Case 1:22-cv-00316-UNA Document 1 Filed 03/10/22 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.,
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`MSN LABORATORIES PRIVATE LIMITED
`and MSN PHARMACEUTICALS INC.
`
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`
`
`
`Plaintiff,
`
`
`
`v.
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`
`
`Defendants.
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`C.A. No. ____________________
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`)
`)
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`COMPLAINT FOR PATENT INFRINGEMENT
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`Plaintiff Otsuka Pharmaceutical Co., Ltd. (“Otsuka”), by way of Complaint against
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`Defendants MSN Laboratories Private Limited (“MSN Laboratories”) and MSN Pharmaceuticals
`
`Inc. (“MSN Pharmaceuticals”) (collectively, “MSN”), hereby alleges as follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is a civil action for patent infringement of U.S. Patent No. 8,501,730 (“the
`
`’730 Patent”) and U.S. Patent No. 10,905,694 (“the ’694 Patent”) (collectively, the “Patents-in-
`
`Suit”) arising under the patent laws of the United States, 35 U.S.C. § 100 et seq.
`
`2.
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`This action arises out of MSN’s submission of an Abbreviated New Drug
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`Application (“ANDA”) No. 216949 (“MSN’s ANDA”) under § 505(j) of the Federal Food, Drug
`
`and Cosmetic Act (“FDCA”), 21 U.S.C. § 355(j), seeking U.S. Food and Drug Administration
`
`(“FDA”) approval to commercially manufacture, use, offer for sell and sell in the United States,
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`and/or import into the United States, generic versions of Otsuka’s SAMSCA® tolvaptan tablets
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`(15 and 30 mg) (“MSN’s ANDA products”) prior to the expiration of the Patents-in-Suit.
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`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`OTSUKA PHARMACEUTICAL CO., LTD.,
`
`
`
`
`
`MSN LABORATORIES PRIVATE LIMITED
`and MSN PHARMACEUTICALS INC.
`
`
`
`
`
`
`
`
`
`
`Plaintiff,
`
`
`
`v.
`
`
`
`Defendants.
`
`
`
`
`
`C.A. No. ____________________
`
`
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiff Otsuka Pharmaceutical Co., Ltd. (“Otsuka”), by way of Complaint against
`
`Defendants MSN Laboratories Private Limited (“MSN Laboratories”) and MSN Pharmaceuticals
`
`Inc. (“MSN Pharmaceuticals”) (collectively, “MSN”), hereby alleges as follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is a civil action for patent infringement of U.S. Patent No. 8,501,730 (“the
`
`’730 Patent”) and U.S. Patent No. 10,905,694 (“the ’694 Patent”) (collectively, the “Patents-in-
`
`Suit”) arising under the patent laws of the United States, 35 U.S.C. § 100 et seq.
`
`2.
`
`This action arises out of MSN’s submission of an Abbreviated New Drug
`
`Application (“ANDA”) No. 216949 (“MSN’s ANDA”) under § 505(j) of the Federal Food, Drug
`
`and Cosmetic Act (“FDCA”), 21 U.S.C. § 355(j), seeking U.S. Food and Drug Administration
`
`(“FDA”) approval to commercially manufacture, use, offer for sell and sell in the United States,
`
`and/or import into the United States, generic versions of Otsuka’s SAMSCA® tolvaptan tablets
`
`(15 and 30 mg) (“MSN’s ANDA products”) prior to the expiration of the Patents-in-Suit.
`
`
`
`
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`
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`Case 1:22-cv-00316-UNA Document 1 Filed 03/10/22 Page 2 of 11 PageID #: 2
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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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`On information and belief, Defendant MSN Laboratories is an Indian corporation,
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`having its principal place of business at MSN House, C-24, Industrial Estate, Sanathnagar,
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`Hyderabad-18, Telangana, India.
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`5.
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`On information and belief, Defendant MSN Pharmaceuticals is a corporation
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`organized under the laws of the State of Delaware, having its principal place of business at 20
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`Duke Road, Piscataway, New Jersey 08854.
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`6.
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`On information and belief, MSN Pharmaceuticals is a wholly-owned subsidiary of
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`MSN Laboratories.
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`7.
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`On information and belief, MSN Pharmaceuticals and MSN Laboratories develop,
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`manufacture, and/or distribute generic drugs for sale and use throughout the United States,
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`including in Delaware.
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`8.
