Case 3:21-cv-16766-MAS-DEA Document 18 Filed 03/10/22 Page 1 of 7 PageID: 111
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
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`BAUSCH & LOMB, INC.;
`BAUSCH & LOMB IRELAND
`LIMITED; and EYE THERAPIES, LLC,
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`C.A. No. 3:21-16766-MAS-DEA
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`Plaintiffs,
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`v.
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`SLAYBACK PHARMA LLC and
`SLAYBACK PHARMA INDIA LLP,
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`Defendants.
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`
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`SLAYBACK DEFENDANTS’ STIPULATION
`TO LIMIT INVALIDITY CONTENTIONS
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`{80283344:1}
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`Page 1 of 7
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`SLAYBACK EXHIBIT 1043
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
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`
`
`
`
`BAUSCH & LOMB, INC.;
`BAUSCH & LOMB IRELAND
`LIMITED; and EYE THERAPIES, LLC,
`
`
`
`
`C.A. No. 3:21-16766-MAS-DEA
`
`Plaintiffs,
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`
`
`v.
`
`
`SLAYBACK PHARMA LLC and
`SLAYBACK PHARMA INDIA LLP,
`
`
`Defendants.
`
`
`
`SLAYBACK DEFENDANTS’ STIPULATION
`TO LIMIT INVALIDITY CONTENTIONS
`
`
`
`
`
`{80283344:1}
`
`
`
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`Page 1 of 7
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`SLAYBACK EXHIBIT 1043
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`Case 3:21-cv-16766-MAS-DEA Document 18 Filed 03/10/22 Page 2 of 7 PageID: 112
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`Defendants Slayback Pharma LLC and Slayback Pharma India LLP (“the
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`Slayback Defendants”) submit this Stipulation to limit the Slayback Defendants’
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`invalidity contentions in this action, and to thereby make the specific proceedings
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`identified below before the United States Patent and Trademark Office a true
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`alternative to this action.
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`BACKGROUND
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`1.
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`On September 10, 2021, Plaintiffs Bausch & Lomb, Inc., Bausch &
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`Lomb Ireland Limited, and Eye Therapies, LLC (collectively, “Plaintiffs”) started
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`this Hatch-Waxman action by filing the Complaint [D.I. 1]. Plaintiffs alleged that
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`the filing of the Slayback Defendants’ ANDA No. 216361 did infringe, and that the
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`Slayback Defendants will infringe two patents, United States Patent Nos. 8,293,742
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`(“the ‘742 patent”) and 9,259,425 (“the ‘425 patent”) (collectively the “Patents-in-
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`Suit”). The Slayback Defendants waived service of the Complaint and the Answer
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`was due November 23, 2021. The Slayback Defendants filed their Answer [D.I. 9]
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`on November 9, 2021, the Court conducted the Initial Scheduling Conference on
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`February 10, 2021, the agreed-to Scheduling Order [D.I. 15] was entered February
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`15, 2022, and a Stipulated Discovery Confidentiality Order was submitted to the
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`Court on March 19, 2022.
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`2.
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`The Patents-in-Suit in this action are also the subject of Petitions for
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`Inter Partes Review (“IPR”) filed November 7, 2021 by the Slayback Defendants
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`{80283344:1}
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`Page 2 of 7
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`SLAYBACK EXHIBIT 1043
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`Case 3:21-cv-16766-MAS-DEA Document 18 Filed 03/10/22 Page 3 of 7 PageID: 113
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`with the Patent Trial and Appeal Board (“PTAB”) of the United States Patent and
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`Trademark Office. The Petition for IPR of the ‘742 patent is Paper No. 2 in IPR2022-
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`00142 (“the ‘142 IPR”), and the Petition for IPR of the ‘425 patent is Paper No. 2 in
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`IPR2022-00146 (“the ‘146 IPR”) (collectively, “the Related IPRs”).
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`3.
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`The Petitions in the Related IPRs assert the following Grounds of
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`invalidity:
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`Ground 1
`Ground 2
`Ground 3
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`
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`Ground 1
`Ground 2
`Ground 3
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`4.
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`U.S. Patent 8,293,742 the ‘142 IPR
`Claims 1-2 anticipated by U.S. Patent 6,294,553
`Claims 1-2 anticipated by Walters 1991
`Claims 1-6 obvious over U.S. Patent 6,294,553 in combination with
`Norden 2002, U.S. Patent 6,242,442, Alphagan® Label 1998 and
`Federal Register 1988
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`U.S. Patent 9,259,425 the ‘146 IPR
`Claims 1-6 anticipated by U.S. Patent 6,294,553
`Claims 1-6 anticipated by Walters 1991
`Claims 1-6 obvious over U.S. Patent 6,294,553 in combination with
`Norden 2002, U.S. Patent 6,242,442, Alphagan® Label 1998 and
`Federal Register 1988
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`On February 22, 2022, the Plaintiffs in this action filed a Preliminary
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`Response in each of the Related IPRs.
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`5.
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`Among other arguments in the Preliminary Responses, Plaintiffs
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`argued that the PTAB should deny institution of the Related IPRs because “the
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`{80283344:1}
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`SLAYBACK EXHIBIT 1043
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`Case 3:21-cv-16766-MAS-DEA Document 18 Filed 03/10/22 Page 4 of 7 PageID: 114
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`defendants have not agreed to forego any invalidity challenges in [this action] based
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`on the grounds and art raised in the petition.”
