Trials@uspto.gov
`571.272.7822
`
`
`
`
`
`Papel No. 73
` 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 IPR2015-01096
`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. 73
` 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 IPR2015-01096
`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
`
`
`
`
`
`
`
`IPR2015-01096
`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 40 (“PO Resp.” with redacted version Paper 41).
`
`Petitioner filed a Reply. Paper 52, (“Reply” with readacted version paper
`
`51). Additionally, Petitioner filed a Motion to Submit Supplemental
`
`Information (Paper 36), a Motion to Exclude Evidence (Paper 61), and a
`
`Motion to Seal (Paper 53). Further, Patent Owner filed a Motion to Exclude
`
`Evidence (Paper 60) and Motions to Seal and for Entry of Protective Order
`
`(Papers 10 and 39).
`
`
`
`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 72 (“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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`
`
`IPR2015-01096
`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. 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, IPR2015-01102
`
`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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`
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`IPR2015-01096
`Patent 6,315,720 B1
`
`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, 1 and 28, are 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 preamble
`
`4
`
`
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`IPR2015-01096
`Patent 6,315,720 B1
`
`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 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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`IPR2015-01096
`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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`IPR2015-01096
`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:
`
`“THALOMID™ (thalidomide) Capsules Revised Package Insert”
`(Jul. 15, 1998) (“Thalomid PI”) (Ex. 1006)
`
`U.S. 5,832,449, Nov. 30, 1998 (“Cunningham”) (Ex. 1009)
`
`Jerome B. Zeldis et al., S.T.E.P.S.TM: A Comprehensive Program for
`Controlling and Monitoring Access to Thalidomide, CLINICAL
`THERAPEUTICS® 21:2, 319–30 (1999) (“Zeldis”) (Ex. 1012)
`
`
`Daniel P. Keravich and Charles E. Daniels, Challenges of Thalidomide
`Distribution in a Hospital Setting, AM. J. HEALTH-SYST. PHARM. vol. 56,
`1721–75 (Sept. 1, 1999) (“Keravich”) (Ex. 1018)
`
`James C. Mundt, Interactive Voice Response Systems in Clinical Research
`and Treatment, PSYCHIATRIC SERVICES (May 1997) 48:5, 611–12, 623
`(“Mundt”) (Ex. 1024)
`
`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
`
`Thalomid PI in view of
`Cunningham and further in view of
`Keravich, Zeldis, and Mundt1
`
`§ 103
`
`1–32
`
`
`1 Petitioner’s heading merely states that claims 1–32 are obvious over
`Thalomid PI in view of Cunningham and further in view of the knowledge
`of one of ordinary skill in the art. Pet. 51. The Petition, however, goes on to
`rely upon additional art to explain the Thalomid PI reference. Specifically,
`the Petitioner relies upon Keravich, Zeldis, and Mundt. Id. at 17, 24–25, 33,
`
`7
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`IPR2015-01096
`Patent 6,315,720 B1
`
`
`
`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. 1021,
`
`Declaration of Dr. Jeffrey Fudin ¶¶ 13, 16. Patent Owner disagrees with
`
`Petitioner’s definition of a person of ordinary skill in art and contends that
`
`
`42, 46–47, 49–50, and 55–56. In the Decision to Institute we included the
`additional art relied upon, Keravich, Zeldis, and Mundt, 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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`IPR2015-01096
`Patent 6,315,720 B1
`
`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.
`
`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, 1006,
`
`1009, 1012, 1018. 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. 1021 ¶¶ 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,
`
`9
`
`
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`IPR2015-01096
`Patent 6,315,720 B1
`
`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
`
`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 assessment, 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
`
`10
`
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`IPR2015-01096
`Patent 6,315,720 B1
`
`pharmaceutical risk management or related fields, such as
`
`pharmacoepidemiology, but did identify two schools located outside the
`
`United States. Ex. 1075, 166:19–167:19.
`
`
`
`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.
`
`
`
`11
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`IPR2015-01096
`Patent 6,315,720 B1
`
`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).
