`Filed: April 1, 2016
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`PAR PHARMACEUTICAL, INC., WOCKHARDT BIO AG, and
`AMNEAL PHARMACEUTICALS LLC,
`
`Petitioners,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.
`
`Patent Owner
`
`________________
`
`Case IPR2015-005541
`Patent 7,668,730
`________________
`
`
`
`PATENT OWNER’S OPPOSITION TO PETITIONERS’
`MOTION TO EXCLUDE EVIDENCE
`
`
`
`
`1 Case IPR2015-01818 has been joined with this proceeding.
`
`
`
`
`
`Patent Owner Opposition to Motion to Exclude IPR2015-00554
`Patent 7,668,730
`
`I.
`
`INTRODUCTION
`
`Petitioners seek to exclude highly relevant evidence regarding whether a
`
`person of ordinary skill in the art (“POSA”) exercising reasonable diligence would
`
`have located the Advisory Committee Materials (“ACA”) (Exs. 1003-1006) based
`
`on the Federal Register notice submitted as Ex. 1015 in this inter partes review
`
`(“IPR”). Petitioners’ objections are based on alleged hearsay, irrelevance, and
`
`improper expert testimony. At the outset, Petitioners’ Motion to Exclude (“Mtn.”)
`
`should be denied because it is not based on “objections in the record” since
`
`Petitioners never satisfied the requirements of 37 C.F.R. § 42.64(b)(1) by filing
`
`their objections. See 37 C.F.R. § 42.64(c). The motion should also be denied
`
`because Petitioners’ objections go to weight rather than admissibility, and for the
`
`specific reasons set forth below.
`
`II. ARGUMENT
`
`A. The objected-to portions of the DiPiro and Bergeron Declarations
`and Exs. 2049-2050 are relevant to public accessibility of the ACA
`
`Petitioners argue that certain portions of the DiPiro (Ex. 2046) and Bergeron
`
`(Ex. 2047) Declarations, as well as Exs. 2049-2050 “are irrelevant to the issue of
`
`public accessibility of the ACA” because: (1) the Federal Register’s notice
`
`function allegedly establishes public accessibility as a matter of law and
`
`(2) Dr. DiPiro’s opinions are allegedly directed to “uninterested” POSAs. See
`
`Mtn. 3-8.
`
`
`
`
`
`Patent Owner Opposition to Motion to Exclude IPR2015-00554
`
`
`Patent 7,668,730
`
`
`Petitioners’ objections, however, failed to provide this particularity, i.e., the
`
`objections did not explain why the exhibits were allegedly irrelevant to public
`
`accessibility. Instead, Petitioners asserted only a boilerplate relevance objection:
`
`JAZZ EXHIBIT 2046 are objected to under Fed. R. Ev. 401–402
`
`because they are irrelevant to the question of whether, more than one
`
`year before December 17, 2002, PAR1004–PAR1006 were
`
`disseminated or otherwise made available to the public to the extent
`
`that persons interested and ordinarily skilled in the subject matter or
`
`art, exercising reasonable diligence, could locate it [sic].
`
`Paper 53 at 1; id. at 2-3 (same for Exs. 2047, 2049, 2050). Thus, Petitioners failed
`
`to “identify the grounds for the objection with sufficient particularity to allow
`
`correction in the form of supplemental evidence.” 37 C.F.R. § 42.64(b)(1). These
`
`objections should be denied for this reason alone. See B/E Aerospace, Inc. v. MAG
`
`Aerospace Indus., LLC, IPR2014-01510, Paper 106 at 6-7 (Mar. 18, 2016).
`
`1.
`
`Petitioners erroneously equate the Federal Register’s
`notice function with the standard for public accessibility
`
`Petitioners object to Jazz’s evidence showing that a POSA exercising
`
`reasonable diligence would not have located the ACA through the half-page entry
`
`in the Federal Register—out of the 67,700 pages of the 2001 version of the Federal
`
`Register—as irrelevant by arguing that “[u]nder Federal law, every person in the
`
`United States, which of course includes POSAs, is deemed to have been given
`
`sufficient notice for items published in the Federal Register.” Mtn. 3-6 (emphasis
`
`
`
`
`- 2 -
`
`
`
`Patent Owner Opposition to Motion to Exclude IPR2015-00554
`
`
`Patent 7,668,730
`
`added). Petitioners’ argument about the legal effect of the Federal Register is
`
`incorrect, and conflates a legal interest with a scientific or technical one.
