Trials@uspto.gov
`571.272.7822
`
`
`
`
`
`Paper No. 21
`Entered: October 27, 2015
`
`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
`____________
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`Before MICHAEL P. TIERNEY, MICHAEL W. KIM, and
`TINA E. HULSE, Administrative Patent Judges.
`
`TIERNEY, Administrative Patent Judge.
`
`
`571.272.7822
`
`
`
`
`
`Paper No. 21
`Entered: October 27, 2015
`
`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
`____________
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`Before MICHAEL P. TIERNEY, MICHAEL W. KIM, and
`TINA E. HULSE, Administrative Patent Judges.
`
`TIERNEY, Administrative Patent Judge.
`
`
`
`IPR2015-01102
`Patent 6,315,720 B1
`
`INTRODUCTION
`I.
`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.”).
`
`We have jurisdiction under 35 U.S.C. § 314. The standard for
`instituting an inter partes review is set forth in 35 U.S.C. § 314(a), which
`provides:
`THRESHOLD.—The Director may not authorize an inter
`partes review to be instituted unless the Director determines
`that the information presented in the petition filed under section
`311 and any response filed under section 313 shows that there
`is a reasonable likelihood that the petitioner would prevail with
`respect to at least 1 of the claims challenged in the petition.
`
`Upon consideration of the Petition and Preliminary Response, we
`
`conclude that the information presented in the Petition demonstrates that
`there is a reasonable likelihood that Petitioner would prevail in challenging
`claims 1–32 as unpatentable. Pursuant to 35 U.S.C. § 314, we hereby
`authorize an inter partes review to be instituted as to claims 1–32 of the ’720
`patent.
`
`
`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.,
`NJD-2-15-00697 (filed Jan. 30, 2015); Celgene Corp. v. Natco Pharma Ltd.,
`NJD-2-10-cv-05197 (filed Oct. 8, 2010); Celgene Corp. v. Barr
`Laboratories, Inc., NJD-2-08-cv-03357 (filed July 3, 2008); Celgene Corp.
`
`2
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`
`v. Barr Laboratories, Inc., NJD-2-07-cv-05485 (filed Nov. 14, 2007);
`Celgene Corp. v. Barr Laboratories, Inc., NJD-2-07-cv-04050 (filed Aug.
`23, 2007); Celgene Corp. v. Barr Laboratories, Inc., NJD-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
`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.
`
`3
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`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 6:33–36. 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 11:63–12:8.
`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 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 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
`
`4
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`IPR2015-01102
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`for the drug. Independent claim 1 is illustrative of the challenged claims,
`and is recited below:
`1.
`In a method for delivering a drug to a patient in need of
`the drug, while avoiding the occurrence of an adverse side
`effect known or suspected of being caused by said drug,
`wherein said method is of the type in which prescriptions for
`said drug are 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
`arise in patients who take the drug in combination with at least one other
`drug.” Prelim. Resp. 15.
`
`
`5
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`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, 79 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
`computerbased 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)
`
`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)
`
`6
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`
`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
`1–32
`
`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 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. 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 is clear as to the
`prior art relied upon.
`
`7
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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 Inc., 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.
`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 and
`contends that the field of the invention is the avoidance of adverse events
`associated with drug products. Prelim. Resp. 19–21. According to Patent
`Owner, a person of ordinary skill in the art would possess at least a
`bachelor’s degree and at least 2 years of experience in risk management
`relating to drug products or a B.S. or M.S. in pharmaceutical drug product
`risk management or a related field. Patent Owner relies upon the following
`evidence for its definition of a person of ordinary skill in the art:
`Celgene’s definition of a POSA is supported by the claims and
`specification of the ’720 patent. See generally Ex. 1001.
`Id. at 20.
`
`8
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`For purposes of this Decision, we consider the cited prior art as
`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. 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”). 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.
`On this record, we credit the testimony of Dr. Fudin and conclude that
`one of ordinary skill in the art encompasses 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.
`Patent Owner disputes that Dr. Fudin has the knowledge of a person
`of ordinary skill in the art. Prelim. Resp. 19–21. We disagree. Dr. Fudin’s
`educational background and experience, Pharm.D, Associate Professor of
`Pharmacy practice, and clinical pharmacy specialist experience, demonstrate
`that Dr. Fudin is qualified to testify as to the knowledge of a person of
`ordinary skill in the art. Ex. 1027 ¶¶ 4–14.
`
`
`II. ANALYSIS
`Claim Interpretation
`A.
