Trials@uspto.gov
`571.272.7822
`
`
`
`
`
`Papel No. 75
` Entered: October 26, 2016
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_____________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`
`
`
`COALITION FOR AFFORDABLE DRUGS VI, LLC,
`Petitioner,
`
`v.
`
`CELGENE CORPORATION,
`Patent Owner.
`_______________
`
`Case IPR2015-01102
`Patent 6,315,720 B1
`____________
`
`
`
`Before MICHAEL P. TIERNEY, GRACE KARAFFA OBERMANN, and
`TINA E. HULSE, Administrative Patent Judges.
`
`TIERNEY, Administrative Patent Judge.
`
`
`
`FINAL WRITTEN DECISION
`Inter Partes Review
`35 U.S.C. §318(a) and 37 C.F.R. § 42.73
`
`
`
`
`
`
`571.272.7822
`
`
`
`
`
`Papel No. 75
` Entered: October 26, 2016
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_____________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`
`
`
`COALITION FOR AFFORDABLE DRUGS VI, LLC,
`Petitioner,
`
`v.
`
`CELGENE CORPORATION,
`Patent Owner.
`_______________
`
`Case IPR2015-01102
`Patent 6,315,720 B1
`____________
`
`
`
`Before MICHAEL P. TIERNEY, GRACE KARAFFA OBERMANN, and
`TINA E. HULSE, Administrative Patent Judges.
`
`TIERNEY, Administrative Patent Judge.
`
`
`
`FINAL WRITTEN DECISION
`Inter Partes Review
`35 U.S.C. §318(a) and 37 C.F.R. § 42.73
`
`
`
`
`
`
`
`IPR2015-01102
`Patent 6,315,720 B1
`
`I.
`
`
`
`INTRODUCTION
`
`Coalition for Affordable Drugs VI, LLC (“Petitioner”), filed a Petition
`
`requesting an inter partes review of claims 1–32 of U.S. Patent 6,315,720
`
`(Ex. 1001, “the ’720 patent”). Paper 1 (“Pet.”). Patent Owner, Celgene
`
`Corporation, (“Patent Owner”) filed a Preliminary Response. Paper 11
`
`(“Prelim. Resp.” with redacted version Paper 12). We determined that there
`
`was a reasonable likelihood that Petitioner would prevail in challenging
`
`those claims as unpatentable. Pursuant to 35 U.S.C. § 314, we authorized an
`
`inter partes review to be instituted, on October 27, 2015. Paper 21 (“Dec. on
`
`Inst.”).
`
`
`
`After institution, Patent Owner filed a redacted Patent Owner
`
`Response. Paper 41 (“PO Resp.” with redacted version Paper 42).
`
`Petitioner filed a Reply. Paper 54 (“Reply” with a redacted version Paper
`
`53). Additionally, Petitioner filed Motions to Submit Supplemental
`
`Information (Papers 36 and 37), a Motion to Exclude Evidence (Paper 63)
`
`and a Motion to Seal (Paper 55). Further, Patent Owner filed a Motion to
`
`Exclude Evidence (Paper 62) and Motions to Seal and for Entry of
`
`Protective Order (Papers 10 and 40).
`
`
`
`An oral hearing was held on July 21, 2016. A transcript of the hearing
`
`has been entered into the record of the proceeding as Paper 74 (“Tr.”).
`
`
`
`We have jurisdiction under 35 U.S.C. § 6(b). This Final Written
`
`Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73.
`
`For the reasons that follow, we determine that Petitioner has shown by a
`
`preponderance of the evidence that claims 1–32 are unpatentable.
`
`
`
`2
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`
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`IPR2015-01102
`Patent 6,315,720 B1
`
`A. Related Proceedings
`
`According to Petitioner, the ’720 patent has been the subject of the
`
`following judicial matters: Celgene Corp. et al. v. Lannett Holdings, Inc.,
`
`DNJ-2-15-00697 (filed Jan. 30, 2015); Celgene Corp. v. Natco Pharma Ltd.,
`
`DNJ-2-10-cv-05197 (filed Oct. 8, 2010); Celgene Corp. v. Barr
`
`Laboratories, Inc., DNJ-2-08-cv-03357 (filed July 3, 2008); Celgene Corp.
