Case 3:21-cv-16766-MAS Document 1 Filed 09/10/21 Page 1 of 12 PageID: 1
`
`William P. Deni, Jr.
`J. Brugh Lower
`GIBBONS P.C.
`One Gateway Center
`Newark, New Jersey 07102
`Tel: (973) 596-4500
`Fax: (973) 596-0545
`
`Attorneys for Plaintiffs
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`BAUSCH & LOMB, INC.;
`BAUSCH & LOMB IRELAND LIMITED;
`and EYE THERAPIES, LLC,
`
`Plaintiffs,
`
`v.
`
`SLAYBACK PHARMA LLC and
`SLAYBACK PHARMA INDIA LLP,
`
`Defendants.
`
`Civil Action No. 21-16766
`
`Document Electronically Filed
`
`COMPLAINT FOR PATENT INFRINGEMENT
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`Plaintiffs Bausch & Lomb, Inc., Bausch & Lomb Ireland Limited, and Eye Therapies, LLC
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`(collectively, “Plaintiffs”) by way of Complaint against Defendants Slayback Pharma LLC and
`
`Slayback Pharma India LLP (collectively, “Defendants”) allege as follows:
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`NATURE OF THE ACTION
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`1.
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`This is an action for infringement of United States Patent Nos. 8,293,742 (“the ’742
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`patent”) and 9,259,425 (“the ’425 patent”), arising under the United States patent laws, Title 35,
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`United States Code, § 100 et seq., including 35 U.S.C. §§ 271 and 281, and for declaratory
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`judgment of infringement under 28 U.S.C. §§ 2201 and 2202. This action relates to Slayback
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`Pharma LLC’s filing of an Abbreviated New Drug Application (“ANDA”) under Section 505(j)
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`of the Federal Food, Drug, and Cosmetic Act (“the Act”), 21 U.S.C. § 355(j), seeking U.S. Food
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`and Drug Administration (“FDA”) approval to market its generic Brimonidine Tartrate
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`Ophthalmic Solution, 0.025% (“Slayback’s generic brimonidine ophthalmic solution”) prior to the
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`expiration of the ’742 patent and the ’425 patent.
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`THE PARTIES
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`2.
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`Plaintiff Bausch & Lomb, Inc. (“Bausch”) is a corporation organized and existing
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`under the laws of New York with a place of business at 1400 N. Goodman St. Rochester, NY
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`14609. Bausch is the registered holder of approved New Drug Application (“NDA”) No. 208144,
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`which covers Lumify® ophthalmic solution/drops (brimonidine tartrate, 0.025%).
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`3.
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`Plaintiff Bausch & Lomb Ireland Limited (“Bausch Ireland”) is a company
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`organized and existing under the laws of Ireland, having its registered office at 3013 Lake Drive,
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`Citywest Business Park, Dublin, Ireland. Bausch Ireland exclusively licenses the ’742 patent and
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`the ’425 patent.
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`4.
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`Plaintiff Eye Therapies, LLC (“Eye Therapies”) is a limited liability company
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`organized and existing under the laws of Delaware, having its principal place of business at 26933
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`Camino De Estrella, 2nd Fl., Dana Point, California 92624. Eye Therapies is the owner of the
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`’742 patent and the ’425 patent.
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`5.
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`Upon information and belief, Slayback Pharma, LLC (“Slayback”) is a Delaware
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`limited liability company having a principal place of business at 301 Carnegie Center, Suite 303,
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`Princeton, NJ 08540, within this judicial district.
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`6.
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`Upon information and belief, Slayback Pharma India LLP (“Slayback India”) is a
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`limited liability partnership organized under the laws of India, having a principal place of business
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`Case 3:21-cv-16766-MAS Document 1 Filed 09/10/21 Page 3 of 12 PageID: 3
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`at 310, 3rd Floor, Manjeera Trinity Corporate, JNTU - Hitech City Road, KPHB Phase 3,
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`Kukutpally Hyderabad, Telangana 500072, India.