`
`In an inter partes review, claim terms in an unexpired patent are given
`
`their broadest reasonable interpretation in light of the specification of the
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`patent in which they appear. 37 C.F.R. § 42.100(b); Office Patent Trial
`Practice Guide, 77 Fed. Reg. 48,756, 48,766 (Aug. 14, 2012); see In re
`Cuozzo Speed Techs., LLC, 793 F.3d 1268, 1276–80 (Fed. Cir. 2015).
`Claim terms are given their ordinary and customary meaning, as understood
`by one of ordinary skill in the art in the context of the entire disclosure. In
`re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007).
`Petitioner proposes constructions for several claim terms including
`“consulted,” “teratogenic effect,” and “[a]dverse side effect.” Pet. 9–11.
`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. Id. at 10. 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. 9.
`
`
`
`
`10
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`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
`Claims 1 and 28 are independent claims, and are directed to improved
`methods for delivering a drug to a patient in need, where the improvement
`involves defining a plurality of patient risk groups, defining a set of
`information obtained from the patient, assigning the patient to a risk group,
`determining whether the adverse effects are acceptable and generating an
`approval code where the risk is acceptable.
`
`
`1. Powell
`Powell is an article that describes guidelines designed to promote the
`safest possible clinical use and dispensing of thalidomide. Ex. 1006, 901.
`Powell teaches that certain patients should be specifically excluded from
`treatment with thalidomide. Id. Patients to be excluded include women of
`childbearing potential who have not practiced a reliable form of
`contraception for 1 year, are unwilling to take reliable contraceptive
`precautions, and those who are not considered capable of complying with
`the requirements for reliable contraception. Id. Additionally, Powell
`excludes pregnant women by requiring that a pregnancy test be taken within
`the 2 weeks prior to starting therapy. Id.
`
`Powell teaches that fully informed consent should be obtained using a
`written consent form. Id. Powell also teaches that appropriate clinical and
`electrophysiological measurements should be recorded before treatment is
`commenced, and that follow-up visits should be at monthly intervals. Id. at
`902. Warnings about possible toxicity and adequate contraception should be
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`IPR2015-01102
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`reinforced during the follow-up visits. Id. Powell provides a sample patient
`information sheet containing information regarding use and potential side
`effects of thalidomide including “[d]amage to babies.” Id. at 902–903.
`
`
`2. Dishman
`Dishman is an article that describes a Veterans Affairs program for
`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
`that prescribers and patients must be registered in a national registry,
`patients are monitored weekly, and that only a one-week supply is dispensed
`at a time. Id. Further, pharmacists may only dispense clozapine upon the
`pharmacist’s verification that the patient’s white blood cell counts are within
`acceptable limits. Id.
`To ensure proper patient monitoring, the VA developed its own
`clozapine monitoring program. Id. at 900. The VA established a National
`Clozapine Coordinating Center (NCCC) where physicians review each
`candidate’s file before granting approval for use and review weekly patient
`tracking sheets. Id. The NCCC requires each hospital have a computerized
`clozapine prescription lockout system tied to the hospital’s laboratory
`database and outpatient pharmacy dispensing software. Id. The lockout
`system prevents the filling of a clozapine prescription where the computer
`notices three consecutive drops in the white blood cell count. Id.
`Dishman teaches that the NCCC requires extensive patient evaluation
`and documentation. Id. In particular, a complete physical examination is
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`required and certain clozapine therapy contraindications are noted including
`seizures and pregnancy. Id.
`
`
`3. Cunningham
`Cunningham describes a method of dispensing, tracking, and
`managing pharmaceutical product samples. Ex. 1008, 1:6–8. The method
`involves communicatively linking prescribers and pharmacies to a central
`computing station. Id. at 1:8–11. Specifically, before filling any
`prescription for a pharmaceutical trial product, a pharmacy must upload
`defined information into a central computing station. Id. at 11:6–13. Only if
`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 11:13–23.
`
`
`4. Mundt
`Mundt describes the use of interactive voice response systems for
`clinical research and treatment. Ex. 1017. According to Mundt, the use of
`interactive voice response systems can strengthen clinical practice, extend
`research methods, and enhance administrative support of service quality and
`value. Id. at 612.
`
`
`5. Mann, Vanchieri, Shinn, Linnarsson, Grönroos, Soyka,
`Hamera, Kosten, and Menill
`
`The references, Mann, Vanchieri, Shinn, Linnarsson, Grönroos,
`Soyka, Hamera, Kosten, and Menill (Exs. 1018–1026) are cited by Petitioner
`as indicative of the knowledge of one of ordinary skill in the art. For
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`example, Petitioner cites Mann and Vanchieri as demonstrating that it was
`well known in the art that certain drugs, such as thalidomide, could be
`transmitted to a sexual partner of a male undergoing treatment with the drug.
