`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 IPR2015-01103
`Patent No. 6,315,720
`
`_________________________
`
`
`
`PATENT OWNER CELGENE CORPORATION’S NOTICE OF APPEAL
`
`
`
`
`
`
`Office of the General Counsel
`Patent and Trademark Office
`Madison East
`10B20 600 Dulany Street
`Alexandria, VA 22314
`
`
`Notice is hereby given, pursuant to 37 C.F.R. § 90.2(a), that Patent Owner
`
`Celgene Corporation (“Celgene”) appeals under 35 U.S.C. §§ 141 and 142 to the
`
`United States Court of Appeals for the Federal Circuit from the Final Written
`
`Decision entered on October 26, 2016 (Paper No. 76) (“Final Written Decision”),
`
`modified in part by the Decision Granting Patent Owner’s Request for Rehearing
`
`entered on September 8, 2017 (Paper No. 79) (“Rehearing Decision”), and all
`
`underlying orders, decisions, rulings, and opinions. Copies of the Final Written
`
`Decision and the Rehearing Decision are attached. This appeal concerns the same
`
`patent claims as those at issue in the appeals of IPR Nos. 2015-01096 and 2015-
`
`01102, which are being filed concurrently.
`
`In accordance with 37 C.F.R. § 90.2(a)(3)(ii), Celgene further indicates that
`
`the issues on appeal are: (1) the correctness of the determination that claims 1-9
`
`and 11-32 of U.S. Patent 6,315,720 are unpatentable, and any finding or
`
`determination supporting or related to those issues, as well as all other issues
`
`decided adversely to Celgene in any orders, decisions, rulings, and opinions; and
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`(2) whether the Patent and Trademkar Office may constitutionally void patents
`
`
`
`-1-
`
`
`
`
`
`consistent with Article III and the Seventh Amendment of the United States
`
`Constitution.
`
`Copies of this Notice of Appeal are being filed simultaneously with the
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`Director, the Board, and the Clerk of the United States Court of Appeals for the
`
`Federal Circuit, along with the filing fee to the Federal Circuit.
`
`
`Dated: November 6, 2017
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`
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`Respectfully submitted,
`
`/s/ Gregory A. Castanias
`GREGORY A. CASTANIAS
`JENNIFER L. SWIZE
`DANIEL KAZHDAN
`JONES DAY
`51 Louisiana Avenue, N.W.
`Washington, D.C. 20001
`(202) 879-3639
`gcastanias@jonesday.com
`jswize@jonesday.com
`dkazhdan@jonesday.com
`
`ANTHONY M. INSOGNA
`JONES DAY
`4655 Executive Drive
`Suite 1500
`San Diego, CA 92121-3134
`(858) 314-1200
`aminsogna@jonesday.com
`
`-2-
`
`
`
`
`
`CERTIFICATE OF FILING
`I hereby certify that, in addition to being filed electronically through the
`
`Patent Trial and Appeal Board’s E2E, the foregoing “Patent Owner Celgene
`
`Corporation’s Notice of Appeal” was filed by on this sixth day of November, 2017,
`
`with the Director of the United States Patent and Trademark Office, by hand
`
`delivery at the following address:
`
`Office of the General Counsel
`Patent and Trademark Office
`Madison East
`10B20 600 Dulany Street
`Alexandria, VA 22314
`
`
`CERTIFICATE OF FILING
`I hereby certify that a true and correct copy of the foregoing “Patent Owner
`
`Celgene Corporation’s Notice of Appeal,” along with the required $500 filing fee,
`
`was filed electronically by CM/ECF on this sixth day of November, 2017, with the
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`United States Court of Appeals for the Federal Circuit, and that a paper copy of the
`
`foregoing “Patent Owner Celgene Corporation’s Notice of Appeal” was hand-
`
`delivered to the Federal Circuit’s Clerk’s Office at the following address:
`
`Office of the Clerk
`United States Court of Appeals for the Federal Circuit
`717 Madison Place, N.W., Suite 401
`Washington, D.C. 20439
`
`
`
`
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`
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`
`
`EXHIBIT A
`
`EXHIBIT A
`
`
`
`Trials@uspto.gov
`Tel: 571.272.7822
`
` Paper No: 78
` Entered: September 8, 2017
`
`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)
`Case IPR2015-01102 (Patent 6,315,720 B1)
`Case IPR2015-01103 (Patent 6,315,720 B1)1
`____________
`
`Before MICHAEL P. TIERNEY, Vice Chief Administrative Patent Judge,
`GRACE KARAFFA OBERMANN, and TINA E. HULSE, Administrative
`Patent Judges.
