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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`
`SLAYBACK PHARMA LLC,
`
`Petitioner,
`
`v.
`
`EYE THERAPIES, LLC,
`
`Patent Owner.
`
`__________________
`
`Case IPR2022-00142
`U.S. Patent No. 8,293,742
`__________________
`
`PATENT OWNER’S PRELIMINARY RESPONSE
`
`
`

`

`Case IPR2022-00142
`
`Table of Contents
`
`
`I.
`II.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Introduction ...................................................................................................... 1
`The Board Should Deny Institution Under 35 U.S.C. § 314(a) ...................... 4
`Legal Framework .................................................................................. 5
`Factor 1: A stay has not been, and is unlikely to be, entered ................ 5
`Factor 2: Trial in the related litigation is likely to occur shortly
`after the deadline for the final written decision .................................... 6
`Factor 3: The parties and the court will invest significant
`resources in the related litigation .......................................................... 7
`Factor 4: The petition relies on substantially the same art and
`arguments likely to be presented in the parallel proceeding ................. 8
`Factor 5: The Petitioner is a defendant in the related litigation .......... 10
`Factor 6: All other circumstances further support denial .................... 10
`III. The Board Should Deny Institution Under 35 U.S.C. § 325(d) .................... 13
`Legal Framework ................................................................................ 13
`The petition relies on the same or substantially the same art or
`arguments overcome during prosecution ............................................ 14
`1.
`The ’442 Patent (EX-1007) was applied and distinguished
`during prosecution .................................................................... 15
`Alphagan® Label 1998 (EX-1008) contains substantially
`the same disclosure as Cantor 2006 (EX-2007), which the
`Examiner Considered ................................................................ 17
`Federal Register 1988 (EX-1009) contains substantially
`the same disclosure as the ’079 patent (EX-2008), which
`the Examiner Considered .......................................................... 18
`Norden 2002 (EX-1006) contains substantially the same
`disclosure as the combination of the ’442 patent (EX-
`
`2.
`
`3.
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`4.
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`i
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`Case IPR2022-00142
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`
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`5.
`
`1007) and Lee (EX-2009), applied as such and
`distinguished during prosecution .............................................. 20
`The ’553 patent contains substantially the same disclosure
`as the ’442 patent (EX-1007), Lee (EX-2009) Cantor 2006
`(EX-2007), and the ’416 patent (EX-2010), which the
`Examiner Considered ................................................................ 23
`6. Walters 1991 (EX-1005) contains substantially the same
`disclosure as the ’442 patent (EX-1007), which was
`applied and distinguished during prosecution .......................... 26
`The Petitioner has not demonstrated that the Office erred in a
`manner material to the patentability of challenged claims. ................ 27
`IV. The Petition Should Be Denied Because the Petitioner Has Failed to Establish
`That Any of the Claims Are Unpatentable .................................................... 28
`Person of Ordinary Skill in the Art ..................................................... 28
`Claim Construction ............................................................................. 29
`1.
`“about 0.025%” ......................................................................... 29
`a.
`A concentration of “about 0.025%” does not include
`0.03% .............................................................................. 29
`The Petitioner’s reasons for asserting that “about
`0.025%” includes 0.03% are unavailing ......................... 32
`“ocular condition” ..................................................................... 35
`2.
`The petition should be denied for failing to establish a reasonable
`likelihood that any of the challenged claims is unpatentable ............. 36
`1.
`Ground 1: The ’553 patent (EX-1004) does not inherently
`anticipate the methods for reducing eye redness recited in
`claims 1 and 2 ........................................................................... 36
`Ground 2: Walters 1991 (EX-1005) does not inherently
`disclose a method for reducing eye redness as recited in
`claims 1 and 2 ........................................................................... 40
`
`b.
`
`
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`2.
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`ii
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`V.
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`
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`Case IPR2022-00142
`
`3.
`
`Ground 3: The Petitioner has failed to establish that claims
`1-6 are obvious .......................................................................... 42
`a.
`Legal Standard ................................................................ 42
`b.
`The Petitioner’s arguments are driven by improper
`hindsight ......................................................................... 44
`i.
`The Petitioner’s
`exclusive
`focus on
`brimonidine is driven by hindsight ...................... 45
`The Petitioner relies on the Alphagan®
`product, but ignores the later-developed
`Alphagan® P product ............................................ 49
`Conclusion ..................................................................................................... 51
`
`ii.
