Case 1:20-cv-01760-UNA Document 1 Filed 12/23/20 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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`MERZ PHARMACEUTICALS, LLC and
`MERZ NORTH AMERICA, INC.,
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`Plaintiffs,
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`v.
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`AUROBINDO PHARMA LTD, and
`AUROBINDO PHARMA USA INC.
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`Defendants.
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`C.A. No. ___________________
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`COMPLAINT FOR PATENT INFRINGEMENT
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`Plaintiffs Merz Pharmaceuticals, LLC (“Merz LLC”) and Merz North America, Inc.
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`(“Merz N.A.”) (together, “Merz” or “Plaintiffs”) bring this action against Defendant Aurobindo
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`Pharma Ltd., (“APL”) and Aurobindo Pharma USA Inc. (“APUI,” collectively, “Aurobindo” or
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`“Defendants”), and allege as follows:
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`NATURE OF THE ACTION
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`1.
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`This is an action for patent infringement of United States Patent Nos. 7,638,552
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`(“the ’552 Patent”) and 7,816,396 (“the ’396 Patent,” collectively, the “patents-in-suit”), arising
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`under the United States patent laws, Title 35, United States Code. This action relates to
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`Aurobindo’s filing of Abbreviated New Drug Application (“ANDA”) No. 214847 under section
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`505(j) of the Federal Food, Drug and Cosmetic Act (“the Act”), 21 U.S.C. § 355(j), seeking
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`United States Food and Drug Administration (“FDA”) approval to manufacture and sell a
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`generic version of Plaintiffs’ CUVPOSA® (glycopyrrolate), 1mg/5mL oral solution
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`(“CUVPOSA®”) prior to the expiration of the ’552 and the ’396 Patents.
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`2.
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`By letter dated November 16, 2020, Defendant Aurobindo notified Plaintiff Merz
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`LLC that it had filed ANDA No. 214847, seeking FDA approval to manufacture and sell a
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`generic version of Plaintiffs’ CUVPOSA®.
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`THE PARTIES
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`3.
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`Plaintiff Merz LLC is a limited liability company organized and existing under
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`the laws of North Carolina, with a principal place of business at 6501 Six Forks Road, Raleigh,
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`North Carolina 27615. Plaintiff Merz LLC is in the business of, inter alia, holding intellectual
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`property and regulatory approval rights to innovative pharmaceutical products.
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`4.
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`Plaintiff Merz N.A. is a corporation organized and existing under the laws of the
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`State of North Carolina, having a principal place of business at 6501 Six Forks Road, Raleigh,
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`North Carolina 27615. Plaintiff Merz N.A. is in the business of, inter alia, researching,
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`developing, manufacturing, marketing, promoting, selling, distributing, and/or obtaining
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`regulatory approval for innovative pharmaceutical products throughout the United States,
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`including in this judicial district.
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`5.
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`On information and belief, Defendant APL is a corporation that is incorporated in
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`India, having a principal place of business at Plot No 2, Maitrivihar, Behind Maitrivanam,
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`Ameerpet, Hyderabad, Telangana TS 500038 IN.
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`6.
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`On information and belief, Defendant APUI is a corporation that is incorporated
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`in Delaware, having a principal place of business at 279 Princeton-Hightstown Rd, East
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`Windsor, NJ 08520-1401.
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`7.
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`On information and belief, Defendant APUI is a wholly owned subsidiary of
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`APL.
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`8.
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`On information and belief, Aurobindo, by itself and/or through its affiliates and
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`agents, is in the business of, inter alia, developing, manufacturing, and obtaining regulatory
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`approval of generic copies of branded pharmaceutical products for distribution and sale
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`throughout the United States, including within the State of Delaware.
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`9.
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`On information and belief, Aurobindo has filed ANDA No. 214847 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. 214847 if it is approved.
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`10.
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`On information and belief, and consistent with their past practices, APL and
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`APUI acted collaboratively in the preparation and submission of ANDA No. 214847.
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`11.
