Trials@uspto.gov Paper 74
`Tel: 571-272-7822
`
`Entered: December 22, 2016
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`PAR PHARMACEUTICAL, INC. and
`AMNEAL PHARMACEUTICALS LLC,
`Petitioners,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.,
`Patent Owner.
`_____________
`
`
`
`Case IPR2015-00551
`Patent 8,457,988 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)
`
`
`
`
`
`
`
`
`Tel: 571-272-7822
`
`Entered: December 22, 2016
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`PAR PHARMACEUTICAL, INC. and
`AMNEAL PHARMACEUTICALS LLC,
`Petitioners,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.,
`Patent Owner.
`_____________
`
`
`
`Case IPR2015-00551
`Patent 8,457,988 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)
`
`
`
`
`
`
`
`
`
`IPR2015-00551
`Patent 8,457,988 B1
`
`
`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. 8,457,988 B1 (Ex. 1001, “the ’988 patent”) to be
`unpatentable. Paper 70 (“Decision” or “Dec.”); Paper 71 (“Rehearing
`Request” or “Req. Reh’g”). Par Pharmaceutical, Inc. and Amneal
`Pharmaceuticals LLC (together “Petitioner”) filed a Response to Patent
`Owner’s Rehearing Request. Paper 73 (“Opp.”). Patent Owner seeks
`reconsideration of the Board’s determination that claims 1–15 of the ’988
`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 misapprehended or overlooked certain evidence when
`(i) determining that Korfhage does not teach away from the use of
`distributed database systems, and (ii) construing the following claim
`limitation: “the prescription requests containing information identifying
`narcoleptic patients, the prescription drug, and various credentials of the any
`and all medical doctors.” Id. at 1–2. Petitioner opposes the Rehearing
`Request. Opp. 2–9.
`Having considered the parties’ submissions concerning 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
`all matters the party believes we misapprehended or overlooked, and the
`place where each matter was addressed previously in a motion, an
`
`
`
`2
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`IPR2015-00551
`Patent 8,457,988 B1
`
`
`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
`
`A. Our Consideration of Korfhage and Dr. Bergeron’s Testimony
`
`Patent Owner asserts that the Board “overlooked and/or
`misapprehended” Patent Owner’s argument and expert testimony that the
`Korfhage reference teaches away from the use of “distributed databases,” as
`recited in claims 2 and 10. Req. Reh’g 2–3; Dec. 56–59. Our Decision
`explained that Korfhage “suggests that a single query can operate over the
`distributed database computers to accommodate user preference ‘to view the
`system as accessing a single logical database in response to a query, even
`when the system must consult multiple physical databases.’” Dec. 57
`(quoting Ex. 1037 at 276). We explicitly considered Patent Owner’s
`submission that Korfhage teaches away from the use of distributed databases
`because of “problems” that may arise. Id. at 57–58 (“Patent Owner further
`argues that Korfhage teaches away from using distributed databases because
`Korfhage discloses that ‘three major problems arise’ when attempting to
`have a single query operate over multiple physical databases.”) (citing PO
`Resp. 59 (which cited Dr. Bergeron’s declaration testimony, Ex. 2047
`¶¶ 62–65)). We considered, but were not persuaded by, Patent Owner’s and
`
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`3
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`IPR2015-00551
`Patent 8,457,988 B1
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`Dr. Bergeron’s interpretation of Korfhage, including any supposed teaching
`away:
`
`We also agree with Petitioner that Korfhage does not teach
`away from the use of distributed databases systems,
`particularly given the acknowledgement of Dr. Bergeron
`that Korfhage offered solutions to the problems identified.
`Id. at 59 (citing Ex. 1037, 276–77; Ex. 1054, 317:13–320:12).
`We did not overlook or misapprehend Patent Owner’s argument and
`evidence, rather, we declined to credit them in view of the text of Korfhage,
`Dr. Valuck’s testimony, and Dr. Bergeron’s deposition testimony. Dec. 56–
`59. The pages of Korfhage cited and quoted in our Decision disclose
`multiple factors “driving information systems to the use of distributed
`document sets and distributed processing,” and set up “[t]hree major
`problems” only to discuss “simple solution[s],” a position supported by Dr.
`Valuck. Dec. 57–59 (citing Ex. 1007 ¶ 157; Ex. 1037 at 276–77). Under
`cross-examination by Petitioner’s counsel, Dr. Bergeron readily
`acknowledged that Korfhage’s discussion of data redundancy and matching
`document evaluation “problems” were paired with disclosed solutions,
`which undercut his declaration testimony (Ex. 2047 ¶¶ 56–65) relied upon
`by Patent Owner. Ex. 1054, 317:13–320:12. Our Decision credits Dr.