`
`
`
`iii
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`

`

`TABLE OF AUTHORITIES
`
`Case IPR2022-00142
`
` Page(s)
`
`Cases
`3M Co., Inc. v. Andover Healthcare, Inc.,
`IPR2014-00630, Paper No. 9 (P.T.A.B. Oct. 20, 2014) ............................... 38, 41
`
`Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte
`GmbH,
`IPR2019-01469, Paper No. 6 (P.T.A.B. Feb. 13, 2020) ..............................passim
`Apple Inc. v. Fintiv, Inc.,
`IPR2020-00019, Paper No. 11 (P.T.A.B. Mar. 20, 2020) ...........................passim
`Apple Inc. v. Fintiv, Inc.,
`IPR2020-00019, Paper No. 15 (P.T.A.B. May 13, 2020) ...........................passim
`Becton, Dickinson & Co. v. B. Braun Melsungen AG,
`IPR2017-01586, Paper No. 8 (P.T.A.B. Dec. 15, 2017) .............................. 13, 14
`Bettcher Indus., Inc. v. Bunzl USA, Inc.,
`661 F.3d 629 (Fed. Cir. 2011) ............................................................................ 37
`Biocon Pharma Ltd. v. Novartis Pharms. Corp.,
`IPR2020-01263, Paper No. 12 (P.T.A.B. Feb. 16, 2021) ....................... 18, 20, 26
`Biodelivery Sci. Int’l, Inc. v. Monosol Rx, LLC,
`IPR2014-00794, Paper No. 7 (P.T.A.B Nov. 5, 2014) ................................. 38, 41
`
`In re Cyclobenzaprine Hydrochloride Extended-Release Capsule
`Patent Litig.,
`676 F.3d 1063 (Fed. Cir. 2012) .......................................................................... 42
`DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc.,
`567 F.3d 1314 (Fed. Cir. 2009) .......................................................................... 50
`Endo Pharm. Sols., Inc. v. Custopharm Inc.,
`894 F.3d 1374 (Fed. Cir. 2018) .......................................................................... 37
`Gen. Plastic Indus. Co., Ltd. v. Canon Kabushiki Kaisha,
`IPR2016-01357, Paper No. 19 (P.T.A.B. Sept. 6, 2017) .................................... 12
`
`iv
`
`

`

`Case IPR2022-00142
`
`Interconnect Planning Corp. v. Feil,
`774 F.2d 1132 (Fed. Cir. 1985) .......................................................................... 44
`Kingston Tech. Co., Inc. v. SPEX Techs., Inc.,
`798 F. App’x 629 (Fed. Cir. 2020) ......................................................... 39, 41-42
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ...................................................................................... 42, 43
`Mylan Labs. Ltd. v. Janssen Pharmaceutica NV,
`IPR2020-00440, Paper No. 17 (P.T.A.B. Sept. 16, 2020) ...........................passim
`NHK Spring Co., Ltd. v. Intri-Plex Techs., Inc.,
`IPR2018-00752, Paper No. 8 (P.T.A.B. Sept. 12, 2018) .................................. 2, 4
`Novo Nordisk A/S v. Caraco Pharm. Labs., Ltd.,
`601 F.3d 1359 (Fed. Cir. 2010) rev’d on other grounds, 566 U.S.