`
`OBERMANN, Administrative Patent Judge.
`
`DECISION
`Granting Patent Owner’s Request for Rehearing
`37 C.F.R. § 42.71(d)
`
`1 Patent Owner filed a substantially identical Request for Rehearing in each
`proceeding. IPR2015-01096, Paper 74; IPR2015-01102, Paper 76;
`IPR2015-01103, Paper 77. This Decision addresses issues common to all
`cases. Accordingly, we issue a single Decision to be entered in each case.
`For convenience, we refer to papers filed in IPR2015-01096.
`
`
`
`IPR2015-01096 (Patent 6,315,720 B1)
`IPR2015-01102 (Patent 6,315,720 B1)
`IPR2015-01103 (Patent 6,315,720 B1)
`
`
`
`
`I. INTRODUCTION
`On November 25, 2016, Celgene Corporation (“Patent Owner”) filed
`a Request for Rehearing of the Final Written Decision. Paper 74 (“Req.”).
`In the Final Written Decision, we held that claims 1–32 of U.S. Patent
`No. 6,315,720 B1 (“the ’720 patent”) are unpatentable. Paper 73, (“Dec.”).
`The Request for Rehearing is confined to our holding that claim 10 is
`unpatentable. Req. 1; see Dec. 27–28 (addressing claim 10).
`For reasons that follow, we grant the Request for Rehearing. We are
`persuaded that the Final Written Decision should be modified as to claim 10.
`Specifically, we hold that Petitioner fails to establish by a preponderance of
`the evidence that claim 10 of the ’720 patent is unpatentable. This Decision
`does not disturb our holding, stated in the Final Written Decision, that
`Petitioner establishes by a preponderance of the evidence that claims 1–9
`and 11–32 are unpatentable. Dec. 34.
`
`II. ANALYSIS
`Patent Owner asserts that the Board overlooked or misapprehended
`evidence and arguments showing that the subject matter of claim 10 would
`not have been obvious under 35 U.S.C. § 103(b). Req. 1.
`In pertinent part, 37 C.F.R. § 42.71(d) states:
`The burden of showing a decision should be modified lies with
`the party challenging
`the decision. The
`request must
`specifically identify all matters the party believes the Board
`misapprehended or overlooked, and the place where each
`matter was previously addressed in a motion, an opposition, or
`a reply.
`
`
`
`2
`
`
`
`IPR2015-01096 (Patent 6,315,720 B1)
`IPR2015-01102 (Patent 6,315,720 B1)
`IPR2015-01103 (Patent 6,315,720 B1)
`
`
`Claim 10 depends from claim 7, which depends from claim 1.
`Claim 1 requires, inter alia, defining a set of information to be obtained
`from a patient. Ex. 1001, 18:30–31. Claim 7 further requires that the
`“information to be obtained” from the patient “includes the results of
`diagnostic testing.” Id. at 18:59–60. Claim 10 requires that “said diagnostic
`testing comprises genetic testing.” Id. at 18:66–67.
`In the Final Written Decision, we found that the subject matter of
`claim 10 would have been obvious, even though “the references of record do
`not disclose or suggest genetic testing.” Dec. 27–28. On that point, we
`credited Dr. Fudin’s declaration testimony that genetic testing was a known
`diagnostic procedure as of the effective filing date of the ’720 patent. Id.
`at 28. We reasoned that Dr. Fudin’s testimony was consistent with FDA
`Meeting Minutes (Ex. 1013), which contained a statement from a Dr.
