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`
`
`IPR2024-00631
`U.S. Patent No. 10,335,462
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`APOTEX INC.,
`Petitioner
`
`v.
`
`NOVO NORDISK A/S,
`Patent Owner
`______________________
`Case IPR2024-00631
`Patent 10,335,462
`______________________
`
`PATENT OWNER’S PRELIMINARY RESPONSE
`UNDER 37 C.F.R. § 42.107
`
`PROTECTIVE ORDER MATERIAL -- FILED UNDER SEAL
`
`

`

`IPR2024-00631
`U.S. Patent No. 10,335,462
`
`LIST OF EXHIBITS
`
`Exhibit Description
`EX2001 Docket Sheet from PTACTS, Mylan Pharms. Inc. v. Novo Nordisk
`A/S, IPR2023-00724
`EX2002 Joint Stipulation to Modify Due Dates 2, 3, 4, 5, 6, 7 and 8, Mylan
`Pharms. Inc. v. Novo Nordisk A/S, IPR2023-00724 Paper 47
`EX2003 June 7, 2024 Joint Stipulation to Modify Due Dates 3, 4, 5, 6, 7 and 8,
`Mylan Pharms. Inc. v. Novo Nordisk A/S, IPR2023-00724, Paper 56
`EX2004 Excerpted Patent Owner’s Response, Mylan Pharms. Inc. v. Novo
`Nordisk A/S, IPR2023-00724, Paper 30
`EX2005 Excerpted Declaration of George L. Bakris, M.D., Mylan Pharms. Inc.
`v. Novo Nordisk A/S, IPR2023-00724, EX2011
`EX2006 Excerpted Declaration of Robin S. Goland, M.D., Mylan Pharms. Inc.
`v. Novo Nordisk A/S, IPR2023-00724, EX2054
`EX2007 Excerpted Declaration of Michael J. Blaha, M.D., Mylan Pharms. Inc.
`v. Novo Nordisk A/S, IPR2023-00724, EX2055
`EX2008 Excerpted Declaration of Christopher A. Vellturo, Ph.D., Mylan
`Pharms. Inc. v. Novo Nordisk A/S, IPR2023-00724, EX2300
`EX2009 Excerpted Declaration of Patrick J. Sinko, Ph.D., Mylan Pharms. Inc.
`v. Novo Nordisk A/S, IPR2023-00724, EX2056
`EX2010 June 10, 2024 Email from Counsel for Petitioner re: IPR2024-00631
`EX2011 Patent Exclusivity for N209637 (Semaglutide/Ozempic), Orange Book:
`Approved Drug Products with Therapeutic Equivalence Evaluations,
`U.S.
`Food
`&
`Drug
`Administration,
`available
`at
`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Produ
`ct_No=001&Appl_No=209637&Appl_type=N
`EX2012 Declaration of Sayem Osman
`
`
`
`
`
`
`
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`IPR2024-00631
`U.S. Patent No. 10,335,462
`
`TABLE OF CONTENTS
`
`I.
`II.
`
`III.
`
`C.
`
`INTRODUCTION ......................................................................................... 1
`FACTUAL BACKGROUND........................................................................ 2
`A. Mylan’s IPR and Apotex’s Choice to File a Late Copycat Petition ..... 2
`The Progress of the Mylan IPR Over the 8 Months Since Its
`B.
`Institution ............................................................................................... 3
`INSTITUTION SHOULD BE DENIED UNDER §314(A) ........................ 5
`A. Discretionary Authority to Deny Under General Plastic ..................... 6
`Institution Should Be Denied Because Petitioner Brings the Same or
`B.
`Substantially the Same Art or Arguments ............................................. 8
`Institution Should Also Be Denied Because the Remaining General
`Plastic Factors Weigh in Favor of Denial ...........................................11
`Factor 1: whether the same petitioner previously filed a petition
`1.
