Paper No.__
`Filed: June 3, 2016
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`AMNEAL PHARMACEUTICALS LLC and PAR PHARMACEUTICAL, INC.
`
`Petitioner,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.
`
`Patent Owner
`
`________________
`
`Case IPR2015-01903
`Patent 8,731,963
`________________
`
`PATENT OWNER RESPONSE
`PURSUANT TO 37 C.F.R. § 42.120
`
`
`
`
`
`
`
`
`
`
`
`Filed: June 3, 2016
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`AMNEAL PHARMACEUTICALS LLC and PAR PHARMACEUTICAL, INC.
`
`Petitioner,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.
`
`Patent Owner
`
`________________
`
`Case IPR2015-01903
`Patent 8,731,963
`________________
`
`PATENT OWNER RESPONSE
`PURSUANT TO 37 C.F.R. § 42.120
`
`
`
`
`
`
`
`
`
`
`
`
`TABLE OF CONTENTS
`
`Paper No.__
`Filed: June 3, 2016
`
`Page
`
`I.
`
`INTRODUCTION ........................................................................................... 1
`
`II.
`
`BACKGROUND ............................................................................................. 2
`
`III. ARGUMENT ................................................................................................... 3
`
`A.
`
`B.
`
`C.
`
`Petitioners have failed to show, by a preponderance of the
`evidence, that the ACA (Exs. 1003-1006) is prior art .......................... 3
`
`Claim Construction................................................................................ 3
`
`Petitioners have failed to prove, by a preponderance of the
`evidence, that the ACA in view of Korfhage would have
`rendered claims 24, 26, and 27 of the ’963 patent obvious .................. 9
`
`1.
`
`A POSA would not have been motivated to combine the
`ACA and Korfhage to arrive at the claimed “central
`computer database being distributed over multiple
`computers” .................................................................................. 9
`
`2.
`
`The ACA would not have disclosed, taught, or suggested
`the claimed periodic reports ...................................................... 15
`
`IV. CONCLUSION .............................................................................................. 20
`
`
`
`
`
`
`
`
`
`
`Patent Owner Response
`
`
`
`
`I.
`
`INTRODUCTION
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Case IPR2015-01903
` Patent 8,731,963
`
`Amneal Pharmaceuticals LLC and Par Pharmaceutical, Inc. (“Petitioners”)
`
`filed an IPR petition (“Petition” or “Pet.”) seeking cancelation of claims 1-28 of
`
`U.S. Patent No. 8,731,963 (the “’963 patent”). Petitioners presented two grounds
`
`of unpatentability: Ground 1 – claims 1-7 and 9-23 as allegedly obvious over the
`
`Advisory Committee Art (Exs. 1003-1006) (the “ACA”); and Ground 2 – claims 8
`
`and 24-28 as allegedly obvious over ACA in view of Korfhage (Ex. 1037). See
`
`Pet. 9. The Board rejected Ground 1 in its entirety, and partially instituted review
`
`on Ground 2 as it relates to claims 24, 26, and 27. See Paper 10. As explained
`
`below, claims 24, 26, and 27 would not have been obvious.
`
`First, Petitioners have failed to meet their burden of proving that the ACA is
`
`prior art to the ’963 patent.
`
`Second, even assuming that the ACA is prior art—it is not—Petitioners have
`
`failed to meet their burden of showing that the ACA in view of Korfhage would
`
`have rendered the challenged claims obvious.
`
`Accordingly, Jazz respectfully requests that the Board confirm the
`
`patentability of claims 24, 26, and 27 of the ’963 patent.
`
`
`
`
`
`
`
`Patent Owner Response
`
`II. BACKGROUND
`
`
`
`
`IPR2015-01903
`Patent 8,731,963
`
`
`
`Petitioners are defendants in a Hatch-Waxman lawsuit involving the
`
`’963 patent; Petitioners are seeking to make generic versions of Xyrem® which are
`
`covered by the ’963 patent. Xyrem is the only FDA-approved treatment for
`
`cataplexy and excessive daytime sleepiness, both debilitating symptoms of
`
`narcolepsy. Ex. 2001 at 1; Ex. 2002 at 1. Xyrem’s active ingredient is a sodium
`
`salt of gammahydroxybutyric acid (“GHB”), a substance which has been
`
`legislatively defined as a “date rape” drug. Ex. 2003 at 1; Ex. 2004 at 3.