`399 (2012) ........................................................................................................... 11
`In re NTP, Inc.,
`654 F.3d 1279 (Fed. Cir. 2011) .................................................................... 48-49
`In re Oelrich,
`666 F.2d 578 (CCPA 1981) ................................................................................ 37
`Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc.,
`520 F.3d 1358 (Fed. Cir. 2008) .......................................................................... 43
`OSI Pharms., LLC v. Apotex Inc.,
`939 F.3d 1375 (Fed. Cir. 2019) .................................................................... 50-51
`Plantronics, Inc. v. Aliph, Inc.,
`724 F.3d 1343 (Fed. Cir. 2013) .................................................................... 42-43
`Polaris Indus., Inc. v. Arctic Cat, Inc.,
`882 F.3d 1056 (Fed. Cir. 2018) .................................................................... 43-44
`Procter & Gamble Co. v. Teva Pharms. USA, Inc.,
`566 F.3d 989 (Fed. Cir. 2009) ............................................................................ 43
`Ruiz v. A.B. Chance Co.,
`357 F.3d 1270 (Fed. Cir. 2004) .......................................................................... 43
`
`v
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`Case IPR2022-00142
`
`Sandoz Inc. v. EKR Therapeutics, LLC,
`IPR2015-00008, Paper No. 20 (P.T.A.B. April 24, 2015) ..................... 38, 40-41
`Star Scientific, Inc., v. R.J. Reynolds Tobacco Co.,
`655 F.3d 1364 (Fed. Cir. 2011) .......................................................................... 44
`Unigene Labs., Inc. v. Apotex, Inc.,
`655 F.3d 1352 (Fed. Cir. 2011) .......................................................................... 43
`Federal Statutes
`21 U.S.C. § 355(j)(5)(B)(iii) .................................................................................. 5, 6
`35 U.S.C. § 102 .......................................................................................................... 9
`35 U.S.C. § 103 .......................................................................................................... 9
`35 U.S.C. § 103(a) ................................................................................................... 22
`35 U.S.C. § 112 .......................................................................................................... 9
`35 U.S.C. § 314(a) ............................................................................................passim
`35 U.S.C. § 325(d) ............................................................................................passim
`America Invents Act ................................................................................................ 12
`Hatch-Waxman Act ............................................................................................ 11, 13
`
`vi
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`Case IPR2022-00142
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`Patent Owner Eye Therapies, LLC (“Eye Therapies” or “the Patent Owner”)
`
`submits this Preliminary Response to the Petition for Inter Partes Review of U.S.
`
`Patent No. 8,293,742 (“the ’742 patent”) filed by Slayback Pharma LLC (“Slayback”
`
`or “the Petitioner”).
`
`I.
`
`Introduction
`The ’742 patent is directed to, inter alia, methods for reducing eye redness
`
`consisting essentially of administering brimonidine to a patient having an ocular
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`condition, wherein the brimonidine is present at a concentration between about
`
`0.001% w/v and about 0.05% w/v. The claimed invention ultimately led to the
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`approval of Lumify®, the first and only FDA-approved over-the-counter redness
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`reliever with low risk of rebound redness and tachyphylaxis, and the first and only
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`over-the-counter eye drop to contain the active ingredient brimonidine tartrate. The
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`success of Lumify® has resulted in several generic competitors, including Slayback,
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`seeking to market generic copies of Lumify® prior to the expiration of the ’742
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`patent.
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`Slayback has launched a multi-front attack on the validity of the ’742 patent,
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`including by filing this petition for inter partes review. But the petition should be
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`denied for any one of the following reasons: (1) under 35 U.S.C. § 314(a) in light of
`
`co-pending Hatch-Waxman litigation; (2) under 35 U.S.C. § 325(d) because the
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`petition relies on the same or substantially the same art already considered and
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`Case IPR2022-00142
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`overcome during prosecution; and (3) on the merits because the Petitioner has failed
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`to establish that claims 1 and 2 are inherently anticipated or that claims 1-6 are
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`obvious.
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`The petition should be denied as a threshold matter under 35 U.S.C. § 314(a)
`
`in light of co-pending Hatch-Waxman litigation involving the ’742 patent. Slayback,
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`seeking to obtain the benefits of the Hatch-Waxman framework, filed an ANDA
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`with a Paragraph IV Certification challenging the validity of the ’742 patent.
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`Slayback is now attempting to mount a duplicative challenge through this petition.
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`Slayback is a party in the co-pending Hatch-Waxman litigation, which is already
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`underway and is unlikely to be stayed, even if an IPR is instituted. The validity of
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`the ’742 patent will be a central issue in the related litigation and there likely will be
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`complete overlap in Slayback’s obviousness and anticipation theories. Slayback is
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`not pursuing inter partes review as an efficient alternative to determine the validity
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`of the ’742 patent. Rather, seeking “two bites at the apple,” Slayback filed this
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`petition in the hopes it could obtain a favorable decision from the PTO at a lower
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`burden of proof before a final decision could be rendered in the related litigation.
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`The Board should exercise its discretion and deny institution under 35 U.S.C.
`
`§ 314(a) because granting this petition would result in significant duplication of
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`efforts and would be an inefficient use of the Board’s and the parties’ resources.
`
`NHK Spring Co., Ltd. v. Intri-Plex Techs., Inc., IPR2018-00752, Paper No. 8 at 20
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`2
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`Case IPR2022-00142
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`(P.T.A.B. Sept. 12, 2018) (precedential); see also Mylan Labs. Ltd. v. Janssen
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`Pharmaceutica NV, IPR2020-00440, Paper No. 17 at 12 (P.T.A.B. Sept. 16, 2020).
