Case 1:20-cv-01531-UNA Document 1 Filed 11/13/20 Page 1 of 14 PageID #: 1
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`
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`
`
`Civil Action No. ________
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`
`
`
`
`OTSUKA PHARMACEUTICAL CO., LTD.
`AND H. LUNDBECK A/S,
`
`
`Plaintiffs,
`
`
`
`v.
`
`
`HETERO LABS LTD., HETERO LABS LTD.
`UNIT-V, HETERO USA, INC., HETERO
`DRUGS LTD. AND HONOUR LAB LTD.,
`
`
`Defendants.
`
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Otsuka Pharmaceutical Co., Ltd. (“Otsuka”) and H. Lundbeck A/S (“Lundbeck”)
`
`(collectively, “Plaintiffs”), by way of Complaint against Defendants Hetero Labs Ltd., Hetero Labs
`
`Ltd. Unit-V, Hetero USA, Inc., Hetero Drugs Ltd. and Honour Lab Ltd. (collectively, “Hetero”),
`
`allege as follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is a civil action for patent infringement of U.S. Reissue Patent No. RE48,059
`
`(“the RE’059 patent”), arising under the United States patent laws, Title 35, United States Code,
`
`§ 100 et. seq., including 35 U.S.C. §§ 271 and 281. This action relates to Hetero’s filing of an
`
`Abbreviated New Drug Application (“ANDA”) under Section 505(j) of the Federal Food, Drug
`
`and Cosmetic Act, 21 U.S.C. § 355(j), seeking U.S. Food and Drug Administration (“FDA”)
`
`approval to engage in the commercial manufacture, use or sale of generic pharmaceutical products
`
`before the expiration of the RE’059 patent.
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`{01628010;v1 }
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`Case 1:20-cv-01531-UNA Document 1 Filed 11/13/20 Page 2 of 14 PageID #: 2
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`THE PARTIES
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`2.
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`Otsuka is a corporation organized and existing under the laws of Japan with its
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`corporate headquarters at 2-9 Kanda Tsukasa-machi, Chiyoda-ku, Tokyo, 101-8535, Japan.
`
`3.
`
`Lundbeck is a corporation organized and existing under the laws of Denmark, with
`
`a place of business at Ottiliavej 9, DK-2500 Valby, Denmark. Otsuka has granted Lundbeck an
`
`exclusive license to the RE’059 patent.
`
`4.
`
`Otsuka and Lundbeck are engaged in the business of researching, developing and
`
`bringing to market innovative pharmaceutical products.
`
`5.
`
`Upon information and belief, Hetero Drugs Ltd. is a corporation organized under
`
`the laws of India and its principal place of business is located at 7-2-A2, Hetero Corporate
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`Industrial Estates, Sanath Nagar, Hyderabad 500 018, Andhra Pradesh, India.
`
`6.
`
`Upon information and belief, Hetero Labs Ltd. is a corporation organized under the
`
`laws of India and its principal place of business is located at 7-2-A2, Hetero Corporate Industrial
`
`Estates, Sanath Nagar, Hyderabad 500 018, Andhra Pradesh, India.
`
`7.
`
`Upon information and belief, Hetero Labs Ltd. Unit-V is a division of Hetero Labs
`
`Ltd. and its principal place of business is located at Polepally, Jadcherla, Mahabubnagar 509 301,
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`Andhra Pradesh, India.
`
`8.
`
`Upon information and belief, Hetero USA, Inc. is a corporation organized under
`
`the laws of Delaware and its principal place of business is located at 1035 Centennial Avenue,
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`Piscataway, NJ 08854. Upon information and belief, Hetero USA, Inc. is the U.S. Regulatory
`
`Agent for Hetero Labs Limited Unit-V, Hetero Labs Ltd. and Hetero Drugs Ltd.
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`9.
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`Upon information and belief, Hetero Drugs Ltd. and Hetero Labs Ltd. each own a
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`50% share of Hetero USA, Inc.
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`10.
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`Upon information and belief, Honour Lab Ltd. is a corporation organized under the
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`laws of India and its principal place of business is located at 8-3-166/7/1, Hetero House, Erragadda,
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`Hyderabad 500 018, Telangana, India.
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`11.
`
`Upon information and belief, Honour Lab Ltd. is a subsidiary or affiliate of the
`
`Hetero group companies, including Hetero Drugs Ltd. and Hetero Labs Ltd.
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`JURISDICTION AND VENUE
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`12.
