Trials@uspto.gov Paper 76
`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,
`Petitioner,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.,
`Patent Owner.
`_____________
`
`
`
`Case IPR2015-00547
`Patent 7,765,107 B2
`______________
`
`
`Before JACQUELINE WRIGHT BONILLA, BRIAN P. MURPHY, and
`JON B. TORNQUIST, Administrative Patent Judges.
`
`BONILLA, 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,
`Petitioner,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.,
`Patent Owner.
`_____________
`
`
`
`Case IPR2015-00547
`Patent 7,765,107 B2
`______________
`
`
`Before JACQUELINE WRIGHT BONILLA, BRIAN P. MURPHY, and
`JON B. TORNQUIST, Administrative Patent Judges.
`
`BONILLA, Administrative Patent Judge.
`
`DECISION
`Denying Patent Owner’s Request for Rehearing
`37 C.F.R. § 42.71(d)
`
`
`
`
`
`
`
`
`
`IPR2015-00547
`Patent 7,765,107 B2
`
`
`INTRODUCTION
`I.
`Jazz Pharmaceuticals, Inc. (“Patent Owner”) filed a Request for
`Rehearing following our Final Written Decision, which determined that
`claims 1–6 of U.S. Patent No. 7,765,107 B2 (Ex. 1001, “the ’107 patent”)
`were 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 74 (“Opp.”). Patent Owner seeks
`reconsideration of the Board’s determination that claims 1–6 of the ’107
`patent are unpatentable under 35 U.S.C. § 103(a) as obvious over the
`Advisory Committee Art (Exs. 1003–1006, collectively “the ACA”). Req.
`Reh’g 1–2. Patent Owner argues that the Board misapprehended or
`overlooked certain evidence when construing the following claim
`limitations: “wherein said request data contain information identifying the
`patient,” and “wherein said request data contain information identifying . . .
`credentials of the medical doctor.” Id. at 2–8. Petitioner opposes the
`Rehearing Request. Opp. 2–6.
`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
`opposition, or a reply. Id. “A Request for Rehearing is not an opportunity
`
`
`
`2
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`IPR2015-00547
`Patent 7,765,107 B2
`
`
`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 claims 1 and 4 of the ’107 patent each recite a method
`step for determining, using a computer processor, current and anticipated
`patterns of potential prescription abuse based on prescription request data
`from a doctor, “wherein said request data contain information identifying the
`patient, [GHB as] the drug prescribed, and credentials of the medical
`doctor.” Ex. 1001, 8:51–59, 9:61–10:5 (the “identifying” element). In its
`Response during trial, Patent Owner argued that exemplary embodiments
`described in the ’107 patent limited the recited “information” in the
`“identifying” element by requiring specific types of information to be read
`into that element. Paper 46 (“PO Resp.”) 29–36. We considered Patent
`Owner’s arguments, construed the different aspects of the “identifying”
`element with particular reference to the ’107 patent specification, explained
`our reasoning, and stated that the “identifying” element was 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 we overlooked
`portions of the ’107 patent specification and certain extrinsic evidence, in
`the form of expert testimony, that was cited by Patent Owner in its Response
`to the Petition. Req. Reh’g 1–8. Patent Owner then repeats its argument
`that the “identifying” element requires specific types of information to be
`read into the claim element. Id. at 3–8. We do not agree that we
`3
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`IPR2015-00547
`Patent 7,765,107 B2
`
`
`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 a 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 excerpts and expert testimony of Dr. DiPiro and Dr. Valuck on
`which Patent Owner’s Rehearing Request relies regarding the “information
`identifying the patient” and the “credentials of the medical doctor” language.
`Id. at 18 (citing PO Resp. 29–33; Ex. 1001, 4:14–28, 8:4–5, 39–42, 10:50–
`53; Ex. 2044, 97:11–98:5, 99:18–100:10; Ex. 2046 ¶¶ 39–44); id. at 18–19
`(citing PO Resp. 30; Ex. 1001, 4:26–28, 8:4–5; Ex. 2044, 97:11–23, 99:18–
`100:10); id. at 20–21 (citing PO Resp. 33–36; Ex. 1001, 2:28–30, 47–48;
`4:12–6:4, 8:4–7, 40–43, 9:54–56, Figs. 2A–C, 9; Ex. 2044, 181:1–23; Ex.
`2046 ¶¶ 45–49); see also Req. Reh’g 3–8 (providing a subset of the above-
`mentioned citations).1
`We did not “overlook” the above-mentioned evidence, including
`certain testimony by Dr. DiPiro and Dr. Valuck, nor consider only Figure 9
`of the ’107 patent specification regarding the identify of patients, as Patent
`
`
`1 Patent Owner cited to the Abstract of the ’107 patent in support of its
`proposed claim construction. PO Resp. 32–33, 35–36; Req. Reh’g 5, 7.
`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.
`4
`
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`IPR2015-00547
`Patent 7,765,107 B2
`
`
`Owner argues. See Req. Reh’g 3–6. For example, rather than limiting our
`analysis to Figure 9, we stated that
`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); see also id. (citing Ex. 1001, 8:4–5).
`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 ‘request data contain
`information identifying the patient’ to refer to information identifying a
`patient, which may include the type of information presented in the
`enrollment form of Figure 9 and noted by Patent Owner (PO Resp. 29–30),
`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 18–19 (citing Ex. 2044, 97:11–98:5, 99:18–
`100:10; Ex. 2046 ¶¶ 39–44).
`We did the same for the “information identifying . . . credentials of the
`medical doctor” 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
`
`
`
`5
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`IPR2015-00547
`Patent 7,765,107 B2
`
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`prescription fails to contain information regarding “credentials,”
`as recited in the claims.
`Id. at 20–21 (citing PO Resp. 33–36; Ex. 1001, 2:28–30, 47–48, 4:12–6:4,
`8:4–7, 40–43, 9:54–56, 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 overlooked. Therefore, Patent Owner’s
`Rehearing Request is denied.
`
`
`
`
`6
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`IPR2015-00547
`Patent 7,765,107 B2
`
`
`IV. ORDER
`
`Accordingly, it is
`ORDERED that Patent Owner’s Rehearing Request is denied.
`
`
`
`
`
`7
`
`
`
`IPR2015-00547
`Patent 7,765,107 B2
`
`
`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
`
`
`
`8
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