`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Filed: March 12, 2021
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`MYLAN INSTITUTIONAL LLC and PFIZER INC.,
`Petitioners,
`
`v.
`
`NOVO NORDISK A/S,
`
`Patent Owner.
`
`
`Case No. IPR2020-003241
`U.S. Patent No. 8,114,833
`
`PETITIONER’S OPPOSITION TO PATENT OWNER’S MOTION TO
`EXCLUDE EVIDENCE
`
`
`
`
`
`1
`IPR2020-01252 has been joined with this proceeding.
`
`
`
`
`
`I.
`
`II.
`
`TABLE OF CONTENTS
`NOVO’S MOTION FAILS TO COMPLY WITH 37 C.F.R. §
`42.64(c) ............................................................................................................ 2
`PETITIONER’S REPLY EVIDENCE APPROPRIATELY
`REPLIES TO THE PATENT OWNER RESPONSE ................................ 3
`A.
`The Scope of Petitioner’s Reply is Not a Proper Ground
`for a Motion to Exclude ........................................................................ 3
`Petitioner’s Reply Evidence is Proper Reply ........................................ 4
`1.
`Evidence Related to Similarities Between hGH
`and GLP-1 ................................................................................... 5
`Evidence Related to Mannitol Precipitation Upon
`Evaporation ................................................................................. 6
`Evidence Related to the Betz Priority Application ..................... 8
`3.
`Dr. Forrest’s Testimony and Exhibits Are Not Prejudicial ................. 10
`C.
`Exhibits 1091-1098, 1103, and 1114-1115 are Relevant .................... 12
`D.
`III. NOVO’S OBJECTION TO EVIDENCE INCORPORATED BY
`REFERENCE IS BOTH UNTIMELY AND UNFOUNDED .................. 13
`IV. CONCLUSION ............................................................................................ 15
`
`
`B.
`
`2.
`
`i
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`
`
`
`
`TABLE OF AUTHORITIES
`
`CASES
`10X Genomics, Inc. v. Univ. of Chicago,
`IPR2015-01157, Paper 51 (PTAB Nov. 15, 2016) ............................................... 4
`Anacor Pharm., Inc. v. Iancu,
`889 F.3d 1372 (Fed. Cir. 2018) ........................................................................ 1, 5
`Belden Inc. v. Berk-Tek LLC,
`805 F.3d 1064 (Fed. Cir. 2015) ............................................................................ 4
`BioMarin Pharma Inc., v. Genzyme Therapeutic Prods. L.P.,
`IPR2013-00537, 2015 WL 1009197 (PTAB Feb 23, 2015) ...................... 2, 5, 11
`Blackberry Corp. v. Zipit Wireless, Inc.,
`IPR2014-01508, Paper 49 (PTAB Mar. 29, 2016) ............................................... 3
`Dynamic Drinkware, LLC v. Nat’l Graphics, Inc.,
`800 F.3d 1375 (Fed. Cir. 2015) ............................................................................ 9
`Edwards Lifesciences Corp. v. Boston Sci. SciMed, Inc.,
`IPR2017-00444, Paper 42 (PTAB Jun. 28, 2018) ................................................ 3
`Global Tel*Link Corp. v. Securus Techs, Inc.,
`PGR2015-00013, Paper 50 (PTAB Dec. 7, 2016) ........................................ 14, 15
`Hospira, Inc. v. Genentech, Inc.,
`IPR2017-00804, 2018 WL 1869685 (PTAB Apr. 18, 2018) ............................... 1
`Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd.,
`IPR2013-00517, Paper 87 (PTAB Feb. 11, 2015) ................................................ 4
`Kyocera Corp. v. Softview LLC,
`IPR2013-00007, Paper 51 (PTAB Mar. 27, 2014) ........................................... 1, 3
`Lupin Ltd. v. Senju Pharm. Co.,
`IPR2015-01099, Paper 69 (PTAB Sept. 12, 2016) ............................................... 4
`Mylan Pharm. Inc. v. Boehringer Ingelheim Int’l. GmbH,
`IPR2016-01563, Paper 14 (PTAB Dec. 7, 2016) ................................................. 9
`
`ii
`
`
`
`
`
`Nippon Suisan Kaisha Ltd. v. Pronova Biopharma Norge AS,
`PGR2017-00033, 2019 WL 237114 (PTAB Jan. 16, 2019) ................................. 3
`Palo Alto Networks, Inc. v. Finjan Inc.,
`IPR2015-01979, Paper 62 (PTAB Mar. 15, 2017) ............................................... 3
