Trials@uspto.gov Paper 73
`Tel: 571-272-7822
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`Entered: December 22, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`AMNEAL PHARMACEUTICALS LLC and PAR PHARMACEUTICAL,
`INC.,
`Petitioners,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.,
`Patent Owner.
`_____________
`
`
`
`Case IPR2015-00545
`Patent 8,589,182 B1
`______________
`
`
`Before JACQUELINE WRIGHT BONILLA, BRIAN P. MURPHY, and
`JON B. TORNQUIST, Administrative Patent Judges.
`
`MURPHY, Administrative Patent Judge.
`
`DECISION
`Denying Patent Owner’s Request for Rehearing
`37 C.F.R. § 42.71(d)
`
`
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`

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`IPR2015-00545
`Patent 8,589,182 B1
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`INTRODUCTION
`I.
`Jazz Pharmaceuticals, Inc. (“Patent Owner”) filed a Request for
`Rehearing following our Final Written Decision determining all challenged
`claims of U.S. Patent No. 8,589,182 B1 (Ex. 1001, “the ’182 patent”) to be
`unpatentable. Paper 69 (“Decision”); Paper 70 (“Rehearing Request” or
`“Req. Reh’g”). Amneal Pharmaceuticals LLC and Par Pharmaceutical, Inc.
`(together “Petitioner”) filed a Response to Patent Owner’s Rehearing
`Request. Paper 71 (“Opp.”). Patent Owner seeks reconsideration of the
`Board’s determination that claims 19–25 of the ’182 patent are unpatentable
`for obviousness over the Advisory Committee Art (Exs. 1003–1006,
`collectively “the ACA”). Req. Reh’g 1. Patent Owner argues that the
`Board: (i) misapprehended the limitation in independent claim 19 reciting
`“verifying two or more of the following using the computer processor prior
`to providing the single prescription drug to the narcoleptic patient: patient
`name; patient address; that the patient has received educational material
`regarding the single prescription drug; a quantity of the single prescription
`drug; and dosing directions for the single prescription drug;” (the
`“verifying” step) and (ii) overlooked the actual disclosures of the ACA in
`finding the ACA disclosed the “verifying” step. Id. Petitioner opposes the
`rehearing request. Opp. 2–5.
`Having considered the parties’ submissions on Patent Owner’s
`Rehearing Request, Patent Owner’s request is denied.
`
`
`STANDARD OF REVIEW
`II.
`A party who requests rehearing bears the burden of showing that a
`decision should be modified. 37 C.F.R. § 42.71(d). The party must identify
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`IPR2015-00545
`Patent 8,589,182 B1
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`all matters the party believes we misapprehended or overlooked, and the
`place where each matter was addressed previously in a motion, an
`opposition, or a reply. Id. “A Request for Rehearing is not an opportunity
`to re-argue old arguments.” Histologics, LLC v. CDX Diagnostics, Inc.,
`Case IPR2014-00779, slip op. at 4 (PTAB Oct. 16, 2014) (Paper 9). With
`the aforementioned principles in mind, we address the rehearing arguments
`presented by Patent Owner.
`
`III. ANALYSIS
`Independent claim 19 of the ’182 patent recites a method step for
`entering patient identifying information into a computer database: “entering,
`using the computer processor, into the single computer database information
`sufficient to identify the narcoleptic patient.” Ex. 1001, 11:9–11. The ’182
`patent describes a patient’s identifying information—name, address
`(“contact information”), and the prescription amount located on the
`“Rx/enrollment form” received from the prescribing physician—as being
`input into the central computer database by an “intake reimbursement
`specialist” using a computer processor. Id. at 4:17–44, Fig. 2A (202–210).
`The ’182 patent generally describes an intake reimbursement specialist
`“entering the patient and physician information into an application/database
`referred to as CHIPS . . . a client home infusion program (CHIP) for
`Xyrem®.” Id. at 4:39–43, Fig. 2A (210).
`Claim 19 also recites a step for
`verifying two or more of the following using the computer
`processor prior to providing the single prescription drug
`to the narcoleptic patient: patient name; patient address;
`that
`the patient has received educational material
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`IPR2015-00545
`Patent 8,589,182 B1
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`regarding the single prescription drug; a quantity of the
`single prescription drug; and dosing directions for the
`single prescription drug.