`
`v. Barr Laboratories, Inc., DNJ-2-07-cv-05485 (filed Nov. 14, 2007);
`
`Celgene Corp. v. Barr Laboratories, Inc., DNJ-2-07-cv-04050 (filed Aug.
`
`23, 2007); Celgene Corp. v. Barr Laboratories, Inc., DNJ-2-07-cv-00286
`
`(filed Jan. 18, 2007). Pet. 2–3. Additionally, the claims of the ’720 patent
`
`have been challenged in two related inter partes review proceedings,
`
`IPR2015-01096 and IPR2015-01103.
`
`
`
`B. The ’720 Patent
`
`The ’720 patent specification describes methods for delivering a drug
`
`to a patient. Ex. 1001, 1:8–9. For example, the method can be used to
`
`deliver a drug known to cause birth defects in pregnant women, while
`
`avoiding the occurrence of known or suspected side effects of the drug. Id.
`
`at 1:9–13, 19–30.
`
`The patent describes prior-art methods that involved filling drug
`
`prescriptions, only after a computer readable storage medium was consulted,
`
`to assure that the prescriber is registered in the medium and qualified to
`
`prescribe the drug, and that the patient is registered in the medium and
`
`approved to receive the drug. Id. at 2:50–60. The ’720 patent specification
`
`is said to describe an improvement over the acknowledged prior art, where
`
`the improvement involves assigning patients to risk groups based on the risk
`
`3
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`IPR2015-01102
`Patent 6,315,720 B1
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`that the drug will cause adverse side effects. The improvement further
`
`requires entering the risk group assignment in the storage medium. After
`
`determining the acceptability of likely adverse effects, a prescription
`
`approval code is generated to the pharmacy before the prescription is filled.
`
`Id. at 2:60–3:4. The specification states that this method may minimize and
`
`simplify demands on the pharmacy and reduce the risk that the drug will be
`
`dispensed to a contraindicated individual. Id. at 2:8–12.
`
`The ’720 patent specification states that it is preferable that
`
`information probative of the risk of a drug’s side effects is collected from the
`
`patient. Id. at 6:30–33. This information can then be compared with a
`
`defined set of risk parameters for the drug, allowing for assignment of the
`
`patient to a particular risk group. Id. at 6:33–37. If the risk of adverse side
`
`effects is deemed acceptable, the patient may receive the drug from a
`
`registered pharmacy, subject to conditions such as a negative pregnancy test,
`
`but may not receive refills without a renewal prescription from the
`
`prescriber. Id. at 11:62–12:8.
`
`The ’720 patent specification states that its method can be used to
`
`deliver teratogenic drugs, and drugs that can cause severe birth defects when
`
`administered to a pregnant woman, such as thalidomide. Id. at 4:1–14,
`
`8:39–45.
`
`
`
`
`
`C. Illustrative Claims
`
`The ’720 patent contains two independent claims and thirty dependent
`
`claims, all of which are challenged by Petitioner. Each of the independent
`
`claims, claims 1 and 28, is directed to a method of delivering a drug to a
`
`patient in need of the drug and is written in a Jepson claim format, where the
`
`4
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`IPR2015-01102
`Patent 6,315,720 B1
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`preamble defines admitted prior art of prescribing drugs only after a
`
`computer readable storage medium has been consulted properly. The
`
`claimed improvement over the admitted prior art includes defining a
`
`plurality of patient risk groups, defining information to be obtained from a
`
`patient that is probative of risk of an adverse side effect, assigning the
`
`patient to a risk group, determining whether the risk of the side effect is
`
`acceptable, and generating an approval code to be retrieved by a pharmacy
`
`before filling a prescription for the drug.
`
`Claims 2–27 depend, directly or through other dependent claims, upon
`
`claim 1. Dependent claims 2–4 and require that a prescription is filled only
`
`following verified full disclosure and consent of the patient. Dependent
`
`claims 5–6 require that the informed consent is verified by the prescriber at
`
`the time the patient is registered in a computer, and consent is transmitted
`
`via facsimile and interpreted by optical character recognition software.