`Silicon Labs, Inc. v. Cresta Techs. Corp.,
`IPR2014-00881, Paper 47 (PTAB Oct. 21, 2015) .................................... 2, 13, 14
`Toyota Motor Corp. v. Am. Vehicular Scis. LLC,
`IPR2013-00424, Paper 50 (PTAB Jan. 12, 2015) ................................................ 4
`Twitter, Inc. v. Vidstream, LLC,
`IPR2017-00829, Paper 68 (PTAB Jan. 28, 2019) .............................................. 11
`STATUTES
`35 U.S.C. § 102(e) ........................................................................................... 8, 9, 10
`OTHER AUTHORITIES
`37 C.F.R. § 42.6 ....................................................................................................... 13
`37 C.F.R. § 42.23 ............................................................................................. 1, 3, 11
`37 C.F.R. § 42.64 ................................................................................................. 2, 13
`Federal Rule of Evidence 403 .................................................................................. 10
`
`iii
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`
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`
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`Pursuant to 37 C.F.R. § 42.23, Petitioner opposes Patent Owner Novo
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`Nordisk A/S’s (“Novo”) Motion to Exclude (Paper 52). The Board should deny
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`Novo’s motion in its entirety for lacking any merit.
`
`A motion to exclude “is neither a substantive sur-reply, nor a proper vehicle
`
`for arguing whether a reply or supporting evidence is of appropriate scope.”
`
`Kyocera Corp. v. Softview LLC, IPR2013-00007, Paper 51, 34 (PTAB Mar. 27,
`
`2014). But Novo’s motion presents nothing more. Petitioner’s Reply evidence is
`
`appropriate because it fairly and directly responds to arguments and evidence first
`
`raised in Novo’s Response. As the Federal Circuit recognized, a petitioner may
`
`introduce new evidence after the petition stage if the evidence is in reply to
`
`evidence introduced by the patent owner, or if it is used to document the
`
`knowledge that POSAs bring to bear in reading the relied-upon prior art. Anacor
`
`Pharm., Inc. v. Iancu, 889 F.3d 1372, 1380-81 (Fed. Cir. 2018). Novo
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`misconstrues the rules; contrary to its arguments, “[n]ew evidence, including new
`
`testimonial evidence, filed in support of a reply, is not per se improper,” as “[a]
`
`Petitioner’s Reply…may only respond to arguments raised in Patent Owner’s
`
`Response.” Hospira, Inc. v. Genentech, Inc., IPR2017-00804, 2018 WL 1869685,
`
`at *1 (PTAB Apr. 18, 2018). The challenged evidence meets this standard.
`
`Novo moves to exclude Dr. Forrest’s Reply Declaration (“the Forrest Reply
`
`Declaration” (Ex. 1106)) in its entirety and Exhibits 1091-1098, 1103, and 1114-
`
`1
`
`
`
`
`
`1115. Novo contends (at 1) that this evidence contains new theories and a new
`
`basis for the prior art status of Betz. Not so. Dr. Forrest and the Exhibits he cites
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`respond directly to arguments and evidence first raised in Novo’s Response.
`
`Novo is also mistaken in its complaint that it did not have an opportunity to
`
`respond to this alleged “new evidence.” In fact, Novo filed a Sur-Reply directly
`
`addressing Petitioner’s Reply evidence. Paper 44, 13-17, 23-25. Not only is there
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`no prejudice to Novo in admitting the Reply evidence but the strong public policy
`
`against excluding evidence also weights against Novo’s motion. BioMarin Pharma
`
`Inc., v. Genzyme Therapeutic Prods. L.P., IPR2013-00537, 2015 WL 1009197, at
`
`*13 (PTAB Feb 23, 2015) (“It is better to have a complete record of the evidence
`
`submitted by the parties than to exclude particular pieces of evidence.”).