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`On information and belief, and consistent with their past practices, following any
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`FDA approval of ANDA No. 214847, APL and APUI will work in concert with one another to
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`make, use, offer to sell, and/or sell the generic drug products that are the subject of ANDA No.
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`214847 throughout the United States, and/or import such generic drug products into the United
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`States, including in this judicial district.
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`JURISDICTION AND VENUE
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`12.
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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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`13.
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`This Court has personal jurisdiction over APL because APL, through its wholly-
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`owned subsidiary APUI, has purposely availed itself of the benefits and protections of
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`Delaware’s laws, as it develops, manufactures, imports, markets, distributes, uses, offers to sell,
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`and/or sells generic drugs throughout the United States, including the State of Delaware.
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`Therefore, APL transacts business related to Merz’s claims and/or has engaged in systematic and
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`continuous business contacts within the State of Delaware.
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`14.
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`Alternatively, to the extent the above facts do not establish personal jurisdiction
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`over APL, this Court may exercise jurisdiction over APL pursuant to Federal Rule of Civil
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`Procedure 4(k)(2) because (a) Plaintiffs’ claims arise under federal law; (b) APL is a foreign
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`defendant not subject to personal jurisdiction in the courts of any state; and (c) APL has
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`sufficient contacts within the United States as a whole, including but not limited to preparing and
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`submitting an ANDA to the FDA and/or manufacturing and/or selling pharmaceutical products
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`distributed throughout the United States, such that this Court’s exercise of jurisdiction over APL
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`satisfies due process.
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`15.
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`This Court has personal jurisdiction over APUI for purposes of this civil action
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`because, inter alia, APUI, on information and belief, is incorporated in the State of Delaware.
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`16.
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`This Court also has personal jurisdiction over APUI for purposes of this civil
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`action because, inter alia, APUI has purposely availed itself of the benefits and protections of
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`Delaware’s laws, as it develops, manufactures, imports, markets, distributes, uses, offers to sell,
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`and/or sells generic drugs throughout the United States, including the State of Delaware.
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`Therefore, APL transacts business related to Merz’s claims and/or has engaged in systematic and
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`continuous business contacts within the State of Delaware.
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`17.
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`This Court has personal jurisdiction over Aurobindo for purposes of this civil
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`action because, inter alia, Aurobindo has filed ANDA No. 214847 and intends to make, use,
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`offer for sale, sell and/or import its proposed ANDA product in the United States, including
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`Delaware, prior to the expiration of the patents-in-suit if ANDA No. 214847 is approved. Such
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`acts will lead to foreseeable harm to Plaintiffs in Delaware.
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`18.
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`On information and belief, Aurobindo has not challenged personal jurisdiction in
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`this Court in one or more prior cases arising out of the filing of its ANDAs. See, e.g., Merck
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`Sharp & Dohme Corp. v. Aurobindo Pharma Ltd et al., C.A. No. 20-1099 (D. Del.); Novartis
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`Pharmaceuticals Corp. v. Aurobindo Pharma Ltd. et al., C.A. No. 20-1426 (D. Del.); Pfizer Inc.
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`et al. v. Aurobindo Pharma Ltd. et al., C.A. No. 20-1528 (D. Del.).
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`19.
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`On information and belief, Aurobindo has previously submitted to the jurisdiction
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`of this Court and has availed itself of the legal protections of the State of Delaware, having
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`asserted counterclaims in this jurisdiction. See, e.g., Merck Sharp & Dohme Corp. v. Aurobindo
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`Pharma Ltd et al., C.A. No. 20-1099 (D. Del.); Novartis Pharmaceuticals Corp. v. Aurobindo
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`Pharma Ltd. et al., C.A. No. 20-1426 (D. Del.); Pfizer Inc. et al. v. Aurobindo Pharma Ltd. et
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`al., C.A. No. 20-1528 (D. Del.).
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`20.
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`Venue is proper in this Court pursuant to 28 U.S.C. §§ 1391 and 1400(b).