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`7.
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`Upon information and belief, Slayback is the parent corporation of Slayback India,
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`and the acts of Slayback complained of herein were done with the cooperation, participation and
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`assistance of Slayback India.
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`JURISDICTION AND VENUE
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`8.
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`This Court has subject matter jurisdiction under 28 U.S.C. §§ 1331, 1338(a), 2201
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`and 2202.
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`9.
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`Upon information and belief, this court has jurisdiction over Slayback. Upon
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`information and belief, Slayback is in the business of, inter alia, developing, manufacturing,
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`marketing, importing and selling pharmaceutical products, including generic drug products. Upon
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`information and belief, Slayback directly, or indirectly, develops, manufactures, markets, and sells
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`generic drug products throughout the United States and in this judicial district, and this judicial
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`district is a likely destination for Slayback’s generic brimonidine ophthalmic solution. Upon
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`information and belief, Slayback purposefully has conducted and continues to conduct business in
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`this judicial district. Upon information and belief, Slayback has its principal place of business at
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`301 Carnegie Center, Suite 303, Princeton, New Jersey 08540. Upon information and belief,
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`Slayback has previously submitted to the jurisdiction of this Court and has further previously
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`availed itself of this Court by asserting counterclaims in other civil actions initiated in this
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`jurisdiction.
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`10.
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`Upon information and belief, Slayback has taken the costly, significant step of
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`applying to the FDA for approval to engage in future activities—including the marketing of its
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`generic drugs—that will be purposefully directed at, upon information and belief, the State of New
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`Jersey and elsewhere. Slayback’s ANDA filings constitute formal acts that reliably indicate plans
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`to engage in marketing of the proposed generic drugs. Upon information and belief, Slayback
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`intends to direct sales of its drugs into New Jersey, among other places, once it has the requested
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`FDA approval to market them. Upon information and belief, Slayback will engage in marketing
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`of its generic brimonidine ophthalmic solution in New Jersey upon approval of its ANDA.
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`11.
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`Upon information and belief, this court has jurisdiction over Slayback India. Upon
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`information and belief, Slayback India is in the business of, inter alia, developing, manufacturing,
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`marketing, importing and selling pharmaceutical products, including generic drug products. Upon
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`information and belief, Slayback India directly, or indirectly, develops, manufactures, markets,
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`and sells generic drug products throughout the United States and in this judicial district, and this
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`judicial district is a likely destination for Slayback’s generic brimonidine ophthalmic solution.
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`Upon information and belief, Slayback India purposefully has conducted and continues to conduct
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`business in this judicial district in concert with Slayback.
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`12.
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`Upon information and belief, Slayback and Slayback India operate as interrelated
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`corporate entities. Upon information and belief, Slayback is the parent corporation of Slayback
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`India. Upon information and belief, Slayback and Slayback India each act as an agent of the other
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`and work together to, inter alia, develop, manufacture, obtain regulatory approval, market, sell
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`and distribute generic copies of branded pharmaceutical products throughout the United States,
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`including in this judicial district.
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`13.
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`Defendants know or should know that Lumify® is manufactured for Bausch, at least
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`because that information is included in the label for Lumify® and is publicly available.
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`14.
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`Upon information and belief, venue is proper in this judicial district under 28 U.S.C.
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`§§ 1391(c) and (d), and § 1400(b).
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`15.
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`Venue is proper against Slayback Pharma, LLC, which maintains a regular and
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`established place of business in this judicial district.
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`16.
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`Venue is proper against Slayback India, a foreign corporation, in any judicial
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`district that has personal jurisdiction, including this judicial district.
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`THE PATENTS IN SUIT
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`17.
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`The PTO issued the ’742 patent on October 23, 2012. The ’742 patent claims, inter
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`alia, methods of reducing eye redness consisting essentially of administering brimonidine into
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`ocular tissue. Plaintiffs hold all substantial rights in the ’742 patent and have the right to sue for
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`infringement thereof. A copy of the ’742 patent is attached hereto as Exhibit 1.
