Case 1:21-cv-01032-UNA Document 1 Filed 07/15/21 Page 1 of 10 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`MERZ PHARMACEUTICALS, LLC and
`MERZ NORTH AMERICA, INC.,
`
`Plaintiffs,
`
`v.
`
`MSN PHARMACEUTICALS INC.
`
`Defendant.
`
`C.A. No. ___________________
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiffs Merz Pharmaceuticals, LLC (“Merz LLC”) and Merz North America, Inc.
`
`(“Merz N.A.”) (together, “Merz” or “Plaintiffs”) bring this action against Defendant MSN
`
`Pharmaceuticals Inc. (“MSN”), and alleges as follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is an action for patent infringement of United States Patent Nos. 7,638,552
`
`(“the ’552 Patent”) and 7,816,396 (“the ’396 Patent,” collectively, the “patents-in-suit”), arising
`
`under the United States patent laws, Title 35, United States Code. This action relates to MSN’s
`
`filing of Abbreviated New Drug Application (“ANDA”) No. 216084 under section 505(j) of the
`
`Federal Food, Drug and Cosmetic Act (“the Act”), 21 U.S.C. § 355(j), seeking United States
`
`Food and Drug Administration (“FDA”) approval to manufacture and sell a generic version of
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`Plaintiffs’ CUVPOSA® (glycopyrrolate), 1mg/5mL oral solution (“CUVPOSA®”) prior to the
`
`expiration of the ’552 and the ’396 Patents.
`
`1
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`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`MERZ PHARMACEUTICALS, LLC and
`MERZ NORTH AMERICA, INC.,
`
`Plaintiffs,
`
`v.
`
`MSN PHARMACEUTICALS INC.
`
`Defendant.
`
`C.A. No. ___________________
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiffs Merz Pharmaceuticals, LLC (“Merz LLC”) and Merz North America, Inc.
`
`(“Merz N.A.”) (together, “Merz” or “Plaintiffs”) bring this action against Defendant MSN
`
`Pharmaceuticals Inc. (“MSN”), and alleges as follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is an action for patent infringement of United States Patent Nos. 7,638,552
`
`(“the ’552 Patent”) and 7,816,396 (“the ’396 Patent,” collectively, the “patents-in-suit”), arising
`
`under the United States patent laws, Title 35, United States Code. This action relates to MSN’s
`
`filing of Abbreviated New Drug Application (“ANDA”) No. 216084 under section 505(j) of the
`
`Federal Food, Drug and Cosmetic Act (“the Act”), 21 U.S.C. § 355(j), seeking United States
`
`Food and Drug Administration (“FDA”) approval to manufacture and sell a generic version of
`
`Plaintiffs’ CUVPOSA® (glycopyrrolate), 1mg/5mL oral solution (“CUVPOSA®”) prior to the
`
`expiration of the ’552 and the ’396 Patents.
`
`1
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`
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`Case 1:21-cv-01032-UNA Document 1 Filed 07/15/21 Page 2 of 10 PageID #: 2
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`2.
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`By letter dated June 9, 2021, MSN notified Merz that MSN had filed ANDA No.
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`216084, seeking FDA approval to manufacture and sell a generic version of Merz’s
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`CUVPOSA®.
`
`THE PARTIES
`
`3.
`
`Merz LLC is a limited liability company organized and existing under the laws of
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`North Carolina, with a principal place of business at 6501 Six Forks Road, Raleigh, North
`
`Carolina 27615. Merz LLC is in the business of, inter alia, researching, developing,
`
`manufacturing, marketing, promoting, selling, distributing, and/or obtaining regulatory approval
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`for innovative pharmaceutical products throughout the United States, including in this judicial
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`district.
`
`4.
`
`Merz N.A. is a corporation organized and existing under the laws of the State of
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`North Carolina, having a principal place of business at 6501 Six Forks Road, Raleigh, North
`
`Carolina 27615. Merz N.A. is in the business of, inter alia, researching, developing,
`
`manufacturing, marketing, promoting, selling, distributing, and/or obtaining regulatory approval
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`for innovative pharmaceutical products throughout the United States, including in this judicial
`
`district.
