`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`CA. No.:
`
`) ) ) ) ) ) 3
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`) ) )
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`SANOFI and SANOFI-AVENTIS U.S. LLC,
`
`Plaintiffs,
`
`V.
`
`LUPIN ATLANTIS HOLDINGS S.A.,
`LUPIN LTD., and LUPIN
`PHARMACEUTICALS INC.,
`
`Defendants.
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiffs Sanofi and Sanofr-Aventis U.S. LLC (“Sanof1 U.S.”) (collectively,
`
`“Plaintiffs”) for their Complaint against defendants Lupin Atlantis Holdings S.A., Lupin Ltd.,
`
`and Lupin Pharmaceuticals Inc. (collectively “Defendants”) hereby allege as follows:
`
`THE PARTIES
`
`1.
`
`Plaintiff Sanofr is a corporation organized and existing under the laws of
`
`France, having its principal place of business at 54 rue La Boetie, 75008 Paris, France.
`
`2.
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`Plaintiff Sanofi U.S. is a wholly owned U.S. subsidiary of Sanofr and is a
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`company organized and existing under the laws of the state of Delaware, having commercial
`
`headquarters at 55 Corporate Drive, Bridgewater, New Jersey 08807.
`
`3.
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`Upon information and belief, Defendant Lupin Ltd.
`
`is a corporation
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`organized and existing under the laws of India, having its principal place of business at
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`B/4 Laxmi Towers, Bandra Kurla Complex, Bandra (E), Mumbai 400051, Maharashtra, India.
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`4.
`
`Upon information and belief, Defendant Lupin Atlantis Holdings S.A.
`
`(“Lupin Atlantis”) is a wholly-owned subsidiary of Lupin Ltd., and is a corporation organized
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`Janssen Ex. 2036
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`Lupin Ltd. v. Janssen Sciences Ireland UC
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`(Page 1 of 12)
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`and existing under the laws of Switzerland, with a principal place of business at Bachstrasse 56,
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`8200 Schaffhausen SH, Switzerland.
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`5.
`
`Upon information and belief, Defendant Lupin Pharmaceuticals,
`
`Inc.
`
`(“Lupin Pharmaceuticals”) is a wholly-owned subsidiary of Lupin Ltd. and is a corporation
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`organized and existing under the laws of the Commonwealth of Virginia, with a principal place
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`of business located at 111 S. Calvert Street, 2lst Floor, Baltimore, MD 21202.
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`JURISDICTION AND VENUE
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`6.
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`This is an action for patent infringement arising under the Patent Laws of
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`the United States and the Food and Drug Laws of the United States, Titles 35 and 21, United
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`States Code. This Court has jurisdiction over the subject matter of this action under 28 U.S.C.
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`§§1331,1338.
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`7.
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`This court has personal jurisdiction over Lupin Atlantis. On information
`
`and belief, Lupin Atlantis regularly does or solicits business in Delaware, engages in other
`
`persistent courses of conduct in Delaware, and/or derives substantial revenue from services or
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`things used or consumed in Delaware, demonstrating that Lupin Atlantis has continuous and
`
`systematic contacts with Delaware.
`
`8.
`
`On information and belief, Lupin Atlantis is in the business of researching,
`
`developing, manufacturing,
`
`and/or
`
`selling pharmaceutical products
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`that are distributed
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`throughout the United States, including in the state of Delaware. On information and belief,
`
`Lupin Atlantis directly or through its affiliates and agents formulates, manufactures, packages,
`
`markets, and/or sells pharmaceutical products throughout the United States, including in this
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`judicial district.
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`Janssen Ex. 2036
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`Lupin Ltd. v. Janssen Sciences Ireland UC
`|PR2015-01030
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`(Page 2 of 12)
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`9.
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`On information and belief, Lupin Atlantis has purposefully conducted
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`business in the state of Delaware, continues to conduct business in Delaware, and Delaware is a
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`likely destination of Lupin Atlantis’s products or the products of its affiliates or agents.
