Case 1:21-cv-00580-UNA Document 1 Filed 04/26/21 Page 1 of 11 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`OTSUKA PHARMACEUTICAL CO., LTD.
`AND H. LUNDBECK A/S,
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`Plaintiffs,
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`
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`v.
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`SANDOZ INC. AND SANDOZ
`INTERNATIONAL GMBH,
`
`
`Defendants.
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`
`
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`Civil Action No. ________
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`COMPLAINT FOR PATENT INFRINGEMENT
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`Otsuka Pharmaceutical Co., Ltd. (“Otsuka”) and H. Lundbeck A/S (“Lundbeck”)
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`(collectively, “Plaintiffs”), by way of Complaint against Defendants Sandoz Inc. and Sandoz
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`International GmbH (“Sandoz GmbH”) (collectively, “Sandoz”), allege as follows:
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`NATURE OF THE ACTION
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`1.
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`This is a civil action for patent infringement of U.S. Reissue Patent No. RE48,059
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`(“the RE’059 patent”), arising under the United States patent laws, Title 35, United States Code,
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`§ 100 et. seq., including 35 U.S.C. §§ 271 and 281. This action relates to Sandoz’s filing of an
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`Abbreviated New Drug Application (“ANDA”) under Section 505(j) of the Federal Food, Drug
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`and Cosmetic Act, 21 U.S.C. § 355(j), seeking U.S. Food and Drug Administration (“FDA”)
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`approval to engage in the commercial manufacture, use or sale of generic pharmaceutical products
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`before the expiration of the RE’059 patent.
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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.
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`3.
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`Lundbeck is a corporation organized and existing under the laws of Denmark, with
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`a place of business at Ottiliavej 9, DK-2500 Valby, Denmark. Otsuka has granted Lundbeck an
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`exclusive license to the RE’059 patent.
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`4.
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`Otsuka and Lundbeck are engaged in the business of researching, developing and
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`bringing to market innovative pharmaceutical products.
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`5.
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`Upon information and belief, Sandoz GmbH is a corporation organized under the
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`laws of Germany and its principal place of business is located at Industriestrasse 25, 83607
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`Holzkirchen, Germany.
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`6.
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`Upon information and belief, Sandoz Inc. is a corporation organized under the laws
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`of Delaware and its principal place of business is located at 100 College Rd. West, Princeton, NJ
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`08540. Upon information and belief, Sandoz Inc. is a majority owned subsidiary of Sandoz GmbH.
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`JURISDICTION AND VENUE
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`7.
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`8.
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`This Court has subject matter jurisdiction under 28 U.S.C. §§ 1331 and 1338(a).
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`This Court has personal jurisdiction over Sandoz GmbH. Upon information and
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`belief, Sandoz GmbH 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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`Sandoz GmbH 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, Sandoz
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`GmbH purposefully has conducted and continues to conduct business in this judicial district, and
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`this judicial district is a likely destination of Sandoz’s generic products.
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`9.
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`Upon information and belief, “Sandoz International GmbH develops, produces, and
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`distributes generic pharmaceuticals.” https://www.bloomberg.com/profile/company/9018001Z:
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`GR (Sandoz GmbH Bloomberg Profile, accessed Apr. 20, 2021). Upon information and belief,
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`Sandoz GmbH “caters their products worldwide.” Id. Upon information and belief, Sandoz
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`GmbH’s pharmaceutical products are available in more than 90 countries, including in the United
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`States. See https://twitter.com/Sandoz_Global/status/1148894947027968000?s=20 (accessed
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`Apr. 20, 2021). Upon information and belief, Sandoz GmbH admits that it is “honored to be named
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`[McKesson’s] 2019 Specialty Generic Partner of the Year! It’s a privilege to be recognized for
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`our efforts
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`to expand patient access
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`to high-quality medicines
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`in
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`the US.”
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`https://twitter.com/Sandoz_Global/status/1144606420282855425?s=20 (accessed Apr. 20, 2021).
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`Upon information and belief, Sandoz GmbH admits it ranks third in the U.S. per IQVIA data.
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`https://www.sandoz.com/sites/www.sandoz.com/files/sandoz-pocket-book.pdf at 9 (accessed
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`Apr. 20, 2021); see also https://accessiblemeds.org/sites/default/files/2019-02/Doug-Long-
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`Access2019.pdf at 30 (accessed Apr. 20, 2021) (IQVIA report indicating that Sandoz ranks third
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`in unbranded generic non-discounted spend in the United States).