`
`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. at 10. Petitioner however, 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 these 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.
`
`21–22. 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
`
`12
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`IPR2015-01096
`Patent 6,315,720 B1
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`only upon a determination that the risk of a side effect
`occurring is acceptable.
`
`Id. at 21, 23. Petitioner disagrees, stating that there is no requirement for an
`
`“affirmative” risk assessment. Reply 9–12.
`
`The specification defines prescription approval code such that the
`
`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
`
`until specific periodic diagnostic tests have been performed and satisfactory
`
`results entered into the storage medium. Id. at 14:37–15:6. As apparent
`
`from the specification, the prescription approval code is “preferably” or
`
`“generally” not provided unless certain information is properly registered in
`
`a storage medium. An affirmative risk assessment, however, is not
`
`13
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`IPR2015-01096
`Patent 6,315,720 B1
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`mentioned in the specification as a mandatory requirement for generation of
`
`the prescription approval code.
`
`
`
`Patent Owner contends that during prosecution they overcame a prior-
`
`art rejection by defining the term prescription approval code. PO Resp. 22.
`
`Specifically, Patent Owner overcame the rejection by noting that the prior
`
`art cited by the Examiner merely described an “identifier for the
`
`prescription, and . . . not an approval code as recited in Applicant’s claims.”
`
`Ex. 1002, 107. Patent Owner also stated that the prior art was merely a
`
`prescription identifier and not reflective of a determination that the risk of
`
`the side effect occurring has been found to be acceptable. Id.
`
`
`
`Patent Owner also states both Petitioner’s expert (Dr. Fudin) and
`
`Patent Owner’s expert (Dr. Frau) agree with Patent Owner’s claim
`
`construction. PO Resp. 23, citing Ex. 2059 ¶¶ 50–52, Ex. 2060 ¶¶ 36–38,
`
`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 card.
`
`Id. citing Ex. 2061 at 432:21–24.
`
`
`
`During cross examination, Dr. Fudin was asked questions regarding
`
`the meaning of the terms “approval code” and “prescription approval code.”
`
`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,
`
`Dr. Fudin testified that it meant a code generated to allow a prescription to
`
`be filled and noted that it could be like a consumer credit card approval
`
`code. Id. at 412:17–25. When questioned as to how Cunningham taught an
`
`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
`
`technology should allow you to combine it with other materials that you
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`14
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`Patent 6,315,720 B1
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`could track. Id. at 429:18–430:10. When Dr. Fudin was asked whether the
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`claimed prescription approval code was merely a number, Dr. Fudin stated
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`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
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`of a side effect occurring was acceptable and that approval and affirmative
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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.
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`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
`
`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.
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`
`
`B.
`
`
`
`Claims 1–32 Obviousness over Thalomid PI in view of
`Cunningham and Further in view of Keravich, Zeldis, and
`Mundt
`
`Petitioner contends that the challenged claims, which utilize approval
`
`codes to implement known drug restriction requirements, represent no more
`
`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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`15
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`IPR2015-01096
`Patent 6,315,720 B1
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`expect from such an arrangement. Pet. 53–54. Patent Owner disagrees. PO
`
`Resp. 16–58.
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`
`
`1. Background on Obviousness
`
`A claimed invention is not patentable under 35 U.S.C. § 103 if it is
`
`obvious. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 426–27 (2007).
`
`In Graham v. John Deere Co., the Supreme Court established the facts
`
`underlying an obviousness inquiry.
`
`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
`
`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
`
`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.
`
`
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`16
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`2. Scope and Content of the Prior Art
`
`a. Thalomid PI
`
`Thalomid PI is a thalidomide capsules revised package insert.