`
`Dependent claims 7–10 require information be obtained from the patient
`
`prior to treatment, including the results of diagnostic testing, which can
`
`comprise genetic testing. Dependent claims 11–14 and 20–25 further
`
`require additional features, such as a teratogenic effect being otherwise
`
`likely to arise in the patient, arise in a fetus carried by the patient, and that
`
`the drug is thalidomide. Dependent claims 15–19 and 26–27 require
`
`defining a second set of information to be collected from the patient on a
`
`periodic basis, which can comprise a telephonic survey regarding the results
`
`of pregnancy testing, and where the adverse side effect of the drug can be a
`
`teratogenic effect.
`
`Dependent claims 29–32 each depend, directly or through other
`
`dependent claims, from independent claim 28. Dependent claims 29–32
`
`5
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`IPR2015-01102
`Patent 6,315,720 B1
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`further require that the information collected be probative of likelihood that
`
`the patient may take the drug and other drugs in combination, and that the
`
`diagnostic testing test for evidence of the use and adverse effect of the other
`
`drug.
`
`Independent claim 1 is illustrative of the challenged claims, and is
`
`recited below:
`
`In a method for delivering a drug to a patient in need of
`1.
`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:
`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.
`
`
`
`Claim 28, the only other independent claim, includes all the elements of
`
`claim 1 and adds a wherein clause that “said adverse side effect is likely to
`
`6
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`IPR2015-01102
`Patent 6,315,720 B1
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`arise in patients who take the drug in combination with at least one other
`
`drug.” Prelim. Resp. at 15.
`
`
`
`
`
`D. Prior Art Relied Upon
`
`Petitioner relies upon the following prior art:
`
`R.J. Powell & J.M.M Gardner-Medwin, Guideline for the clinical use and
`dispensing of thalidomide, 70 POSTGRAD MED. J. 901, 901–04 (1994)
`(“Powell”) (Ex 1006)
`
`Benjamin R. Dishman et al., Pharmacists’ role in clozapine therapy at a
`Veterans Affairs medical center, 51 AM. J. HOSP. PHARM. 899, 899–901
`(1994) (“Dishman”) (Ex 1007)
`
`U.S. 5,832,449; Nov. 3, 1998 (“Cunningham”) (Ex. 1008)
`
`James C. Mundt, Interactive Voice Response Systems in Clinical Research
`and Treatment, 48:5 PSYCHIATRIC SERVICES 611, 611–12, 623 (1997)
`(“Mundt”) (Ex. 1017)
`
`Thaddeus Mann & Cecelia Lutwak-Mann, Passage of Chemicals into
`Human and Animal Semen: Mechanisms and Significance, 11:1 CRC
`CRITICAL REVIEWS IN TOXICOLOGY 1, 1–14 (1982) (“Mann”) (Ex. 1018)
`
`Cori Vanchieri, Preparing for Thalidomide’s Comeback, 127:10 ANNALS OF
`INTERNAL MED. 951, 951–54 (1997) (“Vanchieri”) (Ex. 1019)
`
`Arthur F. Shinn et al., Development of a Computerized Drug Interaction
`Database (MedicomSM) for Use in a Patient Specific Environment,
`17 DRUG INFORM. J. 205, 205–10 (1983) (“Shinn”) (Ex. 1020)
`
`R. Linnarsson, Decision support for drug prescription integrated with
`computer-based patient records in primary care, 18:2 MED. INFORM.