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`The petition should also be denied as a threshold matter under 35 U.S.C.
`
`§ 325(d) because it relies on the same or substantially the same art relied on or
`
`considered by the Examiner during prosecution. Slayback offers three grounds of
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`unpatentability, but each of these grounds relies on the same or substantially the
`
`same art already applied and overcome or considered by the Examiner during
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`prosecution. While certain references were not themselves of record, the art of record
`
`includes the same substantive teachings. Despite this, Slayback makes no attempt to
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`show any error by the Examiner in allowing the claims of the ’742 patent. The Board
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`should thus exercise its discretion and deny institution under 35 U.S.C. § 325(d).
`
`Should the Board reach the merits, there are multiple defects in Slayback’s
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`petition that further warrant denial of institution. With respect to anticipation,
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`Slayback alleges that claims 1 and 2 of the ’742 patent are inherently anticipated by
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`the ’553 patent and Walters 1991. But Slayback has failed to establish that
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`administration of the brimonidine formulations disclosed in these references would
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`necessarily and inevitably reduce redness. Slayback’s obviousness argument fares
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`no better. Indeed, rather than looking at the landscape to determine what a person of
`
`ordinary skill in the art would have done if tasked with formulating a redness
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`reducing eye drop, Slayback is laser-focused on prior art brimonidine formulations
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`Case IPR2022-00142
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`and fails to consider any FDA-approved redness reducers. Moreover, Slayback
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`focuses only on Alphagan®—an old brimonidine product that was discontinued
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`years before the priority date of the ’742 patent—and conspicuously ignores
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`Alphagan® P—the later-in-time brimonidine product that actually was being
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`marketed and sold as of the priority date. This is not surprising because the
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`progression in the art undermines the Petitioner’s entire analysis. When viewed
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`correctly, the art did not provide any reason or motivation for one skilled in the art
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`to use brimonidine as an eye redness reducing agent at a concentration as low as
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`“about 0.01% to about 0.025%.” Slayback’s failure to establish that the challenged
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`claims are either anticipated or obvious further warrants denial of institution.
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`II. The Board Should Deny Institution Under 35 U.S.C. § 314(a)
`The Board should exercise its discretion to deny institution under 35 U.S.C.
`
`§ 314(a) in view of the parallel Hatch-Waxman litigation involving the same patent
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`and parties: Bausch & Lomb, Inc. et al. v. Slayback Pharma LLC et al., Civil Action
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`No. 21-16766 (D.N.J.) (“the related litigation”). The Board should deny institution
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`under § 314(a) to avoid the inefficient use of the Board’s resources and unnecessary
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`duplication of efforts. See NHK, IPR2018-00752, Paper No. 8 at 20; Apple Inc. v.
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`Fintiv, Inc., IPR2020-00019, Paper No. 15 at 17 (P.T.A.B. May 13, 2020)
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`(informative).
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`4
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`Case IPR2022-00142
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` Legal Framework
`Under 35 U.S.C. § 314(a), the “Board may consider events in other
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`proceedings related to the same patent, either at the Office, in district courts, or the
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`ITC.” Fintiv, IPR2020-00019, Paper No. 15 at 7 (internal quotations omitted).
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`In considering whether to deny institution under § 314(a), the Board considers
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`six factors “which relate to whether efficiency, fairness, and the merits support the
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`exercise of authority to deny institution.” Fintiv, IPR2020-00019, Paper No. 15 at 8.
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`“In evaluating the factors, the Board takes a holistic view of whether efficiency and
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`integrity of the system are best served by denying or instituting review.” Id.
`
`Factor 1: A stay has not been, and is unlikely to be, entered
`
`Under the first Fintiv factor, the Board may consider “whether the court
`
`granted a stay or evidence exists that one may be granted if a proceeding is
`
`instituted.” Fintiv, IPR2020-00019, Paper No. 15 at 7.
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`Here, a stay has not been entered in the related litigation, nor has there been
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`any indication that any party intends to file a motion to stay. In view of the 30-month
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`regulatory stay provided by 21 U.S.C. § 355(j)(5)(B)(iii),1 it is also unlikely that any
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`motion to stay would be granted. Mylan, IPR2020-00440, Paper No. 17 at 14.
`
`
`1 The 30-month stay imposed by 21 U.S.C. § 355(j)(5)(B)(iii) is a stay of regulatory
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`approval, during which the FDA cannot grant final approval for the generic product.