`
`13.
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`This Court has subject matter jurisdiction under 28 U.S.C. §§ 1331 and 1338(a).
`
`This Court has personal jurisdiction over Hetero Drugs Ltd. Upon information and
`
`belief, Hetero Drugs Ltd. is in the business of manufacturing, marketing, importing and selling
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`pharmaceutical drug products, including generic drug products. Upon information and belief,
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`Hetero Drugs Ltd. directly, or indirectly, develops, manufactures, markets and sells generic drugs
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`throughout the United States and in this judicial district. Upon information and belief, Hetero Labs
`
`Ltd. purposefully has conducted and continues to conduct business in this judicial district, and this
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`judicial district is a likely destination of Hetero’s generic products.
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`14.
`
`Upon information and belief, Hetero Drugs Ltd. admits it “is one of India’s leading
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`generic pharmaceutical companies” and it “has a strong global presence in over 126 countries[.]”
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`https://www.heteroworld.com/company-profile.php (accessed Nov. 11, 2020). Upon information
`
`and belief, Hetero Drugs Ltd. admits “our R&D has been able to develop niche generics, . . .
`
`ANDAs and FTFs[.]” https://www.heteroworld.com/research.php (accessed Nov. 11, 2020).
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`15.
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`This Court has personal jurisdiction over Hetero Labs Ltd. Upon information and
`
`belief, Hetero Labs Ltd. is in the business of manufacturing, marketing, importing and selling
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`pharmaceutical drug products, including generic drug products. Upon information and belief,
`
`Hetero Labs Ltd. directly, or indirectly, develops, manufactures, markets and sells generic drugs
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`{01628010;v1 }
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`
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`throughout the United States and in this judicial district. Upon information and belief, Hetero Labs
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`Ltd. purposefully has conducted and continues to conduct business in this judicial district, and this
`
`judicial district is a likely destination of Hetero’s generic products.
`
`16.
`
`Upon information and belief, Hetero Labs Ltd. “is a research based global
`
`pharmaceutical company focused on development, manufacturing and marketing of Active
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`Pharmaceutical
`
`Ingredients
`
`(APIs),
`
`Intermediate Chemicals & Finished Dosages.”
`
`https://www.indiamart.com/heterolabs-limited/aboutus.html (Hetero Labs Ltd. Profile, accessed
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`Nov. 11, 2020).
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`17.
`
`Upon information and belief, Hetero Drugs Ltd. and Hetero Labs Ltd. share more
`
`than one common corporate director. See https://www.zaubacorp.com/company/HETERO-
`
`DRUGS-LIMITED/U24230TG1993PLC015582 (Hetero Drugs Ltd. Profile, accessed Nov. 11,
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`2020); https://www.zaubacorp.com/company/HETERO-LABS-LIMITED/U24110TG1989PLC0
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`09723 (Hetero Labs Ltd. Profile, accessed Nov. 11, 2020) (naming five common corporate
`
`directors).
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`18.
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`This Court has personal jurisdiction over Hetero Labs Ltd. Unit-V. Upon
`
`information and belief, Hetero Labs Ltd. Unit-V is in the business of manufacturing, marketing,
`
`importing and selling pharmaceutical drug products, including generic drug products. Upon
`
`information and belief, Hetero Labs Ltd. Unit-V directly, or indirectly, develops, manufactures,
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`markets and sells generic drugs throughout the United States and in this judicial district. Upon
`
`information and belief, Hetero Labs Ltd. Unit-V purposefully has conducted and continues to
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`conduct business in this judicial district, and this judicial district is a likely destination of Hetero’s
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`generic products.
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`19.
`
`Upon information and belief, Hetero Labs Ltd. Unit-V is the drug manufacturing
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`{01628010;v1 }
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`
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`facility for Hetero Labs Ltd. and manufactures Hetero’s generic products. See, e.g.,
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`https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-
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`letters/hetero-labs-limited-unit-v-520359-08152017 (letter from the FDA to Hetero Labs Ltd.
`
`Unit-V, accessed Nov. 11, 2020).
`
`20.
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`This Court has personal jurisdiction over Hetero USA, Inc. Upon information and
`
`belief, Hetero USA, Inc. is in the business of manufacturing, marketing, importing and selling
`
`pharmaceutical drug products, including generic drug products. Upon information and belief,
`
`Hetero USA, Inc. directly, or indirectly, develops, manufactures, markets and sells generic drugs
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`throughout the United States and in this judicial district. Upon information and belief, Hetero
`
`USA, Inc. purposefully has conducted and continues to conduct business in this judicial district,
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`and this judicial district is a likely destination of Hetero’s generic products.