`
`Novo’s remaining arguments are equally without merit. Novo’s motion to
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`exclude should be denied in its entirety.
`
`I.
`
`NOVO’S MOTION FAILS TO COMPLY WITH 37 C.F.R. § 42.64(c)
`A motion to exclude must both identify the objections in the record and
`
`explain them. 37 C.F.R. § 42.64(c). Novo fails to “identify the objections in the
`
`record” as required by § 42.64(c). Novo makes only a passing reference to its
`
`objections, never identifying or explaining them. Paper 52, 2. This failure alone is
`
`sufficient for the Board to deny Novo’s motion. See Silicon Labs, Inc. v. Cresta
`
`Techs. Corp., IPR2014-00881, Paper 47, 11-12 (PTAB Oct. 21, 2015).
`
`2
`
`
`
`
`
`II.
`
`PETITIONER’S REPLY EVIDENCE APPROPRIATELY REPLIES
`TO THE PATENT OWNER RESPONSE
`A. The Scope of Petitioner’s Reply is Not a Proper Ground for a
`Motion to Exclude
`Novo’s motion fails as an initial matter because it is procedurally improper.
`
`As the Board has repeatedly held, a motion to exclude is not the proper vehicle to
`
`challenge the scope of a petitioner’s reply evidence under § 42.23. Kyocera, Paper
`
`51, 34; Edwards Lifesciences Corp. v. Boston Sci. SciMed, Inc., IPR2017-00444,
`
`Paper 42, 12 (PTAB Jun. 28, 2018) (a “motion to exclude evidence filed for the
`
`purpose of striking or excluding an opponent’s brief and/or evidence that a party
`
`believes goes beyond what is permitted under 37 CFR § 42.23 is improper”
`
`(citations omitted)); Palo Alto Networks, Inc. v. Finjan Inc., IPR2015-01979, Paper
`
`62, 66 (PTAB Mar. 15, 2017) (an “allegation that evidence does not comply with
`
`37 CFR § 42.23 is not a sufficient reason under the [FRE] for making an objection
`
`and requesting exclusion of such evidence”); Blackberry Corp. v. Zipit Wireless,
`
`Inc., IPR2014-01508, Paper 49, 40 (PTAB Mar. 29, 2016) (“[A] motion to exclude
`
`is not a proper vehicle for a party to raise the issue of arguments exceeding the
`
`permissible scope of a reply.”). To the contrary, the proper way for Patent Owner
`
`to challenge what it believes to be belatedly presented evidence is not a motion to
`
`exclude, but an authorized motion to strike or authorization for further briefing.
`
`Nippon Suisan Kaisha Ltd. v. Pronova Biopharma Norge AS, PGR2017-00033,
`
`3
`
`
`
`
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`2019 WL 237114, at *24 (PTAB Jan. 16, 2019). Novo requests the Board to
`
`exclude the Forrest Reply Declaration and Exhibits 1091-1098, 1103, and 1114-
`
`1115 as allegedly beyond the scope of a proper reply.2 Paper 52, 4. Novo’s
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`contentions are incorrect on the merits, but the Board need not reach those merits
`
`because the relief Novo requests is not even available.
`
`Petitioner’s Reply Evidence is Proper Reply
`B.
`Petitioner’s Reply evidence is a proper response to arguments raised by
`
`Novo and its expert, Dr. Tessier, in Novo’s Response. No new scientific theories
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`are advanced in the Reply. Petitioner’s theories of invalidity remain the same.
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`“[T]he introduction of new evidence in the course of the trial is to be expected in
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`2 Notably, Novo does not cite a single case in which the Board granted a motion to
`
`exclude, underscoring the impropriety of its motion. See Intelligent Bio-Sys., Inc. v.