`Holmes, said to represent the American College of Medical Genetics and the
`Teratology Society. Ex. 1013, 137. Specifically, Mr. Holmes stated that:
`It may seem strange to you that a genetics society would be
`standing here, commenting on potential environmental
`exposures with awful fetal effects, but many clinical geneticists
`around the country are expected to provide counseling to
`pregnant women about exposures in pregnancies, so the
`geneticists, in fact, are often the clinical teratologists. And I am
`speaking myself as an active clinical teratologist in the Boston
`area.
`
`Id.
`
`Based on that objective support, we held “that the genetic testing of
`dependent claim 10 represents a combination of known elements for their
`known use to achieve a predictable result, genetic testing to obtain
`information for diagnosis and treatment.” Dec. 28. Having reconsidered the
`
`
`
`3
`
`
`
`IPR2015-01096 (Patent 6,315,720 B1)
`IPR2015-01102 (Patent 6,315,720 B1)
`IPR2015-01103 (Patent 6,315,720 B1)
`
`record on rehearing, however, we find that this finding is not supported by a
`preponderance of the evidence.
`As an initial matter, Patent Owner argues that the Board improperly
`shifted the burden of proof by holding that Patent Owner “did not dispute
`that genetic testing was known in the art for obtaining diagnostic
`information.”2 Req. 3 (quoting Dec. 27). Patent Owner, in fact, timely
`disputed that genetic testing would have been understood as common in the
`art, and identified a gap in Petitioner’s evidence on that point. Req. 3 (citing
`PO Resp. 45–56). Specifically, Patent Owner pointed to the absence of
`disclosure in the asserted prior art, which teaches various other tests but not
`genetic testing. PO Resp. 46. Patent Owner argued that the lack of
`disclosure in the record evidence “undermines Dr. Fudin’s opinion that such
`testing was ‘common.’” Id.
`We agree that the proper focus is not whether Patent Owner disputed
`that fact, but whether Petitioner came forward with evidence sufficient to
`demonstrate that genetic testing was known and would have been used in the
`combination required by claim 10. We also agree that the lack of disclosure
`in the prior art of record—coupled with the record’s disclosure of other
`types of tests—cuts against a finding “that genetic testing would be used, let
`alone that it would have been common.” Req. 3. Dr. Fudin states that “[i]t
`was common in the art at the time of” the invention “to conduct genetic
`
`2 Patent Owner asserts that in its Patent Owner Response it did dispute that
`genetic testing was known in the art or common. Req. 3. Other than citing
`its entire argument regarding claim 10, which we already address throughout
`this Decision, Patent Owner does not identify any specific argument or
`evidence that we overlooked or misapprehended in connection with this
`assertion. Id.
`
`
`
`4
`
`
`
`IPR2015-01096 (Patent 6,315,720 B1)
`IPR2015-01102 (Patent 6,315,720 B1)
`IPR2015-01103 (Patent 6,315,720 B1)
`
`testing at the same time as the pregnancy testing taught in” the prior art, but
`directs us to no disclosure in the asserted prior art, or any other objective
`evidence, on point. Pet. 27–31 (citing Ex. 1021 ¶¶ 141–143).
`On that point, Dr. Fudin does not cite, or otherwise explain the
`significance of, the disclosure in the FDA Meeting Minutes that we relied
`upon in the Final Written Decision. Ex. 1021 ¶¶ 140–143. PO Resp. 45–46;
`Pet. 58 (citing Ex. 1021 ¶¶ 229–231); Dec. 28. That disclosure, cited for the
`first time in Petitioner’s Reply3, does not refer to genetic testing, much less
`suggest using genetic testing in the combination required by claim 10.
`Reply 25–26 (citing Ex. 10764, 137); see Req. 3 (arguing on rehearing that
`the Petitioner “relied solely on a single passage” in the FDA Meeting
`Minutes “that focuses on the geneticist acting as a clinical teratologist that
`might counsel patients on the risks of exposure”) (citing Reply 25–26;
`Ex. 1013, 137). Patent Owner correctly points out that “the cited passage
`says nothing about genetic testing, nor does it suggest such testing.” Req. 3
`(emphasis omitted); Ex. 1013, 137; Ex. 1076, 137.
