Case 1:16-cv-00354-UNA Document 1 Filed 05/13/16 Page 1 of 7 PageID #: 1
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`C.A. No.
`
`)))))))))))
`
`
`
`SANTEN PHARMACEUTICAL CO., LTD.,
`ASAHI GLASS CO., LTD., and OAK
`PHARMACEUTICALS, INC.,
`
`
`
`
`
`SANDOZ INC.,
`
`
`
`
`Plaintiffs,
`
`
`
`v.
`
`
`
`Defendant.
`
`COMPLAINT
`
`Plaintiffs Santen Pharmaceutical Co., Ltd. (“Santen”), Asahi Glass Co., Ltd. (“AGC”),
`
`and Oak Pharmaceuticals, Inc. (“Oak”) (collectively, “Plaintiffs”), for their Complaint against
`
`Defendant Sandoz Inc. (“Sandoz”), allege as follows:
`
`NATURE OF THE CASE
`
`1.
`
`This is an action for patent infringement under the patent laws of the United
`
`States, Title 35, United States Code, arising from Sandoz’ filing of an Abbreviated New Drug
`
`Application (“ANDA”) with the United Stated Food and Drug Administration (“FDA”), in
`
`which Sandoz seeks FDA approval to manufacture and sell a generic version of Plaintiffs’
`
`ZIOPTAN® (tafluprost ophthalmic solution) 0.0015% (“ZIOPTAN®”) prior to the expiration
`
`of U.S. Patent No. 5,886,035 (“the ‘035 Patent”).
`
`2.
`
`By letter dated April 6, 2016, Sandoz notified Santen and AGC that it had filed
`
`ANDA No. 209040 (“Sandoz ANDA”), seeking FDA approval to manufacture and sell a generic
`
`version of Plaintiffs’ ZIOPTAN® prior to the expiration of the ‘035 Patent. Although Oak was
`
`listed as a recipient on the face of Sandoz’ April 6 letter, Oak never received the letter. By letter
`
`dated April 20, 2016, Sandoz forwarded a copy of its April 6 letter to Oak.
`
`IPR Page 1/7
`
`Santen/Asahi Glass Exhibit 2046
`Micro Labs v. Santen Pharm. and Asahi Glass
`IPR2017-01434
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`C.A. No.
`
`)))))))))))
`
`
`
`SANTEN PHARMACEUTICAL CO., LTD.,
`ASAHI GLASS CO., LTD., and OAK
`PHARMACEUTICALS, INC.,
`
`
`
`
`
`SANDOZ INC.,
`
`
`
`
`Plaintiffs,
`
`
`
`v.
`
`
`
`Defendant.
`
`COMPLAINT
`
`Plaintiffs Santen Pharmaceutical Co., Ltd. (“Santen”), Asahi Glass Co., Ltd. (“AGC”),
`
`and Oak Pharmaceuticals, Inc. (“Oak”) (collectively, “Plaintiffs”), for their Complaint against
`
`Defendant Sandoz Inc. (“Sandoz”), allege as follows:
`
`NATURE OF THE CASE
`
`1.
`
`This is an action for patent infringement under the patent laws of the United
`
`States, Title 35, United States Code, arising from Sandoz’ filing of an Abbreviated New Drug
`
`Application (“ANDA”) with the United Stated Food and Drug Administration (“FDA”), in
`
`which Sandoz seeks FDA approval to manufacture and sell a generic version of Plaintiffs’
`
`ZIOPTAN® (tafluprost ophthalmic solution) 0.0015% (“ZIOPTAN®”) prior to the expiration
`
`of U.S. Patent No. 5,886,035 (“the ‘035 Patent”).
`
`2.
`
`By letter dated April 6, 2016, Sandoz notified Santen and AGC that it had filed
`
`ANDA No. 209040 (“Sandoz ANDA”), seeking FDA approval to manufacture and sell a generic
`
`version of Plaintiffs’ ZIOPTAN® prior to the expiration of the ‘035 Patent. Although Oak was
`
`listed as a recipient on the face of Sandoz’ April 6 letter, Oak never received the letter. By letter
`
`dated April 20, 2016, Sandoz forwarded a copy of its April 6 letter to Oak.
`
`IPR Page 1/7
`
`Santen/Asahi Glass Exhibit 2046
`Micro Labs v. Santen Pharm. and Asahi Glass
`IPR2017-01434
`
`
`
`Case 1:16-cv-00354-UNA Document 1 Filed 05/13/16 Page 2 of 7 PageID #: 2
`
`THE PARTIES
`
`3.
`
`Plaintiff Santen is a Japanese corporation, having a principal place of business at
`
`9-19, Shimoshinjo 3-chome, Higashiyodogawa-ku, Osaka, Japan.
`
`4.
`
`Plaintiff AGC is a Japanese corporation, having a principal place of business at 1-
`
`5-1, Marunouchi, Chiyoda-ku, Tokyo, Japan.
`
`5.
