. Boyer does not disclose or suggest such an
`approval code.
`(Id. at 106–07.) Applicants further argued that in Boyer, the prescription number “is
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`simply an identifier for the prescription, and is not an approval code, as recited in
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`Applicants’ claims,” and that Boyer provides “no indication that a prescription approval
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`code, as described and claimed in the instant application, must be generated and
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`retrieved by the pharmacist before the prescription may be filled.” (Id. at 107.)
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`The applicants amended Claim 28 to be an independent claim, and then argued
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`that because “[a]ny proper combination of the disclosure of Boyer with that of
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`Elsayed and Schauss does not teach or suggest the invention defined by Applicants’
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`claims,” the Examiner should withdraw the 103 rejection. (Id. at 106–07.)
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`After this response, all of the ’720 Patent claims were allowed. (Id. at 111.)
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`B.
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`Claim Construction of Challenged Claims
`A claim subject to IPR receives the “broadest reasonable construction in light
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`of the specification of the patent in which it appears.” 37 C.F.R. § 42.100(b); see In re
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`Cuozzo Speed Techs., LLC, 778 F.3d 1271, 1279 (Fed. Cir. 2015). In applying such a
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`standard, the broadest reasonable construction of claim language is not one that
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`permits any reading, but instead is one that must be made “in light of the specification
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`Patent No. 6,315,720
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`as it would be interpreted by one of ordinary skill in the art.” In re Am. Acad. of Sci.
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`Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004) (citation omitted).
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`Unless otherwise noted, Petitioner accepts, for purposes of IPR only, that the
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`claim terms of the ’720 Patent are presumed to take on the ordinary and customary
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`meaning that they would have to one of ordinary skill in the art.2
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`1.
`“Consulted”
`“Consulted” means “accessed and considered.” (Ex. 1023 at 3; Ex. 1021 ¶ 39.)
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`“Teratogenic effect”
`2.
`“Teratogenic effect” means “any effect that disturbs the normal growth and
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`development of an embryo or fetus.” (Ex. 1023 at 3; Ex. 1021 ¶ 40.)
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`2 Petitioner notes that, in some instances, the patentee has defined claim terms apart
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`from their plain meaning. See Pacing Techs., LLC v. Garmin Int’l, Inc., 778 F.3d 1021,
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`1024 (Fed. Cir. 2015). These terms include “drug,” “computer readable storage
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`medium,” “patient risk groups,” “risk parameters,” “risk group assignment,” “likely to
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`occur,” “prescription approval code,” “counseled,” “risk avoidance measures,” and
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`“informed consent.” (Ex. 1001 at 3:35–38, 3:45–48, 4:54–56, 5:29–33, 6:30–7:19,
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`8:45–57, 9:8–26, 10:41–46, 13:44–64.)
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`“Adverse side effect”
`3.
`“Adverse side effect” means “any unfavorable abnormality, defect, mutation,
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`lesion, degeneration or injury which may be caused by taking the drug.” (Ex. 1023 at
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`6; Ex. 1021 ¶ 41; see Ex. 1001 at 3:38–44.)
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`C.
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`Statement of Precise Relief Requested for Each Claim Challenged
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`1.
`Claims for Which Review is Requested
`Petitioner requests IPR under 35 U.S.C. § 311 of Claims 1–32 of the ’720
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`Patent, and cancellation of these 32 claims as unpatentable.
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`Statutory Grounds of Challenge
`2.
`Petitioner requests IPR of Claims 1–32 of the ’720 Patent in view of the
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`following references, each of which is prior art to the ’720 Patent under 35 U.S.C.
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`§§ 102(a) and (b) or 103. The Examiner did not reference any of the prior art listed in
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`the following chart in any Office Action. (See generally, Ex. 1002.) Claims 1–32 are
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`unpatentable under 35 U.S.C. §§ 102(b) and 103(a):
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`Ground Proposed Rejections for the ’720 Patent
`1
`Claims 1–32 are anticipated under 35 U.S.C. §
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`Exhibit Number(s)
`1006
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`102(b) by the Thalidomide Package Insert (Ex. 1006,
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`“Thalomid PI”).
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`2
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`Claims 1–32 are obvious under 35 U.S.C. § 103(a) in
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`1006 and 1009
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`view of Thalomid PI (Ex. 1006) and Cunningham (Ex.
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`1009).
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`D. Overview of the State of the Art
`By October of 2000, it was well recognized in the art that teratogenic drugs—
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`which can cause birth defects—needed to be regulated. (See, e.g., Ex. 1007 at 901–04;
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`Ex. 1011 at 101–05.) The central regulatory goal was to avoid pregnancy in patients
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`treated with the drug. (See, e.g., Ex. 1011 at 101.) One notable case of a drug marketed
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`through methods to prevent its use in pregnant patients is isotretinoin, marketed
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`under the trade name Accutane®. (See id. at 101.) Rather than remove this drug from
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`the market once its teratogenicity was realized, isotretinoin became part of a
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`manufacturer-sponsored Pregnancy Prevention Program (“PPP”). (Id. at 101.) The
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`program, among other features, included the distribution to physicians of a kit that
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`included informed consent documents and patient counseling information. (Id. at
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`101.) In particular, patients were warned against the teratogenic risk of isotretinoin
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`and the need to prevent pregnancy while