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`10.
`
`On information and belief, Lupin Atlantis has previously availed itself of
`
`this forum by filing lawsuits in this judicial district as a plaintiff, including but not limited to
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`Lupin Atlantis Holdings S.A. v. Ranbaxy Laboratories Limited, et al., 10-cv-659-SLR (D. Del.
`
`2010).
`
`11.
`
`Alternatively, assuming that the above facts do not establish personal
`
`jurisdiction over Lupin Atlantis,
`
`this Court may exercise jurisdiction over Lupin Atlantis
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`pursuant to Federal Rule of Civil Procedure 4(k)(2) because (a) Plaintiffs’ claims arise under
`
`federal law; (b) Lupin Atlantis is a foreign defendant not subject to personal jurisdiction in the
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`courts of any state; and (c) Lupin Atlantis has sufficient contacts with the United States as a
`
`whole, including but not limited to submitting an Abbreviated New Drug Application (ANDA)
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`to the U.S. Food and Drug Administration (FDA) and manufacturing and/or
`
`selling
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`pharmaceutical products distributed throughout the United States, such that this Court’s exercise
`
`ofjurisdiction over Lupin Atlantis satisfies due process.
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`12.
`
`This court has personal jurisdiction over Lupin Ltd. On information and
`
`belief, Lupin Ltd. regularly does or solicits business in Delaware, engages in other persistent
`
`courses of conduct in Delaware, and/or derives substantial revenue from services or things used
`
`or consumed in Delaware, demonstrating that Lupin Ltd. has continuous and systematic contacts
`
`with Delaware.
`
`13.
`
`On information and belief, Lupin Ltd. is in the business of researching,
`
`developing, manufacturing,
`
`and/or
`
`selling pharmaceutical products
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`that are distributed
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`Janssen Ex. 2036
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`Lupin Ltd. v. Janssen Sciences Ireland UC
`|PR2015-01030
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`(Page 3 of 12)
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`Case 1:15—cv—OO415—RGA Document 1 Filed 05/21/15 Page 4 of 12 Page|D #: 4
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`throughout the United States, including in the state of Delaware. On information and belief,
`
`Lupin Ltd. directly or through its affiliates and agents formulates, manufactures, packages,
`
`markets, and/or sells pharmaceutical products throughout the United States, including in this
`
`judicial district.
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`14.
`
`On information and belief, Lupin Ltd. has purposefully conducted
`
`business in the state of Delaware, continues to conduct business in Delaware, and Delaware is a
`
`likely destination of Lupin Ltd.’s products or the products of its affiliates or agents.
`
`15.
`
`On information and belief, Lupin Ltd. has previously availed itself of this
`
`forum by submitting to the jurisdiction of this court and asserting counterclaims in this judicial
`
`district in, for example, Vz'z'V Healthcare UK Lld.el al. v. Lupin Ltd, er al., 14-cv-369-LPS
`
`(D. Del. 2014).
`
`16.
`
`Alternatively, assuming that the above facts do not establish personal
`
`jurisdiction over Lupin Ltd., this Court may exercise jurisdiction over Lupin Ltd. pursuant to
`
`Federal Rule of Civil Procedure 4(k)(2) because (a) Plaintiffs’ claims arise under federal law;
`
`(b) Lupin Ltd.
`
`is a foreign defendant not subject to personal jurisdiction in the courts of any
`
`state; and (c) Lupin Ltd. has sufficient contacts with the United States as a whole, including but
`
`not limited to manufacturing and/or selling pharmaceutical products distributed throughout the
`
`United States, such that this Court’s exercise of jurisdiction over Lupin Atlantis satisfies due
`
`process.
`
`17.