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`On information and belief, MSN Pharmaceuticals and MSN Laboratories are agents
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`of each other with respect to the development, regulatory approval, marketing, sale, and/or
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`distribution of generic drug products. On information and belief, the acts of MSN Pharmaceuticals
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`and MSN Laboratories complained of herein were done with the cooperation, participation, and
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`assistance of, and at least in part for the benefit of, each other.
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`9.
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`On information and belief, MSN Pharmaceuticals and MSN Laboratories have
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`cooperated and assisted in the preparation and filing of MSN’s ANDA for MSN’s ANDA products,
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`2
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`Case 1:22-cv-00316-UNA Document 1 Filed 03/10/22 Page 3 of 11 PageID #: 3
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`and will be involved in the manufacture, importation, marketing, and sale of the drug that is the
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`subject of MSN’s ANDA if it is approved.
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`JURISDICTION AND VENUE
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`10.
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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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`11.
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`This Court has personal jurisdiction over MSN Pharmaceuticals because, on
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`information and belief, MSN Pharmaceuticals is a corporation organized and existing under the
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`laws of Delaware.
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`12.
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`This Court has personal jurisdiction over MSN Laboratories because, inter alia,
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`MSN Laboratories, itself and/or through its wholly-owned subsidiaries, has purposefully availed
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`itself of the rights and benefits of Delaware law by engaging in systematic and continuous contacts
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`with Delaware. On information and belief, MSN Laboratories directly or indirectly is in the
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`business of developing, manufacturing, marketing, importing, offering to sell and selling
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`pharmaceutical drug products, including generic drug products, throughout the United States,
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`including in Delaware. Upon information and belief, MSN Laboratories derives substantial
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`revenue from the sale of those products in Delaware and has availed itself of the privilege of
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`conducting business within Delaware. Delaware would be a destination of MSN’s ANDA
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`products upon approval and marketing of the ANDA involved in this action. MSN Laboratories’s
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`filing of its ANDA constitutes a formal act that reliably indicates its plans to engage in marketing
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`of the accused infringing ANDA products in Delaware.
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`13.
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`Alternatively, assuming that the above facts do not establish personal jurisdiction
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`over MSN Laboratories, this Court may exercise jurisdiction pursuant to Federal Rule of Civil
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`Procedure 4(k)(2) because (a) Otsuka’s claims arise under federal law; (b) MSN Laboratories is a
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`3
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`Case 1:22-cv-00316-UNA Document 1 Filed 03/10/22 Page 4 of 11 PageID #: 4
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`
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`foreign defendant not subject to general personal jurisdiction in the courts of any state; and (c)
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`MSN Laboratories has sufficient contacts with the United States as a whole, including but not
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`limited to manufacturing and/or selling pharmaceutical products distributed throughout the United
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`States, such that this Court’s exercise of jurisdiction over MSN Laboratories satisfies due process.
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`14.
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`This Court also has personal jurisdiction over MSN Laboratories because it has
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`affirmatively availed itself of the jurisdiction of this Court through the assertion of counterclaims
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`in suits brought in this District and/or by being sued in this District without challenging personal
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`jurisdiction. See, e.g., Vanda Pharmaceuticals, Inc. v. MSN Pharmaceuticals Inc. et al., Civil
`
`Action No. 19-926 (D. Del.); Boehringer Ingelheim Pharmaceuticals Inc. et al., v. MSN
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`Laboratories Private Ltd. et al., Civil Action No. 18-1785 (D. Del.); Millennium Pharmaceuticals,
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`Inc. v. MSN Laboratories Private Ltd. et al., Civil Action No. 16-1255 (D. Del.).
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`15.
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`Venue is proper as to MSN in this judicial district under 28 U.S.C. §§ 1391 and
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`1400(b).
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`OTSUKA’S SAMSCA®
`
`16.
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`Otsuka is the holder of the New Drug Application (“NDA”) No. 22-275 for
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`SAMSCA® tablets in 15 and 30 mg dosage forms (“SAMSCA® tablets”).
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`17.
`
`18.
`
`The FDA approved NDA No. 22-275 on May 19, 2009.
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`SAMSCA® is an oral medication used to treat hyponatremia (low blood sodium
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`levels) in adults with conditions including congestive heart failure, cirrhosis and Syndrome of
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`Inappropriate Antidiuretic Hormone.
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`4
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`Case 1:22-cv-00316-UNA Document 1 Filed 03/10/22 Page 5 of 11 PageID #: 5
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`
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`THE PATENTS-IN-SUIT
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`19.
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`The ’730 Patent, entitled “Process for Preparing Benzazepine Compounds or Salts
`
`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.
`
`20.
`
`The ’730 Patent claims compositions made by processes for preparing novel
`
`benzazepine compounds.