`
`Id. at 11:23–29 (emphasis added). The ’182 patent describes how an intake
`reimbursement specialist verifies the patient information that has been input
`into the computer database, as follows: “CONTACTS MD TO VERIFY
`RECIEPT & ACCURACY OF THE PATIENT’S RX & THIS CONTACT
`IS RECORDED IN CHIPS.” Id. at Fig. 2A (220); 4:51–55 (“[T]he MD is
`contacted at 220 to verify receipt and accuracy of the patient’s Rx. This
`contact is recorded in CHIPS [Client Home Infusion Program database].”).
`Thus, the ’182 patent specification informs a person of ordinary skill in the
`art (“POSA”) that the intake reimbursement specialist uses the computer
`processor to enter the patient’s information into the computer database and
`then verifies the information by “contacting” the prescribing physician. Id.
`at 4:17–55. The ’182 patent does not further describe or limit how the
`prescribing physician is contacted or how the intake reimbursement
`specialist verifies the patient information in the computer database.
`Patent Owner’s Rehearing Request repeats the same argument it made
`in the Patent Owner’s Response, namely that the ACA discloses verification
`of the recited information “by a human” not “by a computer processor.”
`Compare PO Resp. 26–30 with Req. Reh’g 2–3. The argument is based on
`an implicit claim interpretation by Patent Owner that would prohibit a
`human being, such as an intake reimbursement specialist, from contacting a
`prescribing physician by telephone to verify the recited patient information
`that had been entered into the database using a computer processor. Not
`only is such an interpretation at odds with the ’182 patent specification, but
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`we considered and rejected Patent Owner’s argument in our Decision. Dec.
`42–45. We stated:
`
`The claim limitation at issue does not recite that the patient
`information must be verified “by” a computer processor
`and not a human, only that the computer processor is used
`(presumably by a human) to verify the patient information.
`For example, page 310 of the Briefing Booklet (Ex. 1005)
`in the ACA material describes that “a physician . . . will
`write a prescription for Xyrem and fax it to the specialty
`pharmacy.” Ex. 1005, 310 ¶ 4. After receiving the
`prescription, “the specialty pharmacy will contact the
`physician’s office to confirm patient information,” as a
`vehicle to “‘catch’ any prescriptions written on stolen or
`counterfeit prescription pads.” Id. at 310 ¶ 5. The same
`paragraph on this page also states that “[d]uring the call,
`the patient’s name, social security number, telephone
`number and insurance information will also be obtained.”
`Id. Notably, on this page, the ACA indicates that the
`“specialty pharmacy,” i.e., a “single, central pharmacy”
`(Ex. 1005, 306, 308), “confirm[s]” patient information, for
`example during a call to the prescribing doctor’s office.
`Id. at 310 ¶ 5 (emphasis added). Thus, the Briefing
`Booklet in the ACA at least suggests, if not discloses, that
`the central pharmacy obtained patient information from
`the prescription faxed by the physician, entered the patient
`information
`into
`the computer database using
`the
`computer processor, and then “confirms” the patient
`information in the database during the call.
`Dec. 43. We further found “the ACA discloses that the pharmacy has
`patient registry information available for entry into the computer database,
`prior to dispensing the drug—and a natural use for that database information
`would be to verify the patient’s name, address, and other information ‘using
`the computer processor’ as recited in claim 19.” Id. at 44 (citing Ex. 1007
`¶ 62). Patent Owner’s Rehearing Request overlooks the salient portions of
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`our analysis and supporting citations where we considered the “verifying”
`step in claim 19. We did not misapprehend the “verifying” step or Patent
`Owner’s argument regarding the “verifying” step.
`Patent Owner’s further argument—that the Xyrem video evidence
`relied upon by Dr. Valuck depicts a pharmacist on the telephone using pen
`and paper, but not a computer processor, to verify the patient information
`(Req. Reh’g 3–5)—is misinformed for the reasons given above and in our
`Decision. Our Decision cited and considered Dr. Valuck’s deposition
`testimony and the related ACA disclosures being challenged by Patent
`Owner in its Rehearing Request. Dec. 43–45 (citing Ex. 2044, 163:18–
`164:2). As Dr. Valuck testified under cross-examination by Patent Owner’s
`counsel:
`
`[The “verifying” step is] described in the art [ACA],
`displayed in the video, declared on the slides, presented at
`the advisory committee meeting, and would be, in
`addition, implicit based on the skill and experience of a
`POSA. . . .