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`5.
`
`On information and belief, MSN is a corporation that is incorporated in Delaware,
`
`having a principal place of business at 20 Duke Rd, Piscataway, NJ 08854.
`
`6.
`
`On information and belief, MSN, by itself and/or through its affiliates and agents,
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`is in the business of, inter alia, developing, manufacturing, and obtaining regulatory approval of
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`generic copies of branded pharmaceutical products for distribution and sale throughout the
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`United States, including within the State of Delaware.
`
`2
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`Case 1:21-cv-01032-UNA Document 1 Filed 07/15/21 Page 3 of 10 PageID #: 3
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`7.
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`On information and belief, MSN has filed ANDA No. 216084 and will be
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`involved in the manufacture, importation, marketing and sale of the drug that is subject to
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`ANDA No. 216084 if it is approved.
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`JURISDICTION AND VENUE
`
`8.
`
`This Court has jurisdiction over the subject matter of this action under 28 U.S.C.
`
`§§ 1331, 1338(a), 2201 and 2202.
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`9.
`
`This Court has personal jurisdiction over MSN for purposes of this civil action
`
`because, inter alia, MSN, on information and belief, is incorporated in the State of Delaware.
`
`10.
`
`This Court also has personal jurisdiction over MSN for purposes of this civil
`
`action because, inter alia, MSN has filed ANDA No. 216084 and intends to make, use, offer for
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`sale, sell and/or import its proposed ANDA product in the United States, including Delaware,
`
`prior to the expiration of the patents-in-suit if ANDA No. 216084 is approved. Such acts will
`
`lead to foreseeable harm to Plaintiffs in Delaware.
`
`11.
`
`On information and belief, MSN has not challenged personal jurisdiction in this
`
`Court in one or more prior cases arising out of the filing of its ANDAs. See, e.g., Vanda
`
`Pharmaceuticals Inc. v. MSN Pharmaceuticals Inc. et al., C.A. No. 21-283 (D. Del.); Otsuka
`
`Pharmaceutical Co., Ltd. et al. v. MSN Laboratories Pvt. Ltd. et al., C.A. No. 20-1428 (D. Del.).
`
`12.
`
`On information and belief, MSN has previously submitted to the jurisdiction of
`
`this Court and has availed itself of the legal protections of the State of Delaware, having asserted
`
`counterclaims in this jurisdiction. See, e.g., Vanda Pharmaceuticals Inc. v. MSN
`
`Pharmaceuticals Inc. et al. C.A. No. 21-283 (D. Del.); Otsuka Pharmaceutical Co., Ltd. et al. v.
`
`MSN Laboratories Pvt. Ltd. et al., C.A. No. 20-1428 (D. Del.).
`
`13.
`
`Venue is proper in this Court pursuant to 28 U.S.C. §§ 1391 and 1400(b).
`
`3
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`
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`Case 1:21-cv-01032-UNA Document 1 Filed 07/15/21 Page 4 of 10 PageID #: 4
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`THE PATENTS-IN-SUIT AND CUVPOSA®
`
`14.
`
`On December 29, 2009, the United States Patent and Trademark Office (“PTO”)
`
`issued the ’552 Patent, entitled “Method for Increasing The Bioavailability of Glycopyrrolate,”
`
`to Sciele Pharma, Inc., the initial assignee of the named inventors, Alan Roberts and Balaji
`
`Venkataraman. The ’552 Patent was subsequently assigned to Shiongi Pharma, Inc. on January
`
`11, 2010; to Shionogi Inc. on March 31, 2011; and then to Merz LLC on August 24, 2012. Merz
`
`LLC is the current record owner of the ’552 Patent. A copy of the ’552 Patent is attached hereto
`
`as Exhibit A.
`
`15.