`Pet. 31–32. Petitioner cites Shinn, Linnarsson, and Grönroos as
`demonstrating that it was well known in the art that drug-drug interactions
`could cause serious and even lethal adverse side effects. Id. at 41–42.
`Petitioner states that Dishman’s regimen was designed to treat
`schizophrenics and that Soyka, Hamera and Kosten demonstrate that it was
`well known in the art that substance abuse was prevalent among
`schizophrenics. Id. at 42–43. Further, Petitioner cites Menill as
`demonstrating that it was well known in the art that people are generally
`reluctant to admit to alcohol or drug abuse and addiction. Id. at 43–44.
`
`
`6. Background on Obviousness
`A claimed invention is not patentable under 35 U.S.C. § 103 if it is
`obvious. See KSR Int’l 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:
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`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.
`We first turn to claims 1 and 28, the only independent claims, and
`then address dependent claims 2–27 and 29–32.
`
`
`7. Analysis
`Petitioner contends that one skilled in the art would understand that
`Powell describes the desirability of obtaining patient information and
`defining patient risk groups, based on the information, when treating patients
`with drugs associated with adverse side effects to certain risk groups.
`Pet. 19. Petitioner states that Powell teaches a checklist for assigning
`patients to risk groups, for example, risk groups that can and cannot be
`administered drugs such as thalidomide. Id. Petitioner states further that
`Powell discloses that risk groups include women who wish to become
`pregnant, and patients who cannot comply with the prescribing instructions.
`Id. at 19–20. Petitioner acknowledges that Powell does not describe
`explicitly the use of a specific computerized registry to store the risk group
`information. Id. Petitioner states that one skilled in the art would recognize
`that storing risk group assignments in a computer registry, such as that
`described by Dishman, would be useful. Id. at 20–21.
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`Petitioner relies upon Dishman for its disclosure of a program for
`tightly controlling the dispensation of the antipsychotic drug clozapine. Id.
`at 20. Specifically, Petitioner cites Dishman for its description of a
`computerized clozapine lockout system that ties a hospital’s lab database to
`outpatient pharmacy dispensing software. Id. at 21. The lockout system
`prevents the filling of clozapine prescriptions where the computer notices
`three consecutive drops in white blood cell count. Id. at 22. Although
`Dishman does not mention an approval code, Petitioner states that it would
`have been obvious to one of ordinary skill in the art at the time of the
`invention to employ an approval code system in the system of Dishman. Id.
`at 22–24. According to Petitioner, it would have been obvious to combine
`Dishman’s computer lockout system with the computer approval code
`system taught by Cunningham to limit the dispensation of a drug, where the
`drug was known to be associated with adverse effects to certain risk groups.
`Id. at 23–24.
`We understand Petitioner as contending that the challenged claims
`represent a combination of known prior art elements (identifying patient risk
`groups, collecting patient information relating to the risk, determining
`whether the risk is acceptable, and controlling dispensation of the drug using
`an approval code) for their known purpose (control distribution of drug) to
`achieve a predictable result (avoid giving patients drugs that have an
`unacceptable risk of side effects).
`
`Patent Owner contends that one skilled in the art would not have
`combined Powell and Dishma,n as they are not directed towards the same
`endeavor. Prelim. Resp. 29. According to Patent Owner, the commercial
`pharmacy distribution of a teratogenic drug is far more complex, and
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`required different management, than distribution to a small group of
`individuals at the Department of Veterans Affairs. Id. Dr. Fudin testifies
`that Powell seeks to promote the safest possible clinical use and dispensing
`of thalidomide, due to the adverse side effect of teratogenicity, and that
`Dishman describes a computerized program for tightly controlling the
`dispensing of an antipsychotic drug, known to cause agranulocytosis.
`Ex. 1027 ¶¶ 78, 92–94. Dr. Fudin concludes that one skilled in the art would
`have been guided to use the computer system of Dishman with the written
`records of Powell, as both references seek to provide a means to monitor and
`authorize distribution of contraindicated drugs. Id. ¶¶ 104, 108. We credit
`Dr. Fudin’s testimony, as it is consistent with the teachings of the prior art,
`and hold that Powell and Dishman are directed towards similar endeavors,
`controlling the distribution of a drug having known adverse side effects.