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`21.
`
`The ’730 Patent is owned by Otsuka and is listed in Approved Drug Products with
`
`Therapeutic Equivalents (the “Orange Book”) in connection with NDA No. 22-275 for
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`SAMSCA® tablets.
`
`22.
`
`23.
`
`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
`
`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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`24.
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`The ’694 Patent claims pharmaceutical solid preparations obtained by particular
`
`methods.
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`25.
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`The ’694 Patent is owned by Otsuka and is listed in the Orange Book in connection
`
`with NDA No. 22-275 for SAMSCA® tablets.
`
`26.
`
`According to the Orange Book, the ’694 Patent expires on April 7, 2030.
`
`MSN’S ANDA
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`27.
`
`Upon information and belief, MSN submitted ANDA No. 216949 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
`
`sale or sale in the United States, or importation into the United States, of MSN’s ANDA products,
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`which are generic versions of SAMSCA®.
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`5
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`Case 1:22-cv-00316-UNA Document 1 Filed 03/10/22 Page 6 of 11 PageID #: 6
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`28.
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`Upon information and belief, ANDA No. 216949 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 MSN’s ANDA
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`products.
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`29.
`
`Otsuka received a letter sent by MSN, dated January 24, 2022, purporting to be a
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`“Notice of Paragraph IV Certification” for ANDA No. 216949 (“MSN’s Notice Letter”) pursuant
`
`to § 505(j)(2)(B) of the FDCA and 21 C.F.R. § 314.95. MSN’s Notice Letter notified Otsuka that
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`MSN had filed ANDA No. 216949, seeking approval to engage in the commercial manufacture,
`
`use, offer for sale, sale or importation of MSN’s ANDA products before the expiration of the
`
`Patents-in-Suit.
`
`30.
`
`Otsuka commenced this action within 45 days of receipt of MSN’s Notice Letter.
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`COUNT I
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`INFRINGEMENT OF ’730 PATENT
`
`31.
`
`32.
`
`Otsuka incorporates each of the preceding paragraphs as if fully set forth herein.
`
`Upon information and belief, MSN submitted to the FDA ANDA No. 216949
`
`seeking approval to commercially manufacture, use, offer to sell and/or sell MSN’s ANDA
`
`products in the United States, or import them into the United States, before the expiration of the
`
`’730 Patent.
`
`33.
`
`Upon information and belief, MSN submitted to the FDA, pursuant to 21 U.S.C. §
`
`355(j)(2)(A)(vii)(IV), a certification alleging that the claims of the ’730 Patent are invalid,
`
`unenforceable and/or not infringed.
`
`6
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`Case 1:22-cv-00316-UNA Document 1 Filed 03/10/22 Page 7 of 11 PageID #: 7
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`34.
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`Upon information and belief, in its ANDA No. 216949, MSN has represented to
`
`the FDA that MSN’s ANDA products are pharmaceutically and therapeutically equivalent to
`
`Otsuka’s SAMSCA® tablets.
`
`35. MSN has actual knowledge of Otsuka’s ’730 Patent.
`
`36.
`
`Upon information and belief, under 35 U.S.C. § 271(e)(2)(A), MSN has infringed
`
`one or more claims of the ’730 Patent, including at least claim 1, by submitting, or causing to be
`
`submitted, to the FDA ANDA No. 216949, seeking approval to commercially manufacture, use,
`
`offer to sell or sell MSN’s ANDA products, or import them into the United States, before the
`
`expiration date of the ’730 Patent.
`
`37.
`
`Upon information and belief, if ANDA No. 216949 is approved, MSN intends to
`
`and will offer to sell, sell in the United States, or import into the United States, MSN’s ANDA
`
`products.
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`38.
`
`Upon information and belief, if ANDA No. 216949 is approved, MSN 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
`
`importing MSN’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 FDA approval of ANDA No. 216949 shall be no earlier than the expiration
`
`of the ’730 Patent and any additional periods of exclusivity.
`
`39.
`
`Otsuka will be irreparably harmed by MSN’s infringing activities unless this Court
`
`enjoins those activities.
`
`40.
`
`Otsuka does not have an adequate remedy at law.
`
`7
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`Case 1:22-cv-00316-UNA Document 1 Filed 03/10/22 Page 8 of 11 PageID #: 8
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`
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`COUNT II
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`INFRINGEMENT OF THE ’694 PATENT
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`41.
`
`42.
`
`Otsuka incorporates each of the preceding paragraphs as if fully set forth herein.