`
`21.
`
`Upon information and belief, Hetero USA, Inc. admits it is “the US representation
`
`of HETERO, a privately owned; research based global pharmaceutical company” and that it has
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`“a significant presence in the development and marketing of finished dosages (comprising of
`
`various dosage forms of wide range of therapeutic categories), active pharmaceutical ingredients
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`(API’s), over-the-counter products.” https://www.linkedin.com/company/hetero-usa-inc/about/
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`(Hetero USA, Inc. LinkedIn Profile, accessed Nov. 11, 2020).
`
`22.
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`This Court has personal jurisdiction over Honour Lab Ltd. Upon information and
`
`belief, Honour Lab Ltd. is in the business of manufacturing, marketing, importing and selling
`
`pharmaceutical drug products, including generic drug products. Upon information and belief,
`
`Honour Lab Ltd. directly, or indirectly, develops, manufactures, markets and sells generic drugs
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`throughout the United States and in this judicial district. Upon information and belief, Honour
`
`Lab Ltd. purposefully has conducted and continues to conduct business in this judicial district, and
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`{01628010;v1 }
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`this judicial district is a likely destination of Hetero’s generic products.
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`23.
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`Upon information and belief, Honour Lab Ltd. is the holder of FDA Drug Master
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`File No. 32532 for brexpiprazole.
`
`24.
`
`Upon information and belief, Honour Lab Ltd. is vertically integrated with Hetero
`
`Drugs Ltd., Hetero Labs Ltd., Hetero Labs Ltd. Unit-V and Hetero USA, Inc. See, e.g.,
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`https://www.indiamart.com/heterolabs-limited/aboutus.html (“Hetero is building on the strengths
`
`of vertical integration in discovery research, process chemistry, API manufacturing, formulation
`
`development and commercialization.”) (accessed Nov. 11, 2020). Upon information and belief,
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`Honour Lab Ltd. is engaged in manufacturing drug products which are primarily supplied to
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`Hetero Labs Ltd. and other companies within
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`the Hetero group of companies.
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`http://pharma.industry-report.net/honour-lab-ltd/ (accessed Nov. 11, 2020). Upon information and
`
`belief, Hetero Drugs Ltd., Hetero Labs Ltd. and Honour Lab Ltd. share one or more common
`
`corporate directors. See https://www.zaubacorp.com/company/HONOUR-LAB-LIMITED/U24
`
`233TG2011PLC077561
`
`(Honour Lab Ltd. Profile,
`
`accessed Nov.
`
`11,
`
`2020);
`
`https://www.zaubacorp.com/company/HETERO-DRUGS-LIMITED/U24230TG1993PLC0155
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`82 (Hetero Drugs Ltd. Profile, accessed Nov. 11, 2020); https://www.zaubacorp.com/
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`company/HETERO-LABS-LIMITED/U24110TG1989PLC009723 (Hetero Labs Ltd. Profile,
`
`accessed Nov. 11, 2020).
`
`25.
`
`Upon information and belief, Hetero Drugs Ltd., Hetero Labs Ltd., Hetero Labs
`
`Ltd. Unit-V, Hetero USA, Inc. and Honour Lab Ltd. hold themselves out as a unitary entity and
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`operate as a single integrated business with respect to the regulatory approval, manufacturing,
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`marketing, sale and distribution of generic pharmaceutical products throughout the United States,
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`including in this judicial district.
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`{01628010;v1 }
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`26.
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`Hetero’s ANDA filing regarding the RE’059 patent relates to this litigation and is
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`substantially connected with this judicial district because it reliably and non-speculatively predicts
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`Hetero’s intent to market and sell Hetero’s generic products in this judicial district.
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`27.
`
`Hetero has taken the significant step of applying to the FDA for approval to engage
`
`in future activities—including the marketing of its generic drugs—which, upon information and
`
`belief, will be purposefully directed at the District of Delaware and elsewhere throughout the
`
`United States. Upon information and belief, Hetero intends to direct sales of its generic drugs in
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`this judicial district, among other places, once Hetero receives the requested FDA approval to
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`market its generic products. Upon information and belief, Hetero will engage in marketing of its
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`proposed generic products in Delaware upon approval of its ANDA.
`
`28.