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`10.
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`This Court has personal jurisdiction over Sandoz Inc. Upon information and belief,
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`Sandoz Inc. is in the business of manufacturing, marketing, importing and selling pharmaceutical
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`drug products, including generic drug products. Upon information and belief, Sandoz Inc. directly,
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`or indirectly, develops, manufactures, markets and sells generic drugs throughout the United States
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`and in this judicial district. Upon information and belief, Sandoz Inc. purposefully has conducted
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`and continues to conduct business in this judicial district, and this judicial district is a likely
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`destination of Sandoz’s generic products.
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`11.
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`Upon information and belief, “Sandoz Inc. manufactures, markets and/or
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`distributes more than 290 drugs in the United States.” https://www.drugs.com/manufacturer/
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`sandoz-inc-125.html (accessed Apr. 20, 2021); see also https://www.us.sandoz.com/patients-
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`customers/products (accessed Apr. 20, 2021).
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`12.
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`Upon information and belief, Sandoz Inc. is the United States agent for Sandoz
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`GmbH.
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`13.
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`Upon information and belief, Sandoz GmbH and Sandoz Inc. hold themselves out
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`as a unitary entity and operate as a single integrated business with respect to the regulatory
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`approval, manufacturing, marketing, sale and distribution of generic pharmaceutical products
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`throughout the United States, including in this judicial district.
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`14.
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`Upon information and belief, Sandoz GmbH and Sandoz Inc. admit Sandoz GmbH
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`is the “Global (Germany)” office and Sandoz Inc. is the “United States” office for Sandoz.
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`https://www.sandoz.com/about-us/contact-us (accessed Oct. 30, 2019).
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`15.
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`Sandoz’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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`Sandoz’s intent to market and sell Sandoz’s generic products in this judicial district.
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`16.
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`Sandoz has taken the significant step of applying to the FDA for approval to engage
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`in future activities—including the marketing of its generic drugs—which, upon information and
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`belief, will be purposefully directed at the District of Delaware and elsewhere throughout the
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`United States. Upon information and belief, Sandoz intends to direct sales of its generic drugs in
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`this judicial district, among other places, once Sandoz receives the requested FDA approval to
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`market its generic products. Upon information and belief, Sandoz will engage in marketing of its
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`proposed generic products in Delaware upon approval of its ANDA.
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`17.
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`Upon information and belief, Sandoz has thus been, and continues to be, the prime
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`actor in the drafting, submission, approval and maintenance of ANDA No. 213570.
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`18.
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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 Sandoz GmbH is incorporated in Germany and may be sued in any judicial district.
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`19.
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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 Sandoz Inc. is incorporated in the state of Delaware.
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`FACTUAL BACKGROUND
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`The NDA
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`20.
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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®
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`Tablets”).
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`21.
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`22.
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`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
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`ingredient in REXULTI® Tablets.
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`The Patent In Suit
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`23.
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`The United States Patent and Trademark Office (“the PTO”) issued U.S. Patent No.
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`7,888,362 (“the ’362 patent”) on February 15, 2011, entitled “Piperazine-Substituted
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`Benzothiophenes for Treatment of Mental Disorders.”
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`24.
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`The PTO reissued the ’362 patent as the RE’059 patent on June 23, 2020. A true
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`and correct copy of the RE’059 patent is attached hereto as Exhibit A.
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`25.
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`As the reissue of the ’362 patent, Otsuka is the owner of the RE’059 through
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`assignment as recorded by the PTO at Reel 048501, Frame 0122; Reel 021939, Frame 0746 and
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`Reel 048501, Frame 0166.
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`26.
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`Pursuant to 35 U.S.C. § 251, the RE’059 patent issued for the unexpired term of
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`the ’362 patent, which would have expired on April 12, 2026, by virtue of a terminal disclaimer
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`filed in the PTO that disclaimed 317 days of patent term adjustment granted to the ’362 patent
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`under 35 U.S.C. § 154(b). A true and correct copy of the terminal disclaimer is attached as
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`Exhibit B.
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`27.
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`Otsuka filed a Submission Pursuant to 37 C.F.R. § 1.765 for Patent Term Extension
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`Application Under 35 U.S.C. § 156 and Response to Notice of Final Determination, requesting an
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`extension under 35 U.S.C. § 156(c) of 986 days for the ’362 patent. After the RE’059 patent
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`issued, Otsuka filed a Petition Under 37 C.F.R. § 1.182 to Move Patent Term Extension
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`Application from U.S. Patent No. 7,888,362 to RE 48,059, which was granted on October 6, 2020.