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`Case IPR2022-00142
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`Because a stay has not been, and is unlikely to be, entered, Fintiv factor 1
`
`favors denial of institution. Id.
`
`
`
`Factor 2: Trial in the related litigation is likely to occur
`shortly after the deadline for the final written decision
`Under the second Fintiv factor, the Board may consider the “proximity of the
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`court’s trial date to the Board’s projected statutory deadline for a final written
`
`decision.” Fintiv, IPR2020-00019, Paper No. 15 at 8. “If the court’s trial date is at
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`or around the same time as the projected statutory deadline or even significantly after
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`the projected statutory deadline, the decision whether to institute will likely
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`implicate other factors . . . such as the resources that have been invested in the
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`parallel proceeding.” Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper No. 11 at 9
`
`(P.T.A.B. Mar. 20, 2020) (precedential).
`
`While a trial date has not been set for the related litigation, the statutory 30-
`
`month stay imposed by 21 U.S.C. § 355(j)(5)(B)(iii) is due to expire on or about
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`February 16, 2024. EX-2001 at 13. Based on local practice, the Patent Owner
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`anticipates trial will occur as early as fall 2023. Trial for the related litigation thus
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`could begin less than four months after the projected May 22, 2023 deadline for the
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`final written decision.
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`The litigation is not stayed during this period. In fact, the 30-month stay is intended
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`to provide the parties time to resolve the patent litigation.
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`Case IPR2022-00142
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`Given the current uncertainty of the relative timing of the district court trial
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`and a final written decision, the ultimate decision whether to institute should turn on
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`the analysis of the other Fintiv factors, each of which weigh in favor of denial. Fintiv,
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`IPR2020-00019, Paper No. 11 at 9.
`
`
`
`Factor 3: The parties and the court will invest significant
`resources in the related litigation
`Under the third Fintiv factor, the Board may consider the “investment in the
`
`parallel proceeding by the court and the parties.” Fintiv, IPR2020-00019, Paper No.
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`15 at 8. When evaluating this factor, the Board considers “the amount and type of
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`work already completed in the parallel litigation by the court and the parties at the
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`time of the institution decision.” Fintiv, IPR2020-00019, Paper No. 11 at 9.
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`By the time of institution, the parties will have invested significant resources
`
`in the related litigation. Indeed, Slayback’s first discovery requests were served
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`almost two months ago, and fact discovery is underway. EX-2002. By May, the
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`parties will have exchanged a large portion of their document productions, including
`
`all related regulatory filings (Slayback’s ANDA and Bausch’s IND and NDA);
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`served binding contentions related to both validity and infringement, which serve as
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`the framework for the case; and even begun claim construction exchanges. EX-2003.
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`The investment by the parties thus supports denial. Mylan, IPR2020-00440, Paper
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`No. 17 at 17-18.
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`The court in the related proceeding entered its scheduling order on February
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`15, 2022, after conducting the Rule 16 Conference on February 10, 2022. EX-2003;
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`EX-2001 and EX-2004. The court’s consideration of a draft litigation schedule and
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`its issuance of a substantive order regarding scheduling further supports denial.
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`Mylan, IPR2020-00440, Paper No. 17 at 18.
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`Moreover, because a stay is unlikely to be entered in the related litigation, the
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`parties and the court will invest even more resources in assessing the validity of the
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`’742 patent by the time the Board would issue its final written decision. Indeed, by
`
`May 2023, the court likely will have issued its claim construction ruling, fact
`
`discovery will be closed, and expert discovery will be well underway. EX-2003.
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`These facts further support denial. See Mylan, IPR2020-00440, Paper No. 17 at 19.
`
`
`
`Factor 4: The petition relies on substantially the same art
`and arguments likely to be presented in the parallel
`proceeding
`Under the fourth Fintiv factor, the Board may consider the “overlap between
`
`issues raised in the petition and in the parallel proceeding.” Fintiv, IPR2020-00019,
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`Paper No. 15 at 8. If the petition “includes the same or substantially the same claims,
`
`grounds, arguments, and evidence as presented in the parallel proceeding, this fact
`
`has favored denial.” Fintiv, IPR2020-00019, Paper No. 11 at 12.