` The use of the computer is described at various places in
`the advisory committee art, particularly the transcript, the
`slides, the video, the briefing booklet, and the preclinical
`safety review. All of the advisory committee art, the
`computer is -- is interwoven at nearly every step of the
`process, and the POSA would understand and interpret
`that to be the computer is being used for verifying.
`Ex. 2044, 164:3–165:8. Furthermore, the video cited by Patent Owner in the
`Rehearing Request shows a pharmacist sitting in front of a computer
`keyboard at a workstation while on the telephone verifying the patient’s
`information. Req. Reh’g 4 (citing Ex. 1006, V9 00:14–00:30, V10 00:05–
`00:40). Having viewed the video content cited by Patent Owner, in addition
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`to the video transcript and related evidence cited in our Decision (Dec. 24
`n.12, 42–44), particularly Dr. Valuck’s deposition testimony, we reaffirm
`that our Decision did not overlook the actual disclosures of the ACA with
`regard to the “verifying” step.
`Our Decision also cited Dr. Valuck’s Declaration testimony that the
`ACA discloses to a POSA that patient information is entered into a secure
`computer database using a computer processor. Dec. 42, 44 (citing 1007
`¶¶ 60, 62, 85 (citing ¶¶ 60–63)). We reiterate that once a patient’s
`information is entered into the computer database using a computer
`processor, the method step for verifying the information is generally
`described in the ’182 patent as being executed by the intake reimbursement
`specialist “contacting” the prescribing physician. Telephone contact
`suffices, and no further limitation of the “verifying” step is warranted by the
`’182 patent specification or argued by Patent Owner as a matter of claim
`construction in this trial proceeding. See PO Resp. 23–25 (arguing only for
`an express construction of a “wherein” clause in dependent claims 7, 14, and
`25); Dec. 12–17 (addressing only the construction of the “wherein” clause in
`claims 7, 14, and, 25). The evidence cited by Petitioner and in our Decision,
`therefore, appropriately supports our determination that the ACA discloses
`the “verifying” step in independent claim 19. Opp. 2–4.
`Patent Owner’s Response to the Petition and its Rehearing Request
`cite to Dr. Bergeron’s Declaration testimony in support. PO Resp. 26–29
`(citing Ex. 2047 ¶¶ 27–30); Req. Reh’g 2–5 (citing Ex. 2047 ¶¶ 27–30).
`Although we did not cite to Dr. Bergeron’s Declaration testimony in our
`Decision regarding claims 19–25, we did consider Dr. Bergeron’s
`Declaration testimony. Dec. 2. Dr. Bergeron’s Declaration testimony
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`simply restates Patent Owner’s Response arguments, including the argument
`that the ACA discloses “the verification is being done by a human, not a
`computer processor.” Ex. 2047 ¶ 28. We take this opportunity to make
`explicit that we are not persuaded by Dr. Bergeron’s cited Declaration
`testimony (Ex. 2047 ¶¶ 27–30) on the issue of whether the ACA discloses or
`suggests the “verifying” step in claim 19, for the same reasons given in our
`Decision and above.
`Therefore, Patent Owner’s Rehearing Request is denied.
`
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`IV. ORDER
`
`Accordingly, it is
`ORDERED that Patent Owner’s Rehearing Request is denied.
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`IPR2015-00545
`Patent 8,589,182 B1
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`FOR PETITIONER:
`Matthew C. Ruedy
`Steven A. Maddox
`MADDOX EDWARDS PLLC
`mruedy@meiplaw.com
`smaddox@meiplaw.com
`
`Janine A. Carlan
`Richard J. Berman
`Bradford C. Frese
`ARENT FOX LLP
`janine.carlan@arentfox.com
`richard.berman@arentfox.com
`bradford.frese@arentfox.com
`
`
`
`FOR PATENT OWNER:
`F. Dominic Cerrito
`Evangeline Shih
`Frank C. Calvosa
`Eric C. Stops
`QUINN EMANUEL URQUHART & SULLIVAN, LLP
`nickcerrito@quinnemanuel.com
`evangelineshih@quinnemanuel.com
`frankcalvosa@quinnemanuel.com
`ericstops@quinnemanuel.com
`
`John V. Biernacki
`JONES DAY
`jvbiernacki@jonesday.com
`
`
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