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`18.
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`The U.S. Patent and Trademark Office (“PTO”) issued the ’425 patent on February
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`16, 2016. The ’425 patent claims, inter alia, methods of reducing redness of an eye and/or
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`increasing whiteness of an eye comprising administering compositions comprising brimonidine.
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`Plaintiffs hold all substantial rights in the ’425 patent and have the right to sue for infringement
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`thereof. A copy of the ’425 patent is attached hereto as Exhibit 2.
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`19.
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`Bausch is the holder of NDA No. 208144 for Lumify®, which the FDA approved
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`on December 22, 2017. In conjunction with NDA No. 208144, the ’742 and ’425 patents are listed
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`in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (“the Orange
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`Book”).
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`20.
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`Brimonidine tartrate ophthalmic solution, 0.025%, is sold in the United States under
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`the trademark Lumify®.
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`SLAYBACK’S INFRINGING ANDA SUBMISSION
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`21.
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`Upon information and belief, Slayback filed or caused to be filed with the FDA
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`ANDA No. 216361, under Section 505(j) of the Act and 21 U.S.C. § 355(j).
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`22.
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`Upon information and belief, Slayback’s ANDA No. 216361 seeks FDA approval
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`to engage in commercial manufacture, use, and sale in the United States of Slayback’s generic
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`brimonidine ophthalmic solution, intended to be a generic version of Lumify®.
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`23.
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`On or about August 16, 2021, Plaintiffs received a letter from Slayback dated
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`August 13, 2021, purporting to be a Notice of Paragraph IV Certification regarding ANDA No.
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`216361 (“Slayback’s Notice Letter”) under Section 505(j)(2)(B)(iv) of the Act and 21 § C.F.R.
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`314.95. Slayback’s Notice Letter was addressed to Bausch and Eye Therapies.
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`24.
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`Slayback’s Notice Letter alleges that Slayback has submitted to the FDA ANDA
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`No. 216361 seeking approval to engage in the commercial manufacture, use and/or sale of
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`Slayback’s generic brimonidine ophthalmic solution, intended to be generic versions of Lumify®.
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`25.
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`Slayback’s Notice Letter states that Slayback’s ANDA No. 216361 contains the
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`“required bioavailability or bioequivalence data or information with respect to brimonidine tartrate
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`ophthalmic solution, 0.025%,” for Slayback’s generic brimonidine ophthalmic solution.
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`26.
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`Upon information and belief, ANDA No. 216361 seeks approval of Slayback’s
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`generic brimonidine ophthalmic solution that is the same, or substantially the same, as Lumify®.
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`27.
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`Upon information and belief, Slayback’s actions related to ANDA No. 216361
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`complained of herein were done at the direction of, with the authorization of, or with the
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`cooperation, the participation, the assistance of, or at least in part for the benefit of Slayback India.
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`COUNT I FOR PATENT INFRINGEMENT
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`Infringement of the ’742 Patent Under § 271(e)(2)
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`Paragraphs 1-27 are incorporated herein as set forth above.
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`Under 35 U.S.C. § 271(e)(2), Defendants have infringed at least one claim of the
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`28.
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`29.
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`’742 patent by submitting, or causing to be submitted to the FDA, ANDA No. 216361 seeking
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`approval for the commercial marketing of Slayback’s generic brimonidine ophthalmic solution
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`before the expiration date of the ’742 patent.
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`30.
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`Upon information and belief, Slayback’s generic brimonidine ophthalmic solution
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`will, if approved and marketed, infringe at least one claim of the ’742 patent.
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`31.
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`Upon information and belief, Defendants will, through the manufacture, use,
`
`import, offer for sale, and/or sale of Slayback’s generic brimonidine ophthalmic solution, directly
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`infringe, contributorily infringe, and/or induce infringement of at least one claim of the ’742 patent.
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`32.
