Trials@uspto.gov
`571.272.7822
`
`
`
`
`
`Papel 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 IPR2015-01096
`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
`
`
`
`
`
`Papel 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 IPR2015-01096
`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.
`
`
`
`IPR2015-01096
`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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`IPR2015-01096
`Patent 6,315,720 B1
`
`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,
`IPR2015-01102 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
`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 11:62–12:8.
`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,
`8:38–45.
`
`
`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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`IPR2015-01096
`Patent 6,315,720 B1
`
`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 effect is likely to arise
`in patients who take the drug in combination with at least one other drug.”
`Prelim. Resp. at 15.
`
`
`D. Prior Art Relied Upon
`
`5
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`IPR2015-01096
`Patent 6,315,720 B1
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`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. § 102 and/or § 103 based on the following specific grounds (Pet.
`14–60):
`
`Reference(s)
`
`Basis
`
`Claims challenged
`
`Thalomid PI
`Thalomid PI in view of Cunningham
`and further in view of Keravich,
`Zeldis, and Mundt1
`
`§ 102
`§ 103
`
`1–32
`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,
`42, 46–47, 49–50, and 55–56. We include the additional art relied upon,
`Keravich, Zeldis, and Mundt, in the stated grounds, so that the record is clear
`as to the prior art relied upon.
`
`6
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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.
`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 and
`contends that the field of the invention is the avoidance of adverse events
`associated with drug products. Prelim. Resp. 19–20. 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:
`
`
`
`7
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`IPR2015-01096
`Patent 6,315,720 B1
`
`Celgene’s definition of a POSA is supported by the claims and
`specification of the ’720 patent. See generally Ex. 1001.
`
`Id. at 20.
`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. 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; 1015; 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.
`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. 1021 ¶¶ 4–14.
`
`8
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`IPR2015-01096
`Patent 6,315,720 B1
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`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); 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 “adverse 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. at 10.
`
`
`
`
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`Claims 1–32 Anticipation by Thalomid PI
`B.
`To anticipate a patent claim under 35 U.S.C. § 102, “a reference must
`describe . . . each and every claim limitation and enable one of skill in the art
`to practice an embodiment of the claimed invention without undue
`experimentation.” Am. Calcar, Inc. v. Am. Honda Motor Corp., 651 F.3d
`1318, 1341 (Fed. Cir. 2011) (citing In re Gleave, 560 F.3d 1331, 1334 (Fed.
`Cir. 2009)).
`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
`restricted program is called “System for Thalidomide Education and
`Prescribing Safety.” 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 advised of, and
`agree to, comply with the S.T.E.P.S. program in order to receive the product.
`Id. For example, Thalomid PI states that prescriptions for thalidomide for
`women of childbearing potential must not be issued until a written report of
`a negative pregnancy test has been obtained by the prescriber. Id. at 2. For
`sexually mature males, patients must acknowledge 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 supplied only to
`pharmacists registered with the S.T.E.P.S. program, and patient compliance
`with the specific informed consent and patient registry and survey are
`required prior to dispensing thalidomide. Id. at 19.
`
`10
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`IPR2015-01096
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`Thalomid PI describes counseling patients by giving patients both oral
`and written warnings of the hazards of taking thalidomide. Id. 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 baby. Id. at 1–
`2. Further, women of childbearing potential are to be referred 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
`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.
`Petitioner contends that Thalomid PI teaches, explicitly or inherently,
`all limitations present in challenged claims 1–32. Patent Owner disagrees.
`
`11
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`For example, Patent Owner contends that Thalomid PI fails to teach or
`describe generating an approval code to be retrieved by a pharmacy before
`filling a prescription. Prelim. Resp. 28–29.
`According to Petitioner, one skilled in the art would recognize that
`Thalomid PI inherently discloses the claimed approval code. Pet. 20–21.
`Petitioner states that an approval code system was a mechanism outlined in
`the S.T.E.P.S. program and inherent in complying with the S.T.E.P.S.
`program. Id. Patent Owner disputes this understanding, stating that the
`original S.T.E.P.S. program did not employ an approval code and that it was
`not until September 2001 that an approval code was put in place. Prelim.
`Resp. 29.
`Petitioner relies upon Dr. Fudin’s testimony to demonstrate the
`inherent use of a prescription approval code in Thalomid PI. Pet. 20–21.
`We are unpersuaded by Dr. Fudin’s testimony, however, because it does not
`identify sufficient and credible evidence to support the conclusion that a
`person of ordinary skill in the art would have recognized that the S.T.E.P.S.
`program at the relevant time necessarily employed a prescription approval
`code. Specifically, Dr. Fudin’s testimony relies upon Thalomid PI’s general
`statements that thalidomide must be administered in compliance with the
`S.T.E.P.S. program. Ex. 1021 ¶ 104. Thalomid PI, however, does not
`describe explicitly the use of a prescription approval code that is retrieved by
`a pharmacy before filling a prescription, and the relied upon general
`statements in Thalomid PI do not suffice to demonstrate that such an
`approval code was required. Inherency may not be established by mere
`probabilities or possibilities. In re Robertson, 169 F.3d 743, 745 (Fed. Cir.
`1999). We hold that the evidence of record does not establish that the
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`S.T.E.P.S. program, as of the critical date, necessarily employed an approval
`code.
`As all the challenged claims require the generation and use of a
`prescription approval code, we are not persuaded that Petitioner has
`demonstrated a reasonable likelihood that claims 1–32 would have been
`anticipated by Thalomid PI.
`
`C.