`
`FDA would not have approved Xyrem without a method of restricting access
`
`to the drug that could ensure that its benefits would outweigh the risks to patients
`
`and third parties. In fact, FDA approved Xyrem under 21 CFR § 314.520
`
`(“Subpart H”), which allows FDA to approve drugs that are effective, but can only
`
`be used safely under restricted conditions. Ex. 2001 at 1; Ex. 2002 at 1.
`
`Claims 24, 26, and 27 of the ’963 patent claim computer-implemented
`
`systems for treating a narcoleptic patient with a prescription drug that has a
`
`potential for misuse, abuse, or diversion, while preventing that misuse, abuse, and
`
`diversion by means of various controls. See 1001 at 11:7-12:10, 12:23-33; see also
`
`id. at Abstract, 1:41-45. Each of these claims requires a central computer database
`
`to be distributed over multiple computers, and a query that operates over the
`
`distributed databases. See id. at 11:7-12:10, 12:23-33. Claim 27 additionally
`
`
`
`
`- 2 -
`
`
`
`
`
`Patent Owner Response
`
`
`
`
`
`IPR2015-01903
`Patent 8,731,963
`
`
`
`requires using periodic reports, generated from the single computer database, to
`
`identify a current pattern or an anticipated pattern of abuse of the prescription drug.
`
`See id. at 12:23-33.
`
`III. ARGUMENT
`
`A.
`
`Petitioners have failed to show, by a preponderance of the
`evidence, that the ACA (Exs. 1003-1006) is prior art
`
`The parties have briefed and argued Petitioners’ failure to show that the
`
`ACA qualifies as prior art in related IPRs 2015-00545, -546, -547, -548, -551, and
`
`-554. Jazz submits that the Board should apply the decision it reaches in those
`
`IPRs here.
`
`B. Claim Construction
`
`In an IPR, claims are to be given their broadest reasonable interpretation in
`
`light of the specification in which they appear. See 37 C.F.R. § 42.100(b). Claim
`
`terms are also to be given their ordinary and customary meaning as would be
`
`understood by a POSA, in the context of the entire patent’s disclosure, at the time
`
`of the invention. In re Translogic Tech., 504 F.3d 1249, 1257 (Fed. Cir. 2007).
`
`In the Institution Decision, the Board “determine[d] that no claim terms
`
`require express construction for purposes of this Decision.” Paper 10 at 8. Jazz
`
`respectfully submits, however, that the phrase “wherein the current pattern or the
`
`anticipated pattern [of abuse] are identified using periodic reports generated from
`
`the single computer database” in dependent claim 27 requires construction.
`
`
`
`
`- 3 -
`
`
`
`
`
`Patent Owner Response
`
`
`
`
`
`IPR2015-01903
`Patent 8,731,963
`
`
`
`Specifically, the phrase requires that the reports are generated: (1) from the single
`
`computer database; and (2) on a periodic basis, i.e., at regular frequencies or
`
`intervals, as opposed to intermittently or upon request.
`
`Accordingly, Jazz submits that the phrase “wherein the current pattern or the
`
`anticipated pattern [of abuse] are identified using periodic reports generated from
`
`the single computer database” in claim 27 should be construed to mean: querying
`
`the single computer database to generate, at regular frequencies or intervals, as
`
`opposed to intermittently or upon request, reports containing prescriber, patient,
`
`and/or prescription related information to identify a current pattern or an
`
`anticipated pattern of abuse of the prescription drug. See Ex. 2005 ¶¶ 26-33;
`
`Ex. 2006 ¶¶ 25-31. Jazz’s construction gives meaning to the word “periodic” and
`
`is supported by the ’963 patent’s specification, a POSA’s understanding of the
`
`term, and the plain and ordinary meaning of the word periodic.
`
`First, the specification supports Jazz’s construction. See Ex. 2005 ¶¶ 27, 29-
`
`31; Ex. 2006 ¶¶ 26, 28-29. Specifically, the specification explains that Figures
`
`13A-C are “reports obtained by querying a central database having the fields
`
`represented in Fig. 7.”1 Ex. 1001 at 8:23-25; see also id. at 8:29-30 (“The reports
`
`are obtained by running queries against the database. . . .”). The specification
`
`
`
`
`1 The fields in Fig. 7 contain prescriber, patient, and/or prescription related
`
`information. See Ex. 1001 at Fig. 7.
`
`
`
`
`- 4 -
`
`
`
`
`
`Patent Owner Response
`
`
`
`
`
`IPR2015-01903
`Patent 8,731,963
`
`
`
`further explains: “Each report has an associated frequency or frequencies.” Id.