`
`On October 19, 2010, the PTO issued the ’396 Patent, entitled “Method for
`
`Increasing The Bioavailability of Glycopyrrolate,” to Sciele Pharma, Inc., the initial assignee of
`
`the named inventors, Alan Roberts and Balaji Venkataraman. The ’396 Patent was subsequently
`
`assigned to Shionogi Pharma, Inc. on January 11, 2010; to Shionogi Inc. on March 31, 2011; and
`
`then to Merz LLC on August 24, 2012. Merz LLC is the current record owner of the ’396
`
`Patent. A copy of the ’396 Patent is attached hereto as Exhibit B.
`
`16.
`
`On July 28, 2010, the FDA approved New Drug Application (“NDA”) No.
`
`022571 for CUVPOSA®. Merz LLC is the holder of NDA No. 022571 for CUVPOSA®.
`
`17.
`
`In FDA’s publication entitled Approved Drug Products with Therapeutic
`
`Equivalence Evaluations (known as the “Orange Book”), the patents-in-suit are listed as
`
`covering CUVPOSA®.
`
`DEFENDANT’S ANDA
`
`18.
`
`On information and belief, MSN reviewed the patents-in-suit and certain
`
`commercial and economic information relating to CUVPOSA®, including estimates of the
`
`4
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`Case 1:21-cv-01032-UNA Document 1 Filed 07/15/21 Page 5 of 10 PageID #: 5
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`revenues generated by the sale of CUVPOSA®, and decided to file an ANDA, seeking approval
`
`to market a glycopyrrolate oral solution.
`
`19.
`
`On information and belief, MSN submitted to the FDA ANDA No. 216084
`
`seeking approval to engage in the commercial manufacture, use, and sale of glycopyrrolate oral
`
`solution, prior to the expiration of the patents-in-suit.
`
`20.
`
`On information and belief, MSN will manufacture, sell, market, and/or distribute
`
`a glycopyrrolate oral solution upon FDA approval of ANDA No. 216084.
`
`21. Merz LLC received a letter dated June 9, 2021 from MSN notifying Merz LLC
`
`that ANDA No. 216084 includes “a certification pursuant to 21 U.S.C. § 355(j)(2)(B)(vii)(IV),
`
`[sic] that the ’552 and ’396 patents are invalid, unenforceable and/or will not be infringed by the
`
`manufacture, use, or sale of the product” described in ANDA No. 216084 (the “Paragraph IV
`
`certification”).
`
`22.
`
`Plaintiffs commenced this action within 45 days of the date it received MSN’s
`
`notice of ANDA No. 216084 containing the Paragraph IV certification.
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`FIRST CLAIM FOR RELIEF
`(Infringement of the ’552 Patent by MSN)
`
`23.
`
`Plaintiffs repeat and reallege each and every allegation contained in paragraphs 1
`
`through 22 hereof, as if fully set forth herein.
`
`24.
`
`Through the conduct alleged above, MSN has infringed, and continues to infringe,
`
`one or more claims of the ’552 Patent.
`
`25.
`
`By filing ANDA No. 216084 and seeking FDA approval to engage in the
`
`commercial manufacture, use, sale, marketing, distribution, and/or importation of the
`
`glycopyrrolate oral solution disclosed therein prior to the expiration of the ’552 Patent, MSN has
`
`infringed the ’552 Patent under 35 U.S.C. § 271(e)(2)(A).
`5
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`Case 1:21-cv-01032-UNA Document 1 Filed 07/15/21 Page 6 of 10 PageID #: 6
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`26.
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`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the ’552 Patent.
`
`27.
`
`On information and belief, MSN will be actively involved in the infringement of
`
`the ’552 Patent through the manufacture, use, sale, marketing, distribution, and/or importation of
`
`glycopyrrolate oral solution described in ANDA No. 216084, if approved.
`
`28.
`
`Unless enjoined by this Court, upon FDA approval of ANDA No. 216084, MSN
`
`will infringe the ’552 Patent under 35 U.S.C § 271(a) by making, using, offering to sell,
`
`importing, and/or selling the glycopyrrolate oral solution described in ANDA No. 216084.
`
`29.
