Paper No. __
`Filed: November 6, 2015
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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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`AMNEAL PHARMACEUTICALS LLC, PAR PHARMACEUTICAL, INC. and
`WOCKHARDT BIO AG,
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`Petitioners,
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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 IPR2015-005541
`Patent 7,668,730
`________________
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`PATENT OWNER RESPONSE
`PURSUANT TO 37 C.F.R. § 42.120
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`1 Case IPR2015-01818 has been joined with this proceeding.
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`Patent Owner Response
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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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`INTRODUCTION ........................................................................................... 1
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`II.
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`BACKGROUND ............................................................................................. 2
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`III. ARGUMENT ................................................................................................... 3
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`A.
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`Petitioners have failed to show, by a preponderance of the
`evidence, that the ACA (Exs. 1003-1006) is prior art .......................... 3
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`1.
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`Petitioners have not established that Exs. 1004-1006
`were publicly accessible before the critical date ........................ 4
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`(a)
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`(b)
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`(c)
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`The dates on the documents do not establish public
`accessibility before the critical date ................................. 5
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`Internet Archive evidence does not establish
`public accessibility before the critical date ...................... 5
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`Presence/absence of redactions in Exs. 1004-05 do
`not establish public accessibility before the critical
`date .................................................................................... 9
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`(d) The Federal Register does not establish public
`accessibility before the critical date ............................... 11
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`(e) Dr. Valuck’s testimony does not establish public
`accessibility before the critical date ............................... 12
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`(f)
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`The availability of FOIA requests does not
`establish public accessibility before the critical
`date .................................................................................. 13
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`2.
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`Petitioners have failed to show, by a preponderance of
`the evidence, that a POSA would have looked to the
`Federal Register or been sufficiently capable of finding
`Ex. 1015 .................................................................................... 14
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`Patent Owner Response
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` Case IPR2015-00554
`Patent 7,668,730
`(a) A POSA would not have been motivated to look
`to the Federal Register .................................................... 16
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`(b) A POSA would not have been sufficiently capable
`of finding the Federal Register notice announcing
`the June 6, 2001 Advisory Committee Meeting ............. 21
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`B.
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`Claim Construction.............................................................................. 23
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`1.
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`2.
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`3.
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`“generating with the computer processor periodic reports
`via the exclusive computer database to evaluate potential
`diversion patterns” .................................................................... 25
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`“the prescription requests [for GHB] containing
`information identifying patients” .............................................. 29
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`“the prescription requests [for GHB] containing
`information identifying . . . various credentials of the any
`and all [medical doctors/authorized prescribers]” .................... 33
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`C.
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`Petitioners have failed to prove, by a preponderance of the
`evidence, that the ACA would have rendered the ’730 patent’s
`claims obvious ..................................................................................... 36
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`1.
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`2.
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`3.
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`The ACA would not have disclosed, taught, or suggested
`the claimed prescription requests .............................................. 37
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`The ACA would not have disclosed, taught, or suggested
`the claimed periodic reports ...................................................... 42
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`A POSA would not have been motivated to modify the
`risk management system proposed by Orphan Medical to
`require “confirming with a patient that educational
`material has been read prior to [shipping/providing the
`prescription drug/GHB],” instead of after
`shipping/providing the prescription drug/GHB, with a
`reasonable expectation of success ............................................. 48
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`IV. CONCLUSION .............................................................................................. 58
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`Patent Owner Response
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`I.
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`INTRODUCTION
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`IPR2015-00554
`Patent 7,668,730
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`Amneal Pharmaceuticals LLC and Par Pharmaceutical, Inc. (“Petitioners”)
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`filed a petition for inter partes review (“Petition” or “Pet.”) seeking cancelation of
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`claims 1-11 of U.S. Patent No. 7,668,730 (the “’730 patent”). Petitioners
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`presented two grounds of unpatentability based on alleged obviousness, but the
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`Board instituted trial on only Ground 1—Petitioners’ argument that claims 1-11 are
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`allegedly obvious over the Advisory Committee Art (Exs. 1003-1006) (the
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`“ACA”). Paper 19 at 46. As explained below, Ground 1 lacks merit.
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`First, Petitioners have failed to meet their burden of proving that the ACA is
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`prior art to the ’730 patent. Specifically, Petitioners have not established that:
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`(1)Exs. 1004-1006 were publicly accessible before the ’730 patent’s critical date;
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`and (2) a POSA would have been sufficiently capable of locating the ACA.