`
`at 8:28-29 (emphasis added). Figures 13A-C of the ’963 patent also show that
`
`reports regarding prescriber, patient, and/or prescription related information—that
`
`allow for identification of a current pattern or an anticipated pattern of abuse of the
`
`prescription drug—are run at regular frequencies or intervals, as opposed to
`
`intermittently or upon request. Id. at Figs. 13A-C. Thus, the specification supports
`
`Jazz’s construction. See Ex. 2005 ¶ 30; Ex. 2006 ¶ 28; Enpat, Inc. v. Microsoft
`
`Corp., 26 F. Supp. 2d 806, 808-09 (E.D. Va. 1998) (construing “periodic” to mean
`
`“fixed intervals, rather than intermittently or on request” where the specification
`
`disclosed the task being performed on a “pre-determined frequency”).
`
`Second, Jazz’s construction is also supported by the understanding of a
`
`POSA. As Petitioners’ expert, Dr. Valuck, testified during deposition, reports to
`
`investigate abuse can be generated on either “an ad hoc basis or on a regular
`
`basis.” Ex. 2007 at 184:8-16.2 A POSA would understand that ad hoc reports are
`
`done for a particular purpose. 2005 ¶ 28; Ex. 2006 ¶ 27. A POSA would not
`
`consider “ad hoc” reports to be “periodic.” Id.; see also Ex. 2007 at 184:8-16.
`
`
`
`
`
`
`2 The parties have agreed that the expert depositions from IPRs 2015-00545, -546,
`
`-547, -548, -551, and -554 can be used in this proceeding. See Ex. 2009.
`
`
`
`
`- 5 -
`
`
`
`
`
`Patent Owner Response
`
`
`
`
`
`IPR2015-01903
`Patent 8,731,963
`
`
`
`Third, the plain and ordinary meaning of the word periodic supports Jazz’s
`
`construction. Merriam-Webster’s Collegiate Dictionary defines “periodic” as:
`
`
`
`Ex. 2010 at 3. The dictionary reinforces the concept that “periodic” requires
`
`events to occur at regular intervals. See Ex. 2005 ¶ 32; Ex. 2006 ¶ 30.
`
`Jazz notes that, in related IPRs, the Board cited Figure 4B as illustrative of
`
`“a refill request process that permits a pharmacist to identify an early refill request,
`
`generate a ‘risk diversion report,’ and evaluate ‘possible product diversion, misuse
`
`or over-use’ of a prescription drug.” See, e.g., IPR2015-00551, Paper 19 at 22-23.
`
`As mentioned above, however, Dr. Valuck explained at his deposition that
`
`diversion reports can be generated on either “an ad hoc basis or on a regular basis.”
`
`Ex. 2007 at 184:8-16. A POSA would understand that the reports generated in
`
`Figure 4B are “ad hoc” reports done for the particular purpose of investigating
`
`specific early refill requests, and not “regular” or “periodic” reports as set forth in
`
`claim 27. Ex. 2005 ¶ 31; Ex. 2006 ¶ 29.
`
`In reply, Petitioners may argue that the ’963 patent’s parent application’s file
`
`history supports a finding that Figure 4B should be considered a periodic report
`
`because the ’963 applicants cited select portions of Figure 4B as support for a
`
`
`
`
`- 6 -
`
`
`
`
`
`Patent Owner Response
`
`
`
`
`
`IPR2015-01903
`Patent 8,731,963
`
`
`
`similar periodic report claim element. That portion of the file history is reproduced
`
`below.
`
`Ex. 2011 at 8.
`
`
`
`But, as Dr. Bergeron explained at his deposition, the claim element in the
`
`parent application’s file history has two parts – a generating reports part and an
`
`evaluation of potential diversion patterns part. See Ex. 2012 at 342:6-343:23.
`
`Dr. Bergeron further explained that a POSA would understand that the portions of
`
`Figure 4B that the applicants relied upon during prosecution do not say anything
`
`about generating reports. See id. at 339:8-23, 323:25-347:11. Instead, the portions
`
`the applicants cited refer only to the evaluation step. See id. Further, the only
`
`portion of Figure 4B that discloses any type of report is Box 434, and the
`
`applicants chose not to cite that box during prosecution as support for the periodic
`
`report claim element. As Dr. Bergeron explained, a POSA would expect that Box
`
`434 was not cited because Figure 4B did not provide support for the generating
`
`periodic report part of the claim term. See id. at 347:21-348:20. Thus, the
`
`’963 patent’s parent application’s file history does not support a finding that Figure
`
`4B should be considered a periodic report.