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`THE PATENTS-IN-SUIT AND CUVPOSA®
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`21.
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`On December 29, 2009, the United States Patent and Trademark Office (“PTO”)
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`issued the ’552 Patent, entitled “Method for Increasing The Bioavailability of Glycopyrrolate,”
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`to Sciele Pharma, Inc., the initial assignee of the named inventors, Alan Roberts and Balaji
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`Venkataraman. The ’552 Patent was subsequently assigned to Shiongi Pharma, Inc. on January
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`11, 2010; to Shionogi Inc. on March 31, 2011; and then to Plaintiff Merz LLC on August 24,
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`2012. Plaintiff Merz LLC is the current record owner of the ’552 Patent. A copy of the ’552
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`Patent is attached hereto as Exhibit A.
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`22.
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`On October 19, 2010, the PTO issued the ’396 Patent, entitled “Method for
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`Increasing The Bioavailability of Glycopyrrolate,” to Sciele Pharma, Inc., the initial assignee of
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`the named inventors, Alan Roberts and Balaji Venkataraman. The ’396 Patent was subsequently
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`assigned to Shionogi Pharma, Inc. on January 11, 2010; to Shionogi Inc. on March 31, 2011; and
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`then to Plaintiff Merz LLC on August 24, 2012. Plaintiff Merz LLC is the current record owner
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`of the ’396 Patent. A copy of the ’396 Patent is attached hereto as Exhibit B.
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`23.
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`On July 28, 2010, the FDA approved New Drug Application (“NDA”) No.
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`022571 for CUVPOSA®. Plaintiff Merz LLC is the holder of NDA No. 022571 for
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`CUVPOSA®.
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`24.
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`In the publication entitled Approved Drug Products with Therapeutic Equivalence
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`Evaluations (known as the “Orange Book”), the patents-in-suit are listed as covering
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`CUVPOSA®.
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`DEFENDANTS’ ANDA
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`25.
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`On information and belief, Aurobindo reviewed the patents-in-suit and certain
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`commercial and economic information relating to CUVPOSA®, including estimates of the
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`revenues generated by the sale of CUVPOSA®, and decided to file an ANDA, seeking approval
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`to market a glycopyrrolate oral solution.
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`26.
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`On information and belief, Aurobindo submitted to the FDA ANDA No. 214847
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`seeking approval to engage in the commercial manufacture, use, and sale of glycopyrrolate oral
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`solution, prior to the expiration of the patents-in-suit.
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`27.
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`On information and belief, Aurobindo will manufacture, sell, market, and/or
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`distribute a glycopyrrolate oral solution upon FDA approval of ANDA No. 214847.
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`28. Merz LLC received a letter dated November 16, 2020 from Aurobindo notifying
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`Merz LLC that ANDA No. 214847 includes a certification under 21 U.S.C. §
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`355(j)(2)(A)(vii)(IV) (a “Paragraph IV certification”) that, in Aurobindo’s opinion, the patents-
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`in-suit are invalid, unenforceable, or will not be infringed by the commercial manufacture, use,
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`or sale of the glycopyrrolate oral solution described in ANDA No. 214847.
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`29.
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`Plaintiffs commenced this action within 45 days of the date they received
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`Aurobindo’s notice of ANDA No. 214847 containing the Paragraph IV certification.
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`FIRST CLAIM FOR RELIEF
`(Infringement of the ’552 Patent by Aurobindo)
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`30.
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`Plaintiffs repeat and reallege each and every allegation contained in paragraphs 1
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`through 29 hereof, as if fully set forth herein.
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`31.
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`Through the conduct alleged above, Aurobindo has infringed, and continues to
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`infringe, one or more claims of the ’552 Patent.
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`32.
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`By filing ANDA No. 214847 and seeking FDA approval to engage in the
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`commercial manufacture, use, sale, marketing, distribution, and/or importation of the
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`glycopyrrolate oral solution disclosed therein prior to the expiration of the ’552 Patent,
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`Aurobindo has infringed the ’552 Patent under 35 U.S.C. § 271(e)(2)(A).