`Bergeron’s deposition testimony, which acknowledges the distributed
`
`
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`4
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`IPR2015-00551
`Patent 8,457,988 B1
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`database system solutions disclosed in Korfhage, rather than the speculative
`new problems hypothesized in his declaration and Patent Owner’s Response.
`For example, Patent Owner argued that if the prior art ACA system
`for distributing Xyrem were to be run on a distributed database of the type
`suggested by Korfhage, such a system
`
`might create a false indication of duplicate prescriptions
`that could prevent a patient from receiving her prescription
`drug. Ex. 2047 ¶ 64. On the other hand, if the duplicate
`prescription data is “eliminat[ed]” because a pharmacist
`believes it was caused by data redundancy, then a potential
`abuse situation would be overlooked. Id.
`PO Resp. 60. We did not find such testimony persuasive, or particularly
`credible, in view of Korfhage’s express disclosures, Dr. Valuck’s testimony,
`and Dr. Bergeron’s deposition testimony. Dec. 57–59 (citing Ex. 1007
`¶ 157; Ex. 1037, 276–77; Ex. 1054, 317:13–320:12; Ex. 2047 ¶ 57–59).
`Patent Owner’s argument is not persuasive given that the ACA drug
`distribution system was designed to allow a pharmacist to identify and
`resolve duplicate prescriptions before deciding whether to distribute the drug
`to a patient (or delete a duplicate caused by data redundancy). Ex. 1003,
`184:24–185:7; Ex. 1005, 314 ¶ 6. We also were persuaded by Dr. Valuck’s
`testimony that it would have been obvious for one of ordinary skill to
`modify the ACA system “such that the data stored in the central data
`repository was distributed across multiple databases, as disclosed by
`Korfhage in order to accommodate cost, efficiency, and the number of
`
`
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`IPR2015-00551
`Patent 8,457,988 B1
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`prescription requests and associated data.” Ex. 1007 ¶ 157 (cited at Dec.
`57–581).
`In sum, Patent Owner’s “teaching away” argument and evidence were
`fully considered in our Decision. Dec. 56–59. Therefore, Patent Owner’s
`request for rehearing on this basis is denied.
`
`B. Claim construction of the “identifying” element
`
`Independent claims 1 and 9 of the ’988 patent recite a method step for
`receiving prescription requests “containing information identifying
`narcoleptic patients, the prescription drug, and various credentials of the any
`and all medical doctors.” Id. at 8:48–50, 9:49–51 (the “identifying”
`element). In its Response, Patent Owner argued that exemplary
`embodiments described in the ’988 patent limit the “identifying” element by
`requiring specific types of information to be read into the “identifying”
`element. PO Resp. 27–34. We considered Patent Owner’s arguments,
`construed the “identifying” element with particular reference to the ’988
`patent specification, explained our reasoning, and stated that the
`“identifying” element is not limited to the types of information proposed by
`Patent Owner “nor requires all of that information.” Dec. 18–21.
`Patent Owner’s Rehearing Request argues that the Board overlooked
`portions of the ’988 patent specification and certain extrinsic evidence, in
`the form of expert testimony, that was cited by Patent Owner in its Response
`
`
`1 Page 58 of our Decision contains a typographical citation error. We cited
`to page 53 of the Petition, which cited to Dr. Valuck’s Declaration at Exhibit
`1007 ¶ 157. Pet. 53. We incorrectly indicated a citation to paragraph 57 of
`Dr. Valuck’s Declaration, rather than to paragraph 157.
`6
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`IPR2015-00551
`Patent 8,457,988 B1
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`to the Petition. Req. Reh’g, 5–11. Patent Owner then repeats its argument
`that the “identifying” element requires specific types of information to be
`read into the claim element. Id. We do not agree that we misapprehended or
`overlooked the evidence identified by Patent Owner in its Response and
`Rehearing Request. Rather, Patent Owner’s Rehearing Request is an
`attempt to reargue the position rejected in our Decision.
`Our Decision construing the “identifying” element includes extensive
`citation to, and discussion of, Patent Owner’s arguments and evidence. Dec.