`directed to the same claims of the same patent .........................12
`Factor 2: whether at the time of filing of the first petition the
`petitioner knew of the prior art asserted in the second petition or
`should have known of it ............................................................15
`Factor 3: whether at the time of filing of the second petition the
`petitioner already received the patent owner’s preliminary
`response to the first petition or received the Board’s decision on
`whether to institute review in the first petition .........................18
`Factor 4: the length of time that elapsed between the time the
`petitioner learned of the prior art asserted in the second petition
`and the filing of the second petition ..........................................19
`Factor 5: whether the petitioner provides adequate explanation
`for the time elapsed between the filings of multiple petitions
`directed to the same claims of the same patent .........................20
`Factor 6: the finite resources of the Board ................................22
`Factor 7: the requirement under 35 U.S.C. §316(a)(11) to issue
`a final determination not later than 1 year after the date on
`which the Director notices institution of review .......................25
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`PROTECTIVE ORDER MATERIAL
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`2.
`
`3.
`
`4.
`
`5.
`
`6.
`7.
`
`

`

`IPR2024-00631
`U.S. Patent No. 10,335,462
`IV. PETITIONER FAILS TO ADDRESS OBJECTIVE EVIDENCE OF
`NON-OBVIOUSNESS ................................................................................. 26
`V. CONCLUSION ............................................................................................ 29
`
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`IPR2024-00631
`U.S. Patent No. 10,335,462
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`3M Co. v. Bay Materials, LLC,
`IPR2023-00243, Pap.8 (July 7, 2023) .........................................................passim
`Amazon.com, Inc. v. VB Assets, LLC,
`IPR2020-01374, Pap.10 (Feb. 4, 2021) .............................................................. 29
`Apple Inc. v. Uniloc 2017 LLC,
`IPR2020-00854, Pap.9 (Oct. 28, 2020) .......................................................passim
`Cent. Sec. Grp. – Nationwide, Inc. v. Ubiquitous Connectivity, LP,
`IPR2019-01609, Pap.11 (Feb. 26, 2020) .............................................................. 6
`Deeper, UAB v. Vexilar, Inc.,
`IPR2018-01310, Pap.7 (Jan. 24, 2019) ............................................................... 29
`Dish Network LLC v. Sound View Innovations, LLC,
`IPR2020-00969, Pap.20 (Nov. 25, 2020) ........................................................... 27
`Expedia, Inc. v. Int’l Bus. Machs. Corp.,
`IPR2018-01459, Pap.7 (Jan. 29, 2019) ............................................................... 17
`General Plastic Indus. Co. v. Canon Kabushiki Kaisha,
`IPR2016-01357, Pap.19 (Sept. 6, 2017) ......................................................passim
`Google Inc. v. Personalweb Techs., LLC,
`IPR2014-00978, Pap.11 (Oct. 30, 2014) .............................................................. 5
`Intel Corp. v. Inst. of Microelecs., Chinese Acad. of Scis.,
`IPR2019-00834, Pap.14 (June 19, 2020) ............................................................ 20
`Ivantis, Inc. v. Glaukos Corp.,
`IPR2019-00972, Pap.7 (Oct. 10, 2019) ........................................................ 20, 24
`Leo Pharm. Prods., Ltd. v. Rea,
`726 F.3d 1346 (Fed. Cir. 2013) .......................................................................... 26
`Longi Green Energy Tech. Co. v. Hanwa Sols. Corp.,
`IPR2020-00047, Pap.18 (Apr. 27, 2020) ................................................ 21, 23, 25
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`IPR2024-00631
`U.S. Patent No. 10,335,462
`
`Lupin Ltd. v. Vertex Pharms. Inc.,
`IPR2015-00405, Pap.13 (July 9, 2015) .............................................................. 28
`Merck Sharp & Dohme Corp v. Genentech, Inc.,
`PGR2021-00039, Pap.10 (July 24, 2021) ........................................................... 27
`Merial Ltd. v. Virbac,
`IPR2014-01279, Pap.13 (Jan. 22, 2015) ............................................................. 28
`NetApp, Inc. v. Realtime Data LLC,
`IPR2017-01195, Pap.9 (Oct. 12, 2017) .................................................... 7, 23, 25
`Nichia Corp. v. Document Sec Sys., Inc.,
