Case 1:16-cv-00353-UNA Document 1 Filed 05/13/16 Page 1 of 9 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No.
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`SANTEN PHARMACEUTICAL CO., LTD.,
`ASAHI GLASS CO., LTD., and OAK
`PHARMACEUTICALS, INC.,
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`MICRO LABS LIMITED, and MICRO
`LABS USA INC.,
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`Plaintiffs,
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`v.
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`Defendants.
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`COMPLAINT
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`Plaintiffs Santen Pharmaceutical Co., Ltd. (“Santen”), Asahi Glass Co., Ltd. (“AGC”),
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`and Oak Pharmaceuticals, Inc. (“Oak”) (collectively, “Plaintiffs”), for their Complaint against
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`Defendants Micro Labs Limited (“Micro Labs LTD”) and Micro Labs USA Inc. (“Micro Labs
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`USA”) (together, “Micro Labs”), allege as follows:
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`NATURE OF THE CASE
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`1.
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`This is an action for patent infringement under the patent laws of the United
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`States, Title 35, United States Code, arising from Micro Labs’ filing of an Abbreviated New
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`Drug Application (“ANDA”) with the United Stated Food and Drug Administration (“FDA”), in
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`which Micro Labs seeks FDA approval to manufacture and sell a generic version of Plaintiffs’
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`ZIOPTAN® (tafluprost ophthalmic solution) 0.0015% (“ZIOPTAN®”) prior to the expiration
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`of U.S. Patent No. 5,886,035 (“the ‘035 Patent”).
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`2.
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`By letter dated April 5, 2016, Micro Labs USA notified Plaintiffs that Micro Labs
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`LTD had filed ANDA No. 209051 (“Micro Labs ANDA”), seeking FDA approval to
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`IPR Page 1/9
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`Santen/Asahi Glass Exhibit 2045
`Micro Labs v. Santen Pharm. and Asahi Glass
`IPR2017-01434
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`Case 1:16-cv-00353-UNA Document 1 Filed 05/13/16 Page 2 of 9 PageID #: 2
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`manufacture and sell a generic version of Plaintiffs’ ZIOPTAN® prior to the expiration of the
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`‘035 Patent.
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`THE PARTIES
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`3.
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`Plaintiff Santen is a Japanese corporation, having a principal place of business at
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`9-19, Shimoshinjo 3-chome, Higashiyodogawa-ku, Osaka, Japan.
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`4.
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`Plaintiff AGC is a Japanese corporation, having a principal place of business at 1-
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`5-1, Marunouchi, Chiyoda-ku, Tokyo, Japan.
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`5.
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`Plaintiff Oak is a Delaware corporation, having a principal place of business at
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`1925 West Field Court, Suite 300, Lake Forest IL 60045.
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`6.
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`On information and belief, Defendant Micro Labs LTD is an Indian corporation,
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`having a principal place of business at 27 Race Course Road, Bangalore 560001, India.
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`7.
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`On information and belief, Defendant Micro Labs USA is a New Jersey
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`corporation, having a principal place of business at 104 Carnegie Center, Suite 216, Princeton,
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`NJ 08540.
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`8.
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`On information and belief, Micro Labs USA is a wholly owned subsidiary of
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`Micro Labs LTD, and is controlled and/or dominated by Micro Labs LTD.
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`9.
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`On information and belief, Micro Labs LTD and Micro Labs USA are agents of
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`each other and/or operate in concert as integrated parts of the same business group, and enter into
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`agreements with each other that are nearer than arm’s length.
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`10.
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`On information and belief, Micro Labs LTD and Micro Labs USA regularly
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`transact business within Delaware, including but not limited to, through Micro Labs LTD’s
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`direction of the operations and management of Micro Labs USA, as well as shipping generic
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`drugs to Micro Labs USA from locations outside the United States for marketing, sale and
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`distribution by Micro Labs USA within the United States generally, and Delaware specifically.
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`JURISDICTION AND VENUE
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`11.
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`This action arises under the patent laws of the United States of America, Title 35,
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`United States Code. This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331
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`and 1338(a).
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`12. Micro Labs LTD is subject to personal jurisdiction in this District, because, inter
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`alia, it, on information and belief, regularly transacts business in this District and has engaged in
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`systematic and continuous business contacts within the State of Delaware, and its suit-related
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`conduct, i.e., the Micro Labs ANDA seeking FDA approval to manufacture and sell a generic
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`version of ZIOPTAN® in the United States, including in Delaware, creates a substantial
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`connection with Delaware, and also demonstrates Micro Labs LTD’s plans to direct sales of its
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`generic drugs into Delaware. Moreover, Micro Labs LTD has consented to jurisdiction in
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`Delaware (and has filed counterclaims) in other similar actions, in which Micro Labs LTD has
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`been accused of infringement in connection with the filing of ANDAs seeking FDA approval to
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`manufacture and sell generic drugs. See, e.g., Bayer Intellectual Prop. GmbH et al. v. Aurobindo
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`Pharma Ltd. et al., No. 1:15-cv-00902-SLR (D. Del.); Alcon Research, Ltd. v. Micro Labs Ltd. et
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`al., No. 1:14-cv-00014-SLR (D. Del.).