`
`Upon information and belief, Hetero has thus been, and continues to be, the prime
`
`actor in the drafting, submission, approval and maintenance of ANDA No. 213669.
`
`29.
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`Venue is proper in this judicial district under 28 U.S.C. §§ 1391 and 1400(b),
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`because Hetero Drugs Ltd. and Hetero Labs Ltd. are incorporated in India and may be sued in any
`
`judicial district.
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`30.
`
`Venue is proper in this judicial district under 28 U.S.C. §§ 1391 and 1400(b),
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`because Hetero Labs Ltd. Unit-V is a division of Hetero Labs Ltd., which is incorporated in India
`
`and may be sued in any judicial district.
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`31.
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`Venue is proper in this judicial district under 28 U.S.C. §§ 1391 and 1400(b),
`
`because Hetero USA, Inc. is incorporated in the state of Delaware.
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`FACTUAL BACKGROUND
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`The NDA
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`32.
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`Otsuka is the holder of New Drug Application (“NDA”) No. 205422 for
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`REXULTI® (brexpiprazole) Tablets in 0.25, 0.5, 1, 2, 3 and 4 mg dosage forms (“REXULTI®
`
`Tablets”).
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`33.
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`34.
`
`The FDA approved NDA No. 205422 on July 10, 2015.
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`REXULTI® Tablets are prescription drugs approved for the adjunctive treatment of
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`major depressive disorder and the treatment of schizophrenia. Brexpiprazole is the active
`
`ingredient in REXULTI® Tablets.
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`The Patent In Suit
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`35.
`
`The United States Patent and Trademark Office (“the PTO”) issued U.S. Patent No.
`
`7,888,362 (“the ’362 patent”) on February 15, 2011, entitled “Piperazine-Substituted
`
`Benzothiophenes for Treatment of Mental Disorders.”
`
`36.
`
`The PTO reissued the ’362 patent as the RE’059 patent on June 23, 2020. A true
`
`and correct copy of the RE’059 patent is attached hereto as Exhibit A.
`
`37.
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`As the reissue of the ’362 patent, Otsuka is the owner of the RE’059 patent through
`
`assignment as recorded by the PTO for the ’362 patent at Reel 048501, Frame 0122; Reel 021939,
`
`Frame 0746 and Reel 048501, Frame 0166.
`
`38.
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`Pursuant to 35 U.S.C. § 251, the RE’059 patent issued for the unexpired term of
`
`the ’362 patent, which would have expired on April 12, 2026, by virtue of a terminal disclaimer
`
`filed in the PTO that disclaimed 317 days of patent term adjustment granted to the ’362 patent
`
`under 35 U.S.C. § 154(b). A true and correct copy of the terminal disclaimer is attached as
`
`Exhibit B.
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`39.
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`Otsuka filed a Submission Pursuant to 37 C.F.R. § 1.765 for Patent Term Extension
`
`Application Under 35 U.S.C. § 156 and Response to Notice of Final Determination, requesting an
`
`extension under 35 U.S.C. § 156(c) of 986 days for the ’362 patent. After the RE’059 patent
`
`issued, Otsuka filed a Petition Under 37 C.F.R. § 1.182 to Move Patent Term Extension
`
`Application from U.S. Patent No. 7,888,362 to RE 48,059, which was granted on October 6, 2020.
`
`Accordingly, the RE’059 patent will expire on December 23, 2028, based on the 986 days of Patent
`
`Term Extension under 35 U.S.C. § 156(c).
`
`40.
`
`The RE’059 patent is listed in Approved Drug Products With Therapeutic
`
`Equivalence Evaluations (“the Orange Book”) in connection with NDA No. 205422 for
`
`REXULTI® (brexpiprazole) Tablets.
`
`The ANDA
`
`41.
`
`Upon information and belief, Hetero filed ANDA No. 213669 with the FDA under
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`21 U.S.C. § 355(j) seeking FDA approval to engage in the commercial manufacture, use or sale in
`
`the United States of brexpiprazole tablets, 0.25, 0.5, 1, 2, 3 and 4 mg (“Hetero’s generic products”),
`
`which are generic versions of Otsuka’s REXULTI® (brexpiprazole) Tablets.
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`42.