`
`Illumina Cambridge Ltd., IPR2013-00517, Paper 87 (PTAB Feb. 11, 2015)
`
`(dismissing motion to exclude as moot); 10X Genomics, Inc. v. Univ. of Chicago,
`
`IPR2015-01157, Paper 51 (PTAB Nov. 15, 2016) (same); Toyota Motor Corp. v.
`
`Am. Vehicular Scis. LLC, IPR2013-00424, Paper 50 (PTAB Jan. 12, 2015) (no
`
`motion to exclude at issue); Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1081
`
`(Fed. Cir. 2015) (affirming denial of motion to exclude based on § 42.23(b));
`
`Lupin Ltd. v. Senju Pharm. Co., IPR2015-01099, Paper 69 (PTAB Sept. 12, 2016)
`
`(denying motion in part and dismissing in part as moot).
`
`4
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`
`
`
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`[an IPR]” and in fact “[t]he purpose of the trial in [an IPR] is to give the parties an
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`opportunity to build a record by introducing evidence—not simply to weigh
`
`evidence of which the Board is already aware.” Genzyme, 825 F.3d at 1366-67.
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`Novo’s motion should be denied.
`
`Evidence Related to Similarities Between hGH and GLP-1
`1.
`In the Petition, Petitioner established several reasons why a POSA would
`
`have been motivated to combine Flink and Betz. For instance, both references
`
`relate to a desire to improve the stability of proteins and peptides in formulation,
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`and a POSA would have understood that common excipients would be useful in
`
`addressing common issues like aggregation and precipitation. See Paper 2, 49 n.16,
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`49-52; Ex. 1002 ¶¶194-196.
`
`Paragraphs 78-96 of the Forrest Reply Declaration (Ex. 1106) and Exhibits
`
`1091-1098 (“the hGH Reply Evidence”) further support this conventional
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`understanding by responding to argument and evidence Novo introduced in its
`
`Response. This was appropriate, as a petitioner may introduce new evidence after
`
`the petition stage if the evidence replies to evidence introduced by the patent
`
`owner, or if it is used “to document the knowledge that skilled artisans would bring
`
`to bear in reading the prior art identified as producing obviousness.” Anacor
`
`Pharm., 889 F.3d 1380-81 (internal citation omitted). As Novo admits, the hGH
`
`Reply Evidence addresses structural similarities between hGH and GLP-1, and
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`5
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`
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`demonstrate that even “proteins having greater complexity [i.e., hGH] often have
`
`stability issues that are the same as or similar to peptides with less complexity [i.e.,
`
`GLP-1].” Paper 35, 19; Paper 52, 7. Dr. Forrest’s Reply Declaration expressly
`
`states that this evidence is a direct response to Dr. Tessier’s opinions. Ex. 1106
`
`¶¶78-79. Dr. Forrest addresses several disagreements with Dr. Tessier, and uses
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`Exhibits 1091-1098 to support his opinions. Id. at ¶¶80-96 (citing Exs. 1091-1098).
`
`Accordingly, the hGH Reply Evidence, and the portions of the Reply that
`
`cite the hGH Reply Evidence are eminently proper reply evidence.
`
`Evidence Related to Mannitol Precipitation Upon Evaporation
`2.
`The alleged discovery disclosed in the ’833 patent is the unsurprising reality
`
`that mannitol (a solid) will fall out of solution when the solute evaporates, creating
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`problems related to aggregation and precipitation. Novo contends that this is a
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`“new theory” advanced by Petitioner in Reply, but Novo is mistaken.
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`In the Petition, Petitioner explained mannitol’s propensity to cause deposits
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`and clogging is “not surprising given that mannitol is a naturally a solid under
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`standard conditions.” Ex. 1002 ¶202; see also Paper 2, 21-23. Petitioner stated that
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`in contrast, “propylene glycol is naturally a liquid solvent under standard
`
`conditions” and “would not leave deposits behind”, unlike non-volatile solid
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`solutes, like mannitol, which are left behind when water evaporates at ambient
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`conditions. Ex. 1002 ¶¶77-79, 201-203; Paper 2, 21-23. Dr. Forrest expounded on
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`6
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`
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`this opinion during his cross-examination, testifying that “when a solution
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`containing mannitol evaporates, such as during lyophilization and other water-
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`vapor removal processes, mannitol produces a stiff cake.” Ex. 1002 ¶77. Dr.