`We find that the FDA Meeting Minutes fail to support adequately
`Dr. Fudin’s opinion testimony that genetic testing would have been common
`at the time of the invention. Contrary to “Dr. Fudin’s opinion that [genetic]
`testing was ‘common,’” the asserted prior art references do not disclose,
`teach, or suggest genetic testing, “despite disclosing various other types of
`
`
`3 The Petition cites other disclosures in the FDA Meeting Minutes to support
`arguments unrelated to the genetic testing limitation of claim 10. Pet. 13–14
`(citing Ex. 1013).
`4 The same material appears on page 137 of Exhibit 1013, which is cited in
`the Final Written Decision. Dec. 28.
`
`
`
`5
`
`
`
`IPR2015-01096 (Patent 6,315,720 B1)
`IPR2015-01102 (Patent 6,315,720 B1)
`IPR2015-01103 (Patent 6,315,720 B1)
`
`tests.” Req. 2; PO Resp. 46. Given that Dr. Fudin’s opinion on that point is
`unsupported by objective evidence, we assign his testimony little weight in
`the analysis of claim 10. Req. 2–3; PO Resp. 46 (citing 37 C.F.R. § 42.65(a)
`and Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 294
`(Fed. Cir. 1985)). The gap in the disclosures of the prior art, occurring at or
`near the time of the invention, carries more weight than the much later,
`unsupported opinion of Dr. Fudin.
`Petitioner fails to demonstrate that it would have been obvious at the
`time of the invention to use genetic testing in the method of claim 10.
`Req. 3. The objective evidence on point consists of a single paragraph from
`the FDA Meeting Minutes, raised in Petitioner’s Reply, which is not relied
`upon in the relevant witness testimony, and does not disclose genetic testing.
`Accordingly, we hold that Petitioner fails to establish by a preponderance of
`the evidence that claim 10 is unpatentable.
`
`II. CONCLUSION
`For the foregoing reasons, Patent Owner establishes that the Final
`Written Decisions in each proceeding should be modified to hold that, based
`on the record developed in this proceeding, a preponderance of the evidence
`demonstrates that claim 10 is not proven unpatentable.
`III. ORDER
`
`It is
`ORDERED that the Request for Rehearing is granted;
`FURTHER ORDERED that the Final Written Decision is modified to
`hold that, based on the record developed in this proceeding, a preponderance
`of the evidence demonstrates that claim 10 is not proven unpatentable;
`
`
`
`6
`
`
`
`IPR2015-01096 (Patent 6,315,720 B1)
`IPR2015-01102 (Patent 6,315,720 B1)
`IPR2015-01103 (Patent 6,315,720 B1)
`
`
`FURTHER ORDERED that this Decision does not disturb the holding
`in the Final Written Decision that Petitioner establishes by a preponderance
`of the evidence that claims 1–9 and 11–32 are unpatentable.
`
`
`PETITIONER:
`Sarah E. Spires
`Parvathi Kota
`SKIERMONT PUCKETT LLP
`sarah.spires@skiermontpuckett.com
`parvathi.kota@skiermontpuckett.com
`
`PATENT OWNER:
`F. Dominic Cerrito
`Frank Calvosa
`QUINN EMANUEL URQUHART & SULLIVAN, LLP
`nickcerrito@quinnemanuel.com
`frankcalvosa@quinnemanuel.com
`
`Anthony M. Insogna
`Gasper LaRosa
`JONES DAY
`aminsogna@jonesday.com
`gjlarosa@jonesday.com
`
`
`
`
`
`
`7
`
`
`
`
`
`
`
`
`
`EXHIBIT B
`
`EXHIBIT B
`
`
`
`Trials@uspto.gov
`571.272.7822
`
`
`
`
`
`Papel No. 76
` 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 IPR2015-01103
`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
`
`
`
`
`
`
`
`IPR2015-01103
`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 22 (“Dec. on
`
`Inst.”).