`
`
`
`
`- 7 -
`
`
`
`
`
`Patent Owner Response
`
`
`
`
`
`IPR2015-01903
`Patent 8,731,963
`
`
`
`Accordingly, the distinction between running “ad hoc” reports (Ex. 1001 at
`
`Fig. 4B) and running set-frequency/periodic reports (Ex. 1001 at Figs. 13A-C) in
`
`the ’963 patent’s specification further supports Jazz’s construction. See Ex. 2005
`
`¶¶ 29-31; Ex. 2006 ¶¶ 28-29; Enpat, 26 F. Supp. 2d at 808 (holding that the
`
`specification distinguishing between periodic and on request tasks supported a
`
`construction of periodic that means “fixed intervals, rather than intermittently or on
`
`request”).3
`
`For the reasons set forth above, the Board should adopt Jazz’s construction.
`
`
`
`
`
`
`3 “[R]ead in the context of the specification, the claims of the patent need not
`
`encompass all disclosed embodiments.” TIP Sys., LLC v. Phillips &
`
`Brooks/Gladwin, Inc., 529 F.3d 1364, 1373 (Fed. Cir. 2008). Indeed, “[Federal
`
`Circuit] precedent is replete with examples of subject matter that is included in the
`
`specification, but is not claimed.” Id. (holding that “the mere fact that there is an
`
`alternative embodiment disclosed in the [patent-in-suit]” does not mean it is
`
`encompassed by the claims); see also Schoenhaus v. Genesco, Inc., 440 F.3d 1354,
`
`1359 (Fed. Cir. 2006); Maxwell v. J. Baker, Inc., 86 F.3d 1098, 1108 (Fed. Cir.
`
`1996); Unique Concepts, Inc. v. Brown, 939 F.2d 1558, 1562-63 (Fed. Cir. 1991).
`
`The diversion reports in Figure 4B are an unclaimed embodiment.
`
`
`
`
`- 8 -
`
`
`
`
`
`Patent Owner Response
`
`
`
`
`
`IPR2015-01903
`Patent 8,731,963
`
`
`
`C.
`
`Petitioners have failed to prove, by a preponderance of
`the evidence, that the ACA in view of Korfhage would have
`rendered claims 24, 26, and 27 of the ’963 patent obvious
`
`Petitioners have failed to meet their burden of showing that the ACA
`
`qualifies as prior art. Even assuming, however, that the ACA is prior art,
`
`Petitioners have not met their burden of proving that the ACA in view of Korfhage
`
`would have rendered claims 24, 26, and 27 obvious. Specifically, Petitioners have
`
`failed to meet their burden of showing that: (1) a POSA would have been
`
`motivated to combine the ACA with Korfhage to arrive at the “central computer
`
`database being distributed over multiple computers” required for claims 24, 26,
`
`and 27 and (2) the ACA would have disclosed, taught, or suggested the periodic
`
`reports in dependent claim 27.
`
`1.
`
`A POSA would not have been motivated to combine
`the ACA and Korfhage to arrive at the claimed
`“central computer database being distributed
`over multiple computers”
`
`Claims 24, 26, and 27 each require that the central computer database is
`
`distributed over multiple computers. Ex. 1001 at claims 24, 26, 27. Petitioners do
`
`not identify anything in the ACA that would have disclosed, taught, or suggested a
`
`central computer database being distributed over multiple computers. See
`
`generally Pet; Ex. 1007; Ex. 2006 ¶ 43. To the contrary, Petitioners and
`
`Dr. Valuck admit that this limitation does not appear in the ACA. See Pet. 52;
`
`
`
`
`- 9 -
`
`
`
`
`
`Patent Owner Response
`
`
`
`
`
`IPR2015-01903
`Patent 8,731,963
`
`
`
`Ex. 1007 ¶ 144. Thus, Petitioners argue that a POSA would have combined the
`
`ACA with Korfhage. See Pet. 52. Petitioners are wrong.
`
`Without the benefit of hindsight and the claimed inventions in hand, a POSA
`
`would not have been motivated to look to Korfhage, much less single out the one
`
`page discussing a distributed computer architecture. Ex. 2006 ¶ 44. Korfhage is a
`
`treatise on Information Storage and Retrieval within computer systems. See
`
`generally Ex. 1037. Nothing in Korfhage relates to drug distribution or pharmacy
`
`practice generally, and nothing relates to drug abuse, misuse, or diversion. See
`
`generally Ex. 1037; Ex. 2006 ¶ 45. The general concepts simply never appear.