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`Forrest further explained his testimony during his cross examination, explaining
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`that “in processes that involve evaporation, such as lyophilization–which is a
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`production-level process that [he used] a number of times–that mannitol can
`
`crystallize out readily and then it ends up forming a stiff cake.” See Ex. 2079,
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`182:12-183:6. Dr. Forrest also addressed Ex. 1114 during his first deposition,
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`citing it for the proposition that evaporation can cause precipitation of mannitol.
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`See id. at 188:20-191:9. Thus, the so-called “evaporation theory” was not new at
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`all. Novo had every opportunity to address this argument in its Response, including
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`with supporting expert evidence.
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`Contrary to Novo’s assertion, Petitioner’s so-called “evaporation theory” is
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`anything but new. Indeed, Dr. Forrest’s Reply Declaration (at ¶¶108-109) and
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`Exhibits 1114-1115 cite to and summarize Dr. Forrest’s prior declaration and
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`deposition testimony to restate these basic principles to rebut Dr. Tessier’s
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`testimony that “[p]recipitation of mannitol out of supersaturated solutions at
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`[supersaturated] concentration[s] would not have been considered relevant to the
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`much lower concentrations of mannitol used in Flink.” Ex. 2022 ¶79; see also Ex.
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`1106 ¶¶108-109 (citing Ex. 1114-1115).
`
`7
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`
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`Accordingly, paragraphs 108-109 of the Forrest Reply Declaration and
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`Exhibits 1114-1115, and the portions of the Reply that cite to this evidence are
`
`proper reply evidence.
`
`Evidence Related to the Betz Priority Application
`3.
`In its Petition, Petitioner explained that Betz qualifies as prior art under 35
`
`U.S.C. § 102(e). Paper 2, 27. In its response, Novo for the first time asserted that
`
`the inventors reduced the invention to practice by April 23, 2003, a date that
`
`appears nowhere in the ’833 patent or its file history. Paper 25, 49. Petitioner could
`
`not possibly have foreseen Novo’s attempt to antedate Betz, and thus could not
`
`have addressed this argument in its Petition. In direct response to this new and
`
`previously-unknowable date of invention, Petitioner explained in its Reply, and Dr.
`
`Forrest opined in his Reply Declaration, that Betz remains prior art under § 102(e)
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`because Betz claims priority to a July 9, 2002 U.S. application. Paper 35, 26-29,
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`Ex.1106 at ⁋⁋ 113-116. Having met its burden of establishing a prima facie case
`
`that Betz is prior art under § 102(e) upon institution—and in the absence of
`
`evidence to the contrary—Petitioner did not waive its right to establish an earlier
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`§ 102(e) date when Novo presented its antedation argument after institution.
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`Novo’s effort to exclude paragraphs 113-116 of the Forrest Reply
`
`Declaration and Exhibit 1103 is based on an erroneous understanding of the
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`burden-shifting framework for determining whether a reference is § 102(e) prior
`
`8
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`
`
`
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`art. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378-79
`
`(Fed. Cir. 2015) (explaining burdens). Petitioner met its initial burden of
`
`production by establishing that Betz constituted prior art under § 102(e) as of its
`
`July 8, 2003 filing date. See id. at 1379. The burden then shifted to Novo to show
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`that the claims of the ’833 patent were entitled to the benefit of an earlier date. See
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`id. at 1380. Novo did not make this showing in its Preliminary Response, instead
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`waiting until after the Board instituted this IPR to argue for an earlier reduction to
`
`practice. After Novo finally relied on an earlier reduction to practice date, the
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`burden shifted back to Petitioner to prove that the claimed invention in Betz was
`
`entitled to the benefit of a filing date before Novo’s newly-asserted reduction to
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`practice date. Id. Thus, Petitioner’s Reply does not constitute a change in position,
`
`but rather a proper response to address Novo’s antedation evidence within the
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`well-recognized burden-shifting framework. Petitioner was entitled to respond to
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`Novo’s antedation argument after discovery. Mylan Pharm. Inc. v. Boehringer
`
`Ingelheim Int’l. GmbH, IPR2016-01563, Paper 14, 4 (PTAB Dec. 7, 2016) (“Patent
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`Owner bears the burden of proof regarding its antedating contention. Petitioner is
`
`entitled to respond to the contention after discovery.”).