`IPR2018-01167, Pap.10 (Nov. 30, 2018) ........................................................... 13
`Samsung Elecs. Am., Inc. v. Uniloc 2017 LLC,
`IPR2018-01756, Pap.7 (Mar. 11, 2019) ................................................... 8, 10, 11
`Samsung Elecs. Am., Inc. v. Uniloc 2017 LLC,
`IPR2018-01756, Pap.9 (May 28, 2019) .......................................................passim
`Samsung Elecs. Co. v. Elm 3DS Innovations, LLC,
`IPR2017-01305, Pap.11 (Oct. 17, 2017) ...................................................... 13, 14
`Sonos, Inc. v. Google LLC,
`IPR2023-01284, Pap.10 (Mar. 8, 2024) ....................................................... 19, 22
`Stryker Corp. v. KFX Med., LLC,
`IPR2019-00817, Pap.10 (Sept. 16, 2019) ........................................................... 27
`T-Mobile USA, Inc. v. Voip-Pal.com, Inc.,
`IPR2023-00638, Pap.11 (July 28, 2023) ........................................................ 6, 10
`Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling
`USA, Inc.,
`699 F.3d 1340 (Fed. Cir. 2012) .......................................................................... 26
`TrickleStar LLC v. Embertec Pty Ltd.,
`IPR2017-00839, Pap.11 (June 10, 2017) .............................................................. 6
`Unified Pats. Inc. v. Finjan, Inc.,
`IPR2019-01611, Pap.18 (April 13, 2020) ..................................................... 14, 17
`
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`IPR2024-00631
`U.S. Patent No. 10,335,462
`United Fire Prot. Corp. v. Engineered Corrosion Sols., LLC,
`IPR2018-00991, Pap.10 (Nov. 15, 2018) ........................................................... 13
`Valve Corp. v. Elec. Scripting Prods., Inc.,
`IPR2019-00062, Pap.11 (April 2, 2019) ....................................................... 12, 19
`Valve Corp. v. Elec. Scripting Prods., Inc.,
`IPR2019-00064, Pap.10 (May 1, 2019) .................................................. 12, 20, 21
`Statutes
`35 U.S.C. §314(a) ...................................................................................................... 6
`35 U.S.C. § 316(b) ..................................................................................................... 7
`Other Authorities
`37 C.F.R. § 42.4(a) ..................................................................................................... 6
`37 C.F.R. § 42.8(b)(1) .............................................................................................. 13
`37 C.F.R. § 42.20(b) .................................................................................................. 2
`37 C.F.R. § 42.122(b) ............................................................................................ 2, 6
`USPTO, Consolidated Trial Practice Guide (Nov. 2019) ........................................ 7
`
`
`
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`IPR2024-00631
`U.S. Patent No. 10,335,462
`
`I.
`
`Introduction
`As detailed in this §42.1070F
`1 Preliminary Response by Patent Owner Novo
`
`Nordisk A/S (“PO”/“Patent Owner”), Petitioner Apotex Inc.’s
`
`(“Petitioner”/“Apotex”) copycat Petition (“Petition”/“Pet.”) should be denied.
`
`First, the Board should exercise its discretion to deny the Petition under §314(a)
`
`and General Plastic. Petitioner Apotex was aware of and tracking IPR2023-00724
`
`(the “Mylan IPR”), and asserts the very same grounds and arguments that were
`
`brought in the instituted Mylan IPR, but did not seek timely joinder. Pet.1, 5;
`
`EX1507, ¶2. As reflected in PO’s Opposition (Pap.9), Apotex’s late joinder
`
`request should be denied, and a duplicative proceeding would be wasteful, and the
`
`§314(a) General Plastic factors weigh in favor of denial. Second, Petitioner has
`
`not shown a reasonable likelihood of prevailing on its obviousness grounds (on
`
`which it relies for most of the challenged claims) because it has not addressed how
`
`it can overcome the objective evidence of non-obviousness presented in detail in
`
`the POR in the Mylan IPR, which Petitioner is clearly aware of but largely ignores.
`
`
`1 Unless stated, all statutory and regulatory citations are to 35 U.S.C. or 37 C.F.R.,
`
`as context indicates, and all emphases/annotations are added.
`
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`IPR2024-00631
`U.S. Patent No. 10,335,462
`
`II.
`
`Factual Background
`A. Mylan’s IPR and Apotex’s Choice to File a Late Copycat Petition
`On March 16, 2023, Mylan filed an IPR challenging the validity of U.S.