`131, 131–42 (1993) (“Linnarsson”) (Ex. 1021)
`
`P.E. Grönroos et al., A medication database – a tool for detecting drug
`interactions in hospital, 53 EUR. J. CLIN. PHARMACOL. 13, 13–
`17 (1997) (“Grönroos”) (Ex. 1022)
`
`7
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`IPR2015-01102
`Patent 6,315,720 B1
`
`M. Soyka et al., Prevalence of Alcohol and Drug Abuse in Schizophrenic
`Inpatients, 242 EUR. ARCH. PSYCHIATRY CLIN. NEUROSCI. 362, 362–72
`(1993) (“Soyka”) (Ex. 1023)
`
`Edna Hamera et al., Alcohol, Cannabis, Nicotine, and Caffeine Use and
`Symptom Distress in Schizophrenia, 183:9 J. OF NERVOUS AND
`MENTAL DISEASE 559, 559–65 (1995) (“Hamera”) (Ex. 1024)
`
`Thomas R. Kosten & Douglas M. Ziedonis, Substance Abuse and
`Schizophrenia: Editors’ Introduction, 23:2 SCHIZOPHRENIA BULLETIN 181,
`181–86 (1997) (“Kosten”) (Ex. 1025)
`
`Jeffrey C. Menill, Substance Abuse and Women on Welfare, NATIONAL
`CENTER ON ADDICTION AND SUBSTANCE ABUSE AT COLUMBIA
`UNIVERSITY 1–8 (1994) (“Menill”) (Ex. 1026)
`
`Petitioner contends that the challenged claims are unpatentable under
`
`
`
`35 U.S.C. § 103 based on the following specific grounds (Pet. 14–60):
`
`
`
`Reference(s)
`
`Basis
`
`Claims challenged
`
`Powell and Dishman in view of
`Cunningham and further in view of
`Mundt, Mann, Vanchieri, Shinn,
`Linnarsson, Grönroos, Soyka,
`Hamera, Kosten, and Menill.1
`
`§ 103
`
`1–32
`
`
`1 Petitioner’s heading merely states that claims 1–32 are obvious over
`Powell and Dishman in view of Cunningham and further in view of the
`knowledge of one of ordinary skill in the art. Pet. 17. The Petition,
`however, goes on to rely upon additional art to explain the knowledge
`possessed by one skilled in the art at the time of the invention and cites
`additional references to support its position. Specifically, the Petitioner
`relies upon Mundt, Mann, Vanchieri, Shinn, Linnarsson, Grönroos, Soyka,
`Hamera, Kosten, and Menill. In the Decision to Institute we include the
`additional art relied upon, Mundt, Mann, Vanchieri, Shinn, Linnarsson,
`Grönroos, Soyka, Hamera, Kosten, and Menill, in the stated grounds, so that
`the record was clear as to the prior art relied upon. Dec. on Inst.
`
`8
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`IPR2015-01102
`Patent 6,315,720 B1
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`
`
`E. Level of Ordinary Skill in the Art
`
`The person of ordinary skill in the art is a hypothetical person who is
`
`presumed to have known the relevant art at the time of the invention.
`
`Factors that may be considered in determining the level of ordinary skill in
`
`the art include, but are not limited to, the types of problems encountered in
`
`the art, the sophistication of the technology, and educational level of active
`
`workers in the field. In a given case, one or more factors may predominate.
`
`In re GPAC, 57 F.3d 1573, 1579 (Fed. Cir. 1995).
`
`The challenged claims are directed to the subject matter of 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. The
`
`claims are said to be an improvement over prior art distribution systems
`
`where the improvement includes using an approval code to help minimize
`
`and simplify demands on a pharmacy and reduce the risk that the drug will
`
`be dispensed to a contraindicated individual. Ex. 1001 at 2:8–12.
`
`Petitioner contends that a person skilled in the art of pharmaceutical
`
`prescriptions, which would involve controlling distribution of a drug,
`
`typically would have either a Pharm.D. or a B.S. in pharmacy with
`
`approximately 5–10 years of experience and a license to practice as a
`
`registered pharmacist in any one or more of the United States. Ex. 1027,
`
`Declaration of Dr. Jeffrey Fudin, ¶¶ 13, 16. Patent Owner disagrees with
`
`Petitioner’s definition of a person of ordinary skill in art contends that such a
`
`person would have at least 2 years of experience in risk management relating
`
`to pharmaceutical drug products or a B.S. or M.S. in pharmaceutical drug
`
`product risk management or a related field. PO Resp. 12–13.
`
`9
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`IPR2015-01102
`Patent 6,315,720 B1
`
`Based on the record presented, we hold that the cited prior art is
`
`representative of the level of ordinary skill in the art. See Okajima v.