`
`The Board has addressed this issue before. First, in Green Cross Corp. v.
`
`Shire Human Genetic Therapies, Inc., the Board determined a petitioner does not
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`waive its right to establish that a prior art reference is entitled to its provisional
`
`9
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`
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`
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`filing date when it is evident on the face of the reference that it qualifies as prior art
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`under § 102(e). IPR2016-00258, Paper 12, 7-8 (PTAB May 25, 2016). Like the
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`prior art in Green Cross, Betz qualified as prior art under §102(e) on its face, thus
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`Petitioner did not waive its right to establish that Betz is entitled to its provisional
`
`filing date after institution.
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`Moreover, like Petitioner in this case, the petitioner in Activision Blizzard,
`
`Inc. v. Game and Technology Co., Ltd. submitted expert testimony and evidence
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`after a patent owner presented antedating evidence to establish that a prior art
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`reference, Rogers, was entitled to its provisional filing date. IPR2016-01885, Paper
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`22, 5 (PTAB Sept. 15, 2017). Crediting the expert’s reply declaration in view of
`
`the provisional application, the Board found that the petitioner met its burden of
`
`production to show that Rogers was entitled to the provisional application’s
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`priority date, despite the petitioner not raising that earlier filing date in its petition.
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`Id., Paper 2, 6 (PTAB Sept. 23, 2016), Paper 35, 57-60 (PTAB Mar. 14, 2018).
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`Accordingly, paragraphs 113-116 of the Forrest Reply Declaration and
`
`Exhibit 1103, and the portions of the Reply that cite to these paragraphs and this
`
`Exhibit are proper reply evidence.
`
`C. Dr. Forrest’s Testimony and Exhibits Are Not Prejudicial
`Novo argues (at 5, 7-10) that the Forrest Reply Declaration (Ex. 1106) and
`
`Exhibits 1091-1098, 1103, and 1114-1115 should be excluded under FRE 403
`
`10
`
`
`
`
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`because Novo was purportedly denied opportunity to respond to that evidence. But
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`Novo is mistaken. As explained above, this evidence properly replies to Novo’s
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`Patent Owner Response, and in any event, Novo took advantage of its ample
`
`opportunity to respond in its Sur-Reply and through its cross-examination of Dr.
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`Forrest. See Paper 44, 13-17, 23-25; Ex. 2096, 123:21-149:23. The Board routinely
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`denies requests to exclude evidence under such circumstances as these, where the
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`moving party was aware of the evidence and has had an opportunity to respond.
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`Twitter, Inc. v. Vidstream, LLC, IPR2017-00829, Paper 68, 48 (PTAB Jan. 28,
`
`2019) (denying motion to exclude where patent owner had notice and an
`
`opportunity to respond in a sur-reply); BioMarin, 2015 WL 1009197, at *14
`
`(denying motion to exclude where patent owner had opportunity to address
`
`testimony in its response). It is of no moment that Novo’s expert was not entitled
`
`to file a new declaration in sur-reply. That is the Congressionally-defined structure
`
`for inter partes review proceedings and how the burdens are allocated. Rule 42.23
`
`expressly allows for a reply to respond to arguments raised in the corresponding
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`patent owner response and prohibits new evidence with the sur-reply. Petitioner is
`
`entitled to have its expert provide the last word on unpatentability. The Board is
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`perfectly capable of analyzing technical evidence to determine how much weight
`
`to afford Dr. Forrest’s testimony in view of Novo’s Response, Sur-Reply, and
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`Novo’s expert’s testimony. See BioMarin, 2015 WL 1009197, at *14 (denying
`
`11
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`
`
`
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`motion to exclude, noting that the Board “is capable of discerning from the
`
`testimony, and the evidence presented, whether the witness’ testimony should be
`
`entitled to any weight” and of “taking note of . . . inadequacies [raised by patent
`
`owner] and weighing that testimony accordingly”).
