Case 1:22-cv-00513-UNA Document 1 Filed 04/22/22 Page 1 of 13 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. ____________________
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`)))))))))
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`)
`)
`)
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`OTSUKA PHARMACEUTICAL CO., LTD.,
`
`Plaintiff,
`
`v.
`
`TEVA PHARMACEUTICALS INC., TEVA
`PHARMACEUTICALS USA, INC., and
`TEVA PHARMACEUTICAL INDUSTRIES
`LTD.,
`
`Defendants.
`
`COMPLAINT FOR PATENT INFRINGEMENT
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`Plaintiff Otsuka Pharmaceutical Co., Ltd. (“Otsuka”), by way of Complaint against
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`Defendants Teva Pharmaceuticals, Inc. (“Teva Pharmaceuticals”), Teva Pharmaceuticals USA,
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`Inc. (“Teva USA”), and Teva Pharmaceutical Industries Ltd. (“Teva Ltd.”) (collectively, “Teva”),
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`alleges 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. Patent No. 8,501,730 (“the
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`’730 Patent”) and U.S. Patent No. 10,905,694 (“the ’694 Patent”) arising under the patent laws of
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`the United States, 35 U.S.C. § 100 et seq., and for a declaratory judgment of infringement of U.S.
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`Patent No. 8,273,735 (“the ’735 Patent”) (collectively, the “Patents-in-Suit”) under 35 U.S.C. §
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`100 et seq., and 28 U.S.C. §§ 2201 and 2202.
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`2.
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`This action arises out of Teva’s submission of an Abbreviated New Drug
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`Application (“ANDA”) No. 216933 under § 505(j) of the Federal Food, Drug and Cosmetic Act
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`(“FDCA”), 21 U.S.C. § 355(j), seeking U.S. Food and Drug Administration (“FDA”) approval to
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`commercially manufacture, use, offer for sell and sell in the United States, and/or import into the
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`Case 1:22-cv-00513-UNA Document 1 Filed 04/22/22 Page 2 of 13 PageID #: 2
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`United States, tolvaptan tablets (15, 30, 45, 60, and 90 mg) (“Teva’s ANDA products”) prior to
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`the expiration of the Patents-in-Suit.
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`PARTIES
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`3.
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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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`Otsuka is engaged in the research, development, manufacture and sale of innovative
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`pharmaceutical products.
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`4.
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`Upon information and belief, Teva Pharmaceuticals is a corporation organized
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`under the laws of Delaware and its principal place of business is located 400 Interpace Parkway,
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`#3 Parsippany, NJ 07054.
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`5.
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`Upon information and belief, Teva USA is a corporation organized under the laws
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`of Delaware and its principal place of business is located 400 Interpace Parkway, #3 Parsippany,
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`NJ 07054. See https://www.tevausa.com/contact-us/ (Teva USA Contact Information, accessed
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`April 13, 2022).
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`6.
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`Upon information and belief, Teva Ltd. is a corporation organized under the laws
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`of Israel and its principal place of business is located at 124 Dvora HaNevi’a St., Tel Aviv
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`6944020, Israel. See https://www.tevausa.com/contact-us/ (Teva USA Contact Information,
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`accessed April 13, 2022).
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`7.
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`Upon information and belief, Teva Pharmaceuticals and Teva USA are wholly
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`owned subsidiaries of Teva Ltd. See https://www.tevagenerics.com/about-teva-generics/who-we-
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`are/ (Teva Generics, Who We Are, accessed April 13, 2022).
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`JURISDICTION AND VENUE
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`8.
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`This Court has jurisdiction over the subject matter of this action under 28 U.S.C.
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`§§ 1331, 1338(a), 2201 and 2202.
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`9.
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`This Court has personal jurisdiction over Teva Pharmaceuticals. Upon information
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`and belief, Teva Pharmaceuticals is in the business of manufacturing, marketing, importing, and
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`selling pharmaceutical drug products, including generic drug products; directly or indirectly
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`develops, manufactures, markets and sells generic drugs throughout the United States and in this
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`judicial district; and has purposefully conducted and continues to conduct business in this judicial
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`district and this judicial district is a likely destination of Teva’s ANDA products.
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`10.