`
`
`
`After institution, Patent Owner filed a redacted Patent Owner
`
`Response. Paper 42 (“PO Resp.” with redacted version Paper 43).
`
`Petitioner filed a Reply. Paper 55 (“Reply” with a redacted version Paper
`
`54). Additionally, Petitioner filed Motions to Submit Supplemental
`
`Information (Papers 37 and 38), a Motion to Exclude Evidence (Paper 63)
`
`and a Motion to Seal (Paper 56). Further, Patent Owner filed a Motion to
`
`Exclude Evidence (Paper 63) and Motions to Seal and for Entry of
`
`Protective Order (Papers 9 and 41).
`
`
`
`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 75 (“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
`
`
`
`IPR2015-01103
`Patent 6,315,720 B1
`
`A. Related Proceedings
`
`According to Petitioner, the ’720 patent has been the subject of the
`
`following judicial matters: Celgene Corp. et al. v. Lannett Holdings, Inc.,
`
`DNJ-2-15-00697 (filed Jan. 30, 2015); Celgene Corp. v. Natco Pharma Ltd.,
`
`DNJ-2-10-cv-05197 (filed Oct. 8, 2010); Celgene Corp. v. Barr
`
`Laboratories, Inc., DNJ-2-08-cv-03357 (filed July 3, 2008); Celgene Corp.
`
`v. Barr Laboratories, Inc., DNJ-2-07-cv-05485 (filed Nov. 14, 2007);
`
`Celgene Corp. v. Barr Laboratories, Inc., DNJ-2-07-cv-04050 (filed Aug.
`
`23, 2007); Celgene Corp. v. Barr Laboratories, Inc., DNJ-2-07-cv-00286
`
`(filed Jan. 18, 2007). Pet. 2–3. Additionally, the claims of the ’720 patent
`
`have been challenged in two related inter partes review proceedings,
`
`IPR2015-01096 and IPR2015-01102.
`
`
`
`B. The ’720 Patent
`
`The ’720 patent specification describes methods for delivering a drug
`
`to a patient. Ex. 1001, 1:8–9. For example, the method can be used to
`
`deliver a drug known to cause birth defects in pregnant women, while
`
`avoiding the occurrence of known or suspected side effects of the drug. Id.
`
`at 1:9–13, 19–30.
`
`The patent describes prior-art methods that involved filling drug
`
`prescriptions, only after a computer readable storage medium was consulted,
`
`to assure that the prescriber is registered in the medium and qualified to
`
`prescribe the drug, and that the patient is registered in the medium and
`
`approved to receive the drug. Id. at 2:50–60. The ’720 patent specification
`
`is said to describe an improvement over the acknowledged prior art, where
`
`the improvement involves assigning patients to risk groups based on the risk
`
`3
`
`
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`IPR2015-01103
`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, claims 1 and 28, is directed to a method of delivering a drug to a
`
`patient in need of the drug and is written in a Jepson claim format, where the
`
`4
`
`
`
`IPR2015-01103
`Patent 6,315,720 B1
`
`preamble defines admitted prior art of prescribing drugs only after a
`
`computer readable storage medium has been consulted properly. The
`
`claimed improvement over the admitted prior art includes defining a
`
`plurality of patient risk groups, defining information to be obtained from a
`
`patient that is probative of risk of an adverse side effect, assigning the
`
`patient to a risk group, determining whether the risk of the side effect is
`
`acceptable, and generating an approval code to be retrieved by a pharmacy
`
`before filling a prescription for the drug.
`
`Claims 2–27 depend, directly or through other dependent claims, upon
`
`claim 1. Dependent claims 2–4 and require that a prescription is filled only
`
`following verified full disclosure and consent of the patient. Dependent
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`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
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`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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`IPR2015-01103
`Patent 6,315,720 B1
`
`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.
`
`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
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`6
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`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.