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`Thereafter, the Certificate Extending Patent Term Under 35 U.S.C. § 156(c) issued on January 14,
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`2021, which is attached as Exhibit C. Accordingly, the RE’059 patent will expire on December
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`23, 2028, based on the 986 days of Patent Term Extension under 35 U.S.C. § 156(c).
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`28.
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`The RE’059 patent is listed in Approved Drug Products With Therapeutic
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`Equivalence Evaluations (“the Orange Book”) in connection with NDA No. 205422 for
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`REXULTI® (brexpiprazole) Tablets.
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`The ANDA
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`29.
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`Upon information and belief, Sandoz filed ANDA No. 213570 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
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`the United States of brexpiprazole tablets, 0.25, 0.5, 1, 2, 3 and 4 mg (“Sandoz’s generic
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`products”), which are generic versions of Otsuka’s REXULTI® (brexpiprazole) Tablets.
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`30.
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`Otsuka received a letter sent by Sandoz, dated September 18, 2019, purporting to
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`be a “Notice of Certification” for ANDA No. 213570 (“Sandoz’s September 18, 2019, First Notice
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`Letter”) pursuant to § 505(j)(2)(B)(ii)-(iv) of the Federal Food, Drug, and Cosmetic Act and 21
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`C.F.R. § 314.95. Sandoz’s September 18, 2019, First Notice Letter notified Otsuka that Sandoz
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`had filed ANDA No. 213570, seeking approval to engage in the commercial manufacture, use or
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`sale of Sandoz’s generic products before the expiration of the ’362 patent and U.S. Patent Nos.
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`8,349,840 (“the ’840 patent”), 8,618,109 (“the ’109 patent”), 9,839,637 (“the ’637 patent”) and
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`10,307,419 (“the ’419 patent”).
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`31.
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`In response to Sandoz’s September 18, 2019, First Notice Letter, Plaintiffs
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`previously filed separate actions in this Court and the District of Colorado against Sandoz for
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`patent infringement, which included counts of infringement of the ’362, ’840, ’109, ’637 and ’419
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`patents. See Otsuka Pharmaceutical Co., Ltd., et al. v. Sandoz Inc., et al., C.A. No. 19-2080-LPS
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`(D. Del.); Otsuka Pharmaceutical Co., Ltd., et al. v. Sandoz Inc., et al., C.A. No. 19-3112-RBJ (D.
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`Colo.).
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`32.
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`The Colorado action was dismissed after Sandoz agreed not to contest that venue
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`and personal jurisdiction were proper in the related Delaware action. See Otsuka Pharmaceutical
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`Co., Ltd., et al. v. Sandoz Inc., et al., C.A. No. 19-3112-RBJ (D. Colo.), D.I. 10; Otsuka
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`Pharmaceutical Co., Ltd., et al. v. Sandoz Inc., et al., C.A. No. 19-2080-LPS (D. Del.), D.I. 7 and
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`D.I. 11 at ¶ 8.
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`33.
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`On June 23, 2020, the PTO reissued the RE’059 patent as a reissue of the ’362
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`patent. Plaintiffs timely notified the FDA and the RE’059 patent was listed in the Orange Book
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`for REXULTI®.
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`34.
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`Upon information and belief, ANDA No. 213570 contains a certification pursuant
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`to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (“paragraph IV certification”), alleging that the claims of the
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`RE’059 patent are invalid, unenforceable and/or would not be infringed by Sandoz’s generic
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`products.
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`35.
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`Otsuka received a second notice letter sent by Sandoz dated March 12, 2021,
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`purporting to be a “Notice of Certification” for ANDA No. 213570 (Sandoz’s March 12, 2021,
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`Second Notice Letter”) pursuant to § 505(j)(2)(B)(iv) of the Federal Food, Drug and Cosmetic Act
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`and 21 C.F.R. § 314.95. Sandoz’s March 12, 2021, Second Notice Letter notified Otsuka that
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`Sandoz had filed ANDA No. 213570 seeking approval to engage in the commercial manufacture,
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`use or sale of Sandoz’s generic products before expiration of the RE’059 patent.
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`36.