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`Here, there is substantial overlap between the issues raised in the district court
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`case and in the petition. The Petitioner has challenged the validity of all of the claims
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`Case IPR2022-00142
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`of the ’742 patent. The validity of the ’742 patent’s claims surely will be a central
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`issue at trial in the related litigation. In fact, validity may be the only issue at trial
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`because the defendants have not identified any non-infringement position for any of
`
`the asserted claims of the ’742 patent (i.e., claims 1-3). See EX-2005 at 22-23.
`
`In their Paragraph IV letter, the defendants alleged that the claims of the ’742
`
`patent are invalid under 35 U.S.C. §§ 102, 103, and 112. EX-2005 at 24-33. In
`
`connection with their anticipation and obviousness arguments, the defendants cited
`
`the following references, which are also relied upon by the Petitioner here:
`
`• Norden 2002 (EX-1006)
`
`• U.S. Patent No. 6,242,442 (EX-1007)
`
`• Murphy 2007 (EX-1026)
`
`• U.S. Patent No. 6,562,873 (EX-1033)
`
`• Wikberg-Matsson 2001 (EX-1017)
`
`Compare EX-2005 at 24-31 with Petition at 9-11.
`
`
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`It is reasonable to believe that the defendants will raise the art and arguments
`
`presented in the petition before the district court. As an initial matter, the defendants
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`have not agreed to forego any invalidity challenges in the related litigation based on
`
`the grounds and art raised in the petition. The defendants thus are free to raise the
`
`same invalidity arguments in the related litigation. Further, as a general matter,
`
`defendants tend to be over-inclusive in their invalidity contentions to ensure that
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`Case IPR2022-00142
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`they are not later precluded from raising any art or arguments. Because the institution
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`decision will be rendered after the deadline for serving invalidity contentions, the
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`defendants likely will raise the same art and arguments presented in the petition to
`
`preserve their ability to raise them in the district court if the Board denies institution.
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`The invalidity issues in the related litigation thus will significantly overlap with the
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`invalidity issues presented in the petition.
`
`
`
`Because the validity of the claims of the ’742 patent will be a central issue in
`
`the related litigation and the defendants likely will rely on the same art and
`
`arguments presented in the petition, Fintiv factor 4 favors denial. Fintiv, IPR2020-
`
`00019, Paper No. 11 at 12-13; Mylan, IPR2020-00440, Paper No. 17 at 21.
`
`
`
`Factor 5: The Petitioner is a defendant in the related
`litigation
`Under the fifth Fintiv factor, the Board may consider the “whether the
`
`petitioner and the defendant in the parallel proceeding are the same party.” Fintiv,
`
`IPR2020-00019, Paper No. 15 at 8. Here, the Petitioner is a defendant in the related
`
`litigation. EX-2006. Fintiv factor 5 thus favors denial of institution. Fintiv, IPR2020-
`
`00019, Paper No. 15 at 15.
`
`Factor 6: All other circumstances further support denial
`
`Under the sixth Fintiv factor, the Board may consider any “other
`
`circumstances that impact the Board’s exercise of discretion, including the merits.”
`
`Fintiv, IPR2020-00019, Paper No. 15 at 8. “[I]f the merits of the grounds raised in
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`Case IPR2022-00142
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`the petition are a close[] call, then that fact has favored denying institution when
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`other factors favoring denial are present.” Fintiv, IPR2020-00019, Paper No. 11 at
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`14-15. Here, all other circumstances further support denial.
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`First, as discussed below, the petition should be separately denied under 35
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`U.S.C. § 325(d) for asserting the same or substantially the same art previously
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`considered and overcome during prosecution. See infra § III. Moreover, on the
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`merits, the petition fails to establish that the challenged claims are either inherently
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`anticipated or obvious. See infra § IV.C. At most, the petition presents a “close[]
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`call,” which is insufficient to justify institution when other factors favor denial as is
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`the case here. Fintiv, IPR2020-00019, Paper No. 11 at 14-15.
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`Second, the related litigation arises under the Hatch-Waxman Act. In enacting
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`the Hatch-Waxman Act, Congress sought to attain a balance between the interests
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`of brand name pharmaceutical companies and generic drug manufacturers. See, e.g.,
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`Novo Nordisk A/S v. Caraco Pharm. Labs., Ltd., 601 F.3d 1359, 1360 (Fed. Cir.
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`2010) rev’d on other grounds, 566 U.S. 399 (2012). The statutory framework
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`established by the Hatch-Waxman Act “strikes a balance between two potentially
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`competing policy interests—inducing pioneering development of pharmaceutical
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`formulations and methods and facilitating efficient transition to a market with low-
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`cost, generic copies of those pioneering inventions at the close of a patent term.” Id.