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`Second, even assuming that the ACA is prior art—it is not—Petitioners have
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`failed to meet their burden of showing that: (1) ACA would have disclosed,
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`taught, or suggested certain claim elements; and (2) that a person of ordinary skill
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`in the art (“POSA”) would have been motivated to modify the ACA to arrive at the
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`inventions claimed in the ’730 patent with a reasonable expectation of success.
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`Accordingly, Jazz respectfully requests that the Board confirm the
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`patentability of claims 1–11 of the ’730 patent.
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`Patent Owner Response
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`II. BACKGROUND
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`IPR2015-00554
`Patent 7,668,730
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`Petitioners are defendants in Hatch-Waxman lawsuits involving the ’730
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`patent; each is seeking to make a generic version of Xyrem® which is covered by
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`the ’730 patent. Xyrem is the only FDA-approved treatment for cataplexy and
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`excessive daytime sleepiness, both debilitating symptoms of narcolepsy. Ex. 2013
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`at 1; Ex. 2014 at 1. Xyrem’s active ingredient is a sodium salt of
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`gammahydroxybutyric acid (“GHB”), a substance which has been legislatively
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`defined as a “date rape” drug. Ex. 2011 at 1; Ex. 2012 at 3.
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`As a result, the FDA would never have approved Xyrem without a method
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`of restricting access to the drug that could ensure that its benefits would outweigh
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`the risks to both patients and third parties. In fact, the FDA approved Xyrem under
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`a special regulation, 21 CFR § 314.520 (“Subpart H”), which allows the FDA to
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`approve drugs that are shown to be effective, but that can only be used safely under
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`restricted conditions. Ex. 2013 at 1; Ex. 2014 at 1.
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`The methods claimed in the ’730 patent protect patients and the public from
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`abuse, misuse, and diversion of GHB. See Ex. 1001 at 8:36-12:44; see also id. at
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`Abstract, 1:41-45.
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`The independent claims of the ’730 patent claim methods of: (i) receiving in
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`a computer processor, at an exclusive central pharmacy, all prescription requests of
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`all patients being prescribed the prescription drug, with the prescription requests
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`Patent Owner Response
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`IPR2015-00554
`Patent 7,668,730
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`containing information identifying the patient and various credentials of the
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`prescriber; (ii) entering the information into an exclusive computer database for an
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`analysis of potential abuse situations; (iii) checking the prescriber’s credentials to
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`ensure they are eligible to prescribe the drug; (iv) confirming with the patient that
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`they have read educational materials prior to shipping or providing the drug; (v)
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`checking with the exclusive computer database to determine any potential abuse by
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`the patient and prescriber; (vi) mailing or providing the drug to the patient only if
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`the information in the exclusive computer database is not indicative of potential
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`abuse or if no abuse is found by the patient and prescriber; (vii) confirming receipt
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`by the patient of the drug; and (viii) generating periodic reports with the exclusive
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`computer database to evaluate potential drug diversion patterns. See id. at Claims
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`1, 2, and 7-11. The dependent claims add additional limitations for preventing
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`abuse, misuse, and diversion of drugs like GHB. Id. at Claims 3-6.
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`III. ARGUMENT
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`A.
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`Petitioners have failed to show, by a preponderance of the
`evidence, that the ACA (Exs. 1003-1006) is prior art
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`Petitioners have failed to meet their burden of showing that the ACA is prior
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`art. Specifically, Petitioners have failed to show that: (1) Exs. 1004-1006 were
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`publicly accessible before the ’730 patent’s December 17, 2002 priority date (the
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`“critical date”); and (2) a POSA would have been sufficiently capable of locating
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`or learning of the existence and potential relevance of Exs. 1003-1006.
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`Patent Owner Response
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`IPR2015-00554
`Patent 7,668,730
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`To establish that a reference was “publicly accessible,” Petitioners must
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`make “a satisfactory showing that [the reference] has been disseminated or
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`otherwise made available to the extent that persons interested and ordinarily skilled
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`in the subject matter or art exercising reasonable diligence, can locate it.” A.R.M.,
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`Inc. v. Cottingham Agencies Ltd., IPR2014-00671, Paper 10 at 7 (Oct. 3, 2014).