`
`Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). The prior art references,
`
`like the ’720 patent specification, focus on controlling the distribution of a
`
`drug. See, e.g., Ex. 1001, 1:13–16 (describing “the distribution to patients of
`
`drugs, particularly teratogenic drugs, in ways wherein such distribution can
`
`be carefully monitored and controlled”); see generally Exs. 1003; 1008;
`
`1011; 2062; 2066. Consistent with the prior art, Petitioner’s Declarant, Dr.
`
`Fudin, testifies that the types of problems encountered by one of ordinary
`
`skill in the art included creating a restricted drug distribution program to
`
`prevent adverse side effects, such as teratogenic risks. Ex. 1027 ¶¶ 44–50.
`
`Accordingly, the prior art demonstrates that one of ordinary skill in the art
`
`would have experience in controlling the distribution of a drug. To the
`
`extent a more specific definition is required, we hold, for the reasons
`
`provided below, that a person of ordinary skill in the art would have several
`
`years of experience in risk management relating to pharmaceutical drug
`
`products, which encompasses experience as a pharmacist.
`
`Patent Owner contends that a pharmacist would not be considered a
`
`person of ordinary skill in the art. Patent Owner relies upon the declaration
`
`of Dr. Frau, who testifies that “an average pharmacist at the time of the
`
`invention would have lacked the ability and the motivation to design an all
`
`inclusive system of drug delivery for a hazardous drug that is focused on
`
`preprescription patient assessment.” Ex. 2059, ¶ 47. The challenged claims,
`
`however, are directed to an improvement of an existing drug distribution
`
`method that provides an approval code after a prescriber has prescribed the
`
`drug. Specifically, the approval code checks to see if all the requisite
`
`10
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`IPR2015-01102
`Patent 6,315,720 B1
`
`information was properly registered in the storage medium and if the
`
`approval code is provided the pharmacy provides the drug. Ex. 1001,
`
`14:45–57. Additionally, as to preprescription patient, Dr. Frau fails to
`
`explain why pharmacists would lack awareness of preprescription patient
`
`assessment for drugs requiring prescriptions, e.g., checking patient history to
`
`prevent prescription of contraindicated drugs.
`
`
`
`Patent Owner contends that neither of the inventors of the challenged
`
`patent are pharmacists and relies upon the Dr. Frau’s testimony as support
`
`for its position. Ex. 2059, ¶ 46. Although Dr. Frau states that the inventors
`
`are not pharmacists, Dr. Frau does not provide the basis for her testimony.
`
`
`
`Patent Owner contends that the focus of the ’720 patent is avoiding
`
`adverse events associated with drug products and not pharmaceutical
`
`prescriptions. PO Resp. 13. The challenged claims, however, do not
`
`prevent a patient taking a drug from experiencing the side effects associated
`
`with the drug. Rather, the challenged claims attempt to prevent a person
`
`from obtaining a drug where the person has an unacceptable risk associated
`
`with the known side effects of the drug. Specifically, the claims seek to
`
`control the distribution of a prescribed drug.
`
`
`
`Patent Owner, relying on the testimony of Dr. Frau, contends that a
`
`person of ordinary skill in the art would have education or experience
`
`focused on safety surveillance, pharmacovigilance or
`
`pharmacoepidemiology. Id. at 14. On cross-examination, Dr. Frau did not
`
`identify any schools in the United States that offered a degree in
`
`pharmaceutical risk management or related fields, such as
`
`pharmacoepidemiology, but did identify two schools located outside the
`
`United States. Ex. 1086, 166:19–167:19.
`
`11
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`
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`Patent Owner contends that Dr. Fudin acknowledged on cross-
`
`examination that, under his definition, one of ordinary skill in the art would
`
`not know how to design the “full system” claimed in the ’720 patent. PO
`
`Resp. 15 (citing Ex. 2061, 199:8–200:25). The challenged claims of the
`
`’720 patent are Jepson claims where the preamble defines admitted prior art.