`
`Plaintiff Oak is a Delaware corporation, having a principal place of business at
`
`1925 West Field Court, Suite 300, Lake Forest IL 60045.
`
`6.
`
`On information and belief, Defendant Sandoz is a Colorado corporation, having a
`
`principal place of business at 100 College Road West, Princeton, NJ 08540.
`
`7.
`
`On information and belief, Sandoz regularly transacts business within Delaware,
`
`including but not limited to, marketing, sale and distribution of generic drugs within the United
`
`States generally, and Delaware specifically.
`
`JURISDICTION AND VENUE
`
`8.
`
`This action arises under the patent laws of the United States of America, Title 35,
`
`United States Code. This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331
`
`and 1338(a).
`
`9.
`
`Sandoz is subject to personal jurisdiction in this District, because, inter alia, it, on
`
`information and belief, regularly transacts business in this District and has engaged in systematic
`
`and continuous business contacts within the State of Delaware, and its suit-related conduct, i.e.,
`
`the Sandoz ANDA seeking FDA approval to manufacture and sell a generic version of
`
`ZIOPTAN® in the United States, including in Delaware, creates a substantial connection with
`
`Delaware, and also demonstrates Sandoz’ plans to direct sales of its generic drugs into Delaware.
`
`Moreover, Sandoz has consented to jurisdiction in Delaware (and has filed counterclaims) in
`
`2
`
`IPR Page 2/7
`
`
`
`Case 1:16-cv-00354-UNA Document 1 Filed 05/13/16 Page 3 of 7 PageID #: 3
`
`other similar actions, in which Sandoz has been accused of infringement in connection with the
`
`filing of ANDAs seeking FDA approval to manufacture and sell generic drugs. See, e.g., Sanofi
`
`et al. v. Sandoz Inc., 1:15-cv-01207-RGA (D. Del.); Shire Orphan Therapies LLC et al. v.
`
`Sandoz Inc., 1:15-cv-01161-GMS (D. Del.); Indivior Inc. et al. v. Sandoz Inc., 1:15-cv-01051-
`
`RGA (D. Del.).
`
`10.
`
`Venue is proper in this District pursuant to 28 U.S.C. §§ 1391 and 1400(b).
`
`THE ‘035 PATENT AND ZIOPTAN
`
`11.
`
`On March 23, 1999, the United States Patent and Trademark Office (“PTO”)
`
`issued the ‘035 Patent, entitled “Difluoroprostaglandin Derivatives and Their Use,” to AGC and
`
`Santen, the co-assignees of the named inventors, Eiichi Shirasawa, Masaaki Kageyama, Tadashi
`
`Nakajima, Takashi Nakano, Nobuaki Mori, Hideshi Sasakura, Yasushi Matsumura, and
`
`Yoshitomi Morizawa. Plaintiffs Santen and AGC are the record owners of the ‘035 Patent, and
`
`Plaintiff Oak is a licensee in relation to the sales and marketing of tafluprost in the United States.
`
`A copy of the ‘035 Patent is attached hereto as Exhibit A.
`
`12.
`
`13.
`
`The original expiration date of the ‘035 Patent was December 18, 2017.
`
`On February 23, 2016, the PTO issued a Certificate Extending Patent Term Under
`
`35 U.S.C. § 156, extending the expiration date of the ‘035 Patent by 5 years to December 18,
`
`2022.
`
`14.
`
`On February 10, 2012, FDA approved New Drug Application (“NDA”) No.
`
`202514 for ZIOPTAN®. Plaintiff Oak is the holder of NDA No. 202514 for ZIOPTAN®.
`
`15.
`
`In
`
`the publication entitled “Approved Drug Products with Therapeutic
`
`Equivalence Evaluations” (known as the “Orange Book”), the ‘035 Patent is listed as covering
`
`ZIOPTAN®.
`
`3
`
`IPR Page 3/7
`
`
`
`Case 1:16-cv-00354-UNA Document 1 Filed 05/13/16 Page 4 of 7 PageID #: 4
`
`THE SANDOZ ANDA
`
`16.
`
`On information and belief, Sandoz seeks to constantly expand its range of generic
`
`products.
`
`17.
`
`On information and belief, Sandoz engages in the manufacture, marketing and
`
`sale of many pharmaceutical products (including generic drug products manufactured and sold
`
`pursuant to an approved ANDA) within the United States generally, and the State of Delaware
`
`specifically.
`
`18.
`
`On information and belief, Sandoz actively reviews pharmaceutical patents and
`
`seeks opportunities to challenge those patents.
`
`19.
`
`On information and belief, Sandoz reviewed the ‘035 Patent and certain
`
`commercial and economic information relating to ZIOPTAN®, including estimates of the
`
`revenues generated by the sale of ZIOPTAN®, and decided to file an ANDA, seeking approval
`
`to market a generic version of ZIOPTAN®.
`
`20.
`
`On information and belief, Sandoz submitted to FDA the Sandoz ANDA seeking
`
`approval to engage in the commercial manufacture, use, and sale of a generic version of
`
`ZIOPTAN®, prior to the expiration of the ‘035 Patent.