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`“In determining whether a reference was ‘publicly accessible’ . . . a court must
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`consider all of the facts and circumstances surrounding the reference’s disclosure
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`and determine whether an interested researcher would have been sufficiently
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`capable of finding the reference and examining its contents.” Artsana USA, Inc. v.
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`Kolcraft Enters., IPR2014-01053, Paper 22 at 6 (Mar. 6, 2015) (citing In re Lister,
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`583 F.3d 1307, 1312 (Fed. Cir. 2009)). In other words, “once accessibility [has
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`been] shown, an additional inquiry must be answered . . . one must also ‘consider
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`whether anyone would have been able to learn of [the reference’s] existence and
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`potential relevance.’” Id. (citing Lister, 583 F.3d at 1314).
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`1.
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`Petitioners have not established that Exs. 1004-1006
`were publicly accessible before the critical date
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`The Board has concluded, “based on the present record,” that Exs. 1004-
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`1006 were publicly accessible before the critical date. See Paper 19 at 29; see also
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`id. at 27-28. In the Institution Decision, the Board considered: (1) dates on the
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`documents; (2) Internet Archive evidence; (3) the presence or absence of
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`redactions in Exs. 1004 and 1005; (4) a Federal Register notice; and (5) Dr.
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`Patent Owner Response
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`IPR2015-00554
`Patent 7,668,730
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`Valuck’s testimony. Id. at 27-29. However, based on the fully developed record,
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`PTAB’s recent decisions, and the reasons set forth below, Jazz submits that
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`Petitioners have failed to prove, by a preponderance of the evidence, that Exs.
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`1004-1006 qualify as publicly accessible, printed publications.
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`(a) The dates on the documents do not establish
`public accessibility before the critical date
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`The Board considered Petitioners’ discussion of the dates on Exs. 1004-1006
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`in concluding that those materials were publicly accessible before the critical date.
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`Paper 19 at 29; see also id. at 27-28 (citing Pet. at 15-16).
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`The PTAB has held, however, that a date on a document “does not establish
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`when, if ever, the [document] became publicly accessible.” Apple Inc. v. DSS
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`Tech. Mgmt., IPR2015-00373, Paper 8 at 11 (June 25, 2015); see also Coalition for
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`Affordable Drugs IV LLC v. Pharmacyclics, Inc., IPR2015-01076, Paper 33 at 7
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`(Oct. 19, 2015). For example, a date could indicate when the document was
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`created, but not made public. Itron, Inc. v. Certified Measurement, LLC, IPR2015-
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`00573, Paper 13 at 18 (July 9, 2015). Those decisions apply here. The dates on
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`Exs. 1004-1006 do not establish when the documents became publicly accessible.
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`(b)
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`Internet Archive evidence does not establish
`public accessibility before the critical date
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`The Board also considered Petitioners’ argument that Internet Archive
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`evidence supported the public accessibility of Exs. 1004-1006. Pet. at 16; Paper 19
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`Patent Owner Response
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`IPR2015-00554
`Patent 7,668,730
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`at 28. As explained below, however, Internet Archive evidence further supports
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`the fact that Petitioners have failed to meet their burden of showing that Exs. 1004-
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`1006 were publicly accessible before the critical date.
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`As the Board correctly noted, following the link from the Federal Register
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`notice (Ex. 1015) would have led one to “Exhibit 1019, dated July 1, 2001, [which]
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`contains Portable Document Format (‘pdf’) links to ‘Safety Review,’ ‘Briefing
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`Information,’ and Video Script 2/2/01.” Paper 19 at 28 (emphasis added). There
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`is, however, no evidence in the record that establishes that the links led to the
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`documents that are Exs. 1004-1006 before the critical date. Only the links that
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`allegedly led to these documents are submitted as part of the Internet Archive
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`evidence. See Exs. 1018-1020, 1028. Indeed, the documents—Exs. 1004-1006—
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`are absent from the documents that Mr. Butler attested were available on the
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`FDA’s website before the critical date. See Ex. 1028.2
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`In ServiceNow, Inc. v. Hewlett-Packard Co., IPR2015-00707, Paper 12
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`(Aug. 26, 2015), PTAB denied institution because Petitioner failed to establish that
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`certain archived links led to the actual documents asserted as prior art references.
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`2 Petitioners also ignore that the links on Ex. 1019 that they assert led to Exs.
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`1004-1005 are entitled “Safety Review,” and “Briefing Information,” respectively,
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`while the documents that they submitted as Exs. 1004-1005 are entitled,
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`“Preliminary Clinical Safety Review” and “Briefing Booklet,” respectively.