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`D. Prior Art Relied Upon
`
`Petitioner relies upon the following prior art:
`
`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)
`
`Allen A. Mitchell et al., A Pregnancy-Prevention Program in Women of
`Childbearing Age Receiving Isotretinoin, New Eng. J. Med. (Jul. 13, 1995)
`333:2, 101–06 (Ex. 1010, “Mitchell”)
`
`James C. Mundt, Interactive Voice Response Systems in Clinical Research
`and Treatment, 48:5 PSYCHIATRIC SERVICES 611, 611–12, 623 (1997)
`(“Mundt”) (Ex. 1017)
`
`Thaddeus Mann & Cecelia Lutwak-Mann, Passage of Chemicals into
`Human and Animal Semen: Mechanisms and Significance, 11:1 CRC
`CRITICAL REVIEWS IN TOXICOLOGY 1, 1–14 (1982) (“Mann”) (Ex. 1018)
`
`Cori Vanchieri, Preparing for Thalidomide’s Comeback, 127:10 ANNALS OF
`INTERNAL MED. 951, 951–54 (1997) (“Vanchieri”) (Ex. 1019)
`
`Arthur F. Shinn et al., Development of a Computerized Drug Interaction
`Database (MedicomSM) for Use in a Patient Specific Environment,
`17 DRUG INFORM. J. 205, 205–10 (1983) (“Shinn”) (Ex. 1020)
`
`R. Linnarsson, Decision support for drug prescription integrated with
`computer-based patient records in primary care, 18:2 MED. INFORM.
`131, 131–42 (1993) (“Linnarsson”) (Ex. 1021)
`
`P.E. Grönroos et al., A medication database – a tool for detecting drug
`interactions in hospital, 53 EUR. J. CLIN. PHARMACOL. 13, 13–
`17 (1997) (“Grönroos”) (Ex. 1022)
`
`7
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`IPR2015-01103
`Patent 6,315,720 B1
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`M. Soyka et al., Prevalence of Alcohol and Drug Abuse in Schizophrenic
`Inpatients, 242 EUR. ARCH. PSYCHIATRY CLIN. NEUROSCI. 362, 362–72
`(1993) (“Soyka”) (Ex. 1023)
`
`Edna Hamera et al., Alcohol, Cannabis, Nicotine, and Caffeine Use and
`Symptom Distress in Schizophrenia, 183:9 J. OF NERVOUS AND
`MENTAL DISEASE 559, 559–65 (1995) (“Hamera”) (Ex. 1024)
`
`Thomas R. Kosten & Douglas M. Ziedonis, Substance Abuse and
`Schizophrenia: Editors’ Introduction, 23:2 SCHIZOPHRENIA BULLETIN 181,
`181–86 (1997) (“Kosten”) (Ex. 1025)
`
`Jeffrey C. Menill, Substance Abuse and Women on Welfare, NATIONAL
`CENTER ON ADDICTION AND SUBSTANCE ABUSE AT COLUMBIA
`UNIVERSITY 1–8 (1994) (“Menill”) (Ex. 1026)
`
`
`
`Petitioner contends that the challenged claims are unpatentable under
`
`35 U.S.C. § 103 based on the following specific grounds (Pet. 14–60):
`
`
`
`Reference(s)
`
`Basis
`
`Claims challenged
`
`Mitchell and Dishman in view of
`Cunningham and further in view of
`Mundt, Mann, Vanchieri, Shinn,
`Linnarsson, Grönroos, Soyka,
`Hamera, Kosten, and Menill.1
`
`§ 103
`
`1–32
`
`
`1 Petitioner’s heading merely states that claims 1–32 are obvious over
`Mitchell and Dishman in view of Cunningham and further in view of the
`knowledge of one of ordinary skill in the art. Pet. 17. The Petition,
`however, goes on to rely upon additional art to explain the knowledge
`possessed by one skilled in the art at the time of the invention and cites
`additional references to support its position. Specifically, the Petitioner
`relies upon Mundt, Mann, Vanchieri, Shinn, Linnarsson, Grönroos, Soyka,
`Hamera, Kosten, and Menill. In the Decision to Institute, we included the
`additional art relied upon, Mundt, Mann, Vanchieri, Shinn, Linnarsson,
`Grönroos, Soyka, Hamera, Kosten, and Menill, in the stated grounds, so that
`the record was clear as to the prior art relied upon. Dec. on Inst.