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`This Court has personal jurisdiction over Teva USA. Upon information and belief,
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`Teva USA is in the business of manufacturing, marketing, importing, and selling pharmaceutical
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`drug products, including generic drug products; directly or indirectly develops, manufactures,
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`markets and sells generic drugs throughout the United States and in this judicial district; and has
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`purposefully conducted and continues to conduct business in this judicial district and this judicial
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`district is a likely destination of Teva’s ANDA products.
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`11.
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`This Court has personal jurisdiction over Teva Ltd. Upon information and belief,
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`Teva Ltd. is in the business of manufacturing, marketing, importing, and selling pharmaceutical
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`drug products, including generic drug products; directly or indirectly develops, manufactures,
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`markets and sells generic drugs throughout the United States and in this judicial district; and has
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`purposefully conducted and continues to conduct business in this judicial district and this judicial
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`district is a likely destination of Teva’s ANDA products.
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`12.
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`Upon information and belief, Teva USA admits that it is responsible for “1 in 10
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`prescriptions in the United States,” and “rank[s] among the leading pharmaceutical companies in
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`the world.” See https://www.tevausa.com/about-teva/article-pages/facts-and-figures/ (Teva USA,
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`Facts and Figures, accessed on April 12, 2022).
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`13.
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`Upon information and belief, Teva USA has active pharmacy wholesale licenses in
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`the state of Delaware with the license numbers A4-0001468 and A4-0001447 and active controlled
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`substances distributor/manufacturer licenses in the state of Delaware with the license numbers
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`DM-0007115 and DM-0006546.
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`14.
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`Teva’s ANDA filing regarding the Patents-in-Suit relates to this litigation and is
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`substantially connected with this judicial district because it reliably predicts Teva’s intent to
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`market and sell Teva’s ANDA products in this judicial district.
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`15.
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`Teva 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, Teva intends to direct sales of its generic drugs in this
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`judicial district, among other places, once Teva receives the requested FDA approval to market its
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`generic products. Upon information and belief, Teva will engage in marketing of its proposed
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`generic products in Delaware upon approval of its ANDA.
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`16.
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`Venue is proper as to Teva Pharmaceuticals in this judicial district under 28 U.S.C.
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`§§ 1391 and 1400(b) because Teva Pharmaceuticals is incorporated in the state of Delaware.
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`17.
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`Venue is proper as to Teva USA in this judicial district under 28 U.S.C. §§ 1391
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`and 1400(b) because Teva USA is incorporated in the state of Delaware.
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`18.
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`Venue is proper as to Teva Ltd. in this judicial district under 28 U.S.C. §§ 1391 and
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`1400(b) because Teva Ltd. is incorporated in Israel and may be sued in any jurisdiction.
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`OTSUKA’S JYNARQUE®
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`19.
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`Otsuka is the holder of the New Drug Application (“NDA”) No. 204441 for
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`JYNARQUE® tablets in 15, 30, 45, 60, and 90 mg dosage forms (“JYNARQUE® tablets”).
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`20.
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`21.
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`22.
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`The FDA approved NDA No. 204441 on April 23, 2018.
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`JYNARQUE® has orphan drug exclusivity until April 23, 2025.
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`JYNARQUE® tablets are prescription drugs used to slow kidney function decline
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`in adults who are at risk for rapidly progressing autosomal dominant polycystic kidney disease
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`(“ADPKD”).
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`THE PATENTS-IN-SUIT
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`23.
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`The ’730 Patent, entitled “Process for Preparing Benzazepine Compounds or Salts
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`Thereof” was duly and legally issued on August 6, 2013. A true and correct copy of the ’730
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`Patent is attached hereto as Exhibit A.
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`24.
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`The ’730 Patent claims compositions made by processes for preparing novel
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`benzazepine compounds.
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`25.
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`The ’730 Patent is owned by Otsuka and is listed in Approved Drug Products with
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`Therapeutic Equivalents (the “Orange Book”) in connection with NDA No. 204441 for
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`JYNARQUE® tablets.
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`26.
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`27.
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`According to the Orange Book, the ’730 Patent expires on September 1, 2026.
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`The ’694 Patent, entitled “Pharmaceutical Solid Preparation Comprising
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`Benzazepines and Production Method Thereof,” was duly and legally issued on February 2, 2021.