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`Plaintiffs commenced this action within 45 days of receiving Sandoz’s March 12,
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`2021, Second Notice Letter.
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`COUNT I
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`(INFRINGEMENT OF THE RE’059 PATENT)
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`37.
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`38.
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`Plaintiffs reallege, and incorporate fully herein, each preceding paragraph.
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`Upon information and belief, Sandoz filed ANDA No. 213570 seeking approval to
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`manufacture, use, import, offer to sell and/or sell Sandoz’s generic products in the United States
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`before the expiration of the RE’059 patent.
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`39.
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`Upon information and belief, Sandoz filed with the FDA, pursuant to 21 U.S.C.
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`§ 355(j)(2)(A)(vii)(IV) and 21 C.F.R. § 314.94(a)(12)(i)(A)(4), a certification alleging that the
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`claims of the RE’059 patent are invalid, unenforceable and/or not infringed.
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`40.
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`Upon information and belief, in its ANDA No. 213570, Sandoz has represented to
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`the FDA that Sandoz’s generic products are pharmaceutically and therapeutically equivalent to
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`Otsuka’s REXULTI® Tablets.
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`41.
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`Sandoz has actual knowledge of Otsuka’s RE’059 patent, as evidenced by Sandoz’s
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`March 12, 2021, Second Notice Letter.
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`42.
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`Upon information and belief, under 35 U.S.C. § 271(e)(2)(A), Sandoz has infringed
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`one or more claims of the RE’059 patent by submitting, or causing to be submitted, to the FDA
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`ANDA No. 213570, seeking approval to commercially manufacture, use, import, offer to sell or
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`sell Sandoz’s generic products before the expiration date of the RE’059 patent.
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`43.
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`Upon information and belief, if ANDA No. 213570 is approved, Sandoz intends to
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`and will offer to sell, sell and/or import in the United States Sandoz’s generic products.
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`44.
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`Upon information and belief, if ANDA No. 213570 is approved, Sandoz will
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`infringe one or more claims of the RE’059 patent under § 271(a), either literally or under the
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`doctrine of equivalents, by making, using, offering to sell, selling and/or importing Sandoz’s
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`generic products, and/or by actively inducing infringement by others under § 271(b) and/or
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`contributing to infringement under § 271(c), unless this Court orders that the effective date of any
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`FDA approval of ANDA No. 213570 shall be no earlier than the expiration of the RE’059 patent
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`and any additional periods of exclusivity.
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`45.
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`Upon information and belief, Sandoz’s actions relating to Sandoz’s ANDA
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`No. 213570 complained of herein were done by and for the benefit of Sandoz.
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`46.
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`Plaintiffs will be irreparably harmed by Sandoz’s infringing activities unless this
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`Court enjoins those activities.
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`47.
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`Plaintiffs do not have an adequate remedy at law.
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`REQUEST FOR RELIEF
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`WHEREFORE, Plaintiffs respectfully request the following relief:
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`A.
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`The entry of judgment under 35 U.S.C. § 271(e)(2)(A) that Sandoz has infringed at
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`least one claim of the RE’059 patent through Sandoz’s submission of ANDA No. 213570 to the
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`FDA seeking approval to manufacture, use, import, offer to sell and/or sell Sandoz’s generic
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`products in the United States before the expiration of the RE’059 patent;
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`B.
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`The entry of judgment under 35 U.S.C. § 271(a), (b) and/or (c) that Sandoz’s
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`making, using, offering to sell, selling or importing of Sandoz’s generic products before the
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`expiration of the RE’059 patent will infringe, actively induce infringement and/or contribute to the
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`infringement of the RE’059 patent under 35 U.S.C. § 271(a), (b) and/or (c);
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`C.
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`The issuance of an order that the effective date of any FDA approval of Sandoz’s
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`generic products shall be no earlier than the expiration date of the RE’059 patent and any additional
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`periods of exclusivity, in accordance with 35 U.S.C. § 271(e)(4)(A);
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`D.
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`The entry of a preliminary and/or permanent injunction, enjoining Sandoz and all
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`persons acting in concert with Sandoz from commercially manufacturing, using, offering for sale
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`or selling Sandoz’s generic products within the United States, or importing Sandoz’s generic
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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 Sandoz and all
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`persons acting in concert with Sandoz 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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`ASHBY & GEDDES
`
`/s/ Steven J. Balick
`
`
`
`
`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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`Of Counsel:
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`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: April 26, 2021
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