`
`See generally Ex. 1037.4 Petitioners cherry-pick two passages from page 276 of
`
`the 349 page treatise that relate to “Distributed Document Systems,” but their only
`
`explanation for doing so is to “increase the efficiency of the distribution of
`
`Xyrem.” Pet. 52. Elsewhere in the Petition, however, Petitioners argue that large
`
`numbers of Xyrem prescriptions can be handled in an “acelerate[d]” manner using
`
`a “conventional computer,” and that the ACA discloses the use of such a
`
`conventional computer. Pet. 22, 29 (emphasis added). Indeed, a POSA would
`
`have understood that any computer database would sufficiently accommodate drug
`
`distribution by the central pharmacy. Ex. 2006 ¶¶ 46-47.
`
`
`
`
`4 Thus, Dr. Valuck’s testimony that Korfhage “appl[ies] to pharmacy practice” is
`
`entirely unsupported. See Ex. 2007 at 206:10-207:3.
`
`
`
`
`- 10 -
`
`
`
`
`
`Patent Owner Response
`
`
`
`
`
`IPR2015-01903
`Patent 8,731,963
`
`
`
`In short, Petitioners have not identified any problem with the centralized
`
`(i.e., non-distributed) database disclosed in the ACA. See generally Pet; Ex. 1007;
`
`Ex. 2006 ¶ 47. Thus, a POSA would not have been motivated to look for any
`
`substitution, let alone the specific distributed-database architecture in Korfhage.
`
`See Leo Pharm. Prods. v. Rea, 726 F.3d 1346, 1354 (Fed. Cir. 2013) (“Only after
`
`recognizing the existence of the problem would an artisan then turn to the prior
`
`art. . . .”) (emphasis in original).
`
`Further, even if there was a known problem in the prior art, Korfhage
`
`discloses too many options for database architectures to a POSA and provides no
`
`guidance on which option to choose. See Ex. 2006 ¶ 48. Indeed, Petitioners’
`
`declarant admitted that Korfhage “would suggest a lot of possibilities.” Ex. 2008
`
`at 286:11-17; see also id. at 316:23-317:8 (Dr. Valuck admitting that distributed
`
`database document systems are not the only database architecture for handling
`
`documents for pharmacies), 317:12-14 (Dr. Valuck admitting that Korfhage
`
`“covers a host of possibilities for systems”), 318:3-15 (Dr. Valuck testifying that
`
`there are “various forms and different architectures for accomplishing the same
`
`tasks in different ways”). Dr. Valuck further admitted that “all these different
`
`forms were . . . existing in the art and existing in practice for many years in various
`
`systems and various permutations and forms.” Id. at 317:16-23; see also id. at
`
`320:3-4 (“[T]here are different architectures and [] a POSA would know that.”).
`
`
`
`
`- 11 -
`
`
`
`
`
`Patent Owner Response
`
`
`
`
`
`IPR2015-01903
`Patent 8,731,963
`
`
`
`Thus, rather than showing a “finite number of identified, predictable solutions”
`
`(KSR Int’l v. Teleflex Inc., 550 U.S. 398, 421(2007)), Dr. Valuck admitted that the
`
`prior art was replete with a host of possible database architectures.
`
`Notably, Dr. Valuck admitted that he did not consider these other systems
`
`because he “was not asked to opine on . . . all of the different possibilities.”
`
`Ex. 2008 at 316:15-22. Instead, Dr. Valuck admitted that his “whole obviousness
`
`opinion” was based on impermissible hindsight:
`
`A. Again, I looked for where the claim elements were disclosed in the
`
`prior art.
`
`. . .
`
`Q. Right. So you used the patent as a guide to pick the elements out
`
`of the prior art.
`
`A. Well, again, my – my whole obviousness opinion is based on
`
`starting with the elements and referring to prior art and all available
`
`prior art through the eyes of a person of ordinary skill. That was the
`
`process I used.