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`A true and correct copy of the ’694 Patent is attached hereto as Exhibit B.
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`28.
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`The ’694 Patent claims pharmaceutical solid preparations obtained by particular
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`methods.
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`29.
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`The ’694 Patent is owned by Otsuka and is listed in the Orange Book in connection
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`with NDA No. 204441 for JYNARQUE® tablets.
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`30.
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`31.
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`According to the Orange Book, the ’694 Patent expires on April 7, 2030.
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`The ’735 Patent, entitled “Process for Preparing Benzazepine Compounds or Salts
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`Thereof” was duly and legally issued on September 25, 2012. A true and correct copy of the ’735
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`Patent is attached hereto as Exhibit C.
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`32.
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`33.
`
`34.
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`The ’735 Patent claims processes for preparing novel benzazepine compounds.
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`The ’735 Patent is owned by Otsuka.
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`The ’735 patent expires on August 14, 2028.
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`TEVA’S ANDA
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`35.
`
`Upon information and belief, Teva submitted ANDA No. 216933 to the FDA under
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`21 U.S.C. § 355(j) seeking FDA approval to engage in the commercial manufacture, use, offer for
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`sale or sale in the United States, or importation into the United States, of Teva’s ANDA products,
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`which are generic versions of JYNARQUE®.
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`36.
`
`Upon information and belief, ANDA No. 216933 contains certifications pursuant
`
`to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (“Paragraph IV Certifications”), alleging that no valid,
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`enforceable claim of the ’730 Patent or the ’694 Patent will be infringed by Teva’s ANDA
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`products.
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`37.
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`Otsuka received a letter sent by Teva, dated March 8, 2022, purporting to be a
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`“Notice of Paragraph IV Certification” for ANDA No. 216933 (“Teva’s Notice Letter”) pursuant
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`to § 505(j)(2)(B) of the FDCA and 21 C.F.R. § 314.95. Teva’s Notice Letter notified Otsuka that
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`Teva had filed ANDA No. 216933, seeking approval to engage in the commercial manufacture,
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`use, offer for sale, sale or importation of Teva’s ANDA products before the expiration of the
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`Patents-in-Suit.
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`38.
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`Otsuka commenced this action within 45 days of receipt of Teva’s Notice Letter.
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`COUNT I
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`INFRINGEMENT OF ’730 PATENT
`
`39.
`
`40.
`
`Otsuka incorporates each of the preceding paragraphs as if fully set forth herein.
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`Upon information and belief, Teva submitted to the FDA ANDA No. 216933
`
`seeking approval to commercially manufacture, use, offer to sell and/or sell Teva’s ANDA
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`products in the United States, or import them into the United States, before the expiration of the
`
`’730 Patent.
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`41.
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`Upon information and belief, Teva submitted to the FDA, pursuant to 21 U.S.C. §
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`355(j)(2)(A)(vii)(IV), a certification alleging that the claims of the ’730 Patent are invalid,
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`unenforceable and/or not infringed.
`
`42.
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`Upon information and belief, in its ANDA No. 216933, Teva has represented to the
`
`FDA that Teva’s ANDA products are pharmaceutically and therapeutically equivalent to Otsuka’s
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`JYNARQUE® tablets.
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`43.
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`44.
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`Teva has actual knowledge of Otsuka’s ’730 Patent.
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`Upon information and belief, under 35 U.S.C. § 271(e)(2)(A), Teva has infringed
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`one or more claims of the ’730 Patent, including at least claim 1, by submitting, or causing to be
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`submitted, to the FDA ANDA No. 216933, seeking approval to commercially manufacture, use,
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`offer to sell or sell Teva’s ANDA products, or import them into the United States, before the
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`expiration date of the ’730 Patent.
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`45.
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`Upon information and belief, if ANDA No. 216933 is approved, Teva intends to
`
`and will offer to sell, sell in the United States, or import into the United States, Teva’s ANDA
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`products.
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`46.