`
`On this record it is unclear whether Dr. Fudin was testifying that a person of
`
`ordinary skill under his definition would be unable to develop the admitted
`
`prior art. Regardless, Dr. Fudin testified that pharmacists “don’t need to
`
`know how to design it,” which is distinct from would not know how to
`
`design it. Ex. 2061, 201:1–6.
`
`
`
`We credit Dr. Fudin’s testimony that a person of ordinary skill in the
`
`art would encompass a pharmacist as his testimony is consistent with the
`
`’720 patent specification, which states that the use of the approval code is
`
`focused on helping a pharmacy and a pharmacist would understand what
`
`would help simplify demands on a pharmacy. Ex. 1001 at 2:8–12. We
`
`likewise credit Dr. Frau’s testimony that the person of ordinary skill in the
`
`art is not limited to pharmacists but would likewise encompass persons
`
`having at least 2 years of experience in risk management relating to
`
`pharmaceutical products as pharmacists are not the only persons having
`
`restricted drug distribution experience and knowledge. Ex. 2059, ¶ 39.
`
`
`
`II. ANALYSIS
`
`
`
`
`
`A.
`
`Claim Interpretation
`
`In an inter partes review, claim terms in an unexpired patent are given
`
`their broadest reasonable interpretation in light of the specification of the
`
`patent in which they appear. 37 C.F.R. § 42.100(b).
`
`12
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`IPR2015-01102
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`Generally, Petitioner states that the claim terms are presumed to take
`
`on the ordinary and customary meaning that they would have to one of
`
`ordinary skill in the art. Pet. 10. Petitioner proposes constructions for
`
`several claim terms including “consulted,” “teratogenic effect,” and “adverse
`
`side effect.” Id. at 9–11. Patent Owner does not propose distinct
`
`constructions of the identified terms. We determine that the identified claim
`
`terms should be given their ordinary and customary meaning, as would be
`
`understood by one with ordinary skill in the art, and need not be construed
`
`explicitly at this time for purposes of this Decision.
`
`Independent claims 1 and 28 are written in a Jepson claim format.
`
`Patent Owner acknowledges that the challenged claims are written to be an
`
`improvement over its prior program for controlling patient access to
`
`thalidomide known as the System for Thalidomide Education and
`
`Prescribing Safety, or S.T.E.P.S., which originally was claimed in U.S.
`
`Patent No. 6,045,501. Prelim. Resp. at 1, 10.
`
`Patent Owner contends that the term “prescription approval code”
`
`requires construction and that the term has a specific meaning. PO Resp.
`
`21–23. According to Patent Owner, the term “prescription approval code”
`
`means:
`
`[A] code representing that an affirmative risk assessment has
`been made based upon risk-group assignment and the
`information collected from the patient, and that is generated
`only upon a determination that the risk of a side effect
`occurring is acceptable.
`
`Id. at 22–23. Petitioner disagrees stating that there is no requirement for an
`
`“affirmative” risk assessment. Reply 7–9.
`
`The specification defines prescription approval code such that the
`
`13
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`IPR2015-01102
`Patent 6,315,720 B1
`
`prescription approval code is not provided unless certain conditions are met.
`
`Ex. 1001, 13:42–52. The conditions include the prescriber, pharmacy,
`
`patient, patient’s risk group and the patient’s informed consent have been
`
`properly registered in the storage medium. Id. Specifically, the ’720 patent
`
`specification describes “approval code” as follows:
`
`In certain embodiments of the invention, the methods may
`require that the registered pharmacy consult the computer
`readable medium to retrieve a prescription approval code before
`dispensing the drug to the patient. This approval code is
`preferably not provided unless the prescriber, the pharmacy, the
`patient, the patient’s risk group and the patient’s informed
`consent have been properly registered in the storage medium.
`Additionally, depending upon the risk group assignment,
`generation of the prescription approval code may further require
`the registration in the storage medium of the additional set of
`information, including periodic surveys and the results of
`diagnostic tests, as have been defined as being relevant to the
`risk group assignment.
