IPR2020-00324
`Patent 8,114,833 B2
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
`
`MYLAN INSTITUTIONAL LLC and PFIZER INC.,
`Petitioners,
`
`v.
`
`NOVO NORDISK A/S,
`Patent Owner.
`______________
`
`Case IPR2020-003241
`Patent 8,114,833
`______________
`
`PATENT OWNER’S REPLY IN SUPPORT OF ITS
`MOTION TO EXCLUDE EVIDENCE
`
`
`
`
`
`
`1 IPR2020-01252 has been joined with this proceeding.
`
`
`
`
`Patent 8,114,833 B2
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
`
`MYLAN INSTITUTIONAL LLC and PFIZER INC.,
`Petitioners,
`
`v.
`
`NOVO NORDISK A/S,
`Patent Owner.
`______________
`
`Case IPR2020-003241
`Patent 8,114,833
`______________
`
`PATENT OWNER’S REPLY IN SUPPORT OF ITS
`MOTION TO EXCLUDE EVIDENCE
`
`
`
`
`
`
`1 IPR2020-01252 has been joined with this proceeding.
`
`
`
`
`
`IPR2020-00324
`Patent 8,114,833 B2
`
`TABLE OF CONTENTS
`
`Page
`
`I.
`
`NOVO NORDISK IDENTIFIED ITS OBJECTIONS IN ITS MOTION ...... 1
`
`II. DECLINING TO CONSIDER PETITIONERS’ EXHIBITS AS OUTSIDE
`THE SCOPE IS LEFT TO THE BOARD’S DISCRETION .......................... 1
`
`III. EXHIBITS 1091-1098, 1103, 1114-1115, AND THE FORREST REPLY
`DECLARATION LACK RELEVANCE AND ARE PREJUDICIAL ........... 2
`
`IV. PETITIONERS IMPROPERLY INCORPORATE BY REFERENCE .......... 5
`
`V.
`
`CONCLUSION ................................................................................................ 5
`
`
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`i
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`IPR2020-00324
`Patent 8,114,833 B2
`
`Cases
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Altaire Pharms., Inc. v. Paragon Bioteck, Inc.,
`PGR2015-00011, Paper 38 (P.T.A.B. May 18, 2016) .......................................... 2
`
`Anacor Pharm., Inc. v. Iancu,
`889 F.3d 1372 (Fed. Cir. 2018) ............................................................................ 3
`
`Ariosa Diagnostics, Inc. v. Illumina, Inc.,
`IPR2014-01093, Paper 69 (P.T.A.B. Jan. 7, 2016), aff’d, 705 Fed.
`App’x 1002 (Fed. Cir. 2017) ............................................................................ 3, 4
`
`BioMarin Pharma Inc., v. Genzyme Therapeutic Prods. L.P.,
`IPR2013-00537, 2015 WL 1009197 (P.T.A.B. Feb. 23, 2015) ........................... 5
`
`Blackberry Corp. v. Zipit Wireless, Inc.,
`IPR2014-01508, Paper 49 (P.T.A.B. Mar. 29, 2016) ........................................... 1
`
`Conopco, Inc. dba Unilever v. P&G Co.,
`IPR2013-00510, Paper 9 (P.T.A.B. Feb. 12, 2014) .............................................. 5
`
`FLIR Sys., Inc. v. Leak Surveys, Inc.,
`IPR2014-00411, Paper 113 (P.T.A.B. Sept. 3, 2015)........................................... 1
`
`Genzyme Therapeutic Prods. L.P. v. Biomarin Pharm. Inc.,
`825 F.3d 1360 (Fed. Cir. 2016) ............................................................................ 3
`
`Global Tel*Link Corp. v. Securus Techs., Inc.,
`PGR2015-00013, Paper 50 (P.T.A.B. Dec. 7, 2016) ............................................ 5
`
`Green Cross Corp. v. Shire Human Genetic Therapies, Inc.,
`IPR2016-00258, Paper 89, 10 (P.T.A.B. Mar. 22, 2017) ..................................... 4
`
`Hospira, Inc. v. Genentech, Inc.,
`IPR2017-00804, Paper 60 (P.T.A.B. Apr. 18, 2018) ........................................... 2
`
`Illumina, Inc. v. Natera, Inc.,
`IPR2019-01201, Paper 54 (P.T.A.B. Dec. 11, 2020) ........................................... 4
`
`
`
`ii
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`
`
`IPR2020-00324
`Patent 8,114,833 B2
`
`Intri-Plex Techs., Inc. v. Saint-Gobain Performance Plastics Rencol
`Ltd.,
`IPR2014-00309, Paper 83 (P.T.A.B. Mar. 23, 2015) ........................................... 5
`
`Kyocera Corp. v. Softview LLC,
`IPR2013-00007, Paper 51 (P.T.A.B. Mar. 27, 2014) ........................................... 2
`
`Nestlé Purina Petcare Co. v. Oil-Dri Corp. of Am.,
`IPR2015-00737, Paper 37 (P.T.A.B. June 20, 2016) ........................................... 4
`
`Silicon Labs, Inc. v. Cresta Techs. Corp.,