`
`Specifically, the “notice” the Federal Register provides is a legal construct to
`
`prevent individuals from later claiming ignorance of the law if their legally
`
`protected interests are adversely affected. Indeed, as the cases Petitioners cite
`
`explain, “[t]he purpose of notice is to ‘inform [the recipient] that the matter [in
`
`which his protected interests are at stake] is pending.’” Moreau v. F.E.R.C., 982
`
`F.2d 556, 569 (D.D.C. 1993) (emphasis added); see also N. Ala. Express, Inc. v.
`
`United States, 585 F.2d 783, 786 (5th Cir. 1978) (explaining that the
`
`Administrative Procedures Act requires “[r]easonable notice to interested persons
`
`that their legally protected interests may be adversely affected by administrative
`
`action”) (emphasis added); id. at 787 n.2 (noting that the Federal Register provides
`
`“legally sufficient notice to all interested persons”) (emphasis added).
`
`Thus, the notice that the Federal Register provides is specifically directed to
`
`interested persons whose legally protected interests are at jeopardy of being
`
`adversely affected. See id. at 790 (requiring republication of inadequate notice in
`
`the Federal Register to inform competitors of a company granted increased
`
`operating capacity); Moreau, 982 F.2d at 569 (finding notice was given to
`
`individuals whose property interests were affected by a gas pipeline); S. Terminal
`
`Corp. v. E.P.A., 504 F.2d 646, 654, 657 (1st Cir. 1974) (finding that “interested
`
`
`
`
`- 3 -
`
`
`
`Patent Owner Opposition to Motion to Exclude IPR2015-00554
`
`
`Patent 7,668,730
`
`persons”—persons whose legal interests were affected by an air quality
`
`transportation plan—had notice of a technical document in the Federal Register).
`
`Petitioners try to conflate the Federal Register’s “deemed” notice to
`
`individuals with a “legally protected interest,” with a “person of ordinary skill in
`
`the art interested in the subject matter of the patents in suit and exercising
`
`reasonable diligence” actually locating prior art. See Bruckelmeyer v. Ground
`
`Heaters, Inc., 445 F.3d 1374, 1378 (Fed. Cir. 2006) (emphasis added). There is
`
`simply no caselaw holding that the POSA’s “interest[] in the subject matter of the
`
`patents in suit” is a “legally protected interest” that has the potential to be
`
`adversely affected. There is also no caselaw that equates “deemed” notice of a rule
`
`with the ability to actually locate that rule, when exercising reasonable diligence.2
`
`On the other hand, this Board has previously held that statements in the very same
`
`Federal Register notice at issue in this IPR do not show that the ACA “actually
`
`
`
`
`2 For example, just because a person might be on constructive notice of an
`
`obscure mining law published in the Federal Register, does not mean that person,
`
`exercising reasonable diligence, would be able to actually locate the mining law.
`
`The public accessibility caselaw requires that a POSA exercising reasonable
`
`diligence be able to actually locate the prior art in question.
`
`
`
`
`- 4 -
`
`
`
`Patent Owner Opposition to Motion to Exclude IPR2015-00554
`
`
`Patent 7,668,730
`
`w[ere] made available to the extent that interested, ordinarily skilled persons,
`
`exercising reasonable diligence, could have located” them before the critical date.
`
`Coalition for Affordable Drugs III LLC, v. Jazz Pharms., Inc., IPR2015-01018,
`
`Paper 17 at 14-15 (Oct. 15, 2015).
`
`In sum, Petitioners have not asserted, let alone proven, that a POSA’s legally
`
`protected interests could have been affected by the June 6, 2001 Advisory
`
`Committee Meeting at issue in this IPR. There is no evidence that a POSA
`
`exercising reasonable diligence would have located the ACA through the Federal
`
`Register; instead, the evidence of record—which Petitioners seek to exclude—
`
`definitively proves otherwise. Thus, Petitioners’ motion to exclude the objected to
`
`portions of the DiPiro and Bergeron Declarations, as well as Exs. 2049 and 2050,
`
`as “irrelevant as a matter of law” (Mtn. 4), lacks merit and should be denied. The
`
`evidence is relevant because it makes the fact that a POSA exercising reasonable
`
`diligence would not have located the ACA through the Federal Register more
`
`probable. See Fed. R. Evid. 401.