`
`Patent No. 10,335,462 (“’462 Patent”). That IPR was instituted for trial on
`
`October 4, 2023. Pap.10. The Mylan IPR is the subject of two previous copycat
`
`petitions, Dr. Reddy’s Laboratories, Inc. v. Novo Nordisk A/S, IPR2024-00009
`
`(“DRL IPR”) and Sun Pharmaceutical Industries Ltd. v. Novo Nordisk A/S,
`
`IPR2024-00107 (“Sun IPR”). Both of those petitions were filed along with timely
`
`joinder motions within a month of institution of the Mylan IPR. DRL IPR, Pap.19,
`
`12 (Apr. 25, 2024) (“[DRL] timely filed [its] Motion no later than one month after
`
`institution of the Mylan IPR.”); Sun IPR, Pap.16, 12 (May 28, 2024) (same).
`
`Apotex continued monitoring the Mylan IPR, and waited until March 1,
`
`2024, some five months after the Mylan IPR’s institution, to file the instant
`
`2
`copycat Petition along with an unauthorized, four-month-late, joinder motion.1F
`
`Pet.85; Pap.5; §42.122(b).
`
`
`
`
`
` See EX1507, ¶2.
`
`
`2 Apotex filed its motion without the Board’s permission despite having missed the
`
`deadline to file a joinder motion as of right. §42.20(b).
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`B.
`
`IPR2024-00631
`U.S. Patent No. 10,335,462
`The Progress of the Mylan IPR Over the 8 Months Since Its
`Institution
`As the first 8 months since institution have demonstrated, the Mylan IPR is
`
`far from a “standard” IPR in terms of its complexity, the number of witnesses
`
`presenting testimony, and the volume of its evidentiary record. The parties to that
`
`IPR have filed 641 exhibits, including 15 expert declarations (amounting to 1,356
`
`pages), and have thus far taken ten depositions (with six more depositions noticed
`
`based on Mylan’s Reply declarations). EX2001. The schedule for the Mylan IPR
`
`(including the final hearing date) has been extended twice to accommodate the
`
`numerous depositions and voluminous declarations, and the word count limits for
`
`the POR, Reply, and Sur-Reply have also been increased—all for good cause to
`
`allow the parties to address the many issues raised there including swear behind
`
`and secondary indicia. Mylan IPR, Pap.27 (Jan. 9, 2024) (Conduct of the
`
`Proceeding); EX2002; EX2003.
`
`Patent Owner has, for example, presented detailed objective indicia
`
`3
`arguments in the Mylan IPR in response to Mylan’s three obviousness Grounds.2F
`
`
`3 While certain evidence related to commercial success was filed under seal, none
`
`of the expert declarations and evidence relating to unexpected results, industry
`
`praise, skepticism, or a long-felt and unmet need were redacted or filed under seal.
`
`See EX2001, 14, 16 (docket entries for declarations of Drs. Bakris, Goland, and
`
`
`
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`IPR2024-00631
`U.S. Patent No. 10,335,462
`EX2004, 3. The ’462 Patent’s commercial embodiment is Ozempic®, and the
`
`evidence of objective indicia is extensive, covering the ’462 and Ozempic®’s
`
`commercial success, unexpected results, skepticism, failure of others, long-felt but
`
`unmet need, and industry praise. EX2004, 3; EX2001, 12, 14, 16 (docket sheet
`
`entries for Declarations of Drs. Bakris, Goland, Blaha, Vellturo); EX2005, 2 (“I
`
`have been asked to provide my opinions regarding certain objective indicia of non-
`
`obviousness for the ’462 patent.”); EX2006, 2 (same); EX2007, 3 (same); EX2008,
`
`5 (“I have been asked by [Patent Owner] to evaluate the commercial success of the
`
`drug Ozempic® and the extent to which Ozempic®’s commercial success is
`
`causally linked to the claims-at-issue from the [’462 Patent]….”). The
`
`corresponding proof involves testimony from five experts (Drs. Sinko, Goland,
`
`Blaha, Bakris, and Vellturo) and over 200 documentary exhibits. EX2001, 2, 4–
`
`16; EX2004, 3. Petitioner’s rebuttal relies on four experts (Drs. Spiegel,
`
`Schwartzbard, Coca, and McDuff) and approximately 200 documentary exhibits.