`18–21. Our claim construction analysis begins by explicitly and repeatedly
`acknowledging Patent Owner’s arguments and evidence, including the exact
`specification excerpt and expert testimony of Dr. DiPiro and Dr. Valuck on
`which Patent Owner’s Rehearing Request relies regarding the “information
`identifying patients” language. Id. at 18 (citing PO Resp. 30–33; Ex. 2046
`¶¶ 39–44; Ex. 1001 at 4:8–22; 8:4–5, 8:40–44, 10:20–23; Ex. 2044 at 97:11–
`98:5, 99:18–100:10); id. at 18–19 (citing PO Resp. 31; Ex. 1001 at 4:20–22,
`8:4–5, Fig. 9; Ex. 2044 at 97:11–23, 99:18–100:10). 2 We did not
`“overlook” this evidence or consider only Figure 9 of the ’988 patent
`specification regarding the identification of patients, as Patent Owner argues.
`
`
`2 Patent Owner cited to the Abstract of the ’988 patent in support of its
`proposed claim construction. PO Resp. 31, 34; Req. Reh’g 8, 10. With
`regard to the “identifying” element, the Abstract merely states that
`“[i]nformation is kept in the database regarding all physicians allowed to
`prescribe the sensitive drug, and all patients receiving the drug.” Ex. 1001,
`Abstract. The Abstract, therefore, provides only general guidance for
`construing the “identifying” element.
`7
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`IPR2015-00551
`Patent 8,457,988 B1
`
`
`See Req. Reh’g 7–8. We further stated that, rather than limiting our analysis
`to Figure 9,
`
`nothing in the specification suggests that excluding one or
`more pieces of information in the list of a “patient’s name,
`social security number, date of birth, sex, and complete
`address information, including city, state, and zip code,”
`as proposed by Patent Owner, means that a prescription
`fails to contain “information identifying the patient,” as
`recited in the claims.
`Dec. 19 (emphasis added).
`We made clear that the controlling description of the specification
`outweighed Patent Owner’s argument and supporting evidence that specific
`types of information are required to be read into the “identifying” element of
`the claims. Id. (“Thus, we construe ‘prescription requests [for GHB]
`containing information identifying patients’ to refer to information
`identifying a patient, which may include [Patent Owner’s specifically listed
`information], but is not limited to that information nor requires all of that
`information.”) (emphasis added). We also cited to all of the expert
`testimony on which Patent Owner relied for its claim construction, as an
`indication that we considered the testimony. Id. at 18 (citing Ex. 2044,
`97:11–98:5, 99:18–100:10; Ex. 2046 ¶¶ 39–44). We did the same for the
`“information identifying . . . any and all medical doctors” language,
`concluding that:
`
`The specification does not suggest that failing to include
`on the prescription one or more pieces of information from
`the list of a “medical doctor’s name, license number, DEA
`number, and physician specialty,” as proposed by Patent
`Owner, means that a prescription fails to contain
`
`
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`8
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`IPR2015-00551
`Patent 8,457,988 B1
`
`
`information regarding “various credentials,” as recited in
`the claims.
`Id. at 20–21 (citing PO Resp. 33–36; Ex. 1001, 2:22–24, 2:41–42, 4:7–8,
`4:8–14, 4:18–20, 4:20–22, 4:7–5:67, 8:4–7, 8:40–44, 10:20–23, Figs.
`2A–C, 9; Ex. 2044, 181:1–23; Ex. 2046 ¶¶ 45–49). Though we did not
`discuss the expert testimony, we considered it.
`For example, on the same page of testimony cited by Patent Owner,
`Dr. Valuck testified that the information sufficient to identify a patient is
`“whatever the pharmacist believes is required to sufficiently identify the
`patient in their professional judgment.” Ex. 2044, 98:2–16. Even so, our
`Decision puts primary emphasis on the claim language and relevant
`description of the “identifying” element in the specification, not the extrinsic
`expert testimony relied upon by Patent Owner. See Perfect Surgical
`Techniques, Inc. v. Olympus Am., Inc., 841 F.3d 1004, 1012–13 (Fed. Cir.
`2016) (“The legal part of claim construction is the determination of the
`meaning of the term in the claim in light of the patent’s intrinsic record.”);
`see also Phillips v. AWH Corp., 415 F.3d 1303, 1324 (Fed. Cir. 2005) (en
`banc) (stating that sources outside the specification should not be “used to
`contradict claim meaning that is unambiguous in light of the intrinsic
`evidence.”).
`In sum, Patent Owner’s Rehearing Request is an attempt to reargue its
`claim construction positions, not an identification of claim language or
`evidence we misapprehended or overlooked. Therefore, Patent Owner’s
`Rehearing Request is denied.
`
`9
`
`
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`IPR2015-00551
`Patent 8,457,988 B1
`
`
`IV. ORDER
`
`Accordingly, it is
`ORDERED that Patent Owner’s Rehearing Request is denied.
`
`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
`
`
`
`10
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