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`If Defendants’ marketing and sale of Slayback’s generic brimonidine ophthalmic
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`solution prior to the expiration of the ’742 patent is not enjoined, Plaintiffs will suffer substantial
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`and irreparable harm for which there is no adequate remedy at law.
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`COUNT II FOR PATENT INFRINGEMENT
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`Declaratory Judgment of Infringement of the ’742 Patent
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`Paragraphs 1-32 are incorporated herein as set forth above.
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`These claims arise under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and
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`33.
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`34.
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`2202.
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`35.
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`There is an actual case or controversy such that the Court may entertain Plaintiffs’
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`request for declaratory relief consistent with Article III of the United States Constitution, and this
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`actual case or controversy requires a declaration of rights by this Court.
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`36.
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`Defendants have made, and will continue to make, substantial preparation in the
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`United States to manufacture, use, offer to sell, sell, and/or import Slayback’s generic brimonidine
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`ophthalmic solution before the expiration date of the ’742 patent, including Slayback’s filing of
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`ANDA No. 216361.
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`37.
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`Upon information and belief, any commercial manufacture, use, offer for sale, sale,
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`and/or importation of Slayback’s generic brimonidine ophthalmic solution will directly infringe,
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`contributorily infringe, and/or induce infringement of at least one claim of the ’742 patent.
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`38.
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`Plaintiffs are entitled to a declaratory judgment that future commercial
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`manufacture, use, offer of use, sale, and/or importation of Slayback’s generic brimonidine
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`ophthalmic solution will constitute infringement of at least one claim of the ’742 patent.
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`COUNT III FOR PATENT INFRINGEMENT
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`Infringement of the ’425 Patent Under § 271(e)(2)
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`Paragraphs 1-38 are incorporated herein as set forth above.
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`Under 35 U.S.C. § 271(e)(2), Defendants have infringed at least one claim of the
`
`39.
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`40.
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`’425 patent by submitting, or causing to be submitted to the FDA, ANDA No. 216361 seeking
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`approval for the commercial marketing of Slayback’s generic brimonidine ophthalmic solution
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`before the expiration date of the ’425 patent.
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`41.
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`Upon information and belief, Slayback’s generic brimonidine ophthalmic solution
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`will, if approved and marketed, infringe at least one claim of the ’425 patent.
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`42.
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`Upon information and belief, Defendants will, through the manufacture, use,
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`import, offer for sale, and/or sale of Slayback’s generic brimonidine ophthalmic solution, directly
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`infringe, contributorily infringe, and/or induce infringement of at least one claim of the ’425 patent.
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`43.
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`If Defendants’ marketing and sale of Slayback’s generic brimonidine ophthalmic
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`solution prior to the expiration of the ’425 patent is not enjoined, Plaintiffs will suffer substantial
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`and irreparable harm for which there is no adequate remedy at law.
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`COUNT IV FOR PATENT INFRINGEMENT
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`Declaratory Judgment of Infringement of the ’425 Patent
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`Paragraphs 1-43 are incorporated herein as set forth above.
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`These claims arise under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and
`
`44.
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`45.
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`2202.
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`46.
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`There is an actual case or controversy such that the Court may entertain Plaintiffs’
`
`request for declaratory relief consistent with Article III of the United States Constitution, and this
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`actual case or controversy requires a declaration of rights by this Court.
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`47.
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`Defendants have made, and will continue to make, substantial preparation in the
`
`United States to manufacture, use, offer to sell, sell, and/or import Slayback’s generic brimonidine
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`ophthalmic solution before the expiration date of the ’425 patent, including Slayback’s filing of
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`ANDA No. 216361.
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`48.
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`Upon information and belief, any commercial manufacture, use, offer for sale, sale,
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`and/or importation of Slayback’s generic brimonidine ophthalmic solution will directly infringe,
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`contributorily infringe, and/or induce infringement of at least one claim of the ’425 patent.
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`49.
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`Plaintiffs are entitled to a declaratory judgment that future commercial
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`manufacture, use, offer of use, sale, and/or importation of Slayback’s generic brimonidine
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`ophthalmic solution will constitute infringement of at least one claim of the ’425 patent.
