Case 1:15—cv—OO415—RGA Document 1 Filed 05/21/15 Page 1 of 12 Page|D #: 1
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`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
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`CA. No.:
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`) ) ) ) ) ) 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
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`Plaintiffs Sanofi and Sanofr-Aventis U.S. LLC (“Sanof1 U.S.”) (collectively,
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`“Plaintiffs”) for their Complaint against defendants Lupin Atlantis Holdings S.A., Lupin Ltd.,
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`and Lupin Pharmaceuticals Inc. (collectively “Defendants”) hereby allege as follows:
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`THE PARTIES
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`1.
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`Plaintiff Sanofr is a corporation organized and existing under the laws of
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`France, having its principal place of business at 54 rue La Boetie, 75008 Paris, France.
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`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
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`headquarters at 55 Corporate Drive, Bridgewater, New Jersey 08807.
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`3.
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`Upon information and belief, Defendant Lupin Ltd.
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`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.
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`Upon information and belief, Defendant Lupin Atlantis Holdings S.A.
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`(“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
`|PR2015-01030
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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.
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`Upon information and belief, Defendant Lupin Pharmaceuticals,
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`Inc.
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`(“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
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`and belief, Lupin Atlantis regularly does or solicits business in Delaware, engages in other
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`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
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`systematic contacts with Delaware.
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`8.
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`On information and belief, Lupin Atlantis is in the business of researching,
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`developing, manufacturing,
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`and/or
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`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,
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`Lupin Atlantis directly or through its affiliates and agents formulates, manufactures, packages,
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`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.
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`On information and belief, Lupin Atlantis has previously availed itself of
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`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.
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`2010).
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`11.
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`Alternatively, assuming that the above facts do not establish personal
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`jurisdiction over Lupin Atlantis,
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`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
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`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
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`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
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`selling
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`pharmaceutical products distributed throughout the United States, such that this Court’s exercise
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`ofjurisdiction over Lupin Atlantis satisfies due process.
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`12.
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`This court has personal jurisdiction over Lupin Ltd. On information and
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`belief, Lupin Ltd. regularly does or solicits business in Delaware, engages in other persistent
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`courses of conduct in Delaware, and/or derives substantial revenue from services or things used
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`or consumed in Delaware, demonstrating that Lupin Ltd. has continuous and systematic contacts
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`with Delaware.
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`13.
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`On information and belief, Lupin Ltd. is in the business of researching,
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`developing, manufacturing,
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`and/or
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`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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`throughout the United States, including in the state of Delaware. On information and belief,
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`Lupin Ltd. directly or through its affiliates and agents formulates, manufactures, packages,
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`markets, and/or sells pharmaceutical products throughout the United States, including in this
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`judicial district.
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`14.
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`On information and belief, Lupin Ltd. 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 Ltd.’s products or the products of its affiliates or agents.
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`15.
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`On information and belief, Lupin Ltd. has previously availed itself of this
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`forum by submitting to the jurisdiction of this court and asserting counterclaims in this judicial
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`district in, for example, Vz'z'V Healthcare UK Lld.el al. v. Lupin Ltd, er al., 14-cv-369-LPS
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`(D. Del. 2014).
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`16.
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`Alternatively, assuming that the above facts do not establish personal
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`jurisdiction over Lupin Ltd., this Court may exercise jurisdiction over Lupin Ltd. pursuant to
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`Federal Rule of Civil Procedure 4(k)(2) because (a) Plaintiffs’ claims arise under federal law;
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`(b) Lupin Ltd.
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`is a foreign defendant not subject to personal jurisdiction in the courts of any
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`state; and (c) Lupin Ltd. has sufficient contacts with the United States as a whole, including but
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`not limited to manufacturing and/or selling pharmaceutical products distributed throughout the
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`United States, such that this Court’s exercise of jurisdiction over Lupin Atlantis satisfies due
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`process.
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`17.
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`This court has personal jurisdiction over Lupin Pharmaceuticals. On
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`information and belief, Lupin Pharmaceuticals regularly does or solicits business in Delaware,
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`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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`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.
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`18.
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`On information and belief, Lupin Pharmaceuticals is in the business of
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`researching, developing, manufacturing, and/or
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`selling pharmaceutical products that are
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`distributed throughout the United States, including in the state of Delaware. On information and
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`belief, Lupin Pharmaceuticals directly or
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`through its affiliates and agents
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`formulates,
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`manufactures, packages, markets, and/or sells pharmaceutical products throughout the United
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`States, including in this judicial district.
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`19.
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`On information and belief, Lupin Pharmaceuticals has purposefully
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`conducted business in the state of Delaware, continues to conduct business in Delaware, and
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`Delaware is a likely destination of Lupin Pharmaceutical’s products or the products of its
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`affiliates or agents.
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`20.