`
`This court has personal jurisdiction over Lupin Pharmaceuticals. On
`
`information and belief, Lupin Pharmaceuticals regularly does or solicits business in Delaware,
`
`engages in other persistent courses of conduct in Delaware, and/or derives substantial revenue
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`Janssen Ex. 2036
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`Lupin Ltd. v. Janssen Sciences Ireland UC
`|PR2015-01030
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`(Page 4 of 12)
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`Case 1:15—cv—OO415—RGA Document 1 Filed 05/21/15 Page 5 of 12 Page|D #: 5
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`from services or
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`things used or consumed in Delaware, demonstrating that Lupin
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`Pharmaceuticals has continuous and systematic contacts with Delaware.
`
`18.
`
`On information and belief, Lupin Pharmaceuticals is in the business of
`
`researching, developing, manufacturing, and/or
`
`selling pharmaceutical products that are
`
`distributed throughout the United States, including in the state of Delaware. On information and
`
`belief, Lupin Pharmaceuticals directly or
`
`through its affiliates and agents
`
`formulates,
`
`manufactures, packages, markets, and/or sells pharmaceutical products throughout the United
`
`States, including in this judicial district.
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`19.
`
`On information and belief, Lupin Pharmaceuticals has purposefully
`
`conducted business in the state of Delaware, continues to conduct business in Delaware, and
`
`Delaware is a likely destination of Lupin Pharmaceutical’s products or the products of its
`
`affiliates or agents.
`
`20.
`
`On information and belief, Lupin Pharmaceuticals has previously availed
`
`itself of this forum by submitting to the jurisdiction of this court and asserting counterclaims in
`
`this judicial district in, for example, Viz'VHealIhcare UK Ltdet al. v. Lupin Ltd, el al., l4-cv-
`
`369-LPS (D. Del. 2014).
`
`21.
`
`On information and belief, upon approval of Lupin Atlantis’s ANDA No.
`
`205904, Defendants will market and sell Lupin Atlantis’s dronedarone hydrochloride tablets,
`
`eq. 400 mg base in Delaware and throughout the United States and will derive substantial
`
`revenue therefrom.
`
`22.
`
`On information and belief, upon approval of Lupin Atlantis’s ANDA No.
`
`205904, Defendants will place Lupin Atlantis’s Proposed Generic Product into the stream of
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`Janssen Ex. 2036
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`Lupin Ltd. v. Janssen Sciences Ireland UC
`|PR2015-01030
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`(Page 5 of 12)
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`commerce with the reasonable expectation or knowledge and the intent that such product will
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`ultimately be purchased and used by consumers in this judicial district.
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`23.
`
`On information and belief, this Court further has personal jurisdiction over
`
`Defendants because Defendants regularly do or solicit business in Delaware, engage in other
`
`persistent courses of conduct in Delaware, and/or derive substantial revenue from services or
`
`things used or consumed in Delaware and committed the tortious act of patent infringement
`
`under 35 U.S.C. § 27l(e)(2) that has led and/or will lead to foreseeable harm and injury to
`
`plaintiff Sanofi U.S., a Delaware corporation.
`
`24.
`
`This Court has personal jurisdiction over Defendants by virtue of, inter
`
`alia, the above-mentioned facts.
`
`25.
`
`Venue is proper in this judicial district pursuant to 28 U.S.C. § 1391 and
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`28 U.S.C. § 1400(b).
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`THE PATENTS-IN-SUIT
`
`26.
`
`Sanofi U.S. holds approved New Drug Application (“NDA”) No. 022425
`
`for dronedarone tablets, 400 mg, which are prescribed and sold in the United States under the
`
`trademark Multaq®. The FDA approved NDA No. 022425 on July 1, 2009.
`
`27.
`
`Multaq® tablets are indicated to reduce the risk of hospitalization for atrial
`
`fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial
`
`fibrillation.
`
`28.
`
`United States Patent No. 8,318,800 (“the ’800 patent,” copy attached as
`
`Exhibit A) is entitled “Solid Pharmaceutical Compositions Containing Benzofuran Derivatives”
`
`and was duly and legally issued by the United States Patent and Trademark Office (USPTO) on
`
`November 27, 2012. The ’800 patent claims, inter alia, pharmaceutical compositions containing
`
`Janssen Ex. 2036
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`Lupin Ltd. v. Janssen Sciences Ireland UC
`|PR2015-01030
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`(Page 6 of 12)
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`Case 1:15—cv—OO415—RGA Document 1 Filed 05/21/15 Page 7 of 12 Page|D #: 7
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`dronedarone. The ’800 patent is listed in the Orange Book for Multaq® tablets (NDA No.