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`PRAYER FOR RELIEF
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`WHEREFORE, Plaintiffs respectfully request that this Court enter judgment in their favor
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`and against Defendants on the patent infringement claims set forth above and respectfully request
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`that this Court:
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`1.
`
`Enter judgment that, under 35 U.S.C. § 271(e)(2), Defendants have infringed at
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`least one claim of the ’742 patent by submitting or causing to be submitted ANDA No. 216361 to
`
`the FDA to obtain approval for the commercial manufacture, use, import, offer for sale, and/or sale
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`in the United States of Slayback’s generic brimonidine ophthalmic solution before the expiration
`
`of the ’742 patent
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`2.
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`Enter judgment that, under 35 U.S.C. § 271(e)(2), Defendants have infringed at
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`least one claim of the ’425 patent by submitting or causing to be submitted ANDA No. 216361 to
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`the FDA to obtain approval for the commercial manufacture, use, import, offer for sale, and/or sale
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`in the United States of Slayback’s generic brimonidine ophthalmic solution before the expiration
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`of the ’425 patent;
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`3.
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`Order that the effective date of any approval by the FDA of Slayback’s generic
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`brimonidine ophthalmic solution be a date that is not earlier than the expiration of the ’425 patent
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`and the ’742 patent, or such later date as the Court may determine;
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`4.
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`Enjoin Defendants from the commercial manufacture, use, import, offer for sale,
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`and/or sale of Slayback’s generic brimonidine ophthalmic solution until expiration of the ’742
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`patent and the ’425 patent, or such later date as the Court may determine;
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`5.
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`Enjoin Defendants and all persons acting in concert with Slayback from seeking,
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`obtaining, or maintaining approval of Slayback’s ANDA No. 216361 until expiration of the ’742
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`patent and the ’425 patent;
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`6.
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`Declare this to be an exceptional case under 35 U.S.C. §§ 285 and 271(e)(4) and
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`award Plaintiffs costs, expenses, and disbursements in this action, including reasonable attorney’s
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`fees; and
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`7.
`
`Award Plaintiffs such further and additional relief as this Court deems just and
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`proper.
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`Dated: September 10, 2021
`Newark, New Jersey
`
`Respectfully submitted,
`
`
`
`s/ William P. Deni, Jr.
`William P. Deni, Jr.
`J. Brugh Lower
`GIBBONS P.C.
`One Gateway Center
`Newark, New Jersey 07102
`Tel: (973) 596-4500
`Fax: (973) 596-0545
`wdeni@gibbonslaw.com
`jlower@gibbonslaw.com
`
`Of Counsel:
`
`Bryan C. Diner
`Justin J. Hasford
`FINNEGAN, HENDERSON,
`FARABOW, GARRETT & DUNNER, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`Tel: (202) 408-4000
`
`Jessica M. Lebeis (pro hac vice to be submitted)
`FINNEGAN, HENDERSON,
`FARABOW, GARRETT & DUNNER, LLP
`Two Seaport Lane
`Boston, MA 02210-2001
`Tel: (617) 646-1600
`
`Attorneys for Plaintiffs
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`CERTIFICATION OF NON-ARBITRABILITY
`PURSUANT TO LOCAL CIVIL RULE 201.1(d)
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`Pursuant to Local Civil Rule 201.1(d), the undersigned counsel hereby certifies that this
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`action seeks declaratory and injunctive relief and, therefore, is not subject to mandatory
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`arbitration.
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`I hereby certify under penalty of perjury that the foregoing is true and correct.
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`Dated: September 10, 2021
`Newark, New Jersey
`
`
`
`s/ William P. Deni, Jr.
`William P. Deni, Jr.
`GIBBONS P.C.
`One Gateway Center
`Newark, New Jersey 07102
`Tel: (973) 596-4500
`Fax: (973) 596-0545
`wdeni@gibbonslaw.com
`
`Attorneys for Plaintiffs
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