`IPR2014-00881, Paper 47 (P.T.A.B. Oct. 21, 2015) ............................................ 1
`
`TieTex Int’l, Ltd. v. Precision Fabrics Grp., Inc.,
`IPR2014-01248, Paper 39 (P.T.A.B. Jan. 27, 2016) ............................................ 1
`
`Twitter, Inc. v. Vidstream, LLC,
`IPR2017-00829, Paper 68 (P.T.A.B. Jan. 28, 2019) ............................................ 5
`
`Yamaha Golf Car Co. v. Club Car, LLC,
`IPR2017-02143, Paper 72 (P.T.A.B. Apr. 2, 2019) ............................................. 4
`
`Other Authorities
`
`37 C.F.R. § 42.23(b) .............................................................................................. 1, 2
`
`37 C.F.R. § 42.64(c) ................................................................................................... 1
`
`FRE 402-403 .............................................................................................................. 5
`
`
`
`iii
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`
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`IPR2020-00324
`Patent 8,114,833 B2
`
`Patent Owner Novo Nordisk A/S (“Novo Nordisk”) submits this Reply in
`
`further support of its Motion to Exclude Evidence (Paper 52) (“Motion”).
`
`I.
`
`NOVO NORDISK IDENTIFIED ITS OBJECTIONS IN ITS MOTION
`
`Novo Nordisk’s Motion is compliant with 37 C.F.R. § 42.64(c). Specifically,
`
`Novo Nordisk cited to its objections (Paper 38) in its Motion (Paper 52 at 2), and
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`described in detail those objections throughout its Motion (Paper 52 at 5, 7, 11-12,
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`13, 15). That is all that is required. FLIR Sys., Inc. v. Leak Surveys, Inc., IPR2014-
`
`00411, Paper 113, at *7 (P.T.A.B. Sept. 3, 2015). Silicon Labs is inapposite because
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`there the moving party did not identify, nor explain, its objections in its motion to
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`exclude. IPR2014-00881, Paper 47, at *11-12 (P.T.A.B. Oct. 21, 2015). Moreover,
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`the Board in Silicon Labs still considered the motion to exclude. Id. at *12-14.
`
`II. DECLINING TO CONSIDER PETITIONERS’ EXHIBITS AS
`OUTSIDE THE SCOPE IS LEFT TO THE BOARD’S DISCRETION
`
`Petitioners argue that a motion to exclude is not the proper vehicle for arguing
`
`improper scope. Paper 56 at 3-4. But “[w]hether a reply contains arguments or
`
`evidence that are outside of a proper reply under 37 C.F.R. § 42.23(b) is left to [the
`
`Board’s] determination.” Blackberry Corp. v. Zipit Wireless, Inc., IPR2014-01508,
`
`Paper 49, at *40 (P.T.A.B. Mar. 29, 2016). The Board can and should decline to
`
`consider Petitioner’s exhibits and arguments that are improper in scope. See, e.g.,
`
`TieTex Int’l, Ltd. v. Precision Fabrics Grp., Inc., IPR2014-01248, Paper 39, at *14-
`
`
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`1
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`IPR2020-00324
`Patent 8,114,833 B2
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`15, 18 (P.T.A.B. Jan. 27, 2016) (declining to consider arguments and evidence
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`presented in an expert declaration as exceeding the scope of reply).
`
`III. EXHIBITS 1091-1098, 1103, 1114-1115, AND THE FORREST REPLY
`DECLARATION LACK RELEVANCE AND ARE PREJUDICIAL
`
`Petitioners continue to ignore that the meaning of “‘respond’ in the context of
`
`37 C.F.R. § 42.23(b), [which] does not permit Petitioner to depart from the position
`
`originally taken in the Petition and embark in a new direction with a new approach.”
`
`Altaire Pharms., Inc. v. Paragon Bioteck, Inc., PGR2015-00011, Paper 38, at *1
`
`(P.T.A.B. May 18, 2016). The Board “cannot, and will not, rely on improper new
`
`arguments and/or evidence presented in a reply.” Hospira, Inc. v. Genentech, Inc.,
`
`IPR2017-00804, Paper 60, at *3 (P.T.A.B. Apr. 18, 2018).