`
`Otsuka received a letter sent by Hetero, dated September 11, 2019, purporting to
`
`be a “Notice of Certification” for ANDA No. 213669 (“Hetero’s September 11, 2019, First Notice
`
`Letter”) pursuant to 21 U.S.C. § 355(j)(2)(B)(ii), § 505(j)(2)(B)(ii) of the Federal Food, Drug and
`
`Cosmetic Act and 21 C.F.R. § 314.95. Hetero’s September 11, 2019, First Notice Letter notified
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`Otsuka that Hetero had filed ANDA No. 213669, seeking approval to engage in the commercial
`
`manufacture, use or sale of Hetero’s generic products before the expiration of the ’362 patent and
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`U.S. Patent Nos. 8,349,840 (“the ’840 patent”), 8,618,109 (“the ’109 patent”), 9,839,637 (“the
`
`’637 patent”) and 10,307,419 (“the ’419 patent”).
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`43.
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`In response to Hetero’s September 11, 2019, First Notice Letter, Plaintiffs
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`previously filed a separate action in this Court against Hetero for patent infringement, which
`
`included counts of infringement of the ’362, ’840, ’109, ’637 and ’419 patents. See Otsuka
`
`Pharmaceutical Co., Ltd., et al. v. Hetero Labs Ltd., et al., C.A. No. 19-cv-1954-LPS.
`
`44.
`
`On June 23, 2020, the PTO reissued the RE’059 patent as a reissue of the ’362
`
`patent. Plaintiffs timely notified the FDA and the RE’059 patent was listed in the Orange Book
`
`for REXULTI®.
`
`45.
`
`Upon information and belief, ANDA No. 213669 contains a certification pursuant
`
`to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (“paragraph IV certification”), alleging that the claims of the
`
`RE’059 patent are invalid, unenforceable and/or would not be infringed by the commercial
`
`manufacture, use, sale, offer for sale and/or importation of Hetero’s generic products.
`
`46.
`
`Otsuka received a second notice letter sent by Hetero dated October 1, 2020,
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`purporting to be a “Notice of Certification” for ANDA No. 213669 (“Hetero’s October 1, 2020,
`
`Second Notice Letter”) pursuant to 21 U.S.C. § 355(j)(2)(B)(ii), § 505(j)(2)(B)(ii) of the Federal
`
`Food, Drug and Cosmetic Act and 21 C.F.R. § 314.95. Hetero’s October 1, 2020, Second Notice
`
`Letter notified Otsuka that Hetero had filed ANDA No. 213669 seeking approval to engage in the
`
`commercial manufacture, use, sale, offer for sale and/or importation of Hetero’s generic products
`
`before the expiration of the RE’059 patent.
`
`47.
`
`Plaintiffs commenced this action within 45 days of receiving Hetero’s October 1,
`
`2020, Second Notice Letter.
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`COUNT I
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`(INFRINGEMENT OF THE RE’059 PATENT)
`
`48.
`
`Plaintiffs reallege, and incorporate fully herein, each preceding paragraph.
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`49.
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`Upon information and belief, Hetero filed ANDA No. 213669 seeking approval to
`
`manufacture, use, import, offer to sell and/or sell Hetero’s generic products in the United States
`
`before the expiration of the RE’059 patent.
`
`50.
`
`Upon information and belief, Hetero filed with the FDA, pursuant to 21 U.S.C.
`
`§ 355(j)(2)(A)(vii)(IV) and 21 C.F.R. § 314.94(a)(12)(i)(A)(4), a certification alleging that the
`
`claims of the RE’059 patent are invalid, unenforceable and/or not infringed.
`
`51.
`
`Upon information and belief, in its ANDA No. 213669, Hetero has represented to
`
`the FDA that Hetero’s generic products are pharmaceutically and therapeutically equivalent to
`
`Otsuka’s REXULTI® Tablets.
`
`52.
`
`Hetero has actual knowledge of Otsuka’s RE’059 patent, as evidenced by Hetero’s
`
`October 1, 2020, Second Notice Letter.
`
`53.
`
`Upon information and belief, under 35 U.S.C. § 271(e)(2)(A), Hetero has infringed
`
`one or more claims of the RE’059 patent by submitting, or causing to be submitted, to the FDA
`
`ANDA No. 213669, seeking approval to commercially manufacture, use, import, offer to sell or
`
`sell Hetero’s generic products before the expiration date of the RE’059 patent.
`
`54.
`
`Upon information and belief, if ANDA No. 213669 is approved, Hetero intends to
`
`and will offer to sell, sell and/or import in the United States Hetero’s generic products.
`
`55.