`
`D. Exhibits 1091-1098, 1103, and 1114-1115 are Relevant
`Novo also argues that Exhibits 1091-1098, 1103, and 1114-1115 are
`
`irrelevant because they are not cited in Petitioner’s Petition or Reply.3 Paper 52,
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`11-13. But that is not the standard for exclusion. Novo’s reliance on One World
`
`Technologies, Inc. v. The Chamberlain Group, Inc. for support is misplaced. In
`
`One World, the Board excluded an exhibit that was cited in a paragraph of an
`
`expert declaration where that paragraph was never cited in any of patent owner’s
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`papers. IPR2017-00126, Paper 56, 16-17 (PTAB Oct. 24, 2018). Here, however,
`
`Petitioner’s Reply cites extensively to paragraphs 78-96 (citing Exhibits 1091-
`
`3 Novo’s contention that these Exhibits are not relevant is belied by Novo’s own
`
`arguments that Exhibits 1091-1098 are “essential” to “provide an alleged reason
`
`why a person of ordinary skill would have been motivated to combine Betz, which
`
`concerns hGH formulations, with Flink, which concerns GLP-1 formulations”
`
`(Paper 52, 11), that Exhibit 1103, the Betz priority application, is “essential” to
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`Petitioner’s obviousness case (id. at 12); and that Exhibits 1114-1115 support
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`Petitioner’s argument related to evaporation of mannitol solutions (id. at 13).
`
`12
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`
`
`
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`1098), paragraphs 108-109 (citing Exhibits 1114-1115), and paragraphs 113-116
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`(citing Exhibits 1114-1115) of the Forrest Reply Declaration. See Paper 35, 19-21,
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`23, 27. As a result, the challenged Exhibits are relevant, properly relied upon, and
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`properly cited, and should not be excluded
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`III.
`
`NOVO’S OBJECTION TO EVIDENCE INCORPORATED BY
`REFERENCE IS BOTH UNTIMELY AND UNFOUNDED
`In a last-ditch effort to exclude evidence of Betz’s earlier filing date, Novo
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`seeks to exclude paragraphs 113-116 of the Forrest Reply Declaration and Exhibit
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`1103 as allegedly improperly incorporated by reference. Paper 52, 14. But Novo
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`does not identify where in the record it preserved this objection . Such omission is
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`for good reason: Novo never made this objection before and it cannot do so now,
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`for the first time, in a motion to exclude. Novo waived its objection and its belated
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`request to exclude on the basis of improper incorporation should be denied for that
`
`reason alone. See 37 C.F.R. § 42.64(b)(1).
`
`Notwithstanding the procedural impropriety of Novo’s motion, the Reply
`
`does not improperly incorporate any argument by reference, but rather incorporates
`
`evidence like the Forrest Reply Declaration and Exhibit 1103, itself cited in the
`
`Forrest Reply Declaration. As the Board has held, such reference is not an
`
`improper incorporation by reference of argument subject to exclusion under 37
`
`C.F.R. § 42.6(a)(3). Silicon Labs., Paper 64, 17-18 (“§ 42.6(a)(3) prohibits
`
`incorporation of arguments, and an expert declaration, such as that at issue here,
`
`13
`
`
`
`
`
`generally is considered evidence, not argument.” (emphasis in original)).
`
`Petitioner explained in its Reply, to rebut Patent Owner’s attempt to swear
`
`behind Betz, that “Betz claims priority to a July 9, 2002 U.S. application,” Ex.