`
`2.
`
`Paragraphs 54-56 of the DiPiro Declaration are directed to
`the actions of POSAs interested in the subject matter of the
`patents in suit
`
`Petitioners argue that Paragraphs 54-56 of the DiPiro Declaration should be
`
`excluded as irrelevant because Dr. DiPiro purportedly “alleges that a POSA, as
`
`defined by Dr. Valuck, has ‘no focus on drug distribution, safety, and abuse or
`
`
`
`
`- 5 -
`
`
`
`Patent Owner Opposition to Motion to Exclude IPR2015-00554
`
`
`Patent 7,668,730
`
`regulatory affairs.’” Mtn. 7. This is false. Dr. DiPiro clearly testified: “A
`
`Pharmacist POSA, as defined by Dr. Valuck, is not a researcher with a specific
`
`focus on drug distribution, safety, and abuse or regulatory affairs.” Ex. 2046, ¶55
`
`(emphasis added). He also explained this at his deposition. Ex. 1055 at 248:1-4.
`
`There is good reason why Petitioners intentionally omitted the “a researcher
`
`with a specific focus” portion of Dr. DiPiro’s opinion to make their “uninterested”
`
`POSA argument. Petitioners’ counsel attempted, but failed, to have Dr. DiPiro
`
`agree at his deposition that a POSA would not have a “specific interest” in “drug
`
`distribution” and “safety and abuse issues.” See Ex. 1055 at 248:8-249:5. Dr.
`
`DiPiro repeatedly answered “I’m not agreeing.” See id. Instead, Dr. DiPiro
`
`explained that a POSA “would be expected to have an interest in drug distribution
`
`systems, be interested in safety, be interested in [abuse] and regulatory affairs.”
`
`See id. at 249:6-250:17. He also explained the difference between his statement
`
`regarding a “researcher with a specific focus” and a POSA with a “specific
`
`interest.” See id. The POSA is not a “researcher with a specific focus.” In fact,
`
`Dr. Valuck did not mention any “researcher with a specific focus on drug
`
`distribution, safety, and abuse or regulatory affairs” as part of his POSA when he
`
`explained it to Petitioners’ counsel during re-direct testimony at his deposition.
`
`See Ex. 2045 at 237:17-238:1.
`
`
`
`
`- 6 -
`
`
`
`Patent Owner Opposition to Motion to Exclude IPR2015-00554
`
`
`Patent 7,668,730
`
`
`Thus, Petitioners’ argument that “[t]he DiPiro Declaration only relates to
`
`what persons uninterested in the subject matter of the ’059 patent would have
`
`done” lacks credibility. Dr. DiPiro was addressing the correct POSA and his
`
`opinions are relevant. The opinions make the fact that a POSA exercising
`
`reasonable diligence would not have located the ACA through the Federal Register
`
`more probable. See Fed. R. Evid. 401.
`
`Finally, Petitioners’ one-sentence argument that Paragraphs 54-56 should be
`
`excluded under Rule 403 (Mtn. 7-8), also lacks merit. Dr. DiPiro’s opinions
`
`directly contradict Dr. Valuck’s unsupported assertions regarding the Federal
`
`Register. Further, the Board will not be confused by them, as evidenced by
`
`Petitioners’ failure to give even a single example of how confusion would arise.
`
`B.
`
`The Van Buskirk Deposition is admissible under Rule 807,
`and it is not improper expert testimony, nor is it irrelevant
`
`Exhibit 2054 is an excerpt of a deposition in the co-pending district court
`
`litigation addressing the patents-at-issue in this IPR. The witness testifying,
`
`Dr. Glenn Van Buskirk, was hired as an expert by the generic pharmaceutical
`
`company, Roxane Laboratories Inc., in an effort to invalidate Jazz’s patents. Thus,
`
`Roxane and Petitioners share a common goal. During his deposition, however,
`
`Dr. Van Buskirk provided testimony that directly contradicts Petitioners’ argument
`
`in this IPR that a POSA would have located the ACA through the Federal Register.