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`13. Micro Labs USA is subject to personal jurisdiction in this District, because, inter
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`alia, it, on information and belief, regularly transacts business in this District and has engaged in
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`systematic and continuous business contacts within the State of Delaware, and, on information
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`and belief, it has acted in concert with Micro Labs LTD to file the Micro Labs ANDA, and will
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`continue to act in concert to manufacture and sell a generic version of ZIOPTAN® in the United
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`States, including in Delaware. Micro Labs USA has also consented to jurisdiction in Delaware
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`(and has filed counterclaims) in other similar actions, in which Micro Labs USA has been
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`accused of infringement in connection with the filing of ANDAs by Micro Labs LTD seeking
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`FDA approval to manufacture and sell generic drugs. See, e.g., Bayer Intellectual Prop. GmbH
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`et al. v. Aurobindo Pharma Ltd. et al., No. 1:15-cv-00902-SLR (D. Del.); Alcon Research, Ltd. v.
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`Micro Labs Ltd. et al., No. 1:14-cv-00014-SLR (D. Del.).
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`14.
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`Venue is proper in this District pursuant to 28 U.S.C. §§ 1391 and 1400(b).
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`THE ‘035 PATENT AND ZIOPTAN
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`15.
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`On March 23, 1999, the United States Patent and Trademark Office (“PTO”)
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`issued the ‘035 Patent, entitled “Difluoroprostaglandin Derivatives and Their Use,” to AGC and
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`Santen, the co-assignees of the named inventors, Eiichi Shirasawa, Masaaki Kageyama, Tadashi
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`Nakajima, Takashi Nakano, Nobuaki Mori, Hideshi Sasakura, Yasushi Matsumura, and
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`Yoshitomi Morizawa. Plaintiffs Santen and AGC are the record owners of the ‘035 Patent, and
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`Plaintiff Oak is a licensee in relation to the sales and marketing of tafluprost in the United States.
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`A copy of the ‘035 Patent is attached hereto as Exhibit A.
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`16.
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`17.
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`The original expiration date of the ‘035 Patent was December 18, 2017.
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`On February 23, 2016, the PTO issued a Certificate Extending Patent Term Under
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`35 U.S.C. § 156, extending the expiration date of the ‘035 Patent by 5 years to December 18,
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`2022.
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`18.
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`On February 10, 2012, FDA approved New Drug Application (“NDA”) No.
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`202514 for ZIOPTAN®. Plaintiff Oak is the holder of NDA No. 202514 for ZIOPTAN®.
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`19.
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`In
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`the publication entitled “Approved Drug Products with Therapeutic
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`Equivalence Evaluations” (known as the “Orange Book”), the ‘035 Patent is listed as covering
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`ZIOPTAN®.
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`THE MICRO LABS ANDA
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`20.
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`On information and belief, Micro Labs LTD and Micro Labs USA seek to
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`constantly expand the range of generic products sold by them.
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`21.
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`On information and belief, Micro Labs LTD and Micro Labs USA collaborate in
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`the manufacture, marketing and sale of many pharmaceutical products (including generic drug
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`products manufactured and sold pursuant to an approved ANDA) within the United States
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`generally, and the State of Delaware specifically.
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`22.
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`On information and belief, Micro Labs LTD and Micro Labs USA actively review
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`pharmaceutical patents and seek opportunities to challenge those patents.
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`23.
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`On information and belief, Micro Labs LTD and Micro Labs USA reviewed the
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`‘035 Patent and certain commercial and economic information relating to ZIOPTAN®, including
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`estimates of the revenues generated by the sale of ZIOPTAN®, and decided to file an ANDA,
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`seeking approval to market a generic version of ZIOPTAN®.
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`24.
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`On information and belief, Micro Labs LTD and Micro Labs USA collaborated in
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`the research, development, preparation and filing of the Micro Labs ANDA.
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`25.
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`On information and belief, Micro Labs LTD submitted to FDA the Micro Labs
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`ANDA seeking approval to engage in the commercial manufacture, use, and sale of a generic
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`version of ZIOPTAN®, prior to the expiration of the ‘035 Patent.
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`26.
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`Plaintiffs have received a letter dated April 5, 2016 from Micro Labs USA
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`notifying them that the Micro Labs ANDA includes a certification under 21 U.S.C.
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`§ 355(j)(2)(A)(vii)(IV) (a “Paragraph IV certification”) that, in Micro Labs LTD’s opinion, the
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`‘035 Patent is invalid, unenforceable or will not be infringed by the commercial manufacture, use
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`or sale of the generic version of ZIOPTAN® described in the Micro Labs ANDA.
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`27.