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`Upon information and belief, if ANDA No. 216933 is approved, Teva will infringe
`
`one or more claims of the ’730 Patent, including at least claim 1, under § 271(a), either literally or
`
`under the doctrine of equivalents, by commercially making, using, offering to sell, selling and/or
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`importing Teva’s ANDA products, and/or by actively inducing infringement by others under §
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`271(b) and/or contributing to infringement under § 271(c), unless this Court orders that the
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`effective date of any FDA approval of ANDA No. 216933 shall be no earlier than the expiration
`
`of the ’730 Patent and any additional periods of exclusivity.
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`47.
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`Otsuka will be irreparably harmed by Teva’s infringing activities unless this Court
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`enjoins those activities.
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`48.
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`Otsuka does not have an adequate remedy at law.
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`COUNT II
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`INFRINGEMENT OF THE ’694 PATENT
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`49.
`
`50.
`
`Otsuka incorporates each of the preceding paragraphs as if fully set forth herein.
`
`Upon information and belief, Teva submitted to the FDA ANDA No. 216933
`
`seeking approval to commercially manufacture, use, offer to sell and/or sell Teva’s ANDA
`
`products in the United States, or import them into the United States, before the expiration of the
`
`’694 Patent.
`
`51.
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`Upon information and belief, Teva submitted to the FDA, pursuant to 21 U.S.C. §
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`355(j)(2)(A)(vii)(IV), a certification alleging that the claims of the ’694 Patent are invalid,
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`unenforceable and/or not infringed.
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`8
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`52.
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`Upon information and belief, in its ANDA No. 216933, Teva has represented to the
`
`FDA that Teva’s ANDA products are pharmaceutically and therapeutically equivalent to Otsuka’s
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`JYNARQUE® tablets.
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`53.
`
`54.
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`Teva has actual knowledge of Otsuka’s ’694 Patent.
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`Upon information and belief, under 35 U.S.C. § 271(e)(2)(A), Teva has infringed
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`one or more claims of the ’694 Patent, including at least claim 1, by submitting, or causing to be
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`submitted, to the FDA ANDA No. 216933, seeking approval to commercially manufacture, use,
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`offer to sell or sell Teva’s ANDA products, and/or import them into the United States, before the
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`expiration date of the ’694 Patent.
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`55.
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`Upon information and belief, if ANDA No. 216933 is approved, Teva intends to
`
`and will offer to sell and sell in the United States, and/or import into the United States, Teva’s
`
`ANDA products.
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`56.
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`Upon information and belief, if ANDA No. 216933 is approved, Teva will infringe
`
`one or more claims of the ’694 Patent, including at least claim 1, under § 271(a), either literally or
`
`under the doctrine of equivalents, by making, using, offering to sell, selling and/or importing
`
`Teva’s ANDA 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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`FDA approval of ANDA No. 216933 shall be no earlier than the expiration of the ’694 Patent and
`
`any additional periods of exclusivity.
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`57.
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`Otsuka will be irreparably harmed by Teva’s infringing activities unless this Court
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`enjoins those activities.
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`58.
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`Otsuka does not have an adequate remedy at law.
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`9
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`COUNT III
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`DECLARATORY JUDGMENT OF INFRINGEMENT
`OF THE ’735 PATENT UNDER 35 U.S.C. § 271(g)
`
`59.
`
`60.
`
`Otsuka incorporates each of the preceding paragraphs as if fully set forth herein.
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`A definite and concrete, real and substantial, justiciable controversy of sufficient
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`immediacy and reality exists between Otsuka and Teva regarding infringement of the ’735 Patent.
`
`61.
`
`Teva has made and will continue to make substantial and meaningful preparations
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`to import into the United States and/or to use, offer to sell, and/or sell within the United States a
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`product which is made by a process patented by the ’735 Patent prior to the expiration of that
`
`patent.
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`62.
`
`Teva’s actions, including, but not limited to, the filing of ANDA No. 216933 and
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`systematically attempting to meet the applicable regulatory requirements for approval of ANDA
`
`No. 216933 indicate a refusal to change its course of action.
`
`63.
`
`Upon information and belief, Teva’s importation into the United States and/or use,
`
`offer for sale, and/or sale in the United States of Teva’s ANDA products prior to the expiration of
`
`the ’735 Patent would infringe at least claims 6-8 and 10 of the ’735 Patent under 35 U.S.C. §
`
`271(g).
`
`64.