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`Patent Owner Response
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`IPR2015-00554
`Patent 7,668,730
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`There, as here, Petitioner argued that references were available as prior art based
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`on print-outs from the Internet Archive and a declaration from Mr. Butler. Id. at
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`10-15. Further, as here, Petitioner attached to Mr. Butler’s declaration a webpage
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`archived before the critical date that “include[d] download links to various
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`documents (in PDF form), including the . . . References cited in th[e] Petition.” Id.
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`at 11-13 (emphasis added). But the declaration in ServiceNow (like Petitioners’
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`declaration here (Ex. 1028)) did not attach the cited references. Id. Based on those
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`facts, which are also present here, PTAB found that:
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`Petitioner fails to make the critical link between the alleged
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`identification of the [cited] References on the “download page” and
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`the exhibits relied upon in support of its asserted grounds. Despite
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`Petitioner’s arguments and assertion that this “page” was publicly
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`accessible “by no later than August 29, 2001,” Petitioner fails to
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`demonstrate Exhibits 1004-1006, which Petitioner relies upon in
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`support of each of the asserted grounds, were publicly accessible
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`through the webpages included in Exhibit A to the Butler Affidavit
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`more than one year prior to [the challenged patent’s critical date].
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`Id. at 14. A district court has reached a similar conclusion. See Chamilia LLC v.
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`Pandora Jewelry, LLC, No. 04-6017, 2007 WL 2781246, at *6 n.4 (S.D.N.Y. Sept.
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`24, 2007) (“[T]he pages preceding the one-year period . . . do not contain
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`Defendant’s products, but only a link that Plaintiff contends might have lead to a
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`page with Defendant’s products. In short, they would not prove anything.”).
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`Patent Owner Response
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`IPR2015-00554
`Patent 7,668,730
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`Here, as explained above, Petitioners “fail[] to make the critical link between
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`. . . the ‘download page’ [Exhibit 1019] and the exhibits relied upon in support of
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`[their] asserted grounds [Exhibits 1004-1006].” See ServiceNow, IPR2015-00707,
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`Paper 12 at 14. The page with the links, but without the actual documents, does
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`“not prove anything.” See Chamilia, 2007 WL 2781246, at *6 n.4.
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`Moreover, Jazz submits additional Internet Archive evidence here (as did the
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`Patent Owner in ServiceNow (IPR2015-00707, Paper 12 at 14-15)) in the form of
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`another declaration from Mr. Butler—the same declarant that Petitioners rely
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`upon—showing that “the URLs of the archived documents obtained by linking to
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`the indicated documents on the ‘download page’”—Exhibit 1019—were not
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`available until after the critical date. See Ex. 2052.
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`Patent Owner Response
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`IPR2015-00554
`Patent 7,668,730
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`Ex. Calendar View
`Earliest Archive Date3
`1004 November 21, 2011
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`(Ex. 2052 at 495.)
`1005 September 13, 2011
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`(Ex. 2052 at 498.)
`1006 August 30, 2003
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`(Ex. 2052 at 501.)
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`Earliest Archived URL
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`http://web.archive.org/web/20111121200908/http://w
`ww.fda.gov/ohrms/dockets/ac/01/briefing/3754b1_02
`_section%203.pdf (Ex. 2052 at 6.)
`https://web.archive.org/web/20110913175049/http://
`www.fda.gov/ohrms/dockets/ac/01/briefing/3754b1_
`01_1-orphan-medical.pdf (Ex. 2052 at 129.)
`http://web.archive.org/web/20030830152750/http://w
`ww.fda.gov/OHRMS/DOCKETS/ac/01/briefing/375
`4b1_01_2-orphan-medical%20video%20tape%20
`Revised%20Script.pdf (Ex. 2052 at 483.)
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`This further supports the fact that Petitioners have failed to meet their burden of
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`proving that Exs. 1004-1006 were publicly accessible before the critical date.
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`(c) Presence/absence of redactions in Exs. 1004-05 do not
`establish public accessibility before the critical date
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`The Board considered Petitioners’ argument regarding the presence or
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`absence of redactions in Exs. 1004 and 1005 (Paper 19 at 27-28), but the presence
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`3 In the Institution Decision, the Board asked for an explanation of the “note” at
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`the bottom of the calendar view page. Paper 19 at 29. The note means that “the
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`capture dates are not indicative of when or whether a change was made on a
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`webpage or in any file residing at the specified URL. Rather, they reflect the dates
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`for which records are available for the specified URL. The dates that crawlers
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`visited a URL may have been determined relatively independently of the dates of
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`any changes made in that URL’s file.” Ex. 2052 ¶ 10.