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`On information and belief, Lupin Pharmaceuticals has previously availed
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`itself of this forum by submitting to the jurisdiction of this court and asserting counterclaims in
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`this judicial district in, for example, Viz'VHealIhcare UK Ltdet al. v. Lupin Ltd, el al., l4-cv-
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`369-LPS (D. Del. 2014).
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`21.
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`On information and belief, upon approval of Lupin Atlantis’s ANDA No.
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`205904, Defendants will market and sell Lupin Atlantis’s dronedarone hydrochloride tablets,
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`eq. 400 mg base in Delaware and throughout the United States and will derive substantial
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`revenue therefrom.
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`22.
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`On information and belief, upon approval of Lupin Atlantis’s ANDA No.
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`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.
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`On information and belief, this Court further has personal jurisdiction over
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`Defendants because Defendants regularly do or solicit business in Delaware, engage in other
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`persistent courses of conduct in Delaware, and/or derive substantial revenue from services or
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`things used or consumed in Delaware and committed the tortious act of patent infringement
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`under 35 U.S.C. § 27l(e)(2) that has led and/or will lead to foreseeable harm and injury to
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`plaintiff Sanofi U.S., a Delaware corporation.
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`24.
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`This Court has personal jurisdiction over Defendants by virtue of, inter
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`alia, the above-mentioned facts.
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`25.
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`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
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`26.
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`Sanofi U.S. holds approved New Drug Application (“NDA”) No. 022425
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`for dronedarone tablets, 400 mg, which are prescribed and sold in the United States under the
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`trademark Multaq®. The FDA approved NDA No. 022425 on July 1, 2009.
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`27.
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`Multaq® tablets are indicated to reduce the risk of hospitalization for atrial
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`fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial
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`fibrillation.
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`28.
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`United States Patent No. 8,318,800 (“the ’800 patent,” copy attached as
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`Exhibit A) is entitled “Solid Pharmaceutical Compositions Containing Benzofuran Derivatives”
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`and was duly and legally issued by the United States Patent and Trademark Office (USPTO) on
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`November 27, 2012. The ’800 patent claims, inter alia, pharmaceutical compositions containing
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`Janssen Ex. 2036
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`Lupin Ltd. v. Janssen Sciences Ireland UC
`|PR2015-01030
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`dronedarone. The ’800 patent is listed in the Orange Book for Multaq® tablets (NDA No.
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`022425)
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`29.
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`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
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`Sanofi.
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`30.
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`United States Patent No. 8,410,167 (“the ’167 patent,” copy attached as
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`Exhibit B) is entitled “Use of Dronedarone for the Preparation of a Medicament for Use in the
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`Prevention of Cardiovascular Hospitalization or of Mortality” and was duly and legally issued by
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`the USPTO on April 2, 2013. The ’167 patent claims, inter alia, methods of decreasing the risk
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`of cardiovascular hospitalization in certain patients by administering dronedarone. The ’167
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`patent is listed in the Orange Book for Multaq® tablets (NDA No. 022425).
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`31.
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`The named inventors on the ’167 patent are Davide Radzik, Martin Van
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`Eickels, Nacera Hamdani, and Christophe Gaudin. The ’167 patent is assigned to Sanofi.
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`CLAIMS FOR RELIEF — PATENT INFRINGEMENT
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`32.
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`Lupin Atlantis submitted ANDA No. 205904 to the FDA seeking approval
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`to engage in the commercial manufacture, use, offer for sale, sale, and/or importation of
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`dronedarone hydrochloride tablets, eq. 400 mg base (“Lupin Atlantis’s Proposed Generic
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`Product”).
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`33.
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`On information and belief, ANDA No. 205904 seeks FDA approval of
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`Lupin Atlantis’s Proposed Generic Product
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`for
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`the indication of reducing the risk of
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`hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or
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`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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`34.
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`On information and belief, Lupin Ltd. and Lupin Pharmaceuticals actively
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`participated in and/or directed activities related to the submission of ANDA No. 205904 and the
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`research and development of Lupin Atlantis’s Proposed Generic Product, were actively involved
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`in preparing the ANDA, and/or intend to directly benefit from and have a financial stake in the
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`approval of the ANDA.
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`35.
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`On information and belief, upon approval of Lupin Atlantis’s ANDA,
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`Lupin Ltd. and Lupin Pharmaceuticals will be involved in the manufacture,
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`formulation,
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`distribution, and/or marketing of Lupin Atlantis’s Proposed Generic Product.
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`36.
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`By letter dated April 6, 2015, and pursuant to 21 U.S.C. § 355(j)(2)(B) and
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`21 C.F.R. § 314.95(c), Lupin Atlantis notified Plaintiffs that it had submitted ANDA No. 205904
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`to the FDA seeking approval
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`to engage in the commercial manufacture, use, sale, and/or
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`importation of Lupin Atlantis’s Proposed Generic Product before the expiration of the ’800
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`patent and the ’167 patent.
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`37.