`
`1106, on its face, which “contains a nearly identical specification and provides
`
`support for the claims.” Paper 35, 27. That the priority application has a nearly
`
`identical specification compels a finding that the prior application necessarily
`
`supports the claims of Betz; indeed, the claims of the priority application are
`
`identical to those in Betz. Petitioner’s Reply appropriately cited Dr. Forrest’s
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`Reply Declaration, which explained this basic proposition and further discussed the
`
`issue of Betz’s priority. Novo’s attempt to characterize the evidence provided in
`
`the Forrest Declaration (including Exhibit 1103) for this proposition as improper
`
`argument is unavailing. Indeed, as the Board has held, such discussion of the
`
`factual record is not argument at all. See Silicon Labs., Paper 64, 16-18; see also
`
`Global Tel*Link Corp. v. Securus Techs, Inc., PGR2015-00013, Paper 50, 16
`
`(PTAB Dec. 7, 2016). (exhibits cited by a declarant were not incorporated by
`
`reference, but instead petitioner was “making of record the documents cited...so
`
`that a reader can determine for herself that cited facts are supported”).
`
`The cases relied upon by Novo (at 14-15) do not support its position that
`
`Exhibit 1103 and Paragraphs 113-116 of Dr. Forrest’s reply are improperly
`
`incorporated by reference. In Boston Scientific Neuromodulation Corp. v. Nevro
`
`14
`
`
`
`
`
`Corp., a patent owner alleged that certain products practice a claim of the asserted
`
`patent, but its response failed to address elements of that claim. 813 F. App’x 572,
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`582 (Fed. Cir. 2020). Those missing elements were only addressed in the
`
`incorporated exhibit. Id. at 582-83. Here, Petitioner fully included its argument in
`
`its Reply. Similarly, in Surgalign Spine Technologies, Inc. v. LifeNet Health, a
`
`patent owner relied on two claim charts to support its assertions of nexus and
`
`copying. IPR2019-00570, Paper 74, 12 (PTAB Aug. 26, 2020). The Board
`
`excluded the claim charts because the expert did not mention them, nor did the
`
`charts represent the testimony of any witness. Id. at 13. That is not the case here,
`
`where Novo’s entire argument appears predicated on the fact that the Reply itself
`
`does not cite Exhibit 1103—only Dr. Forest’s discussion of it. But this, too, does
`
`not run afoul of the evidentiary requirements. As the Board has held, in rejecting
`
`similar arguments, there is no requirement that exhibits be cited by “papers” and
`
`not other exhibits because “[m]any exhibits, such as declarations, prior art
`
`references, and deposition transcripts, cite to other exhibits in normal trial
`
`practice.” Global Tel*Link, PGR2015-00013, Paper 50, *16. Novo’s motion to
`
`exclude must fail for this additional reason.
`
`IV.
`
`CONCLUSION
`For at least the reasons set forth above, the Board should deny Novo’s
`
`motion in its entirety.
`
`15
`
`
`
`Dated: March 12, 2021
`
`
`/s/ Lara J. Dueppen
`Lara J. Dueppen
`Reg. No. 65,002
`
`Counsel for Petitioner Mylan
`Institutional LLC
`
`
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`Pursuant to 37 C.F.R. § 42.6(e), I certify that I caused to be served a true and
`
`correct copy of the foregoing: Petitioner’s Opposition to Patent Owner’s Motion to
`
`Exclude Evidence by email to the electronic service addresses for Patent Owner
`
`and Petitioner Pfizer Inc.:
`
`Jeffrey Oelke
`Laura T. Moran
`Ryan P. Johnson
`FENWICK & WEST LLP
`joelke@fenwick.com
`laura.moran@fenwick.com
`ryan.johnson@fenwick.com
`Novo833IPR@fenwick.com
`
`Counsel for Patent Owner
`
`Thomas J. Meloro
`Michael W. Johnson
`WILLKIE FARR & GALLAGHER LLP
`tmeloro@willkie.com
`mjohnson1@willkie.com
`
`Counsel for Petitioner Pfizer Inc.
`
`/s/ Lara J. Dueppen
`Lara J. Dueppen
`Reg. No. 65,002
`
`Counsel for Petitioner Mylan
`Institutional LLC
`
`Dated: March 12, 2021
`
`
`
`
`
`
`
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