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`Patent Owner Response
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`IPR2015-00554
`Patent 7,668,730
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`or absence of redactions on the documents as they exist today says nothing about
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`when the documents became publicly accessible.
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`First, the Board noted that “Exhibit 1004 is . . . asserted by Petitioner[s] to
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`have small portions redacted, thereby indicating an intent to make the document
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`publicly available.” Paper 19 at 27. But Petitioners have not established when the
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`redactions were made, much less that the documents were actually publicly
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`available before the critical date. Specifically, Petitioners have not presented any
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`evidence that Ex. 1004 was available before it was first crawled by the Wayback
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`Machine in 2011. Ex. 2052, Ex. A at 2, Ex. B at 2. The redactions in Ex. 1004,
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`therefore, only evidence what was publicly available in 2011. “Petitioner[s] ha[ve]
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`not directed [the Board] to evidence demonstrating that the portions now relied
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`upon by Petitioner[s] would have escaped redaction” if Ex. 1004 would have
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`become public before the critical date. Medtronic, Inc. v. NuVasive, Inc.,
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`IPR2014-00076, Paper 13 at 8 (Apr. 8, 2014); see also Oxford Nanopore Techs. v.
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`Univ. Washington & UAB Research Found., IPR2014-00512, Paper 12 at 11 (Sept.
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`15, 2014) (“[B]ecause of the opportunity for redaction, the copies of [the cited
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`references] obtained on December 13, 2013 . . . demonstrate what was available to
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`the public on December 13, 2013. . . . [They] do not establish, however, what
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`would have been publicly available any time prior.”). In short, the redactions in
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`Ex. 1004 do not evidence public accessibility before the critical date.
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`Patent Owner Response
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`IPR2015-00554
`Patent 7,668,730
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`Second, the Board noted that “[t]he cover page of the Briefing Booklet says
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`“AVAILABLE FOR PUBLIC DISCLOSURE WITHOUT REDACTION.” See
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`Pet. at 15-16; Paper 19 at 27-28. But Petitioners have not presented any evidence
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`showing that the Briefing Booklet was actually released or distributed to the public
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`before the critical date. Further, Petitioners ignore that the Briefing Booklet is
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`addressed to a limited Advisory Committee panel that was responsible for
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`reviewing the Xyrem drug application for FDA approval. See Ex. 1005 at 1.
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`(addressing letter to “Advisory Committee Member”). Petitioners have not
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`alleged, let alone established, that the panel members receiving the booklet were
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`members of the general public or POSAs. See generally Pet.4 Dr. Valuck also
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`testified during his deposition that he had no opinion on whether the attendees of
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`the Advisory Committee Meeting were POSAs. Ex. 2044 at 43:10-44:3.
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`The lack of evidence of public availability, extrinsic to the Briefing Booklet,
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`weighs against a finding of public accessibility. See Symantec Corp. v. Trustees of
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`Columbia Univ. in the City of N.Y., IPR2015-00371, Paper 13 at 8 (June 17, 2015)
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`(“We acknowledge that Cardinale contains the notation ‘[a]pproved for public
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`release; distribution unlimited.’. . . Petitioner, however, has not provided evidence
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`4 In fact, Ex. 1003 notes that the Advisory Committee Members were “special
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`government employees.” Ex. 1003 at 6:18; see also 5 C.F.R. § 2640.102(t).
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`IPR2015-00554
`Patent 7,668,730
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`extrinsic to Exhibit 1008 tending to show when the thesis actually may have been
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`released or distributed to the public.”).
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`(d) The Federal Register does not establish
`public accessibility before the critical date
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`The Board also considered a Federal Register notice provided by Petitioners
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`as evidence of Exs. 1004-1006’s public accessibility. Paper 19 at 29. But the
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`Board denied institution of another IPR that relied on the same Federal Register
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`notice, holding that statements on the Federal Register notice by themselves do not
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`show that the materials “actually w[ere] made available to the extent that
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`interested, ordinarily skilled persons, exercising reasonable diligence, could have
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`located” them before the critical date. Coalition for Affordable Drugs III LLC, v.