`
`Ex. 1006, 1. Thalomid PI states that, in an effort to make the chance of fetal
`
`exposure to thalidomide as negligible as possible, thalidomide is approved
`
`by the FDA only under a special restricted distribution program. Id. The
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`restricted program is called “System for Thalidomide Education and
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`Prescribing Safety,” (i.e., “S.T.E.P.S.”). Id. According to Thalomid PI, only
`
`prescribers and pharmacists registered with the program may prescribe and
`
`dispense the product. Id. Further, under the program, patients must be
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`advised of, and agree to, comply with the S.T.E.P.S. program in order to
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`receive the product. Id. For example, Thalomid PI states that prescriptions
`
`for thalidomide for women of childbearing potential must not be issued until
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`a written report of a negative pregnancy test has been obtained by the
`
`prescriber. Id. at 2. For sexually mature males, patients must acknowledge
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`the need for using barrier contraception. Id. at 4. Sexually mature males
`
`and women of childbearing potential also are required to be capable of
`
`complying with a S.T.E.P.S. patient survey. Id. at 3–4. Thalidomide is to be
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`supplied only to pharmacists registered with the S.T.E.P.S. program, and
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`patient compliance with the specific informed consent and patient registry
`
`and survey are required prior to dispensing thalidomide. Id. at 19.
`
`Thalomid PI describes counseling patients by giving patients both oral
`
`and written warnings of the hazards of taking thalidomide. Id. at 3–4. In
`
`addition to counseling, before starting treatment, women of childbearing
`
`potential should have a pregnancy test within 24 hours prior to beginning
`
`therapy, so as to avoid risks of severe birth defects or death to an unborn
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`17
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`IPR2015-01096
`Patent 6,315,720 B1
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`baby. Id. at 1–2. Further, women of childbearing potential are to be referred
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`to a qualified provider of contraceptive methods, if needed. Id. at 2.
`
`Authorization for thalidomide is provided by a physician only after the
`
`patient and physician acknowledge that the patient has been given a warning
`
`as to the nature, purpose, and risks of the treatment. Id. at 21.
`
`When taking thalidomide, Thalomid PI teaches that pregnancy testing
`
`should occur weekly during the first month of use, then monthly thereafter.
`
`Id. at 2. Thalomid PI also teaches that drug prescribing should be contingent
`
`upon initial and confirmed negative results of pregnancy testing. Id. at 18.
`
`In addition to pregnancy testing, white blood cell count and differential
`
`should be monitored on an ongoing basis. Id. at 10. Patients taking
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`thalidomide must participate in a survey and patient registry. Id. at 20–21.
`
`
`
`Thalomid PI describes adverse side effects when taking thalidomide in
`
`combination with other drugs. For example, Thalomid PI teaches that
`
`thalidomide has been reported to enhance sedative activity of barbiturates,
`
`alcohol, chlorpromazine, and reserpine. Id. at 12. Further, medications
`
`known to be associated with peripheral neuropathy are to be used with
`
`caution when taking thalidomide. Id. Thalomid PI also teaches testing
`
`pharmacokinetic profiles of patients on oral contraceptives. Id. at 12.
`
`
`
`b. Cunningham
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`Cunningham describes a method of dispensing, tracking, and
`
`managing pharmaceutical product samples. Ex. 1009, 1:6–10. The method
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`involves communicatively linking prescribers and pharmacies to a central
`
`computing station. Id. at 1:8–11. Specifically, before filling any
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`prescription for a pharmaceutical trial product, a pharmacy must upload
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`18
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`IPR2015-01096
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`defined information into a central computing station. Id. at 11:6–13. Only if
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`the central computing station establishes that the uploaded information is
`
`valid, can the central computing station issue a pharmacy approval code for
`
`the pharmacy to dispense the pharmaceutical product. Id. at 11:13–24.
`
`
`
`c. Keravich
`
`Keravich states that pharmacies under the S.T.E.P.S. program are to
`
`dispense a maximum 28-day supply and that refills are not authorized.
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`Ex. 1018, 1722. Under the S.T.E.P.S. program, patients are eligible to
`
`continue to receive thalidomide, if they participate in a mandatory and
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`confidential patient survey every 30 days for women and 90 days for men.
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`Id. Keravich states that Celgene provides telephone and fax services for
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`patient registration, approval, and prescriber verification. Id. at 1723–24.
`
`Keravich also teaches that the S.T.E.P.S. program patient dat
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