`
`
`
`
`- 7 -
`
`
`
`Patent Owner Opposition to Motion to Exclude IPR2015-00554
`
`
`Patent 7,668,730
`
`Petitioners are now making every effort they can to exclude it—asserting that it is
`
`inadmissible hearsay, improper expert testimony, and irrelevant. Petitioners have
`
`not met their burden to exclude Ex. 2054.
`
`1.
`
`The Van Buskirk Deposition is admissible under Rule 807
`
`Petitioners argue that Exhibit 2054 is inadmissible hearsay because “neither
`
`of the exceptions in Rule 801(d) apply.” Mtn. 8-9. Petitioners ignore, however,
`
`that the Van Buskirk Deposition is admissible under the residual exception to
`
`hearsay. Fed. R. Evid. 807. Rule 807 has four requirements: (1) the statement has
`
`equivalent circumstantial guarantees of trustworthiness; (2) it is offered as
`
`evidence of a material fact; (3) it is more probative on the point for which it is
`
`offered than any other evidence that the proponent can obtain through reasonable
`
`efforts; and (4) admitting it will best serve the purposes of the Federal Rules of
`
`Evidence and the interests of justice. The Van Buskirk Deposition meets these
`
`requirements.
`
`First, because the Van Buskirk Deposition is sworn testimony taken during a
`
`legal proceeding, it has the requisite guarantees of trustworthiness. See Pozen Inc.
`
`v. Par Pharm., Inc., 696 F.3d 1151, 1161 n.6 (Fed. Cir. 2012). Second, the Van
`
`Buskirk Deposition is offered as evidence of a material fact because it relates to the
`
`issue of whether a POSA would have located the ACA based on the Federal
`
`Register. See United States v. Fountain, 2 F.3d 656, 667 n. 6 (6th Cir. 1993) (“A
`
`
`
`
`- 8 -
`
`
`
`Patent Owner Opposition to Motion to Exclude IPR2015-00554
`
`
`Patent 7,668,730
`
`fact or proposition is ‘material’ if it is properly provable in a case in the sense that
`
`it is disputed or, at least, is ‘in issue.’”). Third, the Van Buskirk Deposition is
`
`more probative on the point for which it is offered than any other evidence that can
`
`be obtained through reasonable efforts. While taking positions against Jazz,
`
`Dr. Van Buskirk is the only expert, not specifically involved in this IPR, who
`
`testified about what information would be conveyed to a POSA based on the
`
`Federal Register. Fourth, the Van Buskirk Deposition will best serve the purposes
`
`of the rules and the interests of justice for the reasons set forth above.
`
`Petitioners were well aware of Jazz’s intent to rely on the Van Buskirk
`
`Deposition, but made no efforts to challenge it. Petitioners could have asked Jazz
`
`to secure Dr. Van Buskirk’s deposition in this IPR. They did not. Petitioners also
`
`could have easily requested from Roxane, or Dr. Van Buskirk directly, a
`
`declaration countering what is set forth in the Van Buskirk Deposition. Again,
`
`they did not. Instead, Petitioners made no efforts to challenge the merits of the
`
`Van Buskirk Deposition. Accordingly, even if it is hearsay, the Van Buskirk
`
`Deposition is admissible under Fed. R. Evid. 807.
`
`Finally, even if the Van Buskirk Deposition does not qualify for the residual
`
`exception, Jazz cured Petitioners’ objection by timely serving Ex. 2059. Exhibit
`
`2059 is a declaration from Dr. DiPiro in which he relies on Dr. Van Buskirk’s
`
`testimony as evidence consistent with his testimony that a POSA would not have
`
`
`
`
`- 9 -
`
`
`
`Patent Owner Opposition to Motion to Exclude IPR2015-00554
`
`
`Patent 7,668,730
`
`been motivated to look to the Federal Register and, therefore, would not have
`
`located the ACA. Ex. 2059, ¶¶3-4. An expert is permitted to rely on hearsay, and
`
`Ex. 2059 cures Petitioners’ hearsay objection. While Petitioners complain that
`
`“Jazz has never made Exhibit 2059 part of record in this proceeding, and has
`
`neither identified how it cured Petitioners’ objections nor how Jazz was relying on
`
`the supplemental evidence,” Jazz was not required to do so. See Sealed Air Corp.
