Paper No.__
`Filed: August 26, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`________________
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`PAR PHARMACEUTICAL, INC. and AMNEAL PHARMACEUTICALS, LLC
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`Petitioner,
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`v.
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`JAZZ PHARMACEUTICALS, INC.
`
`Patent Owner
`
`________________
`
`Case IPR2015-00554
`Patent 7,668,730
`________________
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`PATENT OWNER REQUEST FOR REHEARING
`PURSUANT TO 37 C.F.R. § 42.71(d)
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`Filed: August 26, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
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`PAR PHARMACEUTICAL, INC. and AMNEAL PHARMACEUTICALS, LLC
`
`Petitioner,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.
`
`Patent Owner
`
`________________
`
`Case IPR2015-00554
`Patent 7,668,730
`________________
`
`PATENT OWNER REQUEST FOR REHEARING
`PURSUANT TO 37 C.F.R. § 42.71(d)
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`Patent Owner Request for Rehearing
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`Case IPR2015-00554
` Patent 7,668,730
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`TABLE OF CONTENTS
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`Page
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`I.
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`II.
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`STATEMENT OF RELIEF REQUESTED .........................................................................1
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`THE PTAB OVERLOOKED/MISAPPREHENDED EVIDENCE SUPPORTING
`JAZZ’S PROPOSED CLAIM CONSTRUCTION .............................................................2
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`A.
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`B.
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`“the prescription requests containing information identifying patients” .................3
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`“the prescription requests containing information identifying . . . various
`credentials of the any and all medical doctors” .......................................................6
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`III.
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`CONCLUSION ....................................................................................................................9
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`Patent Owner Request for Rehearing
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`Case IPR2015-00554
` Patent 7,668,730
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`Pursuant to 37 C.F.R. § 42.71(d), Patent Owner Jazz Pharmaceuticals, Inc.
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`(“Jazz”) submits this Request for Rehearing in response to the Final Written
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`Decision entered July 27, 2016 (Paper 68) (“Final Decision”) by the Patent Trial
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`and Appeal Board (“PTAB”) regarding U.S. Patent No. 7,668,730 (“the ’730
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`patent”).
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`I.
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`Statement of Relief Requested
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`In the Final Decision, the PTAB held that claims 1-11 of the ’730 patent are
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`unpatentable as obvious over the Advisory Committee Art (Exs. 1003-1006) (the
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`“ACA”). See Final Decision at 61.
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`In doing so, the PTAB misapprehended and/or overlooked evidence
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`supporting a claim construction issue where both parties’ experts agreed that the
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`specification of the ’730 patent required Jazz’s construction of the disputed claim
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`term.
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`Specifically, both parties’ experts agreed that, consistent with the
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`specification of the ’730 patent, the claim term “the prescription requests
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`containing information identifying patients, the prescription drug, and various
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`credentials of the any and all medical doctors” necessarily requires that the
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`claimed prescription requests contain:
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`• the patient’s name, social security number, date of birth, sex, and
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`complete address information, including city, state, and zip code; and
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`IPR2015-00554
`Patent Owner Request for Rehearing
`Patent 7,668,730
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`• the medical doctor’s name, license number, DEA number, and
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`physician specialty.
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`Accordingly, as further explained below, the PTAB should vacate its Final
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`Decision and confirm the patentability of the challenged claims.
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`II. The PTAB Overlooked/Misapprehended Evidence Supporting
`Jazz’s Proposed Claim Construction
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`In the Final Decision, the PTAB construed the claim term “the prescription
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`requests containing information identifying patients, the prescription drug, and
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`various credentials of the any and all medical doctors” to mean:
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`• information identifying a patient, which may include
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`the type of information presented in the enrollment
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`form of Figure 9 and noted by Patent Owner (PO
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`Resp. 30), but is not limited to that information nor
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`requires all of that information; and
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`• information identifying various credentials, i.e., at
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`least two different types of credentials, of the
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`prescribing doctor, which may include the type of
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`prescriber information described in relation to Figures
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`2A–C, presented in the enrollment form of Figure 9,
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`and noted by Patent Owner (PO Resp. 34–35), but are
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`- 2 -
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`Patent Owner Request for Rehearing
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`IPR2015-00554
`Patent 7,668,730
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`not limited to that information nor require all of that
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`information.
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`Final Decision at 19, 21. Jazz respectfully submits that the PTAB’s construction
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`omits the requirements listed in the specification of the ’730 patent and in so doing
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`overlooks that all experts in this inter partes review, including Petitioners’ expert,
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`Dr. Robert Valuck, agreed that these requirements were part of the claim term.