`
`Ex. 2007 at 198:6-22 (emphasis added). It is improper, however, to pick and
`
`choose in hindsight from the prior art. See Bausch & Lomb, Inc. v. Barnes-
`
`Hind/Hydrocurve, Inc., 796 F.2d 443, 448 (Fed. Cir. 1986) (reversing obviousness
`
`holding and explaining that the prior art must be considered as a whole); KSR, 550
`
`U.S. at 421 (noting that fact finders must guard against “the distortion caused by
`
`hindsight bias and must be cautious of arguments reliant upon ex post reasoning”);
`
`
`
`
`- 12 -
`
`
`
`
`
`Patent Owner Response
`
`
`
`
`
`IPR2015-01903
`Patent 8,731,963
`
`
`
`In re Fine, 837 F.2d 1071, 1075 (Fed. Cir. 1988) (“One cannot use hindsight
`
`reconstruction to pick and choose among isolated disclosures in the prior art to
`
`deprecate the claimed invention.”). Thus, Petitioners’ obviousness analysis fails
`
`because it provides no reason to arrive at the specific distributed database
`
`architecture in Korfhage. See Ex. 2006 ¶ 49.
`
` Further, Petitioners and Dr. Valuck ignore that Korfhage teaches away
`
`from using distributed databases and, therefore, teaches away from combining
`
`Korfhage with the ACA, because it discloses to a POSA that “three major
`
`problems arise” when a user attempts to have a single query operate over multiple
`
`physical databases. See Ex. 1037 at 276-277 (describing problems); see also Ex.
`
`2006 ¶¶ 50-53. While Dr. Valuck testified that he “wasn’t asked to provide an
`
`opinion on problems associated with distributed database systems for . . . [his]
`
`declarations” (Ex. 2008 at 320:24-321:5), he eventually conceded that Korfhage
`
`expressly discloses such problems. See id. at 323:15-324:15; see also id. at
`
`321:21-322:8 (Dr. Valuck testifying that the “problems arise from the situation
`
`described where the user . . . is interested in locating and obtaining a document
`
`regardless of where it resides, either physically or within a computer system”).
`
`A POSA would have understood that the second “major problem” in
`
`Korfhage would have been particularly relevant to the distribution system
`
`disclosed in the ACA. Ex. 2006 ¶¶ 51-52. Specifically, Korfhage explains that
`
`
`
`
`- 13 -
`
`
`
`
`
`Patent Owner Response
`
`
`
`
`
`IPR2015-01903
`Patent 8,731,963
`
`
`
`“[t]he second problem is that of data redundancy. Different databases may include
`
`copies of the same or equivalent document.” Ex. 1037 at 276. Korfhage suggests
`
`that “eliminating the duplication requires relatively little work,” but “in some
`
`instances the documents may be sufficiently different to cause problems.” Id. As
`
`Petitioners admit, the ACA explains that the “central data repository ‘allows for the
`
`identification of duplicate prescriptions.’” Pet. 31. The return of redundant data in
`
`the distributed databases might create a false indication of duplicate prescriptions
`
`that could prevent a patient from receiving her prescription drug. Ex. 2006 ¶ 52.
`
`On the other hand, if the duplicate prescription data is “eliminat[ed]” because a
`
`pharmacist believes it was caused by data redundancy, then a potential abuse
`
`situation would be overlooked. Id.
`
`The “major problems” disclosed in Korfhage would have expressly taught a
`
`POSA away from combining it with the ACA and modifying the distribution
`
`system disclosed in the ACA. Id. ¶ 53. “[R]eferences that teach away cannot
`
`serve to create a prima facie case of obviousness.” McGinley v. Franklin Sports,
`
`Inc., 262 F.3d 1339, 1354 (Fed. Cir. 2001).
`
`Accordingly, Petitioners have failed to meet their burden of proving that
`
`claims 24, 26, and 27 would have been obvious.
`
`- 14 -
`
`
`
`
`
`
`
`
`
`
`Patent Owner Response
`
`
`
`
`
`IPR2015-01903
`Patent 8,731,963
`
`
`
`2.
`
`The ACA would not have disclosed, taught, or
`suggested the claimed periodic reports
`
`Petitioners’ challenge also fails for claim 27 because they failed to meet
`
`their burden of showing that the ACA would have disclosed, taught, or suggested
`
`the additional limitation of claim 27: “wherein the current pattern or the
`
`anticipated pattern [of abuse] are identified using periodic reports generated from
`
`the single computer database.” Petitioners rely on the ACA alone for alleged
`
`disclosure of this claim limitation. See Pet. 53-54, see also id. at 41-43 (citing only
`
`the ACA and not Korfhage).