`
`022425)
`
`29.
`
`The named inventors on the ’800 patent are Bernard Abramovici, Jean-
`
`Claude Gautier, Jean-Claude Gromenil, and Jean-Marie Marrier. The ’800 patent is assigned to
`
`Sanofi.
`
`30.
`
`United States Patent No. 8,410,167 (“the ’167 patent,” copy attached as
`
`Exhibit B) is entitled “Use of Dronedarone for the Preparation of a Medicament for Use in the
`
`Prevention of Cardiovascular Hospitalization or of Mortality” and was duly and legally issued by
`
`the USPTO on April 2, 2013. The ’167 patent claims, inter alia, methods of decreasing the risk
`
`of cardiovascular hospitalization in certain patients by administering dronedarone. The ’167
`
`patent is listed in the Orange Book for Multaq® tablets (NDA No. 022425).
`
`31.
`
`The named inventors on the ’167 patent are Davide Radzik, Martin Van
`
`Eickels, Nacera Hamdani, and Christophe Gaudin. The ’167 patent is assigned to Sanofi.
`
`CLAIMS FOR RELIEF — PATENT INFRINGEMENT
`
`32.
`
`Lupin Atlantis submitted ANDA No. 205904 to the FDA seeking approval
`
`to engage in the commercial manufacture, use, offer for sale, sale, and/or importation of
`
`dronedarone hydrochloride tablets, eq. 400 mg base (“Lupin Atlantis’s Proposed Generic
`
`Product”).
`
`33.
`
`On information and belief, ANDA No. 205904 seeks FDA approval of
`
`Lupin Atlantis’s Proposed Generic Product
`
`for
`
`the indication of reducing the risk of
`
`hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or
`
`persistent atrial fibrillation.
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`Janssen Ex. 2036
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`Lupin Ltd. v. Janssen Sciences Ireland UC
`|PR2015-01030
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`(Page 7 of 12)
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`Case 1:15—cv—OO415—RGA Document 1 Filed 05/21/15 Page 8 of 12 Page|D #: 8
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`34.
`
`On information and belief, Lupin Ltd. and Lupin Pharmaceuticals actively
`
`participated in and/or directed activities related to the submission of ANDA No. 205904 and the
`
`research and development of Lupin Atlantis’s Proposed Generic Product, were actively involved
`
`in preparing the ANDA, and/or intend to directly benefit from and have a financial stake in the
`
`approval of the ANDA.
`
`35.
`
`On information and belief, upon approval of Lupin Atlantis’s ANDA,
`
`Lupin Ltd. and Lupin Pharmaceuticals will be involved in the manufacture,
`
`formulation,
`
`distribution, and/or marketing of Lupin Atlantis’s Proposed Generic Product.
`
`36.
`
`By letter dated April 6, 2015, and pursuant to 21 U.S.C. § 355(j)(2)(B) and
`
`21 C.F.R. § 314.95(c), Lupin Atlantis notified Plaintiffs that it had submitted ANDA No. 205904
`
`to the FDA seeking approval
`
`to engage in the commercial manufacture, use, sale, and/or
`
`importation of Lupin Atlantis’s Proposed Generic Product before the expiration of the ’800
`
`patent and the ’167 patent.
`
`37.
`
`In its April 6, 2015 letter, Lupin Atlantis notified Plaintiffs that, as a part
`
`of its ANDA,
`
`it had filed a certification of the type described in 21 U.S.C. § 355(j)(2)(A)
`
`(vii)(IV) (a “Paragraph IV Certification”) with respect to the ’800 patent and the ’167 patent. On
`
`information and belief, Lupin certified that, in its opinion and to the best of its knowledge, the
`
`’800 patent and the ’167 patent are invalid and/or will not be infringed by the manufacture, use,
`
`or sale of Lupin Atlantis’s Proposed Generic Product.