`
`EX2001, 16–22.
`
`In addition to objective indicia, the Mylan IPR also involves art subject to a
`
`swear-behind dispute. That same art is at issue here. Mylan and Apotex rely on
`
`Sinko declarations of Bakris, Goland, Sinko); EX2005; EX2006; EX2009;
`
`
`
`EX2004.
`
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`IPR2024-00631
`U.S. Patent No. 10,335,462
`WO421 for two of the five IPR Grounds. Pet.1, 5. So far in the Mylan IPR, the
`
`swear behind argument has involved the preparation and filing of four fact
`
`declarations, numerous exhibits, document production, two depositions of
`
`witnesses based overseas, and substantial factual development of the type not
`
`typically present in an IPR. EX2004, 2–3; EX2001, 14–15 (docket sheet entries
`
`for Declarations of Drs. Jensen, Flint, and Mses. Jiang and DiCicco).
`
`III.
`
`Institution Should Be Denied Under §314(a)
`The Board should deny institution of Apotex’s copycat Petition under
`
`§314(a) General Plastic because Apotex’s Petition presents precisely the same art
`
`and arguments as the instituted Mylan IPR, Petitioner chose not to seek timely
`
`joinder, and the General Plastic factors weigh in favor of discretionary denial.
`
`Apotex’s Petition is a copycat/“me-too” filing that is “assert[ing] the same
`
`unpatentability grounds” and is “substantively identical to Mylan’s petition” in the
`
`Mylan IPR. Pet.1. The Apotex Petition is also untimely: the deadline for seeking
`
`joinder passed nearly four months before Apotex filed the instant petition and its
`
`unauthorized joinder motion. §42.122(b) (“Any request for joinder must be filed,
`
`as a motion under §42.22, no later than one month after the institution date of any
`
`inter partes review for which joinder is requested.”); see also Google Inc. v.
`
`Personalweb Techs., LLC, IPR2014-00978, Pap.11, 4–5 (Oct. 30, 2014) (denying
`
`untimely motion for joinder filed one month after the statutory deadline in
`
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`IPR2024-00631
`U.S. Patent No. 10,335,462
`§42.122(b)); TrickleStar LLC v. Embertec Pty Ltd., IPR2017-00839, Pap.11, 32–33
`
`(June 10, 2017) (denying joinder motion filed five days after deadline). And while
`
`the Board has, at times, considered whether a timely joinder motion was filed when
`
`analyzing General Plastic, there was none here. Cf. Cent. Sec. Grp. – Nationwide,
`
`Inc. v. Ubiquitous Connectivity, LP, IPR2019-01609, Pap.11, 8 (Feb. 26, 2020)
`
`(finding General Plastic “not particularly relevant” where a different petitioner
`
`files a copycat petition “in conjunction with a timely motion to join”).
`
`Moreover, a §314(a) analysis is appropriate even if, arguendo, Petitioner
`
`were entitled to seek joinder: “before determining whether to join [copycat
`
`petitioner] as a party to the [] IPR, even though the Petition is a ‘me-too petition,’
`
`[the Board] first determines whether application of the General Plastic factors
`
`warrants the exercise of discretion to deny the Petition under §314(a).” See Apple
`
`Inc. v. Uniloc 2017 LLC, IPR2020-00854, Pap.9, 5 (Oct. 28, 2020) (precedential);
`
`T-Mobile USA, Inc. v. Voip-Pal.com, Inc., IPR2023-00638, Pap.11, 5–6 (July 28,
`
`2023) (citing Apple, IPR2020-00854, Pap.9). The General Plastic factors weigh in
`
`favor of discretionary denial, and Petitioner’s late unauthorized joinder motion
`
`cannot change or avoid this analysis.
`
`A. Discretionary Authority to Deny Under General Plastic
`The Director has discretionary authority to institute or deny inter partes
`
`review, and has delegated that authority to the Board. §314(a); see also §42.4(a).