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`In the Final Decision, the PTAB based its construction on the finding that
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`Figures 2A-C and Figure 9 are “examples” of the type of information identifying a
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`patient or a prescriber but that such information was not necessarily required by the
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`claim terms “information identifying patients” and “various credentials of the any
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`and all medical doctors.” See Final Decision at 19-21. The Final Decision,
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`however, overlooked that while the specification describes Figures 2A-C and
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`Figure 9 as “examples” of process flowcharts and an enrollment form, the
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`specification requires the identifying information included in the specification,
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`consistent with Jazz’s proposed construction. In other words, while Figures 2A-C
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`and Figure 9 may be examples of the “form” of a prescription request, the
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`“substance” of the patient and prescriber information included in Jazz’s proposed
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`construction is required by the specification.
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`A.
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`“the prescription requests containing
`information identifying patients”
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`Patent Owner Request for Rehearing
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`IPR2015-00554
`Patent 7,668,730
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`The PTAB found that “[t]he specification does not indicate . . . that
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`‘information identifying narcoleptic patients,’ as recited in the claims, necessarily
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`includes each and every piece of information in the enrollment form of Figure 9.”
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`Id. at 19. The PTAB also found that “nothing in the specification suggests that
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`excluding one or more pieces of information in the list of a ‘patient’s name, social
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`security number, date of birth, sex, and complete address information, including
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`city, state and zip code,’ as proposed by Patent Owner, means that a prescription
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`fails to contain ‘information identifying the patient,’ as recited in the claims.” Id.
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`But the Final Decision did not address, and therefore misapprehended and/or
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`overlooked, other evidence in Jazz’s Response.
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`Specifically, Jazz explained that, separate and apart from Figure 9, the
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`specification states that patient information “includes name, social security
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`number, date of birth, gender, [and] contact information.” Patent Owner Response
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`(Paper 39, “Response”) at 31 (citing Ex. 1001 at 4:20-22) (emphasis added). As
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`Jazz explained in response to PTAB’s questions at the Oral Hearing, the use of the
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`word “includes” in the specification means that this patient information must be
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`present when identifying the patient. Record of Oral Hearing (Paper 67) at 60:10-
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`61:19. That is why Jazz argued that the construction of this term, with respect to
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`patient information, should be construed to mean “at a minimum: the prescription
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`requests [for GHB] containing the patient’s name, social security number, date of
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`Patent Owner Request for Rehearing
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`IPR2015-00554
`Patent 7,668,730
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`birth, sex, and complete address information, including city, state and zip code.”
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`See Response at 30.
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`Jazz also explained that both its expert, Dr. DiPiro, and Petitioners’ expert,
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`Dr. Valuck, agreed that the patient information needed on the prescription form
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`would include, at a minimum, the information necessary for the pharmacist to be
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`able to sufficiently identify the patient to whom the drug is prescribed is actually
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`the patient receiving the drug. See id. at 31-32 (citing Ex. 2046 ¶¶ 43-44; Ex. 2044
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`at 97:11-98:5). Jazz also noted that its construction is consistent with the entire
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`goal of the ’730 patent, and that the patient information allows the central
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`pharmacy to control access to a prescription drug and guard against potential
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`abuse, misuse, and diversion. See id. at 33 (citing Ex. 1001 at Abstract; 2046 ¶¶
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`41, 43).
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`Jazz further explained that Petitioners’ expert, Dr. Valuck testified that he
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`agreed with Jazz’s construction:
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`Q. So what specific fields do you consider through the eyes of a
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`person of ordinary skill in the art to be sufficient to identify the
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`narcoleptic patient?
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`A. These would include the elements specified; patient name,
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`Social Security number, date of birth, sex, complete address
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`information, city, state, zip.
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`Patent Owner Request for Rehearing
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`IPR2015-00554
`Patent 7,668,730
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`Id. at 31-32 (citing Ex. 2044 at 99:18-100:10). Jazz’s expert, Dr. DiPiro, had the
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`same understanding. See id. at 32 (citing Ex. 2046 ¶¶ 43-44).
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`The PTAB did not address, and therefore misapprehend and/or overlooked,
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`this undisputed evidence. Jazz’s construction of “the information identifying the
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`patient” is consistent with the specification’s requirement that patient-identifying
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`information at least includes, but is not limited to, the information identified in the
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`specification.
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`B.
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`“the prescription requests containing information identifying . . .
`various credentials of the any and all medical doctors”
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`As Jazz explained, the specification states that the information on
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`prescription requests identifying prescriber information “contains standard contact
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`information as well as license number, DEA number and physician specialty.”
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`Response at 35 (citing Ex. 1001 at 4:20-22) (emphasis added). The use of the
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`word “contains” here means that the claim term identifying the “various credentials
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`of the any and all medical doctors” must include the recited information and may
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`include additional information. See Response at 34-35. The PTAB found,
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`however, that “the specification does not suggest that failing to include on the
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`prescription one or more pieces of information from the list of a ‘medical doctor’s
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`name, license number, DEA number, and physician specialty,’ as proposed by
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`Patent Owner, means that a prescription fails to contain information regarding
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`‘various credentials,’ as recited in the claims.” See Final Decision at 21. Again,
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`Patent Owner Request for Rehearing
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`IPR2015-00554
`Patent 7,668,730
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`the Final Decision did not address, and therefore misapprehended and/or
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`overlooked, the fact that both parties’ experts agreed that the claim term must
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`include this information.