`
`Infringement of U.S. Patent No. 8,318,800 Under 35 U.S.C. §271(e)(2)
`
`COUNT I
`
`38.
`
`Plaintiffs repeat and reallege paragraphs 1 through 37 as if fully set forth
`
`herein.
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`Janssen Ex. 2036
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`|PR2015-01030
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`(Page 8 of 12)
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`Case 1:15—cv—OO415—RGA Document 1 Filed 05/21/15 Page 9 of 12 Page|D #: 9
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`39.
`
`By submitting ANDA No. 205904 to the FDA to obtain approval under
`
`the Food, Drug, and Cosmetic Act to engage in the commercial manufacture, use, offer for sale,
`
`sale, and/or importation of Lupin Atlantis’s Proposed Generic Product throughout the United
`
`States prior to the expiration of the ’800 patent, Defendants committed an act of infringement of
`
`the ’800 patent under 35 U.S.C. §271(e)(2). On information and belief, Lupin was aware of the
`
`’800 patent at the time the ANDA was submitted.
`
`40.
`
`The commercial manufacture, use, offer for sale, sale, and/or importation
`
`of Lupin Atlantis’s Proposed Generic Product, for which Lupin seeks approval in ANDA No.
`
`205904, will infringe, induce infringement, and/or contributorily infringe one or more claims of
`
`the ’800 patent under 35 U.S.C. §§ 27l(a), 27l(b), and/or 27l(c).
`
`41.
`
`Plaintiffs will be irreparably harmed by Lupin’s infringing activities and
`
`do not have an adequate remedy at law.
`
`Infringement of U.S. Patent No. 8,410,167 Under 35 U.S.C. §271(e)(2)
`
`COUNT II
`
`42.
`
`Plaintiffs repeat and reallege paragraphs 1 through 41 as if fully set forth
`
`herein.
`
`43.
`
`By submitting ANDA No. 205904 to the FDA to obtain approval under
`
`the Food, Drug, and Cosmetic Act to engage in the commercial manufacture, use, offer for sale,
`
`sale, and/or importation of Lupin Atlantis’s Proposed Generic Product throughout the United
`
`States prior to the expiration of the ’167 patent, Defendants committed an act of infringement of
`
`the ’167 patent under 35 U.S.C. §271(e)(2). On information and belief, Defendants were aware
`
`of the ’167 patent at the time the ANDA was submitted.
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`Janssen Ex. 2036
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`Lupin Ltd. v. Janssen Sciences Ireland UC
`|PR2015-01030
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`(Page 9 of 12)
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`44.
`
`Lupin Atlantis’s Proposed Generic Product will have the same clinical
`
`instructions on use, be administered in the same manner, and achieve the same results as
`
`Plaintiffs’ Multaq® product.
`
`45.
`
`Lupin Atlantis’s Proposed Generic Product label will
`
`instruct doctors,
`
`caregivers, and/or patients to practice the methods claimed in the ’l67 patent.
`
`46.
`
`The commercial manufacture, use, offer for sale, sale, and/or importation
`
`of Lupin Atlantis’s Proposed Generic Product, for which Lupin Atlantis seeks approval
`
`in
`
`ANDA No. 205904, will infringe, induce infringement, and/or contributorily infringe one or
`
`more claims of the ’l67 patent under 35 U.S.C. §§ 27l(a), 27l(b), and/or 27l(c).
`
`47.
`
`Plaintiffs will be irreparably harmed by Defendants’ infringing activities
`
`and do not have an adequate remedy at law.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiffs pray for a judgment
`
`in their
`
`favor and against
`
`Defendants and respectfully request the following relief:
`
`A.
`
`A judgment
`
`that under 35 U.S.C.