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`In its April 6, 2015 letter, Lupin Atlantis notified Plaintiffs that, as a part
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`of its ANDA,
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`it had filed a certification of the type described in 21 U.S.C. § 355(j)(2)(A)
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`(vii)(IV) (a “Paragraph IV Certification”) with respect to the ’800 patent and the ’167 patent. On
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`information and belief, Lupin certified that, in its opinion and to the best of its knowledge, the
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`’800 patent and the ’167 patent are invalid and/or will not be infringed by the manufacture, use,
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`or sale of Lupin Atlantis’s Proposed Generic Product.
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`Infringement of U.S. Patent No. 8,318,800 Under 35 U.S.C. §271(e)(2)
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`COUNT I
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`38.
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`Plaintiffs repeat and reallege paragraphs 1 through 37 as if fully set forth
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`herein.
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`Janssen Ex. 2036
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`39.
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`By submitting ANDA No. 205904 to the FDA to obtain approval under
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`the Food, Drug, and Cosmetic Act to engage in the commercial manufacture, use, offer for sale,
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`sale, and/or importation of Lupin Atlantis’s Proposed Generic Product throughout the United
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`States prior to the expiration of the ’800 patent, Defendants committed an act of infringement of
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`the ’800 patent under 35 U.S.C. §271(e)(2). On information and belief, Lupin was aware of the
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`’800 patent at the time the ANDA was submitted.
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`40.
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`The commercial manufacture, use, offer for sale, sale, and/or importation
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`of Lupin Atlantis’s Proposed Generic Product, for which Lupin seeks approval in ANDA No.
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`205904, will infringe, induce infringement, and/or contributorily infringe one or more claims of
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`the ’800 patent under 35 U.S.C. §§ 27l(a), 27l(b), and/or 27l(c).
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`41.
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`Plaintiffs will be irreparably harmed by Lupin’s infringing activities and
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`do not have an adequate remedy at law.
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`Infringement of U.S. Patent No. 8,410,167 Under 35 U.S.C. §271(e)(2)
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`COUNT II
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`42.
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`Plaintiffs repeat and reallege paragraphs 1 through 41 as if fully set forth
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`herein.
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`43.
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`By submitting ANDA No. 205904 to the FDA to obtain approval under
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`the Food, Drug, and Cosmetic Act to engage in the commercial manufacture, use, offer for sale,
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`sale, and/or importation of Lupin Atlantis’s Proposed Generic Product throughout the United
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`States prior to the expiration of the ’167 patent, Defendants committed an act of infringement of
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`the ’167 patent under 35 U.S.C. §271(e)(2). On information and belief, Defendants were aware
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`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.
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`Lupin Atlantis’s Proposed Generic Product will have the same clinical
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`instructions on use, be administered in the same manner, and achieve the same results as
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`Plaintiffs’ Multaq® product.
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`45.
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`Lupin Atlantis’s Proposed Generic Product label will
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`instruct doctors,
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`caregivers, and/or patients to practice the methods claimed in the ’l67 patent.
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`46.
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`The commercial manufacture, use, offer for sale, sale, and/or importation
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`of Lupin Atlantis’s Proposed Generic Product, for which Lupin Atlantis seeks approval
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`in
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`ANDA No. 205904, will infringe, induce infringement, and/or contributorily infringe one or
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`more claims of the ’l67 patent under 35 U.S.C. §§ 27l(a), 27l(b), and/or 27l(c).
`
`47.
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`Plaintiffs will be irreparably harmed by Defendants’ infringing activities
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`and do not have an adequate remedy at law.
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`PRAYER FOR RELIEF
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`WHEREFORE, Plaintiffs pray for a judgment
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`in their
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`favor and against
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`Defendants and respectfully request the following relief:
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`A.
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`A judgment
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`that under 35 U.S.C.
`
`§ 27l(e)(2)(A), Defendants have
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`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
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`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.
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`A judgment declaring that the ’800 patent remains valid and enforceable;
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`A permanent injunction restraining and enjoining Defendants and their
`
`officers, agents, attorneys, and employees, and those acting in privity or concert therewith, from
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`10
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`Janssen Ex. 2036
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`Lupin Ltd. v. Janssen Sciences Ireland UC
`|PR2015-01030
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`engaging in the commercial manufacture, use, offer for sale, sale, and/or importation of Lupin
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`Atlantis’s Proposed Generic Product until the expiration of the ’8OO patent or any later date of
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`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
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`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.
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`A judgment
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`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.
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`A judgment
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`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.
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`A judgment declaring that the ’l67 patent remains valid and enforceable;
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`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
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`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
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`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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`|PR2015-01030
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`K.
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`A determination that this case is “exceptional” under 35 U.S.C. § 285 and
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`an award of attorneys’ fees;
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`L.
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`Costs and expenses in this action; and
`
`M.
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`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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`Lupin Ltd. v. Janssen Sciences Ireland UC
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`(Page 12 of 12)