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`6.
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`The Slayback Defendants note for the Court that in an IPR unrelated to
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`this action or the Patents-in-Suit, Sotera Wireless. Inc. v. Masimo Corporation,
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`IPR2020-01019 (“Sotera IPR”), the petitioner in the Sotera IPR relied on a broad
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`stipulation filed in a parallel district court litigation, Masimo Corp. v. Sotera
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`Wireless, Inc., Case No. 3:19-cv-01100-BAS-NLS (S.D. Cal.) [D.I. 86], which
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`stipulated that if the Sotera IPR was instituted in the parallel district court litigation
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`the petitioner would not pursue any invalidity defense in the district court litigation
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`that could have reasonably been raised in the Sotera IPR. Sotera, IPR2020-01019,
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`Paper 12, p. 19 (PTAB Dec. 1, 2020) (precedential). The PTAB held in the Sotera
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`IPR that the defendant’s broad stipulation in district court mitigated any concerns of
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`duplicative efforts between the district court and the PTAB, and made the Sotera
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`IPR a “true alternative” to the district court proceeding:
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`Petitioner’s stipulation here mitigates any concerns of
`duplicative efforts between the district court and the Board, as well
`as concerns of potentially conflicting decisions. See Sand Revolution
`12. Importantly, Petitioner broadly stipulates to not pursue “any ground
`raised or that could have been reasonably raised.” Reply 6. As noted in
`Sand Revolution, such a broad stipulation better addresses concerns of
`duplicative efforts and potentially conflicting decisions in a much more
`substantial way. Sand Revolution 12 n.5. Accordingly, Petitioner’s
`broad stipulation ensures that an inter partes review is a ‘true
`alternative’ to the district court proceeding. Id.
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`SLAYBACK EXHIBIT 1043
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`Case 3:21-cv-16766-MAS-DEA Document 18 Filed 03/10/22 Page 5 of 7 PageID: 115
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`Thus, we find that this factor weighs strongly in favor of not
`exercising discretion to deny institution under 35 U.S.C. § 314(a).
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`Id. (emphasis supplied).
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`7.
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`Like the defendant in the Sotera IPR, the Slayback Defendants in this
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`action seek to mitigate any concern of duplicative efforts between the Related IPRs
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`and this action, and to thereby make the Related IPRs a “true alternative.”
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`Therefore, the Slayback Defendants STIPULATE as follows:
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`
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`A.
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`If the Patent Trial and Appeal Board (“PTAB”) institutes IPR in
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`IPR2022-00142, the Slayback Defendants will not pursue in this action the specific
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`grounds identified above in connection with U.S. Patent No. 8,293,742 (“the ‘742
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`patent”) and the claim(s) as originally issued, or any other ground for the ‘742 patent
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`that was raised or could have been reasonably raised in an IPR (i.e., any ground that
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`could be raised under 35 U.S.C. §§ 102 or 103 on the basis of prior art patents or
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`printed publications).
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`B.
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`If the Patent Trial and Appeal Board (“PTAB”) institutes IPR in
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`IPR2022-00146, the Slayback Defendants will not pursue in this action the specific
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`grounds identified above in connection with U.S. Patent No. 9,259,425 (“the ‘425
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`patent”) and the claim(s) as originally issued, or any other ground for the ‘425 patent
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`that was raised or could have been reasonably raised in an IPR (i.e., any ground that
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`could be raised under 35 U.S.C. §§ 102 or 103 on the basis of prior art patents or
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`printed publications).
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`{80283344:1}
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`SLAYBACK EXHIBIT 1043
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`Case 3:21-cv-16766-MAS-DEA Document 18 Filed 03/10/22 Page 6 of 7 PageID: 116
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`C.
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`This Stipulation is not intended, and should not be construed, to limit
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`the Slayback Defendants’ ability in this action to assert invalidity of the asserted
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`claims of the ‘742 patent or the ‘425 patent on any other ground (e.g., invalidity
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`under 35 U.S.C. § 112), regardless of whether Inter Partes Review is instituted.
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`Date: March 10, 2022
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`Respectfully submitted,
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`/s/ Louis H. Weinstein
`Louis H. Weinstein
`Anandita Vykarnam
`WINDEL MARX LANE &
`MITTENDORF, LLP
`One Giralda Farms
`Madison, NJ 07940
`(973) 966-3200
`Attorneys for Defendants Slayback Pharma
`LLC and Slayback Pharma India LLP
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`{80283344:1}
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`Page 6 of 7
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`SLAYBACK EXHIBIT 1043
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`Case 3:21-cv-16766-MAS-DEA Document 18 Filed 03/10/22 Page 7 of 7 PageID: 117
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`CERTIFICATE OF SERVICE
`I, Louis H. Weinstein, certify that I caused to be served a true and correct copy
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`
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`of the foregoing SLAYBACK DEFENDANTS’ STIPULATION TO LIMIT
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`INVALIDITY CONTENTIONS via ECF and via e-mail to:
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`Bryan C. Diner bryan.diner@finnegan.com
`Justin J. Hasford justin.hasford@finnegan.com
`J. Brugh Lower JLower@gibbonslaw.com
`Caitlin E. O’Connell caitlin.O’connell@finnegan.com
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`Dated: March 10, 2022
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` By: /s/ Louis H. Weinstein
` Louis H. Weinstein
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`{80283344:1}
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`Page 7 of 7
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`SLAYBACK EXHIBIT 1043
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