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`Jazz explained that Dr. Valuck agreed that the information in Jazz’s
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`construction is necessary for prescribers, and what is meant by “credentials of the
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`medical doctor”:
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`Q. In the context of the Jazz patents, what is meant by
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`“credentials of the medical doctor”?
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`. . .
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`A. A POSA would understand the credentials of the physician
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`to be the – inclusive of their training, licensure, certifications;
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`all of those qualifications that relate to their training, licensure
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`and ability to practice medicine.
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`Q. Would you include DEA numbers as part of the licensure?
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`A. I would include DEA as part of credentialing. It’s not
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`explicitly medical licensure per se, but DEA registration is a
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`form of credentialing for physicians and pharmacies.
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`Response at 33-34 (citing Ex. 2044 at 181:1-23.) Jazz’s expert, Dr. DiPiro, had the
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`same understanding. See id. at 36 (citing Ex. 2046 ¶¶ 47, 49).
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`Patent Owner Request for Rehearing
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`IPR2015-00554
`Patent 7,668,730
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`Jazz’s construction is consistent with the entire goal of the ’730 patent, and
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`that the various credentials allow the central pharmacy to control access to a
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`prescription drug and guard against potential abuse, misuse, and diversion. See id.
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`at 36 (citing Ex. 1001 at Abstract; Ex. 2046 ¶¶ 47).
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`The PTAB did not address, and therefore misapprehend and/or overlooked,
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`this evidence. Jazz’s construction of the “various credentials” is consistent with
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`the specification’s requirement that information identifying the prescribers
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`credentials must at least include, but is not limited to, the information identified in
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`the specification. See id. at 36.
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`In sum, the PTAB misapprehended and/or overlooked that, based on the
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`specification of the ’730 patent and the understanding of a POSA, the claims
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`necessarily require the patient and prescriber information identified in Jazz’s
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`proposed constructions. Petitioners put forward no evidence that the ACA taught
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`or suggested the identifying information required by Jazz’s construction on the
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`prescription requests. See id. at 37-42. Because the Final Decision’s finding with
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`respect to this claim term was not based on the proper claim construction, Jazz
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`respectfully requests that the PTAB vacate the Final Decision, and confirm the
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`patentability of claims 1-11.
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`Patent Owner Request for Rehearing
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`III. Conclusion
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`IPR2015-00554
`Patent 7,668,730
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`For the reasons described above, Jazz respectfully requests that the PTAB
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`vacate its Final Decision, and confirm the patentability of the challenged claims.
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`Date: August 26, 2016
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` Respectfully submitted,
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`By: /F. Dominic Cerrito (Reg. No. 38,100)/
` F. Dominic Cerrito (Reg. No. 38,100)
` Evangeline Shih (Reg. No. 50,170)
` Frank C. Calvosa (Reg. No. 69,064)
`QUINN EMANUEL URQUHART &
`SULLIVAN, LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`General Tel: (212) 849-7000
`Fax: (212) 849-7100
`nickcerrito@quinnemanuel.com
`evangelineshih@quinnemanuel.com
`frankcalvosa@quinnemanuel.com
`
`David B. Cochran
`Reg. No. 39,412
`JONES DAY
`North Point
`901 Lakeside Avenue
`Cleveland, Ohio 44114
`General Tel: (216) 586-3939
`Direct Tel: (216) 586-7747
`Fax: (216) 579-0212
`dcochran@jonesday.com
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`Attorneys for Jazz Pharmaceuticals, Inc.
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`________________
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`PAR PHARMACEUTICAL, INC. and AMNEAL PHARMACEUTICALS, LLC
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`Petitioner,
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`v.
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`JAZZ PHARMACEUTICALS, INC.
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`Patent Owner
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`________________
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`Case IPR2015-00554
`Patent 7,668,730
`________________
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`CERTIFICATE OF SERVICE
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6(e), the undersigned hereby certifies that
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`PATENT OWNER REQUEST FOR REHEARING PURSUANT TO 37 C.F.R. §
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`42.71(d) was served on August 26, 2016 by filing this document through the Patent
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`Review Processing System, as well as e-mailing a copy to
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`janine.carlan@arentfox.com, bradford.frese@arentfox.com,
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`richard.berman@arentfox.com, and XYREM@arentfox.com.
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`Date: August 26, 2016
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` Respectfully submitted,
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`By: /F. Dominic Cerrito (Reg. No. 38,100)/
` F. Dominic Cerrito (Reg. No. 38,100)
`QUINN EMANUEL URQUHART &
`SULLIVAN, LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`General Tel: (212) 849-7000
`Fax: (212) 849-7100
`nickcerrito@quinnemanuel.com
`
`Lead Counsel for Jazz Pharmaceuticals,
`Inc.
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