`
`Upon information and belief, if ANDA No. 213669 is approved, Hetero will
`
`infringe one or more claims of the RE’059 patent under § 271(a), either literally or under the
`
`doctrine of equivalents, by making, using, offering to sell, selling and/or importing Hetero’s
`
`generic products, and/or by actively inducing infringement by others under § 271(b) and/or
`
`contributing to infringement under § 271(c), unless this Court orders that the effective date of any
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`{01628010;v1 }
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`FDA approval of ANDA No. 213669 shall be no earlier than the expiration of the RE’059 patent
`
`and any additional periods of exclusivity.
`
`56.
`
`Upon information and belief, Hetero’s actions relating to Hetero’s ANDA No.
`
`213669 complained of herein were done by and for the benefit of Hetero.
`
`57.
`
`Plaintiffs will be irreparably harmed by Hetero’s infringing activities unless this
`
`Court enjoins those activities.
`
`58.
`
`Plaintiffs do not have an adequate remedy at law.
`
`REQUEST FOR RELIEF
`
`WHEREFORE, Plaintiffs respectfully request the following relief:
`
`A.
`
`The entry of judgment under 35 U.S.C. § 271(e)(2)(A) that Hetero has infringed at
`
`least one claim of the RE’059 patent through Hetero’s submission of ANDA No. 213669 to the
`
`FDA seeking approval to manufacture, use, import, offer to sell and/or sell Hetero’s generic
`
`products in the United States before the expiration of the RE’059 patent;
`
`B.
`
`The entry of judgment under 35 U.S.C. § 271(a), (b) and/or (c) that Hetero’s
`
`making, using, offering to sell, selling or importing of Hetero’s generic products before the
`
`expiration of the RE’059 patent will infringe, actively induce infringement and/or contribute to the
`
`infringement of the RE’059 patent under 35 U.S.C. § 271(a), (b) and/or (c);
`
`C.
`
`The issuance of an order that the effective date of any FDA approval of Hetero’s
`
`generic products shall be no earlier than the expiration date of the RE’059 patent and any additional
`
`periods of exclusivity, in accordance with 35 U.S.C. § 271(e)(4)(A);
`
`D.
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`The entry of a preliminary and/or permanent injunction, enjoining Hetero and all
`
`persons acting in concert with Hetero from commercially manufacturing, using, offering for sale
`
`or selling Hetero’s generic products within the United States, or importing Hetero’s generic
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`{01628010;v1 }
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`12
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`Case 1:20-cv-01531-UNA Document 1 Filed 11/13/20 Page 13 of 14 PageID #: 13
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`products into the United States, until the expiration of the RE’059 patent, in accordance with 35
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`U.S.C. §§ 271(e)(4)(B) and 283;
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`E.
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`The entry of a preliminary and/or permanent injunction, enjoining Hetero and all
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`persons acting in concert with Hetero from seeking, obtaining or maintaining approval of the
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`ANDA until the expiration of the RE’059 patent, in accordance with 35 U.S.C. §§ 271(e)(4)(B)
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`and 283;
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`F.
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`The issuance of a declaration that this is an exceptional case and an award to
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`Plaintiffs of their costs, expenses and disbursements in this action, including reasonable attorney
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`fees, pursuant to 35 U.S.C. §§ 285 and 271(e)(4);
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`G.
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`An award to Plaintiffs of any further appropriate relief under 35 U.S.C. § 271(e)(4);
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`and
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`H.
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`An award to Plaintiffs of any further and additional relief that this Court deems just
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`and proper.
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`{01628010;v1 }
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`13
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`Case 1:20-cv-01531-UNA Document 1 Filed 11/13/20 Page 14 of 14 PageID #: 14
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`Of Counsel:
`
`James B. Monroe
`Denise Main
`Erin M. Sommers
`C. Collette Corser
`Tyler B. Latcham
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4431
`(202) 408-4000
`
`Dated: November 13, 2020
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`
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`ASHBY & GEDDES
`
`/s/ Steven J. Balick
`
`
`
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`Steven J. Balick (#2114)
`Andrew C. Mayo (#5207)
`500 Delaware Avenue, 8th Floor
`P.O. Box 1150
`Wilmington, Delaware 19899
`(302) 654-1888
`sbalick@ashbygeddes.com
`amayo@ashbygeddes.com
`
`Attorneys for Plaintiffs Otsuka
`Pharmaceutical Co., Ltd. and H. Lundbeck
`A/S
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`{01628010;v1 }
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`14
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