`
`As discussed above, “wherein the current pattern or the anticipated pattern
`
`[of abuse] are identified using periodic reports generated from the single computer
`
`database” should be construed to mean: querying the single computer database to
`
`generate, at regular frequencies or intervals, as opposed to intermittently or upon
`
`request, reports containing prescriber, patient, and/or prescription related
`
`information to identify a current pattern or an anticipated pattern of abuse of the
`
`prescription drug. See supra at pp. 3-8. The ACA does not teach this limitation
`
`because it does not teach reports to identify current or anticipated patterns of abuse
`
`that are generated: (1) periodically, i.e., at regular frequencies or intervals, as
`
`opposed to intermittently or upon request; and (2) by querying the single computer
`
`database. See Ex. 2005 ¶¶ 34-36, 38-42; Ex. 2006 ¶¶ 32-41.
`
`
`
`
`- 15 -
`
`
`
`
`
`Patent Owner Response
`
`
`
`
`
`IPR2015-01903
`Patent 8,731,963
`
`
`
`First, Petitioners argue that the “ACA discloses using the central data
`
`repository to identify patterns of abuse and diversion.” Pet. 42 (citing Ex. 1003 at
`
`184:24-185:7, Slides at 158; Ex. 1005 at 304, 310-11); see also Ex. 1007 ¶ 121
`
`(citing same). While these disclosures specify the information available in the
`
`“central data repository,” none disclose, teach, or suggest running queries on that
`
`data to generate any types of reports, much less periodic reports. See Ex. 1003 at
`
`184:24-185:7, Slides at 158; Ex. 1005 at 304, 310-11; Ex. 2006 ¶ 34.
`
`Second, Petitioners argue that “the ACA describes preventing diversion and
`
`illicit use, as well as providing assistance to ‘law enforcement for investigation and
`
`prosecution efforts,’ as a goal of the system.” Pet. 42 (citing Ex. 1003 at 15:6-8;
`
`Ex. 1004 at 110; Ex. 1005 at 298, 301, 306-308); see also Ex. 1007 ¶ 121 (citing
`
`same). Petitioners also argue that the central pharmacy “employs numerous
`
`mechanisms, controls, and verification procedures to ensure that Xyrem is not
`
`obtained fraudulently or abused or diverted by the patient or prescriber.” Pet. 41
`
`(citing Ex. 1003 at 184:24-185:7, Slides at 158; Ex. 1004 at 110; Ex. 1005 at 304,
`
`310, 311; Ex. 1006 at 4 n.14, 8 nn. 29, 33 and 9 n.38); see also Ex. 1007 ¶ 120
`
`(citing same). Petitioners further argue that “[i]t would have been obvious to a
`
`POSA that, for the database to determine such abuse or patterns of abuse . . . it
`
`must be queried periodically to generate reports” and that a POSA “would have
`
`understood that such data generation obtained through querying via the central data
`
`
`
`
`- 16 -
`
`
`
`
`
`Patent Owner Response
`
`
`
`
`
`IPR2015-01903
`Patent 8,731,963
`
`
`
`repository is synonymous with generating periodic reports via the computer
`
`database to evaluate potential diversion patterns.” Pet. 41-43 (citing Ex. 1003 at
`
`24:21-24; Ex. 1004 at 110, 115; Ex. 1005 at cover letter, 304, 310, 311; Ex. 1006
`
`at 4 n.14, 7 n.25, 8 nn.29, 33, 9 n.38, 10 nn.41-42; V5 00:10-00:27, V13 00:17-
`
`00:31; Ex. 1003 at 24:21-24); see also Ex. 1007 ¶¶ 120, 122 (citing same).
`
`Petitioners are wrong. The cited evidence would not have disclosed, taught,
`
`or suggested generating periodic reports. See Ex. 1003 at 15:6-8, 24:21-24,
`
`184:24-185:7, Slides at 158; Ex. 1004 at 110, 115; Ex. 1005 at cover letter, 298,
`
`301, 304, 306-308, 310, 311; Ex. 1006 at 4 n.14, 7 n.25, 8 nn.29, 33, 9 n.38, 10
`
`nn.41-42; V5 00:10-00:27, V13 00:17-00:31; Ex. 1003 at 24:21-24; Ex. 2006 ¶¶
`
`35-36. Instead, the evidence cited discloses that “[t]he database will be made
`
`available for review by the DEA as well as other federal and state agencies upon
`
`request.” Ex. 1004 at 110 (emphasis added); see also Ex. 2006 ¶ 36. A POSA
`
`would understand reports generated “upon request” are “ad hoc” reports, not
`
`“periodic” reports. Ex. 2006 ¶ 36; see also id. ¶ 27; Ex. 2005 ¶ 28. Further, as
`
`discussed in detail below, the ACA discloses that the proposed system “preserves
`
`[the] important feature” of not having the central pharmacy police medicine.