`
`Unless enjoined by this Court, upon FDA approval of ANDA No. 216084, MSN
`
`will induce infringement of the ’552 Patent under 35 U.S.C. § 271(b) by making, using, offering
`
`to sell, importing, and/or selling the glycopyrrolate oral solution described in ANDA No.
`
`216084. On information and belief, through the product labeling for the glycopyrrolate oral
`
`solution described in ANDA No. 216084, MSN will, with knowledge of the ’552 Patent,
`
`intentionally encourage medical care workers and individuals to administer the glycopyrrolate
`
`oral solution described in ANDA 216084 to patients to treat sialorrhea in a manner that infringes
`
`the ’552 Patent.
`
`30.
`
`Unless enjoined by this Court, upon FDA approval of ANDA No. 216084, MSN
`
`will contributorily infringe the ’552 Patent under 35 U.S.C. § 271(c) by making, using, offering
`
`to sell, importing, and/or selling the glycopyrrolate oral solution described in ANDA No.
`
`216084. On information and belief, MSN knows that the glycopyrrolate oral solution described
`
`in ANDA No. 216084 and the product labeling for that product, are especially made or adapted
`
`for use in infringing the ’552 Patent and are not suitable for substantial noninfringing use.
`
`6
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`Case 1:21-cv-01032-UNA Document 1 Filed 07/15/21 Page 7 of 10 PageID #: 7
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`31. MSN was aware of the existence of the ’552 Patent prior to filing ANDA No.
`
`216084, but took such action knowing that by doing so, they would infringe, actively induce
`
`infringement, and/or contribute to the infringement of the patents-in-suit.
`
`32.
`
`On information and belief, MSN acted without reasonable basis for a good faith
`
`belief that they would not be liable for infringing the ’552 Patent.
`
`33. MSN’s conduct renders this case “exceptional” as described in 35 U.S.C. § 285.
`
`34.
`
`Plaintiffs will be irreparably harmed if MSN is not enjoined from infringing the
`
`’552 Patent.
`
`SECOND CLAIM FOR RELIEF
`(Infringement of the ’396 Patent by MSN)
`
`35.
`
`Plaintiffs repeat and reallege each and every allegation contained in paragraphs 1
`
`through 34 hereof, as if fully set forth herein.
`
`36.
`
`Through the conduct alleged above, MSN has infringed, and continues to infringe,
`
`one or more claims of the ’396 Patent.
`
`37.
`
`By filing ANDA No. 216084 and seeking FDA approval to engage in the
`
`commercial manufacture, use, sale, marketing, distribution, and/or importation of the
`
`glycopyrrolate oral solution disclosed therein prior to the expiration of the ’396 Patent, MSN has
`
`infringed the ’396 Patent under 35 U.S.C. § 271(e)(2)(A).
`
`38.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the ’396 Patent.
`
`39.
`
`On information and belief, MSN will be actively involved in the infringement of
`
`the ’396 Patent through the manufacture, use, sale, marketing, distribution, and/or importation of
`
`glycopyrrolate oral solution described in ANDA No. 216084, if approved.
`
`7
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`
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`Case 1:21-cv-01032-UNA Document 1 Filed 07/15/21 Page 8 of 10 PageID #: 8
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`40.
`
`Unless enjoined by this Court, upon FDA approval of ANDA No. 216084, MSN
`
`will infringe the ’396 Patent under 35 U.S.C § 271(a) by making, using, offering to sell,
`
`importing, and/or selling the glycopyrrolate oral solution described in ANDA No. 216084.
`
`41.
`
`Unless enjoined by this Court, upon FDA approval of ANDA No. 216084, MSN
`
`will induce infringement of the ’396 Patent under 35 U.S.C. § 271(b) by making, using, offering
`
`to sell, importing, and/or selling the glycopyrrolate oral solution described in ANDA No.
`
`216084. On information and belief, through the product labeling for the glycopyrrolate oral
`
`solution described in ANDA No. 216084, MSN will, with knowledge of the ’396 Patent,
`
`intentionally encourage medical care workers and individuals to administer the glycopyrrolate
`
`oral solution described in ANDA 216084 to patients to treat sialorrhea in a manner that infringes
`
`the ’396 Patent.