`
`§ 27l(e)(2)(A), Defendants have
`
`infringed one or more claims of the ’800 patent by submitting ANDA No. 205904 seeking FDA
`
`approval for the commercial manufacture, use, offer for sale, sale, and/or importation of Lupin
`
`Atlantis’s Proposed Generic Product before the expiration of the ’800 patent.
`
`B.
`
`A judgment
`
`that
`
`the manufacture, use, offer
`
`for sale,
`
`sale, and/or
`
`importation of Lupin Atlantis’s Proposed Generic Product will infringe the ’800 patent;
`
`C.
`
`D.
`
`A judgment declaring that the ’800 patent remains valid and enforceable;
`
`A permanent injunction restraining and enjoining Defendants and their
`
`officers, agents, attorneys, and employees, and those acting in privity or concert therewith, from
`
`10
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`Janssen Ex. 2036
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`Lupin Ltd. v. Janssen Sciences Ireland UC
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`(Page 10 of 12)
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`
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`engaging in the commercial manufacture, use, offer for sale, sale, and/or importation of Lupin
`
`Atlantis’s Proposed Generic Product until the expiration of the ’8OO patent or any later date of
`
`exclusivity to which Plaintiffs are or become entitled;
`
`E.
`
`An order that the effective date of any approval of ANDA No. 205904
`
`under Section 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(j)) shall be a
`
`date that is not earlier than the expiration of the ’8OO Patent or any later date of exclusivity to
`
`which Plaintiffs and/or this patent are or become entitled;
`
`F.
`
`A judgment
`
`that under 35 U.S.C.
`
`§ 27l(e)(2)(A), Defendants have
`
`infringed one or more claims of the ’l67 patent by submitting ANDA No. 205904 seeking FDA
`
`approval for the commercial manufacture, use, offer for sale, sale, and/or importation of Lupin
`
`Atlantis’s Proposed Generic Product before the expiration of the ’l67 patent;
`
`G.
`
`A judgment
`
`that
`
`the manufacture, use, offer
`
`for sale,
`
`sale, and/or
`
`importation of Lupin Atlantis’s Proposed Generic Product will infringe the ’ 167 patent;
`
`H.
`
`I.
`
`A judgment declaring that the ’l67 patent remains valid and enforceable;
`
`A permanent injunction restraining and enjoining Defendants and their
`
`officers, agents, attorneys, and employees, and those acting in privity or concert therewith, from
`
`engaging in the commercial manufacture, use, offer for sale, sale, and/or importation of Lupin
`
`Atlantis’s Proposed Generic Product until the expiration of the ’l67 patent or any later date of
`
`exclusivity to which Plaintiffs are or become entitled;
`
`J .
`
`An order that the effective date of any approval of ANDA No. 205904
`
`under Section 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(j)) shall be a
`
`date that is not earlier than the expiration of the ’l67 patent or any later date of exclusivity to
`
`which Plaintiffs and/or this patent are or become entitled;
`
`ll
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`Janssen Ex. 2036
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`(Page 11 of 12)
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`K.
`
`A determination that this case is “exceptional” under 35 U.S.C. § 285 and
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`an award of attorneys’ fees;
`
`L.
`
`Costs and expenses in this action; and
`
`M.
`
`Such other and further relief as the Court may deem just and proper.
`
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`
`/3/®e1’e@]. Tafmestocfi
`
`Jack B. Blumenfeld (#1014)
`Derek J. Fahnestock (#4705)
`1201 North Market Street
`
`P.O. 1347
`
`Wilmington, DE 19899
`(3 02) 658-9200
`jblumenfeld@mnat.com
`dfahnestock@mnat.com
`
`Attorneysfor Plaintiffs Scmofi and Scm0f-
`Aventis US. LLC
`
`OF COUNSEL:
`
`William E. Solander
`
`James R. Tyminski
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`
`New York, NY 10104
`(212) 218-2100
`
`May 21, 2015
`9169566
`
`12
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`Janssen Ex. 2036
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`(Page 12 of 12)