`
`Instead, the ACA contemplated having the central pharmacy become involved in
`
`an investigation of abuse only on an ad hoc basis, after authorities asked for its
`
`
`
`
`- 17 -
`
`
`
`
`
`Patent Owner Response
`
`
`
`
`
`IPR2015-01903
`Patent 8,731,963
`
`
`
`assistance. See infra at pp. 19-20. In other words, the ACA only taught the
`
`generation of ad hoc reports.
`
`Third, Petitioners argue that “the ACA discloses generating data by
`
`‘recording prescribers, patients, and dosing that could provide information for any
`
`possible investigations and prosecutions for state and federal authorities’ using a
`
`computer.” Pet. 32 (citing Ex. 1006 at 4 nn.13-14; V5 00:10-00:27); see also Ex.
`
`1007 ¶ 122 (citing same). Petitioners also argue that the ACA discloses that “[a]ll
`
`data collected will be available to state and federal authorities, on whatever
`
`timeframe they determine appropriate,” and imply that “timeframe” refers to
`
`periodic reporting. Pet. 42 (citing Ex. 1005 at 307); Ex. 1007 ¶ 122.
`
`But Petitioners ignore that “[g]enerating data . . . for any possible
`
`investigations and prosecutions” is not the same as generating periodic reports.
`
`See Ex. 2005 ¶¶ 38-41; Ex. 2006 ¶¶ 37-40. The ACA’s full disclosure teaches a
`
`POSA that any reports generated for state or federal agencies are done so “upon
`
`request” to assist the authorities with cases of abuse, which the ACA indicates will
`
`be rare. Ex. 2005 ¶ 39; Ex. 2006 ¶ 38; Ex. 1004 at 110; Ex. 1005 at 306
`
`(“Available data … will assist appropriate authorities in an investigation, should
`
`one become necessary. The centralized, real-time nature of these data will allow
`
`for rapid identification in the rare case of diversion.”) (emphasis added).) Thus,
`
`the ACA only discloses generating retrospective reports to aid in investigations of
`
`
`
`
`- 18 -
`
`
`
`
`
`Patent Owner Response
`
`
`
`
`
`IPR2015-01903
`Patent 8,731,963
`
`
`
`abuse. The ACA would not have disclosed, taught, or suggested the claimed
`
`prospective reports to identify current or anticipated patterns of abuse. Ex. 2005
`
`¶ 39; Ex. 2006 ¶ 38
`
`Indeed, the ACA discloses to a POSA that the pharmacy can only assist with
`
`an investigation once it becomes necessary and has begun. Ex. 2005 ¶ 40.
`
`Specifically, the ACA discloses that “[t]he practicalities of how prescriptions are
`
`filled in the U.S. do not allow for a specialty pharmacy to ‘police’ the practice of
`
`medicine.” Ex. 1005 at 307. Instead, “the current system used in the U.S. for
`
`managing the risks associated with controlled substances allows for appropriate
`
`stakeholders to police individual physician and patient behavior. The Xyrem
`
`system preserves this important feature.” Id.; see also id. (noting the pharmacy
`
`will cooperate with the appropriate stakeholders—“state and federal authorities,
`
`including State Medical Boards, DEA and FDA, in any investigation dealing with
`
`physician or patient behavior”).
`
`Based on the ACA’s disclosures, a POSA would have understood that the
`
`“timeframe” statement cited by Petitioners is similar to the statement in Ex. 1005
`
`that the centralized data “allow[s] for rapid identification in the rare case of
`
`diversion.” Ex. 1005 at 306. Specifically, a POSA would have understood that the
`
`statement boasts the benefit of centralized data being available in real-time, which
`
`is that potential investigations will be able to proceed without delay from the
`
`
`
`
`- 19 -
`
`
`
`
`
`Patent Owner Response
`
`
`
`
`
`IPR2015-01903
`Patent 8,731,963
`
`
`
`pharmacy. Ex. 2005 ¶ 41; Ex. 2006 ¶¶ 39-40. The timeframe is contingent on
`
`particular events. It is not an implication of periodic reporting. Id.
`
`Accordingly, Petitioners have failed to meet their burden of proving that
`
`claim 27 would have been obvious for this additional reason.
`
`IV. CONCLUSION
`
`For the foregoing reasons, Pe
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