`
`
`Id. The specification also states that if a patient’s risk group assignment so
`
`indicates, a prescription approval code “generally” will not be generated
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`until specific periodic diagnostic tests have been performed and satisfactory
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`results entered into the storage medium. Id. at 14:37–15:6. As apparent
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`from the specification, the prescription approval code is “preferably” or
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`“generally” not provided unless certain information is properly registered in
`
`a storage medium. An affirmative risk assessment, however, is not
`
`mentioned in the specification as a mandatory requirement for generation of
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`the prescription approval code.
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`
`
`Patent Owner contends that during prosecution they overcame a prior-
`
`art rejection by defining the term prescription approval code. PO Resp. 22–
`
`23. Specifically, Patent Owner overcame the rejection by noting that the
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`14
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`Patent 6,315,720 B1
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`prior art cited by the Examiner merely described an “identifier for the
`
`prescription, and is not an approval code as recited in Applicant’s claims.”
`
`Ex. 1002, 107. Patent Owner also stated that the prior art was merely a
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`prescription identifier and not reflective of a determination that the risk of
`
`the side effect occurring has been found to be acceptable. Id.
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`
`
`Patent Owner also states both Petitioner’s expert (Dr. Fudin) and
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`Patent Owner’s expert (Dr. Frau) agree with Patent Owner’s claim
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`construction. PO Resp. 23 (citing Ex. 2059 ¶¶ 50–52, Ex. 2060 ¶¶ 36–38,
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`Ex. 2061, 434:8–15). Patent Owner notes that Dr. Fudin also insisted that
`
`the claimed prescription code is just a number and could even be a credit
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`card. Id. (citing Ex. 2061 at 432:21–24).
`
`
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`During cross examination, Dr. Fudin was asked questions regarding
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`the meaning of the terms “approval code” and “prescription approval code.”
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`Ex. 2061 at 412:17–25, 429:18–430:10, 433:14–434:15. When Dr. Fudin
`
`was asked what an “approval code” means as used in the ’720 patent claims,
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`Dr. Fudin testified that it meant a code generated to allow a prescription to
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`be filled and noted that it could be like a consumer credit card approval
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`code. Id. at 412:17–25. When questioned as to how Cunningham taught an
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`approval code used to represent a determination made concerning risk of
`
`side effects, Dr. Fudin testified that the code is used to track things and the
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`technology should allow you to combine it with other materials that you
`
`could track. Id. at 429:18–430:10. When Dr. Fudin was asked whether the
`
`claimed prescription approval code was merely a number, Dr. Fudin stated
`
`that it was a number associated with the prescription and agreed that the
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`claimed prescription approval code represented a determination that the risk
`
`of a side effect occurring was acceptable and that approval and affirmative
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`15
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`IPR2015-01102
`Patent 6,315,720 B1
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`decision had been made for the prescription to be filled. Id. at 433:14–
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`434:15.
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`
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`Based on the record presented, we adopt Patent Owner’s construction
`
`of the term prescription approval code. Specifically, we credit Dr. Fudin’s
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`testimony that an approval code may be an identifier, such as an approval
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`code identifier used in consumer credit card transactions
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`(approved/declined). We further credit Dr. Fudin’s testimony, as well as Dr.
`
`Frau and Dr. DiPiro’s, that a prescription approval code represents the fact
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`that a prescription has been provided and that the prescription approval code
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`thereby represents that an affirmative risk assessment has been made based
`
`upon risk-group assignment and the information collected from the patient,
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`and that is generated only upon a determination that the risk of a side effect
`
`occurring is acceptable.
`
`
`
`B.
`
`
`
`Claims 1–32 Obviousness over Powell and Dishman in view of
`Cunningham and further in view of Mundt, Mann, Vanchieri,
`Shinn, Linnarsson, Grönroos, Soyka, Hamera, Kosten, and
`Menill
`
`Petitioner contends that the challenged claims, which utilize approval
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`codes to implement known drug restriction requirements, represent no more
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`than an arrangement of old elements with each performing the same
`
`functions it had been known to perform and yields no more than one would
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`expect from such an arrangement. Pet. 23. Patent Owner disagrees. PO
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`Resp. 24–60.