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`On information and belief, Micro Labs USA collaborated with Micro Labs LTD
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`for the purpose of preparing and filing the Micro Labs ANDA with FDA.
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`28. Micro Labs LTD and Micro Labs USA were necessarily aware of the ‘035 Patent
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`when the Micro Labs ANDA was filed with a Paragraph IV certification.
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`29.
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`Plaintiffs commenced this action within 45 days of the date they received notice
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`of the Micro Labs ANDA containing the Paragraph IV certification.
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`30.
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`On information and belief, Micro Labs LTD and Micro Labs USA continue to
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`collaborate in seeking FDA approval of the Micro Labs ANDA and intend to collaborate in the
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`commercial manufacture, marketing, and sale of a generic version of ZIOPTAN® (including
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`commercial marketing and sale in the State of Delaware) in the event that FDA approves the
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`Micro Labs ANDA.
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`FIRST CLAIM FOR RELIEF
`(Direct Infringement of the ‘035 Patent by Micro Labs LTD and Micro Labs USA)
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`31.
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`Plaintiffs repeat and reallege each and every allegation contained in paragraphs 1
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`through 30 hereof, as if fully set forth herein.
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`32.
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`Through the conduct alleged above, Micro Labs LTD and Micro Labs USA have
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`directly infringed, and continue to directly infringe, one or more claims of the ‘035 Patent.
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`33.
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`By filing the Micro Labs ANDA with a Paragraph IV certification seeking FDA
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`approval to engage in the commercial manufacture, use and sale of the generic version of
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`ZIOPTAN® disclosed therein, prior to the expiration of the ‘035 Patent, Micro Labs LTD and
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`Micro Labs USA have infringed the ‘035 Patent under 35 U.S.C. § 271(e)(2).
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`34. Micro Labs LTD and Micro Labs USA were aware of the existence of the ‘035
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`Patent prior to the filing of the Micro Labs ANDA, but took such action knowing that it would
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`constitute infringement of the ‘035 Patent.
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`35.
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`On information and belief, Micro Labs LTD and Micro Labs USA acted without a
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`reasonable basis for a good faith belief that they would not be liable for infringing the ‘035
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`Patent.
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`36. Micro Labs LTD and Micro Labs USA’s conduct renders this case “exceptional”
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`as described in 35 U.S.C. § 285.
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`37.
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`Plaintiffs will be irreparably harmed if Micro Labs LTD and Micro Labs USA are
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`not enjoined from infringing the ‘035 Patent.
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`SECOND CLAIM FOR RELIEF
`(Inducement of Infringement of the ‘035 Patent by Micro Labs USA)
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`38.
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`Plaintiffs repeat and reallege each and every allegation contained in paragraphs 1
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`through 37 hereof, as if fully set forth herein.
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`39.
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`Through the conduct alleged above, Micro Labs USA has knowingly and actively
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`induced Micro Labs LTD to infringe, and continue to infringe, one or more claims of the ‘035
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`Patent.
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`40.
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`By reason of Micro Labs USA’s inducement of Micro Labs LTD’s direct
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`infringement of the ‘035 Patent, Micro Labs USA has caused and continues to cause irreparable
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`harm to Plaintiffs.
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`41.
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`On information and belief, Micro Labs USA’s inducement of Micro Labs LTD’s
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`direct infringement of the ‘035 Patent will continue unless enjoined by this Court.
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`42.
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`Plaintiffs have no adequate remedy at law for Micro Labs USA’s inducement of
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`Micro Labs LTD’s direct infringement of the ‘035 Patent.
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`43.
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`This is an exceptional case within the meaning of 35 U.S.C. § 285, which
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`warrants reimbursement of Plaintiffs’ reasonable attorney fees.
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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 Micro Labs LTD and Micro Labs
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`USA have directly infringed the ‘035 Patent;
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`B.
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`An order adjudging and decreeing that Micro Labs USA has induced
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`infringement of the ‘035 Patent;
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`C.
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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 the Micro Labs ANDA be no earlier than December 18, 2022, the date on
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`which the ‘035 Patent expires;
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`D.
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`A permanent injunction pursuant to 35 U.S.C. § 271(e)(4)(B) restraining
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`and enjoining Micro Labs LTD and Micro Labs USA, their officers, agents, attorneys, and
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`employees, and those acting in privity or concert with them, from engaging in the commercial
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`manufacture, use, offer for sale, or sale within the United States, or importation into the United
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`States, of the generic version of ZIOPTAN® described in the Micro Labs ANDA until December
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`18, 2022;
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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;
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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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`OF COUNSEL:
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`Eric J. Lobenfeld
`Arlene L. Chow
`HOGAN LOVELLS US LLP
`875 Third Avenue
`New York, NY 10022
`(212) 918-3000
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`May 13, 2016
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`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
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`/s/ Maryellen Noreika
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`Jack. B. Blumenfeld (#1024)
`Maryellen Noreika (#3208)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@mnat.com
`mnoreika@mnat.com
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`Attorneys for Plaintiffs
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