`
`Petitioners introduced in Reply new arguments about how hGH and GLP-1
`
`are allegedly similar and why they allegedly have similar stability problems. Paper
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`52 at 7-8. This evidence and argument did not merely support the “conventional
`
`understanding” that a skilled artisan would have wanted to improve formulation
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`stability of proteins and peptides. Paper 56 at 5. Dr. Forrest’s attempt to pay lip
`
`service to the rules, arguing that his new theories are in “direct response” to Dr.
`
`Tessier’s opinions (Paper 56 at 6), does not make it so. Petitioners’ authorities are
`
`inapposite, because in those cases, the patent owner first introduced the substantive
`
`issue. Kyocera Corp. v. Softview LLC, IPR2013-00007, Paper 51, at *34 (“[T]he
`
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`2
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`IPR2020-00324
`Patent 8,114,833 B2
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`Patent Owner…raised several substantive issues that were not raised in the
`
`Petition.”); Genzyme Therapeutic Prods. L.P. v. Biomarin Pharm. Inc., 825 F.3d
`
`1360, 1367 (Fed. Cir. 2016) (same); Anacor Pharm., Inc. v. Iancu, 889 F.3d 1372,
`
`1381 (Fed. Cir. 2018) (patent owner raised contested references in response). That
`
`is not the case here. Instead, the hGH evidence was introduced on Reply to belatedly
`
`supplement Petitioners’ evidence that should have been included in the Petition.
`
`Similarly, despite protests to the contrary (Paper 56 at 6-7), Petitioners’
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`evaporation theory was new in Reply. Petition statements that mannitol is “naturally
`
`a solid” and propylene glycol is “naturally a liquid” are a far cry from Petitioners’
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`attempt on Reply to resuscitate irrelevant references concerning supersaturated
`
`mannitol formulations by arguing the possibility that the formulations at issue might
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`evaporate, making the supersaturated references somehow relevant.
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`Additionally, Petitioners improperly failed to put Novo Nordisk on notice in
`
`the Petition of their intent to rely on the provisional ’699 application (EX1103) to
`
`supply the Betz 102(e) reference date. See Paper 52 at 12-13. Accordingly,
`
`Petitioners “did not put Patent Owner on notice as to Petitioner[s’] prior art theory,
`
`and did not meet [their] initial burden of production as required by Dynamic
`
`Drinkware.” See Ariosa Diagnostics, Inc. v. Illumina, Inc., IPR2014-01093, Paper
`
`69, *12-14 (P.T.A.B. Jan. 7, 2016) (finding reference at issue not prior art where
`
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`3
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`IPR2020-00324
`Patent 8,114,833 B2
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`Petitioner failed to put Patent Owner on proper notice), aff’d, 705 Fed. App’x 1002
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`(Fed. Cir. 2017). Petitioners’ cited cases do not present the same scenario. See, e.g.,
`
`Green Cross Corp. v. Shire Human Genetic Therapies, Inc., IPR2016-00258, Paper
`
`89, 10 (P.T.A.B. Mar. 22, 2017) (Board “[had] no need to determine whether
`
`Petitioner is entitled to rely on the date of the [] Provisional application”). Exhibit
`
`1103 and related Forrest testimony should be excluded. Ariosa, Paper 69, *12-14.
`
`
`
`Petitioners do not suggest that they cite Exhibits 1091-1098, 1103, or 1114-
`
`1115 anywhere in the Petition or Reply. String citing nearly 20 paragraphs of reply
`
`declaration, which in turn introduce 8 new exhibits, as support for 3 sentences in the
`
`Reply is improper, and it flouts the rules. Yamaha Golf Car Co. v. Club Car, LLC,
`
`IPR2017-02143, Paper 72, at *35-36 (P.T.A.B. Apr. 2, 2019) (declining to consider
`
`“string citation here to some thirty (30) odd paragraphs of new expert testimony” as
`
`procedurally and substantively improper); Illumina, Inc. v. Natera, Inc., IPR2019-
`
`01201, Paper 54, at *27 (P.T.A.B. Dec. 11, 2020) (declining to consider exhibits
`
`only discussed in a declaration and not discussed in the Reply itself).
`
`Dr. Tessier’s inability to submit a declaration in response to Petitioners’ new
`
`arguments prejudiced Novo Nordisk. Nestlé Purina Petcare Co. v. Oil-Dri Corp. of
`
`Am.,
`
`IPR2015-00737, Paper 37, at *24-25
`
`(P.T.A.B. June 20, 2016)
`
`(“[C]onsideration…of the arguments in the Reply and evidence presented in the
`
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`4
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`IPR2020-00324
`Patent 8,114,833 B2
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`[Reply Declaration]… would be unfair…”). Petitioners’ cited authority is not on
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`point. Twitter, Inc. v. Vidstream, LLC, IPR2017-00829, Paper 68, at *48 (P.T.A.B.