`
`v. Pregis Innovative Packaging, Inc., IPR2013-00554, Paper 18 at 2-3 (Apr. 1,
`
`2014) (explaining that previously-served supplemental evidence should not be
`
`made of record until an opposition to a motion to exclude is filed). Thus,
`
`Petitioners’ complaint is baseless.
`
`2.
`
`The Van Buskirk Deposition is proper expert testimony
`
`Petitioners also argue that the Van Buskirk Deposition is “improperly relied
`
`upon as expert opinion testimony” because “Jazz has not qualified . . . Dr. Van
`
`Buskirk[] as an expert in this proceeding.” Mtn. 9. Petitioners do not explain why
`
`Dr. Van Buskirk would not have the competency to testify concerning the
`
`pharmacist POSA. Instead, Petitioners ignore that Dr. Van Buskirk testified that
`
`he has the degree required for a pharmacist POSA—a B.S. in Pharmacy—and is
`
`also a registered pharmacist. Compare Ex. 2054 at 115:10- 22 with Ex. 1007, ¶ 20.
`
`Further, even if Dr. Van Buskirk does not qualify as a POSA, that would not
`
`cure Petitioners’ faulty argument. He has relevant experience in what Petitioners
`
`
`
`
`- 10 -
`
`
`
`Patent Owner Opposition to Motion to Exclude IPR2015-00554
`
`
`Patent 7,668,730
`
`have asserted is the field of invention—pharmacy. See Mytee Prods. v. Harris
`
`Research, Inc., 439 F. App’x 882, 886–87 (Fed. Cir. 2011) (upholding admission
`
`of the testimony of an expert who “had experience relevant to the field of the
`
`invention,” despite admission that he was not a POSA). Moreover, there need not
`
`be a perfect match between the expert’s qualifications and the patent at issue. See
`
`SEB S.A. v. Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010).
`
`Accordingly, Petitioners have not met their burden of showing that the
`
`Van Buskirk Deposition is improper expert testimony.
`
`3.
`
`The Van Buskirk Deposition is relevant
`
`In a last-ditch effort, Petitioners repeat the same relevancy argument that is
`
`based upon the Federal Register’s “notice” function. As discussed above,
`
`however, Petitioners’ argument is legally incorrect and should be rejected.
`
`C. The Przybylski Declaration is not hearsay, nor is it irrelevant
`
`Exhibit 2057 is a declaration from Jazz’s paralegal Lyndsey Przybylski.
`
`On November 5 and 6, 2015, Ms. Przybylski spoke with three employees,
`
`including Ms. Adams-Buckley, at the Health Sciences Library at the University of
`
`Colorado Denver (the “Library”). Ex. 2057 ¶3. During these conversations, the
`
`three employees confirmed that the only paper copy of the Federal Register in the
`
`Library is from 1968. Id. Ms. Adams-Buckley also confirmed this through e-mail.
`
`Id., Ex. 1. Exhibit 2057, and the e-mail sent by Ms. Adams-Buckley, directly
`
`
`
`
`- 11 -
`
`
`
`Patent Owner Opposition to Motion to Exclude IPR2015-00554
`
`
`Patent 7,668,730
`
`contradict Dr. Valuck’s testimony regarding how he allegedly views materials in
`
`the Federal Register. Realizing the damage this does to their case, Petitioners now
`
`attempt to exclude Ex. 2057 as hearsay and irrelevant. Petitioners have not met
`
`their burden.
`
`1.
`
`The Przybylski Declaration is not hearsay
`
`Petitioners assert that Ex. 2057 “solely contains out-of-court statements by
`
`others to prove the truth of the matter asserted .” Mtn. 11. Not so. Jazz offered
`
`Exhibit 2057 as direct testimony in this IPR. The PTAB has repeatedly held that
`
`declarations offered in IPRs are not “out-of-court statements.” See Phigenix, Inc v.