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`Jazz Pharms., Inc., IPR2015-01018, Paper 17 at 14-15 (Oct. 15, 2015). Thus,
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`Petitioners are wrong to suggest (Pet. at 14-15) that the Federal Register notice
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`evidences a general practice of the FDA, and can establish the public accessibility
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`of Exs. 1004-1006. As the Board held, it cannot.
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`Petitioners’ implication that the Federal Register notice alone establishes a
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`“general practice” is also unsupported by the case law that they cite. In IPR2014-
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`00059, general practices were not relied upon to establish public availability.
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`Instead, in that proceeding, the petitioner presented sworn testimony that the
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`specific prior art at issue was actually posted to websites one year before the
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`patent’s earliest priority date. See Rackspace US, Inc. v. PersonalWeb Techs.,
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`Patent Owner Response
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`IPR2015-00554
`Patent 7,668,730
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`IPR2014-00059, Paper 9 at 33-34 (Apr. 15, 2014). In In re Hall, evidence of
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`public availability was also presented in the form of sworn testimony that the
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`specific prior art at issue was publicly available on an approximate date estimated
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`from the library’s date of receipt and its general indexing, cataloging, and shelving
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`practices. 781 F.2d 897, 899-900 (Fed. Cir. 1986). Petitioners have not offered
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`any similar testimony, nor have they otherwise shown that the Federal Register
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`notice is even referring or applicable to the publication of Exs. 1004-1006. The
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`Board should disregard Petitioners’ reliance on the Federal Register notice.
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`(e) Dr. Valuck’s testimony does not establish
`public accessibility before the critical date
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`The Board considered testimony from Dr. Valuck that Exs. 1004-1006
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`would have been available from the FDA website based on the Federal Register
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`notice. Ex. 1007 ¶ 47; see also Paper 19 at 29. But Dr. Valuck admitted he only
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`“visited the FDA website to obtain the materials during the course of preparing
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`[his] IPR declarations” (Ex. 2044 at 60:6-8), which he did in 2014, long after the
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`critical date. Ex. 2045 at 341:13-18. Dr. Valuck also testified that he did not recall
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`visiting the page at any time prior to the critical date. Ex. 2044 at 57:3-60:8.
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`Dr. Valuck’s testimony does not satisfy Petitioners’ burden of showing that
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`Exs. 1004-1006 were publicly accessible prior to the critical date. See ServiceNow,
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`IPR2015-00707, Paper 12 at 18 (holding that declarant’s testimony did not
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`establish that the cited references could be found at links listed on a webpage
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`IPR2015-00554
`Patent 7,668,730
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`archived by the Wayback Machine before the critical date because “[the declarant]
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`does not testify that he downloaded Exhibits 1004-1006 from the download page
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`before [the critical date], or that he is aware of anyone else who did”); see also
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`Dish Network L.L.C. v. Dragon Intellectual Prop., LLC, IPR2015-00499, Paper 7
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`at 10-11 (July 17, 2015) (finding that declarant “lack[ed] personal knowledge as to
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`when and how the [alleged prior art reference] was made available to the public”
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`because he did not attempt to find the reference until long after the critical date).
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`(f) The availability of FOIA requests does not
`establish public accessibility before the critical date
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`Although not specifically noted in the Institution Decision, Petitioners also
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`argued that “even if the materials were not available on the FDA’s website, they
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`would have been available via a Freedom of Information Act request.” Pet. at 17.
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`But Petitioners have not shown that a FOIA request would or even could have
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`returned Exs. 1004-1006 at any time prior to the critical date, or even before the
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`2011 publication dates evidenced by the Internet Archive (see supra at III.A.1.(b)).
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`Thus, Petitioners’ FOIA contention is nothing but attorney argument, and should
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`be disregarded. In re Pearson, 494 F.2d 1399, 1405 (C.C.P.A. 1974) (noting that
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`an “attorney’s argument . . . cannot take the place of evidence.”).
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`Further, “[d]espite acknowledging th[e] opportunity to redact” information
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`before releasing documents pursuant to a FOIA request (see Pet. at 17),
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`“Petitioner[s] ha[ve] not directed [the Board] to evidence demonstrating that the
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`IPR2015-00554
`Patent 7,668,730
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`portions now relied upon by Petitioner[s] would have escaped redaction” before
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`the critical date. See Medtronic, IPR2014-00076, Paper 13 at 8-9 (FDA documents
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`obtained through FOIA request after the critical date are not evidence of
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`documents having that same content existing before the critical date). Thus,
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`Petitioners have failed to meet their burden of showing that a FOIA request would
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`have returned Exs. 1004-1006 (as they existed in 2014 when Petitioners obtained
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`them) at any time relevant to the critical date.