`
`
`
`1. Background on Obviousness
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`A claimed invention is not patentable under 35 U.S.C. § 103 if it is
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`16
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`Patent 6,315,720 B1
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`obvious. See KSR Int’l v. Teleflex Inc., 550 U.S. 398, 426–27 (2007). In
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`Graham v. John Deere Co., the Supreme Court established the facts
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`underlying an obviousness inquiry.
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`Under § 103, the scope and content of the prior art are to be
`determined; differences between the prior art and the claims at
`issue are to be ascertained; and the level of ordinary skill in the
`pertinent art resolved. Against this background, the obviousness
`or nonobviousness of the subject matter is determined.
`
`Graham v. John Deere Co., 383 U.S. 1, 17 (1966). In addressing the
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`findings of fact, “[t]he combination of familiar elements according to known
`
`methods is likely to be obvious when it does no more than yield predictable
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`results.” KSR, 550 U.S. at 416. As explained in KSR:
`
`If a person of ordinary skill can implement a predictable
`variation, § 103 likely bars its patentability. For the same reason,
`if a technique has been used to improve one device, and a person
`of ordinary skill in the art would recognize that it would improve
`similar devices in the same way, using the technique is obvious
`unless its actual application is beyond his or her skill.
`
`Id. at 417. Accordingly, a central question in analyzing obviousness is
`
`“whether the improvement is more than the predictable use of prior art
`
`elements according to their established functions.” Id.
`
`
`
`2. Scope and Content of the Prior Art
`
`a. Powell
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`Powell is an article that describes guidelines designed to promote the
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`safest possible clinical use and dispensing of thalidomide. Ex. 1006, 901.
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`Powell teaches that certain patients should be specifically excluded from
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`treatment with thalidomide. Id. Patients to be excluded include women of
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`childbearing potential who have not practiced a reliable form of
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`17
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`IPR2015-01102
`Patent 6,315,720 B1
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`contraception for 1 year, are unwilling to take reliable contraceptive
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`precautions, and those who are not considered capable of complying with
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`the requirements for reliable contraception. Id. Additionally, Powell
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`excludes pregnant women by requiring that a pregnancy test be taken within
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`the 2 weeks prior to starting therapy. Id.
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`
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`Powell teaches that fully informed consent should be obtained using a
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`written consent form. Id. Powell also teaches that appropriate clinical and
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`electrophysiological measurements should be recorded before treatment is
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`commenced, and that follow-up visits should be at monthly intervals. Id. at
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`902. Warnings about possible toxicity and adequate contraception should be
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`reinforced during the follow-up visits. Id. Powell provides a sample patient
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`information sheet containing information regarding use and potential side
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`effects of thalidomide including “[d]amage to babies.” Id. at 902–903.
`
`
`
`b. Dishman
`
`Dishman is an article that describes a Veterans Affairs program for
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`controlling the dispensation of clozapine, an antipsychotic drug. Ex. 1007.
`
`A high frequency side effect of clozapine is agranulocytosis, a life-
`
`threatening side effect. Id. at 899. To avoid such effects, Dishman teaches
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`that prescribers and patients must be registered in a national registry,
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`patients are monitored weekly, and that only a one-week supply is dispensed
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`at a time. Id. Further, pharmacists may only dispense clozapine upon the
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`pharmacist’s verification that the patient’s white blood cell counts are within
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`acceptable limits. Id.
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`To ensure proper patient monitoring, the VA developed its own
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`clozapine monitoring program. Id. at 900. The VA established a National
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`18
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`IPR2015-01102
`Patent 6,315,720 B1
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`Clozapine Coordinating Center (NCCC) where physicians review each
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`candidate’s file before granting approval for use and review weekly patient
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`tracking sheets. Id. The NCCC requires each hospital have a computerized
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`clozapine prescription lockout system tied to the hospital’s laboratory
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`database and outpatient pharmacy dispensing software. Id. The lockout
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`system prevents the filling of a clozapine prescription where the computer
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`notices three consecutive drops in the white blood cell count. Id.
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`Dishman teaches that the NCCC requires extensive patient evaluation
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`and documentation. Id. In particular, a complete physical examination is
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`required and certain clozapine therapy contraindica
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