`
`Claims 1–32 Obviousness over Thalomid PI in view of
`Cunningham and Further in view of Keravich, Zeldis, and
`Mundt
`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. Dependent claims 2–4 further
`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
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`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 from independent claim 28, and further require that the information
`collected be probative of likelihood that the patient may take the drug and
`other drug in combination, and that the diagnostic testing test for evidence of
`the use and adverse effect of the other drug.
`
`
`1. Cunningham
`Cunningham describes a method of dispensing, tracking, and
`managing pharmaceutical product samples. Ex. 1009, 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.
`
`
`2. 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.
`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
`confidential patient survey every 30 days for women and 90 days for men.
`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 database provides
`critical patient related information that is found on a consent form. Id. at
`1723.
`
`
`3. Zeldis
`Zeldis teaches that the S.T.E.P.S. program provides a method for
`controlling and monitoring access to thalidomide. Ex. 1012, 319. Zeldis
`also teaches that thalidomide is efficacious in treating erythema nodosum
`leprosum (ENL). Id. at 320–21.
`
`
`4. Mundt
`Mundt describes the use of interactive voice response systems for
`clinical research and treatment. Ex. 1024. 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. 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
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`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.
`
`
`6. Analysis
`For purposes of the § 103 analysis, Petitioner contends that Thalomid
`PI describes all of the claim limitations recited in independent claims 1 and
`28, with the exception of the generation of a prescription approval code to be
`retrieved by a pharmacy before the prescription is filled. Pet. 52. Petitioner
`states that one skilled in the art, following the teachings of Thalomid PI and
`seeking to avoid treating pregnant women with thalidomide, would have
`implemented the methods disclosed in Cunningham to limit dispensation of
`a drug associated with adverse effects to certain risk groups. Id. at 54. 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
`
`16
`
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`IPR2015-01096
`Patent 6,315,720 B1
`
`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 Thalomid PI does not disclose defining a
`set of information to be obtained from a patient, where the information is
`probative of risk of the adverse side effect. Prelim. Resp. 24–25. Patent
`Owner states that Celgene did not introduce a system to conduct a
`prospective risk analysis until after the ’720 patent had been filed. Id. We
`disagree. Thalomid PI provides specific guideline on the information that is
`probative of the risk associated with taking thalidomide. Dr. Fudin testifies
`that one skilled in the art would recognize that Thalomid PI warns patients
`that serious birth defects can occur if taken during pregnancy, and that this
`defines a set of information to be obtained, namely, information related to
`pregnancy. Ex. 1021 ¶¶ 86–87. Further, Thalomid PI teaches that a patient
`survey is required prior to dispensing the product. Ex. 1006, 19. Based on
`the record presented, we credit Dr. Fudin’s testimony and conclude that one
`skilled in the art seeking to dispense thalidomide would have defined a set of
`information, such as potential pregnancy, to be obtained from a patient that
`is probative of the risk of an adverse side effect, birth defects.
`
`Patent Owner contends that Thalomid PI fails to disclose assigning
`patients to risk groups and entering the risk group assignment into a
`computer database. Prelim. Resp. 25–28. 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. Prior art Thalomid PI identifies different risk groups, including
`
`17
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`IPR2015-01096
`Patent 6,315,720 B1
`
`women of childbearing potential and sexually mature males. Ex. 1006, 3–4.
`The set of conditions for thalidomide treatment differs based on the risk
`group assigned. Dr. Fudin testifies that, at the time of the invention,
`computers were used by physicians and pharmacists to enter and track
`patient information for harmful and teratogenic drug prescriptions. Ex. 1021
`¶ 91. Dr. Fudin also testifies that one of ordinary skill in the art would have
`understood that patient risk group assignment would have been entered into
`a computer database before prescribing and filling prescriptions for
`thalidomide. 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 contends that Thalomid PI does not disclose
`determining whether the risk that an adverse side effect is likely to occur is
`acceptable. Prelim. Resp. 28. We disagree. Thalomid PI states that a
`prescription for thalidomide for a woman of childbearing potential must not
`be issued until a written report of a negative pregnancy test has been
`obtained by the prescriber. Ex. 1006, 2. Accordingly, we find that
`Thalomid PI discloses determining that the risk is unacceptable for a positive
`pregnancy test.
`
`Patent Owner contends that Thalomid PI does not describe generating
`an approval code. Prelim. Resp. 28–29. Patent Owner further contends that
`Petitioner has failed to provide a rationale to combine Thalomid PI and
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`IPR2015-01096
`Patent 6,315,720 B1
`
`Cunningham to arrive at the claimed invention. Id. at 43–47. 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
`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. 1021 ¶¶ 215–216.
`Dr. Fudin’s testimony is consistent with the prior art, e.g., Cunningham’s
`teaching that an approval code validation aids in the controlled distribution
`of a pharmaceutical product. Ex. 1009, 11:6–23; Ex. 1015, 1.
`
`As to the dependent claims, claims 2–27 and 29–32, Petitioner
`provides detailed claim charts identifying where the additional limitations
`are taught in the prior art. Pet. 41–51. For example, Petitioner identifies
`how Keravich teaches that one using the S.T.E.P.S. program would
`understand that patients can be registered via fax (claim 6) and how
`Thalomid PI discloses that information obtained from a patient can include
`results of a pregnancy test (claim 26). Additionally, Petitioner relies upon
`the Declaration of Dr. Fudin to demonstrate that the one of ordinary skill in
`the art would understand that the prior art teaches each and every
`requirement of the challenged dependent claims, and that one would have
`had a reason to employ the additional requirements in combination with the
`subject matter of the independent claims. Ex. 1021 ¶¶ 107–212, 217–223.
`
`Patent Owner contends that Petitioner has failed to meet its burden of
`showing that dependent claim 5 would have been obvious. Prelim. Resp.
`47–49. Dependent claim 5 requires the prescriber to verify
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