`
`Immunogen, Inc., IPR2014-00676, Paper 39 at 28 (Oct. 27, 2015); Toyota Motor
`
`Corp. v. Am. Vehicular Scis. LLC, IPR2013-00417, 2015 WL 124522, at *5 (Jan.
`
`7, 2015). Notably, Petitioners had the opportunity to depose Ms. Przybylski and
`
`challenge her statements and the exhibit she cited, but chose not to do so. That is
`
`Petitioners’ failing, not Jazz’s. Ms. Przybylski’s statements are not hearsay, and
`
`Petitioners’ efforts to exclude them as such should be rejected.
`
`But even if Ex. 2057 is hearsay—it is not—it qualifies for the residual
`
`exception to hearsay under Fed. R. Evid. 807. It is offered as evidence of a
`
`material fact—whether Dr. Valuck’s testimony regarding his practice of reading
`
`the Federal Register is accurate—that has guarantees of trustworthiness, as it was
`
`submitted as a declaration in this IPR. It is also more probative on the point for
`
`
`
`
`- 12 -
`
`
`
`Patent Owner Opposition to Motion to Exclude IPR2015-00554
`
`
`Patent 7,668,730
`
`which it is offered than other evidence in this proceeding, and admitting it will best
`
`serve the purposes of the rules and the interests of justice.
`
`Moreover, Jazz files concurrently herewith Ex. 2058, which it timely served
`
`as supplemental evidence, to cure the objection. Exhibit 2058 is a declaration from
`
`Ms. Adams-Buckley, wherein she attests to the same facts regarding paper copies
`
`of the Federal Register at the Library that are set forth in the Przybylski
`
`Declaration. See Ex. 2058. Petitioners complain that “Jazz has never made
`
`Exhibit 2058 part of record in this proceeding, and has neither identified how it
`
`cured Petitioners’ objections nor how Jazz was relying on the supplemental
`
`evidence.” Mtn. 11. Jazz was not required to do so. See Sealed Air, IPR2013-
`
`00554, Paper 18 at 2-3. In any event, Ex. 2058’s content makes clear that it was
`
`served to cure Petitioners’ objection to the Przybylski Declaration.3 Accordingly,
`
`Petitioners’ motion to exclude Ex. 2057 as hearsay should be denied.
`
`2.
`
`The Przybylski Declaration is relevant
`
`Exhibit 2057 (and Exhibit 2058) prove that the Library does not have any
`
`paper copies of the Federal Register, except a 1968 version. Petitioners argue that
`
`this is irrelevant because the evidence provides information “regarding the contents
`
`
`
`
`3 Petitioners may argue that Ex. 2058 is hearsay. They would be incorrect. See
`
`See Phigenix, IPR2014-00676, Paper 39 at 28; Toyota, 2015 WL 124522, at *5.
`
`
`
`
`- 13 -
`
`
`
`Patent Owner Opposition to Motion to Exclude IPR2015-00554
`
`
`Patent 7,668,730
`
`of the [Library] as of November 2015,” and Dr. Valuck’s testimony regarding
`
`reading paper copies of the Federal Register allegedly applied only to 2001, not
`
`2015. Mtn. 11-12. This is incorrect, as demonstrated by Dr. Valuck’s testimony
`
`shown below.
`
`As an initial matter, however, Petitioners’ objections made no mention of the
`
`alleged date discrepancy they now allege. Instead, Petitioners asserted only a
`
`boilerplate relevance objection: “JAZZ EXHIBIT 2057 is objected to under Fed.
`
`R. Ev. 401–402 because it is irrelevant to any issue at dispute in this proceeding.”
`
`Paper 53 at 6. Thus, Petitioners’ objection failed to provide Jazz “with sufficient
`
`particularity to allow correction in the form of supplemental evidence.” 37 C.F.R.
`
`§ 42.64(b)(1). The objection should be denied for this reason alone. See B/E
`
`Aerospace, IPR2014-01510, Paper 106 at 6-7.
`
`In any event, Petitioners’ relevance objection is baseless. The disputed
`
`testimony-at-issue is:
`
`Q.
`
`A.
`
`
`
`[I]s the Federal Register online or paper?
`
`The – can you be more specific? You mean today or . . . at the
`
`time of this particular notice or at a specific point in time?
`
`Q. Sure. Let’s start with 2001 at the time of this notice in
`
`
`
`PAR1015.