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`33.
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`There is a justiciable controversy between the parties hereto as to the infringement
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`of the ’552 Patent.
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`34.
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`On information and belief, Aurobindo will be actively involved in the
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`infringement of the ’552 Patent through the manufacture, use, sale, marketing, distribution,
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`and/or importation of glycopyrrolate oral solution described in ANDA No. 214847, if approved.
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`35.
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`Unless enjoined by this Court, upon FDA approval of ANDA No. 214847,
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`Aurobindo will infringe the ’552 Patent under 35 U.S.C § 271(a) by making, using, offering to
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`sell, importing, and/or selling the glycopyrrolate oral solution described in ANDA No. 214847.
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`36.
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`Unless enjoined by this Court, upon FDA approval of ANDA No. 214847,
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`Aurobindo will induce infringement of the ’552 Patent under 35 U.S.C. § 271(b) by making,
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`using, offering to sell, importing, and/or selling the glycopyrrolate oral solution described in
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`ANDA No. 214847. On information and belief, through the product labeling for the
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`glycopyrrolate oral solution described in ANDA No. 214847, Aurobindo will, with knowledge of
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`the ’552 Patent, intentionally encourage medical care workers and individuals to administer the
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`glycopyrrolate oral solution described in ANDA 214847 to patients to treat sialorrhea in a
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`manner that infringes the ’552 Patent.
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`37.
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`Unless enjoined by this Court, upon FDA approval of ANDA No. 214847,
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`Aurobindo will contributorily infringe the ’552 Patent under 35 U.S.C. § 271(c) by making,
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`using, offering to sell, importing, and/or selling the glycopyrrolate oral solution described in
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`ANDA No. 214847. On information and belief, Aurobindo knows that the glycopyrrolate oral
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`solution described in ANDA No. 214847 and the product labeling for that product, are especially
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`made or adapted for use in infringing the ’552 Patent and are not suitable for substantial
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`noninfringing use.
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`38.
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`Aurobindo was aware of the existence of the ’552 Patent prior to filing ANDA
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`No. 214847, but took such action knowing that by doing so, they would infringe, actively induce
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`infringement, and/or contribute to the infringement of the patents-in-suit.
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`39.
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`On information and belief, Aurobindo acted without reasonable basis for a good
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`faith belief that they would not be liable for infringing the ’552 Patent.
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`40.
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`Aurobindo’s conduct renders this case “exceptional” as described in 35 U.S.C. §
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`285.
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`41.
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`Plaintiffs will be irreparably harmed if Aurobindo is not enjoined from infringing
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`the ’552 Patent.
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`SECOND CLAIM FOR RELIEF
`(Infringement of the ’396 Patent by Aurobindo)
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`42.
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`Plaintiffs repeat and reallege each and every allegation contained in paragraphs 1
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`through 41 hereof, as if fully set forth herein.
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`43.
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`Through the conduct alleged above, Aurobindo has infringed, and continues to
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`infringe, one or more claims of the ’396 Patent.
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`44.
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`By filing ANDA No. 214847 and seeking FDA approval to engage in the
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`commercial manufacture, use, sale, marketing, distribution, and/or importation of the
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`glycopyrrolate oral solution disclosed therein prior to the expiration of the ’396 Patent,
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`Aurobindo has infringed the ’396 Patent under 35 U.S.C. § 271(e)(2)(A).
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`45.
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`There is a justiciable controversy between the parties hereto as to the infringement
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`of the ’396 Patent.
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`46.
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`On information and belief, Aurobindo will be actively involved in the
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`infringement of the ’396 Patent through the manufacture, use, sale, marketing, distribution,
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`and/or importation of glycopyrrolate oral solution described in ANDA No. 214847, if approved.
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`47.
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`Unless enjoined by this Court, upon FDA approval of ANDA No. 214847,
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`Aurobindo will infringe the ’396 Patent under 35 U.S.C § 271(a) by making, using, offering to
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`sell, importing, and/or selling the glycopyrrolate oral solution described in ANDA No. 214847.