`
`Jan. 28, 2019) (moving party raised issue first); BioMarin, 2015 WL 1009197, at
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`*14 (concerns a motion to exclude evidence submitted with a petition, not a reply).
`
`IV. PETITIONERS IMPROPERLY INCORPORATE BY REFERENCE
`
`Novo Nordisk timely objected to Exhibit 1103 as lacking relevance and
`
`prejudicial under FRE 402-403. Paper 38 at 17-18. Its improper incorporation by
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`reference of both arguments and supporting evidence (see Paper 52 at 14) to
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`circumvent page limits was one reason for that objection. This is improper because
`
`the Board’s “rules prohibit arguments made in a supporting document from being
`
`incorporated by reference into a [paper].” Conopco, Inc. dba Unilever v. P&G Co.,
`
`IPR2013-00510, Paper 9, at *8-9 (P.T.A.B. Feb. 12, 2014) (declining to consider
`
`information in a declaration, but not a paper, as circumventing page limits); Intri-
`
`Plex, IPR2014-00309, Paper 83, at *14 (P.T.A.B. Mar. 23, 2015) (excluding exhibits
`
`cited only in a declaration, and not a reply). Global Tel*Link further supports Novo
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`Nordisk by acknowledging that “[i]f Petitioner’s declarant or the cited exhibits
`
`contained arguments not made in a paper, we would likely ignore such arguments.”
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`PGR2015-00013, Paper 50, at *16 (P.T.A.B. Dec. 7, 2016).
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`V. CONCLUSION
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`Novo Nordisk respectfully requests that the Board grant its Motion.
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`IPR2020-00324
`Patent 8,114,833 B2
`
`Dated: March 19, 2021
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`
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`Respectfully submitted,
`
`
`
`
`/Jeffrey J. Oelke/
`Jeffrey J. Oelke (Reg. No. 37,409)
`Lead Counsel
`
`Ryan P. Johnson
`Laura T. Moran
`Back-Up Counsel
`
`FENWICK & WEST LLP
`902 Broadway, Suite 14
`New York, NY 10010
`(212) 430-2600
`joelke@fenwick.com
`ryan.johnson@fenwick.com
`laura.moran@fenwick.com
`Counsel for Patent Owner Novo Nordisk A/S
`
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`6
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`IPR2020-00324
`Patent 8,114,833 B2
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6(e), I hereby certify that on March 19, 2021, the
`
`foregoing document is being served by filing this document through the Patent Trial
`
`and Appeal Board End to End System, as well as delivering a copy via electronic
`
`mail upon the following attorneys of record for the Petitioners:
`
`Brandon M. White (Reg. No. 52,354)
`Perkins Coie LLP
`700 Thirteenth Street, N.W., Suite 600
`Washington, D.C., 20005
`Telephone: (202) 654-6206
`Fax: (202) 654-9681
`BMWhite@perkinscoie.com
`White-ptab@perkinscoie.com
`
`Lara Dueppen (Reg. No. 65,002)
`Perkins Coie LLP
`1888 Century Park East
`Suite 1700
`Los Angeles, CA 90067
`Telephone: (310) 788-3349
`Fax: (310) 788-3399
`LDueppen@perkinscoie.com
`Dueppen-ptab@perkinscoie.com
`Liraglutide@perkinscoie.com
`
`Emily J. Greb (Reg. No. 68,244)
`Perkins Coie LLP
`33 East Main Street, Suite 201
`Madison, WI 53703
`Telephone: (308) 663-7494
`Fax: (608) 283-4494
`greb-ptab@perkinscoie.com
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`7
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`IPR2020-00324
`Patent 8,114,833 B2
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`Thomas J. Meloro (Reg. No. 33,538)
`Michael W. Johnson (Reg. No. 63,731)
`Willkie Farr & Gallagher LLP
`787 Seventh Avenue
`New York, NY 10019
`Telephone: (212) 728-8428
`Fax: (212) 728-8111
`tmeloro@willkie.com
`mjohnson1@willkie.com
`amoore@willkie.com
`mao-ny@willkie.com
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`
`
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`Date: March 19, 2021
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`
`
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`Respectfully submitted,
`
`
`
`/Jeffrey J. Oelke/
`Jeffrey J. Oelke (Reg. No. 37,409)
`Lead Counsel
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`8
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