`
`Upon information and belief, Teva had actual and constructive notice of the ’735
`
`Patent prior to the filing of ANDA No. 216933 seeking approval of Teva’s ANDA products.
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`65.
`
`Otsuka should be granted a judicial declaration that the importation into the United
`
`States and/or the use, offer for sale, and/or sale in the United States of Teva’s ANDA products will
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`constitute infringement of the ’735 Patent under 35 U.S.C. § 271(g).
`
`66.
`
`Otsuka will be irreparably harmed by Teva’s infringing activities unless this Court
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`enjoins those activities
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`10
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`67.
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`Otsuka does not have an adequate remedy at law.
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`PRAYER FOR RELIEF
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`WHEREFORE, Otsuka respectfully requests the following relief:
`
`A.
`
`The entry of judgment under 35 U.S.C. § 271(e)(2)(A) that Teva has infringed at
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`least one claim of each of the ’730 Patent and the ’694 Patent by Teva’s submission of ANDA No.
`
`216933 to the FDA seeking approval to manufacture, use, offer to sell and/or sell Teva’s ANDA
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`products in the United States, and/or import them into the United States, before the expiration of
`
`those patents;
`
`B.
`
`The entry of judgment under 35 U.S.C. § 271(a), (b) and/or (c) that Teva’s making,
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`using, offering to sell, selling or importation of Teva’s ANDA products before the expiration of
`
`the ’730 Patent and the ’694 Patent will infringe, actively induce infringement and/or contribute
`
`to the infringement of those patents under 35 U.S.C. § 271(a), (b) and/or (c);
`
`C.
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`The issuance of an order that the effective date of any FDA approval of Teva’s
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`ANDA products shall be no earlier than the expiration date of the ’730 Patent and the ’694 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 permanent injunction, enjoining Teva and all
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`persons acting in concert with Teva from commercially manufacturing, using, offering for sale or
`
`selling Teva’s ANDA products within the United States, or importing Teva’s ANDA products into
`
`the United States, until the expiration of the ’730 Patent and the ’694 Patent, in accordance with
`
`35 U.S.C. §§ 271(e)(4)(B) and 283;
`
`E.
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`The entry of a preliminary and permanent injunction, enjoining Teva and all
`
`persons acting in concert with Teva from seeking, obtaining or maintaining approval of the ANDA
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`until the expiration of the ’730 Patent and the ’694 Patent, in accordance with 35 U.S.C. §§
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`271(e)(4)(B) and 283;
`
`F.
`
`The entry of judgment declaring that the importation into the United States and/or
`
`the use, offer for sale, and/or sale in the United States of Teva’s ANDA products would constitute
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`infringement of the ’735 Patent by Teva pursuant to 35 U.S.C. § 271(g);
`
`G.
`
`A judgement permanently enjoining Teva and all persons acting in concert with
`
`Teva from importing into the United States and/or using, offering to sell, or selling in the United
`
`States the Teva ANDA products until after expiration of the ’735 Patent;
`
`H.
`
`The issuance of a declaration that this is an exceptional case and an award to Otsuka
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`of its costs, expenses and disbursements in this action, including reasonable attorney fees, pursuant
`
`to 35 U.S.C. §§ 285 and 271(e)(4);
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`An award to Otsuka of any further appropriate relief under 35 U.S.C. § 271(e)(4);
`
`An award to Otsuka of any further and additional relief that this Court deems just
`
`and
`
`I.
`
`J.
`
`and proper.
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`Case 1:22-cv-00513-UNA Document 1 Filed 04/22/22 Page 13 of 13 PageID #: 13
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`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`
`/s/ Jeremy A. Tigan
`
`Jack B. Blumenfeld (#1014)
`Jeremy A. Tigan (#5239)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@morrisnichols.com
`jtigan@morrisnichols.com
`
`Attorneys for Plaintiff
`Otsuka Pharmaceutical Co., Ltd.
`
`OF COUNSEL:
`
`John D. Murnane
`Joshua I. Rothman
`Alicia A. Russo
`Zachary L. Garrett
`VENABLE LLP
`1290 Avenue of the Americas
`New York, NY 10104-3800
`(212) 218-2100
`
`April 22, 2022
`
`13
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`