`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.
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`Patent Owner
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`________________
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`Case IPR2015-00547
`Patent 7,765,107
`________________
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`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 IPR2015-00547
` Patent 7,765,107
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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 narcoleptic
`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 ....................................................................................................................8
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`Patent Owner Request for Rehearing
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`Case IPR2015-00547
` Patent 7,765,107
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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 70) (“Final Decision”) by the Patent Trial
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`and Appeal Board (“PTAB”) regarding U.S. Patent No. 7,765,107 (“the ’107
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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 1-6 of the ’107 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 53.
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`In doing so, the PTAB misapprehended and/or overlooked that both parties’
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`experts agreed that, consistent with the specification of the ’107 patent, the claim
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`term “wherein said [prescription] request data contain information identifying the
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`patient, [GHB as the drug prescribed/the drug prescribed], and credentials of the
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`medical doctor” necessarily requires that the claimed prescription requests contain:
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`• the narcoleptic patient’s name, social security number, date of birth,
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`sex, and complete address information, including city, state, and zip
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`code; and
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`• the medical doctor’s name, license number, DEA number, and
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`physician specialty.
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`Patent Owner Request for Rehearing
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`IPR2015-00547
`Patent 7,765,107
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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 narcoleptic patients, the prescription
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`drug, and 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. 29-30), but is not limited to that information nor
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`requires all of that information; and
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`• information identifying credentials, i.e., at least two
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`credentials, of the prescribing doctor, which may
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`include the type of prescriber information described in
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`relation to Figures 2A–C, presented in the enrollment
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`form of Figure 9, and noted by Patent Owner (PO
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`Resp. 33-34), but are not limited to that information
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`nor require all of that 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 ’107 patent and in so doing
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`Patent Owner Request for Rehearing
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`IPR2015-00547
`Patent 7,765,107
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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 narcoleptic patients” and “various credentials
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`of the any and all medical doctors.” See Final Decision at 18-21. The Final
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`Decision, however, overlooked that while the specification describes Figures 2A-C
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`and 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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`“wherein said [prescription] request data
`contain information identifying the patient”
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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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`Patent Owner Request for Rehearing
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`IPR2015-00547
`Patent 7,765,107
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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.” See Paper 46
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`(“Response”) at 30 (citing Ex. 1001 at 4:26-28 ) (emphasis added). As Jazz
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`explained in response to PTAB’s questions at the Oral Hearing, the use of the word
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`“includes” in the specification means that this patient information must be present
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`when identifying the narcoleptic patient. Record of Oral Hearing (Paper 69) at
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`60:10-61:19. That is why Jazz argued that the construction of this term, with
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`respect to patient information, should be construed to mean “at a minimum: the
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`prescription requests containing the narcoleptic patient’s name, social security
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`number, date of birth, sex, and complete address information, including city, state
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`and zip code.” See Response at 29-30.
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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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`Patent Owner Request for Rehearing
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`IPR2015-00547
`Patent 7,765,107
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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 32 (citing Ex. 2046 ¶¶ 43-44; Ex. 2044 at
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`97:11-98:5). Jazz also noted that its construction is consistent with the entire goal
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`of the ’107 patent, and that the patient information allows the central pharmacy to
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`control access to a prescription drug and guard against potential abuse, misuse, and
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`diversion. See id. at 32-33 (citing Ex. 1001 at Abstract; 2046 ¶¶ 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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`Id. at 31 (citing Ex. 2044 at 99:18-100:10). Jazz’s expert, Dr. DiPiro, had the same
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`understanding. See id. at 31 (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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`Patent Owner Request for Rehearing
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`IPR2015-00547
`Patent 7,765,107
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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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`“wherein said [prescription] request data contain information
`identifying . . . credentials of the medical doctor”
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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 4:24-26) (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. The PTAB found, however,
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`that “the specification does not suggest that failing to include on the prescription
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`one or more pieces of information from the list of a ‘medical doctor’s name,
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`license number, DEA number, and physician specialty,’ as proposed by Patent
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`Owner, means that a prescription fails to contain information regarding
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`‘credentials,’ as recited in the claims.” See Final Decision at 21. Again, the Final
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`Decision did not address, and therefore misapprehended and/or overlooked, the
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`fact that both parties’ experts agreed that the claim term must include this
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`information.
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`Patent Owner Request for Rehearing
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`IPR2015-00547
`Patent 7,765,107
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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 35 (citing Ex. 2044 at 181:1-23.) Jazz’s expert, Dr. DiPiro, had the
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`same understanding. See id. (citing Ex. 2046 ¶¶ 47, 49).
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`Jazz’s construction is consistent with the entire goal of the ’107 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 35-36 (citing Ex. 1001 at Abstract; Ex. 2046 ¶47).
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`Patent Owner Request for Rehearing
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`IPR2015-00547
`Patent 7,765,107
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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 33-36.
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`In sum, the PTAB misapprehended and/or overlooked that, based on the
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`specification of the ’107 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 36-41. 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 1-6.
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`III. Conclusion
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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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`Patent Owner Request for Rehearing
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`IPR2015-00547
`Patent 7,765,107
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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
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`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 IPR2015-00547
`Patent 7,765,107
`________________
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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
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`Lead Counsel for Jazz Pharmaceuticals,
`Inc.