`
`42.
`
`Unless enjoined by this Court, upon FDA approval of ANDA No. 216084, MSN
`
`will contributorily infringe the ’396 Patent under 35 U.S.C. § 271(c) by making, using, offering
`
`to sell, importing, and/or selling the glycopyrrolate oral solution described in ANDA No.
`
`216084. On information and belief, MSN knows that the glycopyrrolate oral solution described
`
`in ANDA No. 216084 and the product labeling for that product, are especially made or adapted
`
`for use in infringing the ’396 Patent and are not suitable for substantial noninfringing use.
`
`43. MSN was aware of the existence of the ’396 Patent prior to filing ANDA No.
`
`216084, but took such action knowing that by doing so, they would infringe, actively induce
`
`infringement, and/or contribute to the infringement of the patents-in-suit.
`
`44.
`
`On information and belief, MSN acted without reasonable basis for a good faith
`
`belief that they would not be liable for infringing the ’396 Patent.
`
`45. MSN’s conduct renders this case “exceptional” as described in 35 U.S.C. § 285.
`
`8
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`Case 1:21-cv-01032-UNA Document 1 Filed 07/15/21 Page 9 of 10 PageID #: 9
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`46.
`
`Plaintiffs will be irreparably harmed if MSN is not enjoined from infringing the
`
`’396 Patent.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiffs respectfully requests the following relief:
`
`A.
`
`An order adjudging and decreeing that MSN has infringed one or more
`
`claims of the patents-in-suit by submitting ANDA No. 216084, and that the making, using,
`
`offering to sell, or selling in the United States, or importing into the United States, of the
`
`glycopyrrolate oral solution described in ANDA No. 216084 by MSN will infringe, actively
`
`induce infringement, and/or contribute to the infringement of the patents-in-suit;
`
`B.
`
`An order pursuant to 35 U.S.C. § 271(e)(4)(A) decreeing that the effective
`
`date of any approval of ANDA No. 216084 be no earlier than the expiration date of the patents-
`
`in-suit, including any extensions and/or exclusivities;
`
`C.
`
`A permanent injunction pursuant to 35 U.S.C. § 271(e)(4)(B) restraining
`
`and enjoining MSN, its officers, agents, attorneys, and employees, and those acting in privity or
`
`concert with them, from engaging in the commercial manufacture, use, offer for sale, or sale
`
`within the United States, or importation into the United States, of the glycopyrrolate oral solution
`
`described in ANDA No. 216084 until the expiration date of the patents-in-suit, including any
`
`extensions and/or exclusivities;
`
`D.
`
`A declaration that the commercial manufacture, use, sale, marketing,
`
`distribution, and/or importation of the glycopyrrolate oral solution described in ANDA No.
`
`216084 will directly infringe, induce, or contribute to the infringement of the patents-in-suit;
`
`E.
`
`A declaration that this case is exceptional and an award of attorneys’ fees
`
`under 35 U.S.C. § 285 and costs and expenses in this action; and
`
`9
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`Case 1:21-cv-01032-UNA Document 1 Filed 07/15/21 Page 10 of 10 PageID #: 10
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`F.
`
`Such other and further relief as the Court may deem just and proper.
`
`Dated: July 15, 2021
`
`MCCARTER & ENGLISH, LLP
`
`OF COUNSEL:
`
`Jason A. Leonard
`Vincent Li
`HOGAN LOVELLS US LLP
`390 Madison Avenue
`New York, NY 10017
`(212) 918-3000
`jason.leonard@hoganlovells.com
`vincent.li@hoganlovells.com
`
`/s/ Daniel M. Silver
`Daniel M. Silver (#4758)
`Alexandra M. Joyce (#6423)
`Renaissance Centre
`405 N. King Street, 8th Floor
`Wilmington, Delaware 19801
`(302) 984-6300
`dsilver@mccarter.com
`ajoyce@mccarter.com
`
`Attorneys for Plaintiffs
`
`10
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