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`The essence of that balance is the generic’s right to prepare and file its ANDA
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`without liability for infringement given in exchange for the patent owner’s right to
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`resolve the dispute in federal court under the protection of the 30-month stay of FDA
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`approval of the generic product. By filing an ANDA with a Paragraph IV
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`Certification challenging the validity of the ’742 patent, the Petitioner availed itself
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`of the benefits of the Hatch-Waxman framework. Yet, the Petitioner seeks to deprive
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`the Patent Owner of its right to have the dispute resolved in federal court by
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`challenging the validity of the ’742 patent on substantially the same grounds in an
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`IPR proceeding.
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`Institution here would also run counter to the objectives of the America
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`Invents Act (“the AIA”). Indeed, the AIA sought to provide “an effective and
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`efficient alternative to district court litigation.” Gen. Plastic Indus. Co., Ltd. v.
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`Canon Kabushiki Kaisha, IPR2016-01357, Paper No. 19 at 16-17 (P.T.A.B. Sept. 6,
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`2017) (precedential) (emphasis added). The related litigation was initiated through
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`the Petitioner’s filing of an ANDA with a Paragraph IV Certification. But now, the
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`Petitioner is seeking to mount a duplicative challenge in an IPR proceeding—
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`effectively
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`forcing parallel, yet duplicative proceedings with nearly
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`contemporaneous timelines, thus forcing the parties to spend time and money in both
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`the district court and at the PTAB, because the Petitioner wants two bites at the apple.
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`The reason for this is clear. The Petitioner filed this petition in the hopes it could
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`obtain a favorable decision from the PTO before a final decision could be rendered
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`in the related litigation. Denial of this petition is warranted to conserve judicial
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`resources, prevent the possibility of conflicting judgments, and deter future petitions
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`that similarly undermine the goals of the Hatch-Waxman Act and AIA.
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`At least these additional factors support denial.
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`III. The Board Should Deny Institution Under 35 U.S.C. § 325(d)
` Legal Framework
`Under 35 U.S.C. § 325(d), the Board may decline to institute where “the same
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`or substantially the same prior art or arguments previously were presented to the
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`Office.” 35 U.S.C. § 325(d); see also Becton, Dickinson & Co. v. B. Braun
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`Melsungen AG, IPR2017-01586, Paper No. 8 at 17 (P.T.A.B. Dec. 15, 2017)
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`(precedential); Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte
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`GmbH, IPR2019-01469, Paper No. 6 at 7 (P.T.A.B. Feb. 13, 2020) (precedential).
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`The Board applies a two-part framework when considering whether to deny
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`institution under § 325(d). First, the Board considers whether “the same or
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`substantially the same art previously was presented to the Office or whether the same
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`or substantially the same arguments previously were presented to the Office.”
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`Advanced Bionics, IPR2019-01469, Paper No. 6 at 8. Second, “if either condition of
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`[the] first part of the framework is satisfied, [the Board considers] whether the
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`petitioner has demonstrated that the Office erred in a manner material to the
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`patentability of challenged claims.” Id.
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`In connection with this framework, the Board weighs the non-exclusive
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`factors set forth in Becton Dickinson: (a) the similarities and material differences
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`between the asserted art and the prior art involved during examination; (b) the
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`cumulative nature of the asserted art and the prior art evaluated during examination;
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`(c) the extent to which the asserted art was evaluated during examination, including
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`whether the prior art was the basis for rejection; (d) the extent of the overlap between
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`the arguments made during examination and the manner in which the petitioner
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`relies on the prior art or the Patent Owner distinguishes the prior art; (e) whether the
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`petitioner has pointed out sufficiently how the Examiner erred in its evaluation of
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`the asserted prior art; and (f) the extent to which additional evidence and facts
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`presented in the Petition warrant reconsideration of prior art or arguments. See
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`Advanced Bionics, IPR2019-01469, Paper No. 6 at 10; Becton Dickinson, IPR2017-
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`01586, Paper No. 8 at 17-18. Becton Dickinson factors (a), (b), and (d) relate to the
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`first prong of the inquiry (whether the same or substantially the same art or
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`arguments were presented during prosecution), while Becton Dickinson factors (c),
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`(e), and (f) relate to whether the petition has established a material error during
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`prosecution. Advanced Bionics