`
`Patent Owner argues that Cunningham is directed to a different
`endeavor than Powell and Dishman, and that one skilled in the art would not
`have looked to the teachings of Cunningham for a method of restricting
`distribution of pharmaceutical drugs. Prelim. Resp. 30. Cunningham
`describes a system where a pharmacy cannot dispense a pharmaceutical
`product until authenticity is established and a central computing station
`issues a pharmacy approval code. Ex. 1008, 11:6–8, 17–23. Dr. Fudin
`testifies that one skilled in the art would have implemented the methods
`disclosed in Dishman and Cunningham to limit the distribution of a drug.
`Ex. 1027 ¶ 104. Based upon the record presented, we conclude that
`Cunningham is directed to the same general endeavor as Powell and
`Dishman, controlling the distribution of pharmaceutical products.
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`Patent Owner contends that the Clozaril system of Dishman, as a
`
`whole, was a failure, and teaches away from the use of such a system.
`Prelim. Resp. 12–13, 29. Patent Owner relies upon an article by Dr.
`Honigfeld, which describes the effects of the National Clozapine Registry
`System on the incidence of deaths related to agranulocytosis. Id. (citing Ex.
`2014). We note, however, that Honigfeld states that the actual number of
`cases of agranulocytosis and related deaths was lower than expected for the
`national registry maintained by the U.S. manufacturer of clozapine.
`Ex. 2014, 52 (concluding the national registry “brought about lower than
`expected rates of agranulocytosis and associated deaths”). We hold that
`Patent Owner has failed to identify sufficient and credible evidence that the
`specific computerized system described by Dishman, which was approved
`by the U.S. manufacturer of clozapine, was considered by one of ordinary
`skill in the art to be a failure.
`
`According to Patent Owner, Powell fails to disclose assigning patients
`to risk groups and entering the risk group assignment into a computer
`database. Prelim. Resp. 32–33. We disagree. The challenged claims are
`written in a Jepson format, where the admitted prior art recites filling
`prescriptions only after consulting a computer readable storage medium.
`Powell identifies different risk groups, including patients that should be
`excluded such as women who wish to become pregnant and women of
`childbearing potential who have not practiced a reliable form of
`contraception for 1 year. Ex. 1006, 901. Hence, we find that Powell
`discloses that the set of conditions for thalidomide treatment differs based on
`the risk group assigned. Dr. Fudin testifies that, at the time of the invention,
`records would be kept relating to risk groups and that electronic records,
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`such as patient risk group assignments, would be useful and easy to achieve
`through entry on a computer, and that a computerized system, such as that
`taught by Dishman, would help determine which prescriptions should be
`“locked out.” Ex. 1027, 89–94. We credit Dr. Fudin’s testimony, as it is
`consistent with the admitted prior art and prior art of record. Based on the
`record presented, we conclude that one of ordinary skill in the art would
`have assigned risk groups, and entered that information into a computer
`database, to ensure that physicians and pharmacists had access to the
`information when prescribing thalidomide and filling such prescriptions to
`avoid the risk of harmful birth defects.
`
`Patent Owner states that Dishman does not describe risk group
`assignments or determining whether the risk that an adverse effect is likely
`to occur is acceptable. According to Patent Owner, locking out a
`prescription when a patient has three consecutive drops in the white blood
`count has “nothing to do with risk group assignments.” Prelim. Resp. 34.
`We disagree. Dishman teaches that clozapine prescriptions are only to be
`dispensed upon a pharmacist’s verification that the white blood cell count is
`within acceptable limits. Ex. 1007, 899. In other words, Dishman discloses
`that patients having three consecutive drops in the white blood count are
`assigned to such a risk group.
`
`Patent Owner takes the position that Dishman does not describe
`generating an approval code. Prelim. Resp. 35–37. Patent Owner further
`contends that Petitioner has failed to provide a rationale to combine
`Dishman and Cunningham to arrive at the claimed invention. Id. We
`disagree. On this record, we are persuaded that, as recognized by Dr. Fudin,
`one skilled in the art seeking to control the distribution of thalidomide would
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`have looked to the approval code of Cunningham to limit dispensation of a
`drug with known severe adverse side effects to certain risk groups, i.e.,
`further control distribution in order to avoid severe birth defects associated
`with distributing thalidomide to pregnant women. Ex. 1027 ¶¶ 102–105.
`Dr. Fudin’s testimony is consistent with the prior art, e.g., Cunningham’s
`teaching that an approval code validation aids i
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