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`IPR2024-00631
`U.S. Patent No. 10,335,462
`General Plastic Indus. Co. v. Canon Kabushiki Kaisha, IPR2016-01357, Pap.19,
`
`16 (Sept. 6, 2017) (precedential) (“General Plastic”), enumerates a non-exclusive
`
`list of factors the Director may consider and weigh to decide whether to institute
`
`under §314(a). But the Consolidated Trial Practice Guide also expressly
`
`contemplates that “additional factors that may bear on the Board’s discretionary
`
`decision” will “be considered along with the General Plastic factors”: “There may
`
`be other reasons besides the ‘follow-on’ petition context where the ‘effect… on the
`
`economy, the integrity of the patent system, the efficient administration of the
`
`Office and the ability of the Office to timely complete proceedings,’… includ[ing],
`
`for example, events in other proceedings related to the same patent, either at the
`
`Office, in district courts, or the ITC.” USPTO, Consolidated Trial Practice Guide
`
`(Nov. 2019), at 58 (emphasis added) (quoting §316(b); citing NetApp, Inc. v.
`
`Realtime Data LLC, IPR2017-01195, Pap.9, 12–13 (Oct. 12, 2017)). One
`
`additional unenumerated factor contemplated for consideration is whether “the
`
`same or substantially the same prior art or arguments previously were presented to
`
`the Office”—a factor that, as detailed below, weighs in favor of discretionary
`
`denial. General Plastic, 19; Samsung Elecs. Am., Inc. v. Uniloc 2017 LLC,
`
`IPR2018-01756, Pap.9, 3 (May 28, 2019).
`
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`B.
`
`IPR2024-00631
`U.S. Patent No. 10,335,462
`Institution Should Be Denied Because Petitioner Brings the Same
`or Substantially the Same Art or Arguments
`Although the other General Plastic factors also favor denial here (see infra,
`
`§III.C), the Board may exercise its discretion to deny institution of Apotex’s
`
`Petition solely on the basis that Apotex raises the same art and arguments as in the
`
`previously-instituted Mylan IPR—indeed, the Board has found far less overlap
`
`sufficient for denial. See Samsung, IPR2018-01756, Pap.9, 3.
`
`In Samsung, a first-time petitioner sought to challenge a patent for which
`
`several co-pending IPRs, brought by other parties, had already been instituted.
`
`IPR2018-01756, Pap.7, 23, 25 (Mar. 11, 2019). The petitioner was not a party to
`
`any of the previously-filed IPRs. And, while the new petitioner had not mirrored
`
`the previously-filed petitions, its petition included certain overlapping grounds and
`
`arguments from the earlier IPRs. Id. at 25. The Board determined that “most of
`
`the prior art and arguments advanced by Petitioner are the same as or substantially
`
`the same as the prior art and arguments advanced in the [earlier] IPRs,” and on that
`
`basis “exercise[d its] discretion to deny review under 35 U.S.C. §314(a)” in order
`
`“to preserve the Board’s resources.” Id. at 25–26, 30.
`
`Subsequently, the petitioner sought rehearing, arguing the Board failed to
`
`provide a reasoned balancing of the General Plastic factors in favor of focusing
`
`exclusively on the similarity of the prior art and arguments from the previous IPRs.
`
`Samsung, IPR2018-01756, Pap.9, 3–4. The petitioner argued the Board erred in
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`IPR2024-00631
`U.S. Patent No. 10,335,462
`denying the petition because it was petitioner’s first challenge—a factor
`
`purportedly weighing “particularly heavily in favor of institution”—while factors
`
`2–5 were of little relevance and factor 6 was an unreasonable basis to outweigh the
`
`others. Samsung, IPR2018-01756, Pap.9, 3–4. The Board disagreed, explaining
`
`General Plastic itself “expressly contemplates that the similarity of prior art and
`
`arguments raised in a petition and follow-on petition are additional factors that can
`
`be considered ‘in the exercise of discretion under §314(a).’” Id. (quoting General
`
`Plastic, 19). The Board further explained that, even “[a]ssuming Petitioner is
`
`correct” and the only relevant factors to be considered were the petitioner’s first-
`
`time-filing status and petitioner bringing the same or substantially similar prior art,
`
`arguments, and grounds, the Board’s “[d]ecision does just that.” Id. at 5. “[T]he
`
`General Plastic factors… are not intended to represent all situations where it may
`
`be appropriate to deny a petition,” and analyzing “the cumulative nature of the
`
`prior art and arguments raised in the Petition and in the [previous IPRs] is
`
`consistent with” the Board’s discretionary denial framework. Id. at 7–8. Thus, the
`
`Board “disagree[d] that [it] erred in exercising [its] discretion to deny the Petition
`
`under 35 U.S.C. §314(a) because the Petition presented the same or substantially
`
`similar prior art and arguments already presented to the Board in the [previously
`
`filed petitions].” Id. at 12.