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`2.
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`Petitioners have failed to show, by a
`preponderance of the evidence, that a POSA
`would have looked to the Federal Register or
`been sufficiently capable of finding Ex. 1015
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`Petitioners rely on Ex. 1015 as the sole guide a POSA would use to locate
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`the ACA (Exs. 1003-1006). Specifically, Petitioners argue that a POSA would
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`have located the ACA “by exercising reasonable diligence” and ‘following this
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`link’ [to the FDA website] on the Federal Register notice.” Paper 19 at 28; see
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`also Ex. 1007 ¶ 47 (Dr. Valuck opining that “[a] POSA exercising reasonable
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`diligence would have been able to locate the ACA” based upon a link to the FDA
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`website in Ex. 1015); Ex. 2044 at 57:13-18 (Dr. Valuck testifying he found the
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`ACA by “search[ing] for the . . . website that was indicated in the Federal Register
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`announcement”); 60:9-61:16 (Dr. Valuck testifying he “can’t confirm without,
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`again, going . . . to the Federal Register to verify which website [he] went to,
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`which is where [he] then obtained all of . . . those materials that are included in
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`IPR2015-00554
`Patent 7,668,730
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`[his] exhibits”). In other words, Petitioners concede that a POSA would not have
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`been able to find the ACA without knowledge of the Federal Register and,
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`specifically, its meeting notices.
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`Petitioners have provided no reason, however, to conclude that a POSA
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`(under any of Dr. Valuck’s proposed definitions) would have been motivated to
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`look to the Federal Register for advisory committee meeting announcements.
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`Further, even if a POSA would have been motivated to look to the Federal
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`Register, Petitioners and Dr. Valuck have provided no explanation of how a POSA
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`would have been sufficiently capable of finding the single page (Ex. 1015)
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`announcing the June 6, 2001 Advisory Committee Meeting out of the
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`approximately 67,700 pages in the 2001 Federal Register.
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`(a) A POSA would not have been motivated
`to look to the Federal Register
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`Dr. Valuck offers three different POSAs: the first “POSA would hold a
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`Bachelors or Doctor of Pharmacy degree and a license as a registered pharmacist
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`with 3-5 years of relevant work experience” (Ex. 2044 at 38:20-25) (“Pharmacist
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`POSA”); the second POSA would have “a computer science undergraduate degree
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`or equivalent work experience and work experience relating to business
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`applications, for example, including familiarity with drug distribution procedures”
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`(id. at 39:8-21) (“Computer POSA”); and the third POSA would “have a blend of
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`computer science and pharmacy drug distribution knowledge and/or experience.
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`IPR2015-00554
`Patent 7,668,730
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`For example, such a POSA may have computer science education qualifications
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`and experience relating to computerized drug distribution systems” (id. at 40:22-
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`41:1) (“Blended POSA”). See also id. at 37:23-41:5; Ex. 1007 ¶ 20.
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`Petitioners did not explain (in the Petition or Dr. Valuck’s Declaration) how
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`or why any of Dr. Valuck’s POSAs would have been familiar with the Federal
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`Register, or motivated to look to the Federal Register for notices regarding FDA
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`Advisory Committee Meetings in general, let alone those related to drug
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`distribution, safety, or abuse prevention. See generally Pet; Ex. 1007. Nor did Dr.
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`Valuck supply this information during Jazz’s cross-examination at his deposition.
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`Instead, Dr. Valuck did not provide his explanation until Petitioners’ counsel
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`recognized this hole in their obviousness argument, and attempted to fix it during
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`Dr. Valuck’s deposition redirect examination.5 There, he testified, for the first
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`time, that a POSA would have become familiar with the Federal Register:
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`[I]n their education. If they’re a pharmacist, we teach them about it
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`and expect them to learn how to use it. If they’re working in the
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`practice setting, whether – as I mentioned, the POSA may come from
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`a – different aspects of a team but would find out about it and learn
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`about it in those practice settings where it’s typical that a POSA
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`would – would have access to and see the Federal Register.
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`Ex. 2045 at 293:24-294:11.
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