`
`
`
`A. My – at that time, I was using a paper-based subscription sort of
`
`
`
`
`
`
`
`
`format, if you will, of the Federal Register. Our health sciences
`
`library has copies of the Federal Register that – that come
`
`- 14 -
`
`
`
`Patent Owner Opposition to Motion to Exclude IPR2015-00554
`
`
`Patent 7,668,730
`
`
`
`
`
`
`there. So they’re available to us on campus that way. And that
`
`happens to be how I typically would see the Federal Register.
`
`Ex. 2045 at 341:19-342:6 (emphasis added). As is clear from the exchange, Jazz’s
`
`counsel asked Dr. Valuck to explain how he views the Federal Register, starting
`
`with 2001. Dr. Valuck provided his answer using the past tense, starting with
`
`2001. Dr. Valuck then proceeded to testify in the present tense. He testified that
`
`the Library has paper copies of the Federal Register and that they are available.
`
`Thus, Petitioners’ irrelevancy argument is without merit. Dr. Valuck’s testimony
`
`was not limited to 2001.
`
`Tellingly, Petitioners did not attempt to rebut Ex. 2057 in their reply.
`
`Petitioners could have easily obtained a counter-declaration from the Library
`
`showing that the Library did in fact possess paper copies of the Federal Register in
`
`2001 if that were true. Petitioners either chose not to do so or could not do so.
`
`Petitioners’ irrelevancy objection should be rejected.
`
`III. CONCLUSION
`
`For the foregoing reasons, the Board should deny Petitioners’ Motion to
`
`Exclude.
`
`
`
`
`
`
`- 15 -
`
`
`
`Patent Owner Opposition to Motion to Exclude IPR2015-00554
`
`
`Patent 7,668,730
`
`
`Date: April 1, 2016
`
`
`
`
`
`
`Respectfully submitted,
`
`By: /F. Dominic Cerrito (Reg. No. 38,100)/
` F. Dominic Cerrito (Reg. No. 38,100)
` Eric C. Stops (Reg. No. 51,163)
` 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
`ericstops@quinnmemanuel.com
`evangelineshih@quinnemanuel.com
`frankcalvosa@quinnemanuel.com
`
`John V. Biernacki
`Reg. No. 40,511
`JONES DAY
`North Point
`901 Lakeside Avenue
`Cleveland, Ohio 44114
`General Tel: (216) 586-3939
`Direct Tel: (216) 586-7747
`Fax: (216) 579-0212
`jvbiernacki@jonesday.com
`
`Attorneys for Jazz Pharmaceuticals, Inc.
`
`
`
`- 16 -
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`PAR PHARMACEUTICAL, INC., WOCKHARDT BIO AG, and
`AMNEAL PHARMACEUTICALS LLC,
`
`Petitioners,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.
`
`Patent Owner
`
`________________
`
`Case IPR2015-005544
`Patent 7,668,730
`________________
`
`
`
`CERTIFICATE OF SERVICE
`
`
`
`
`
`
`4 Case IPR2015-01818 has been joined with this proceeding.
`
`
`
`
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), the undersigned hereby certifies that
`
`PATENT OWNER’S OPPOSITION TO PETITIONERS’ MOTION TO
`
`EXCLUDE EVIDENCE and Exs. 2058-2059 were served on April 1, 2016 by
`
`filing these documents through the Patent Review Processing System, as well as e-
`
`mailing copies to bradford.frese@arentfox.com, richard.berman@arentfox.com,
`
`janine.carlan@arentfox.com, and PCGallagher@duanemorris.com.
`
`Date: April 1, 2016
`
`
`
`
`
`
`
`
` Respectfully submitted,
`
`By: /F. Dominic Cerrito (Reg. No. 38,100)/
` F. Dominic Cerrito (Reg. No. 38,100)
` QUINN EMANUEL URQUHART &
` SULLIVAN, LLP
` 51 Madison Avenue, 22nd Floor
` New York, NY 10010
` General Tel: (212) 849-7000
`Fax: (212) 849-7100
`nickcerrito@quinnemanuel.com
`
`Lead Counsel for
`Jazz Pharmaceuticals, Inc.
`
`
`
`- 2 -