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`IPR2024-00631
`U.S. Patent No. 10,335,462
`Here there is far more duplication than in the petition denied institution in
`
`Samsung. Petitioner here admits its Petition “is substantively identical to Mylan’s
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`petition,” and “asserts the same unpatentability grounds….” Pet.1. Thus, unlike in
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`Samsung, there is no question here about how much of the prior art or arguments
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`are the same or substantially the same. The facts otherwise are very similar to
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`those in Samsung, including because the Samsung petitioner had the benefit of that
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`patentee’s preliminary response, the Board’s Institution Decision, and even
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`patentee’s response to the prior petitions. Samsung, IPR2018-01756, Pap.7, 24–
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`25. Here, too, Apotex had the benefit of PO’s POPR, the Institution Decision, and
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`PO’s POR, and—if instituted for trial—is scheduled to have the benefit of PO’s
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`Sur-reply and oral arguments and the Board’s final written decision in the Mylan
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`IPR before any post-institution papers are due here.
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`Apotex’s belated filing of a late joinder motion and copycat petition does not
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`change this analysis. See Apple, IPR2020-00854, Pap.9, 5; T-Mobile USA,
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`IPR2023-00638, Pap.11, 5–6. Indeed, as with the Samsung petitioner, Apotex
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`“could have requested [timely] joinder” or “filed its own petition that substantially
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`differed from the petition filed in” the earlier IPR. Samsung, IPR2018-01756,
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`Pap.9, at 11. Apotex didn’t, and institution should be denied. Id. Apotex’s
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`Petition here would impose an unjustifiable burden on the Board and PO with none
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`of the benefits or efficiencies that might generally be gained from timely copycat
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`petitions. Again, the Mylan IPR already includes 313 exhibits filed by Mylan and
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`328 exhibits filed by Patent Owner, with 13 experts (including 15 expert
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`declarations so far), 8 fact witnesses (including the ’462 inventor and a
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`corroborating witness), numerous depositions (10 so far, with 6 additional
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`depositions now scheduled), increased word counts for the parties, and two
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`authorized schedule extensions to accommodate the unusually large record and
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`discovery required. Mylan IPR, Pap.27 (Jan. 9, 2024) (Conduct of the
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`Proceeding); EX2002; EX2003. Given the copycat nature of Apotex’s Petition, the
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`same issues, volume of evidence, and extensions are almost certain to be present
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`here. The Board should thus exercise its discretion to deny the Petition under
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`§314(a) because the Petition merely presents the same or substantially similar prior
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`art and arguments already presented to the Board in the Mylan IPR particularly in
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`view of the volume and complexity of the Mylan IPR. See Samsung, IPR2018-
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`01756, Pap.7, 25–26; Samsung, IPR2018-01756, Pap.9, 5, 12. These issues will
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`likely be resolved in the Mylan IPR later this year, not long after the institution
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`decision for this IPR.
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`C.
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`Institution Should Also Be Denied Because the Remaining General
`Plastic Factors Weigh in Favor of Denial
`As noted above, the Board need not reach the expressly-enumerated General
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`Plastic factors to deny institution here. See Samsung, IPR2018-01756, Pap.9, 5,
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`12. Nonetheless, the enumerated General Plastic factors considered as a group, as
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`well as other additional factors, also weigh in favor of discretionary denial. See,
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`e.g., 3M Co. v. Bay Materials, LLC, IPR2023-00243, Pap.8, 11 (July 7, 2023)
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`(denying institution under General Plastic for challenges to the same claims in
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`multiple, staggered petitions).
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`1.
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`Factor 1: whether the same petitioner previously filed a
`petition directed to the same claims of the same patent
`Factor 1 considers whether Apotex or a party with whom Apotex has a
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`significant relationship previously filed a petition directed to the same claims of
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`the same patent. Valve Corp. v. Elec. Scripting Prods., Inc., IPR2019-00064,
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`Pap.10, 10 (May 1, 2019) (precedential).