`
`21.
`
`Plaintiffs Santen and AGC have received a letter dated April 6, 2016 from Sandoz
`
`notifying
`
`them
`
`that
`
`the Sandoz ANDA
`
`includes a certification under 21 U.S.C.
`
`§ 355(j)(2)(A)(vii)(IV) (a “Paragraph IV certification”) that, in Sandoz’ opinion, the ‘035 Patent
`
`is invalid, unenforceable or will not be infringed by the commercial manufacture, use or sale of
`
`the generic version of ZIOPTAN® described in the Sandoz ANDA. Although Plaintiff Oak was
`
`listed as a recipient on the face of Sandoz’ April 6 letter, Oak never received the letter. By letter
`
`dated April 20, 2016, Sandoz forwarded a copy of its April 6 letter to Oak.
`
`4
`
`IPR Page 4/7
`
`
`
`Case 1:16-cv-00354-UNA Document 1 Filed 05/13/16 Page 5 of 7 PageID #: 5
`
`22.
`
`Sandoz was necessarily aware of the ‘035 Patent when the Sandoz ANDA was
`
`filed with a Paragraph IV certification.
`
`23.
`
`Plaintiffs commenced this action within 45 days of the date they received notice
`
`of the Sandoz ANDA containing the Paragraph IV certification.
`
`24.
`
`On information and belief, Sandoz continues to seek FDA approval of the Sandoz
`
`ANDA and intends to engage in the commercial manufacture, marketing, and sale of a generic
`
`version of ZIOPTAN® (including commercial marketing and sale in the State of Delaware) in
`
`the event that FDA approves the Sandoz ANDA.
`
`FIRST CLAIM FOR RELIEF
`(Direct Infringement of the ‘035 Patent by Sandoz)
`
`25.
`
`Plaintiffs repeat and reallege each and every allegation contained in paragraphs 1
`
`through 24 hereof, as if fully set forth herein.
`
`26.
`
`Through the conduct alleged above, Sandoz has directly infringed, and continues
`
`to directly infringe, one or more claims of the ‘035 Patent.
`
`27.
`
`By filing the Sandoz ANDA with a Paragraph IV certification seeking FDA
`
`approval to engage in the commercial manufacture, use and sale of the generic version of
`
`ZIOPTAN® disclosed therein, prior to the expiration of the ‘035 Patent, Sandoz has infringed
`
`the ‘035 Patent under 35 U.S.C. § 271(e)(2).
`
`28.
`
`Sandoz was aware of the existence of the ‘035 Patent prior to the filing of the
`
`Sandoz ANDA, but took such action knowing that it would constitute infringement of the ‘035
`
`Patent.
`
`29.
`
`On information and belief, Sandoz acted without a reasonable basis for a good
`
`faith belief that it would not be liable for infringing the ‘035 Patent.
`
`30.
`
`Sandoz’ conduct renders this case “exceptional” as described in 35 U.S.C. § 285.
`
`5
`
`IPR Page 5/7
`
`
`
`Case 1:16-cv-00354-UNA Document 1 Filed 05/13/16 Page 6 of 7 PageID #: 6
`
`31.
`
`Plaintiffs will be irreparably harmed if Sandoz is not enjoined from infringing the
`
`‘035 Patent.
`
`
`
`WHEREFORE, Plaintiffs respectfully request the following relief:
`
`A.
`
`An order adjudging and decreeing that Sandoz has directly infringed the
`
`‘035 Patent;
`
`B.
`
`An order pursuant to 35 U.S.C. § 271(e)(4)(A) decreeing that the effective
`
`date of any approval of the Sandoz ANDA be no earlier than December 18, 2022, the date on
`
`which the ‘035 Patent expires;
`
`C.
`
`A permanent injunction pursuant to 35 U.S.C. § 271(e)(4)(B) restraining
`
`and enjoining Sandoz, its officers, agents, attorneys, and employees, and those acting in privity
`
`or concert with them, from engaging in the commercial manufacture, use, offer for sale, or sale
`
`within the United States, or importation into the United States, of the generic version of
`
`ZIOPTAN® described in the Sandoz ANDA until December 18, 2022;
`
`
`
`D.
`
`A declaration that this case is exceptional and an award of attorneys’ fees
`
`under 35 U.S.C. § 285 and costs and expenses in this action;
`
`E.
`
`Such other and further relief as the Court may deem just and proper.
`
`6
`
`IPR Page 6/7
`
`
`
`Case 1:16-cv-00354-UNA Document 1 Filed 05/13/16 Page 7 of 7 PageID #: 7
`
`
`
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`
`/s/ Maryellen Noreika
`
`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
`
`Attorneys for Plaintiffs
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`OF COUNSEL:
`
`Eric J. Lobenfeld
`Arlene L. Chow
`HOGAN LOVELLS US LLP
`875 Third Avenue
`New York, NY 10022
`(212) 918-3000
`
`May 13, 2016
`
`
`7
`
`IPR Page 7/7
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