`
`Upon information and belief, MSN submitted to the FDA ANDA No. 216949
`
`seeking approval to commercially manufacture, use, offer to sell and/or sell MSN’s ANDA
`
`products in the United States, or import them into the United States, before the expiration of the
`
`’694 Patent.
`
`43.
`
`Upon information and belief, MSN submitted to the FDA, pursuant to 21 U.S.C. §
`
`355(j)(2)(A)(vii)(IV), a certification alleging that the claims of the ’694 Patent are invalid,
`
`unenforceable and/or not infringed.
`
`44.
`
`Upon information and belief, in its ANDA No. 216949, MSN has represented to
`
`the FDA that MSN’s ANDA products are pharmaceutically and therapeutically equivalent to
`
`Otsuka’s SAMSCA® tablets.
`
`45. MSN has actual knowledge of Otsuka’s ’694 Patent.
`
`46.
`
`Upon information and belief, under 35 U.S.C. § 271(e)(2)(A), MSN has infringed
`
`one or more claims of the ’694 Patent, including at least claim 1, by submitting, or causing to be
`
`submitted, to the FDA ANDA No. 216949, seeking approval to commercially manufacture, use,
`
`offer to sell or sell MSN’s ANDA products, and/or import them into the United States, before the
`
`expiration date of the ’694 Patent.
`
`47.
`
`Upon information and belief, if ANDA No. 216949 is approved, MSN intends to
`
`and will offer to sell and sell in the United States, and/or import into the United States, MSN’s
`
`ANDA products.
`
`48.
`
`Upon information and belief, if ANDA No. 216949 is approved, MSN will infringe
`
`one or more claims of the ’694 Patent, including at least claim 1, under § 271(a), either literally or
`
`8
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`Case 1:22-cv-00316-UNA Document 1 Filed 03/10/22 Page 9 of 11 PageID #: 9
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`
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`under the doctrine of equivalents, by making, using, offering to sell, selling and/or importing
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`MSN’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
`
`FDA approval of ANDA No. 216949 shall be no earlier than the expiration of the ’694 Patent and
`
`any additional periods of exclusivity.
`
`49.
`
`Otsuka will be irreparably harmed by MSN’s infringing activities unless this Court
`
`enjoins those activities.
`
`50.
`
`Otsuka does not have an adequate remedy at law.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Otsuka respectfully requests the following relief:
`
`A.
`
`The entry of judgment under 35 U.S.C. § 271(e)(2)(A) that MSN has infringed at
`
`least one claim of each of the Patents-in-Suit by MSN’s submission of ANDA No. 216949 to the
`
`FDA seeking approval to manufacture, use, offer to sell and/or sell MSN’s ANDA products in the
`
`United States, and/or import them into the United States, before the expiration of the Patents-in-
`
`Suit;
`
`B.
`
`The entry of judgment under 35 U.S.C. § 271(a), (b) and/or (c) that MSN’s making,
`
`using, offering to sell, selling or importation of MSN’s ANDA products before the expiration of
`
`the Patents-in-Suit 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.
`
`The issuance of an order that the effective date of any FDA approval of MSN’s
`
`ANDA products shall be no earlier than the expiration date of the Patents-in-Suit and any
`
`additional periods of exclusivity, in accordance with 35 U.S.C. § 271(e)(4)(A);
`
`9
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`Case 1:22-cv-00316-UNA Document 1 Filed 03/10/22 Page 10 of 11 PageID #: 10
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`
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`D.
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`The entry of a preliminary and permanent injunction, enjoining MSN and all
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`persons acting in concert with MSN from commercially manufacturing, using, offering for sale or
`
`selling MSN’s ANDA products within the United States, or importing MSN’s ANDA products
`
`into the United States, until the expiration of the Patents-in-Suit, in accordance with 35 U.S.C. §§
`
`271(e)(4)(B) and 283;
`
`E.
`
`The entry of a preliminary and permanent injunction, enjoining MSN and all
`
`persons acting in concert with MSN from seeking, obtaining or maintaining approval of the ANDA
`
`until the expiration of the Patents-in-Suit, in accordance with 35 U.S.C. §§ 271(e)(4)(B) and 283;
`
`F.
`
`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);
`
`G.
`
`An award to Otsuka of any further appropriate relief under 35 U.S.C. § 271(e)(4);
`
`and
`
`H.
`
`An award to Otsuka of any further and additional relief that this Court deems just
`
`and proper.
`
`10
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`Case 1:22-cv-00316-UNA Document 1 Filed 03/10/22 Page 11 of 11 PageID #: 11
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`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
`
`March 10, 2022
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`
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`
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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.
`
`11
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`
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