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`. See Apple,
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`IPR2020-00854, Pap.9, 9, 11 (finding petitioner’s “lack of explanation” for certain
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`factors (2, 4, and 5) weighed in favor of denial for those factors)).
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`Even if it were assumed, arguendo, that Petitioner had no relationship at all
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`with Mylan, DRL, or Sun, this factor would be entitled to little weight (and
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`discretionary denial would nevertheless be appropriate) because of the complete
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`overlap of the Grounds in this IPR and the Mylan IPR. Pet.5; Samsung Elecs. Co.
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`v. Elm 3DS Innovations, LLC, IPR2017-01305, Pap.11, 19 (Oct. 17, 2017) (“[T]he
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`high degree of similarity of Samsung’s instant Petition with the prior petitions by
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`Petitioners…, as discussed above, reduces the weight we accord this factor.”);
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`Nichia Corp. v. Document Sec Sys., Inc., IPR2018-01167, Pap.10, 19, 25 (Nov. 30,
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`2018) (exercising discretion to deny, finding factor 1 “weighs minimally against”
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`denying institution where “the instant Petition uses the prior art asserted in the
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`[prior] Petition… [and] in the same manner” and that “degree of similarity”
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`between the two “reduces the weight [the Board] accord[s] this factor”); United
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`4
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`Fire Prot. Corp. v. Engineered Corrosion Sols., LLC, IPR2018-00991, Pap.10, 12–
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`13, 17–18 (Nov. 15, 2018) (exercising discretion to deny, finding factor 1 weighed
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`only “moderately against exercising… discretion to deny institution” given “the
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`Petition presents many issues and arguments” that are present in a prior IPR and
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`“is directed to the same claims of the same patent as the [prior] IPR petition”); see
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`also Unified Pats. Inc. v. Finjan, Inc., IPR2019-01611, Pap.18, 12 (April 13, 2020)
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`(“We agree with Patent Owner that the similarity of the set of challenged claims,
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`which has been repeated over multiple petitions for inter partes review, weighs in
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`favor of a discretionary denial. But this is counterbalanced by the fact that
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`Petitioner is not ‘the same petitioner’ who filed such prior petitions. Accordingly,
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`we treat this factor as neutral in our weighing of the General Plastic factors.”).
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`And while Petitioner does not literally use the same experts as Mylan, the fact that
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`Petitioner filed the Mylan declarations (EX1003, EX1005, EX1007) and
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`Petitioner’s experts “adopt[] the opinions set forth by [the experts] in connection
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`with the Mylan IPR” with largely verbatim declarations further reduces the weight
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`that this factor should be accorded. Pet.5; EX1501, ¶1 (“I agree with Dr. Bantle’s
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`opinions set forth in his declaration, so I have adopted them.”); EX1503 (“I agree
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`with Dr. Jusko’s opinions set forth in his declaration, so I have adopted them.”),
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`¶1; EX1505, ¶1 (“I agree with Dr. Dalby’s opinions set forth in his declaration, so I
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`have adopted them.”); cf. Elm 3DS, IPR2017-01305, Pap.11, 19 (“Petitioner’s use
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`of the same expert… in this Petition as used to support the reasoning in prior
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`petitions further reduces the weight we accord this factor…. [W]e conclude [factor
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`1] weighs minimally against exercising our discretion.”); compare EX1003 with
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`EX1501; compare EX1005 with EX1503; compare EX1007 with EX1505.
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`2.
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`Factor 2: whether at the time of filing of the first petition the
`petitioner knew of the prior art asserted in the second petition
`or should have known of it
`“The relevant issue under factor 2 is… whether the prior art references relied
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`on in the follow-on petitions… could have been found with reasonable diligence”
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`at the time the first petition was filed. General Plastic, 19–20.
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`5 PO acknowledges that General Plastic factors 2–5 may not be considered since
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`Apotex itself is a first-time petitioner. However, consideration of factors 2–5 here
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`is warranted given the unusual circumstance of this untimely copycat Petition.
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`Petitioner knew or should have known of most of the art in its Petition at
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`least as of the time it learned of the ‘462 itself, and of all o