`
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`E. Level of Ordinary Skill in the Art
`
`The person of ordinary skill in the art is a hypothetical person who is
`
`presumed to have known the relevant art at the time of the invention.
`
`Factors that may be considered in determining the level of ordinary skill in
`
`the art include, but are not limited to, the types of problems encountered in
`
`the art, the sophistication of the technology, and educational level of active
`
`workers in the field. In a given case, one or more factors may predominate.
`
`In re GPAC, 57 F.3d 1573, 1579 (Fed. Cir. 1995).
`
`The challenged claims are directed to the subject matter of delivering
`
`a drug to a patient in need of the drug, while avoiding the occurrence of an
`
`adverse side effect known or suspected of being caused by said drug. The
`
`claims are said to be an improvement over prior art distribution systems
`
`where the improvement includes using an approval code to help minimize
`
`and simplify demands on a pharmacy and reduce the risk that the drug will
`
`be dispensed to a contraindicated individual. Ex. 1001 at 2:8–12.
`
`Petitioner contends that a person skilled in the art of pharmaceutical
`
`prescriptions, which would involve controlling distribution of a drug,
`
`typically would have either a Pharm.D. or a B.S. in pharmacy with
`
`approximately 5–10 years of experience and a license to practice as a
`
`registered pharmacist in any one or more of the United States. Ex. 1027,
`
`Declaration of Dr. Jeffrey Fudin, ¶¶ 13, 16. Patent Owner disagrees with
`
`Petitioner’s definition of a person of ordinary skill in art contends that such a
`
`person would have at least 2 years of experience in risk management relating
`
`to pharmaceutical drug products or a B.S. or M.S. in pharmaceutical drug
`
`product risk management or a related field. PO Resp. 12–13.
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`Based on the record presented, we hold that the cited prior art is
`
`representative of the level of ordinary skill in the art. See Okajima v.
`
`Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). The prior art references,
`
`like the ’720 patent specification, focus on controlling the distribution of a
`
`drug. See, e.g., Ex. 1001, 1:13–16 (describing “the distribution to patients of
`
`drugs, particularly teratogenic drugs, in ways wherein such distribution can
`
`be carefully monitored and controlled”); see generally Exs. 1003; 1008;
`
`1011; 2062; 2067. 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 ¶¶ 43–50.
`
`Accordingly, the prior art demonstrates that one of ordinary skill in the art
`
`would have experience in controlling the distribution of a drug. To the
`
`extent a more specific definition is required, we hold, for the reasons
`
`provided below, that a person of ordinary skill in the art would have several
`
`years of experience in risk management relating to pharmaceutical drug
`
`products, which encompasses experience as a pharmacist.
`
`Patent Owner contends that a pharmacist would not be considered a
`
`person of ordinary skill in the art. Patent Owner relies upon the declaration
`
`of Dr. Frau, who testifies that “an average pharmacist at the time of the
`
`invention would have lacked the ability and the motivation to design an all
`
`inclusive system of drug delivery for a hazardous drug that is focused on
`
`preprescription patient assessment.” Ex. 2059, ¶ 47. The challenged claims,
`
`however, are directed to an improvement of an existing drug distribution
`
`method that provides an approval code after a prescriber has prescribed the
`
`drug. Specifically, the approval code checks to see if all the requisite
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`information was properly registered in the storage medium and if the
`
`approval code is provided the pharmacy provides the drug. Ex. 1001,
`
`14:45–57. Additionally, as to preprescription patient, Dr. Frau fails to
`
`explain why pharmacists would lack awareness of preprescription patient
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`assessment for drugs requiring prescriptions, e.g., checking patient history to
`
`p
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