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`48.
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`Unless enjoined by this Court, upon FDA approval of ANDA No. 214847,
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`Aurobindo will induce infringement of the ’396 Patent under 35 U.S.C. § 271(b) by making,
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`using, offering to sell, importing, and/or selling the glycopyrrolate oral solution described in
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`ANDA No. 214847. On information and belief, through the product labeling for the
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`glycopyrrolate oral solution described in ANDA No. 214847, Aurobindo will, with knowledge of
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`the ’396 Patent, intentionally encourage medical care workers and individuals to administer the
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`glycopyrrolate oral solution described in ANDA 214847 to patients to treat sialorrhea in a
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`manner that infringes the ’396 Patent.
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`49.
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`Unless enjoined by this Court, upon FDA approval of ANDA No. 214847,
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`Aurobindo will contributorily infringe the ’396 Patent under 35 U.S.C. § 271(c) by making,
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`using, offering to sell, importing, and/or selling the glycopyrrolate oral solution described in
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`ANDA No. 214847. On information and belief, Aurobindo knows that the glycopyrrolate oral
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`solution described in ANDA No. 214847 and the product labeling for that product, are especially
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`made or adapted for use in infringing the ’396 Patent and are not suitable for substantial
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`noninfringing use.
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`50.
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`Aurobindo was aware of the existence of the ’396 Patent prior to filing ANDA
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`No. 214847, but took such action knowing that by doing so, they would infringe, actively induce
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`infringement, and/or contribute to the infringement of the patents-in-suit.
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`51.
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`On information and belief, Aurobindo acted without reasonable basis for a good
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`faith belief that they would not be liable for infringing the ’396 Patent.
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`52.
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`Aurobindo’s conduct renders this case “exceptional” as described in 35 U.S.C. §
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`285.
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`53.
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`Plaintiffs will be irreparably harmed if Aurobindo is not enjoined from infringing
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`the ’396 Patent.
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`PRAYER FOR RELIEF
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`WHEREFORE, Plaintiffs respectfully request the following relief:
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`A.
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`An order adjudging and decreeing that Aurobindo has infringed one or
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`more claims of the patents-in-suit by submitting ANDA No. 214847, and that the making, using,
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`offering to sell, or selling in the United States, or importing into the United States, of the
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`glycopyrrolate oral solution described in ANDA No. 214847 by Aurobindo will infringe,
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`actively induce infringement, and/or contribute to the infringement of the patents-in-suit;
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`B.
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`An order pursuant to 35 U.S.C. § 271(e)(4)(A) decreeing that the effective
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`date of any approval of ANDA No. 214847 be no earlier than the expiration date of the patents-
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`in-suit, including any extensions and/or exclusivities;
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`C.
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`A permanent injunction pursuant to 35 U.S.C. § 271(e)(4)(B) restraining
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`and enjoining Aurobindo, its officers, agents, attorneys, and employees, and those acting in
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`privity or concert with them, from engaging in the commercial manufacture, use, offer for sale,
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`or sale within the United States, or importation into the United States, of the glycopyrrolate oral
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`solution described in ANDA No. 214847 until the expiration date of the patents-in-suit,
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`including any extensions and/or exclusivities;
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`D.
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`A declaration that the commercial manufacture, use, sale, marketing,
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`distribution, and/or importation of the glycopyrrolate oral solution described in ANDA No.
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`214847 will directly infringe, induce, or contribute to the infringement of the patents-in-suit;
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`E.
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`A declaration that this case is exceptional and an award of attorneys’ fees
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`under 35 U.S.C. § 285 and costs and expenses in this action; and
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`F.
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`Such other and further relief as the Court may deem just and proper.
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`Dated: December 23, 2020
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`OF COUNSEL:
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`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
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`MCCARTER & ENGLISH, LLP
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`
`/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
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`Attorneys for Plaintiffs
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