Case 1:14-cv-00667-JBS-KMW Document 1 Filed 01/31/14 Page 1 of 6 PageID: 1
`
`SENJU PHARMACEUTICAL CO., LTD.,
`BAUSCH & LOMB, INC. and BAUSCH &
`LOMB PHARMA HOLDINGS CORP.
`
`
`Plaintiffs,
`
`
`
`
`
`Civil Action No.:
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`v.
`
`LUPIN, LTD. and LUPIN
`PHARMACEUTICALS, INC.,
`
`
`Defendants.
`
`
`
`
`
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiffs Senju Pharmaceutical Co., Ltd., Bausch & Lomb Incorporated and Bausch &
`
`Lomb Pharma Holdings Corp. (collectively “Plaintiffs”) by way of Complaint against
`
`Defendants Lupin, Ltd. and Lupin Pharmaceuticals, Inc. (collectively “Lupin”) allege as follows:
`
`THE PARTIES
`
`1.
`
`Plaintiff Senju Pharmaceutical Co., Ltd. (“Senju”) is a corporation organized and
`
`existing under the laws of Japan, with a principal place of business at 2-5-8, Hirano-machi,
`
`Chuo-ku, Osaka 541-0046, Japan.
`
`2.
`
`Plaintiff Bausch & Lomb Incorporated (“B+L”) is a corporation organized and
`
`existing under the laws of New York, with a place of business at 1400 North Goodman St.,
`
`Rochester, New York 14609. B+L is the registered holder of approved New Drug Application
`
`No. 203168, which covers Prolensa®.
`
`3.
`
`Plaintiff Bausch & Lomb Pharma Holdings Corp. (“B+L Pharma Holdings”) is a
`
`corporation organized and existing under the laws of Delaware, with a place of business at 700
`
`
`#23581246 v1 (140859.2)
`
`
`
`SENJU PHARMACEUTICAL CO., LTD.,
`BAUSCH & LOMB, INC. and BAUSCH &
`LOMB PHARMA HOLDINGS CORP.
`
`
`Plaintiffs,
`
`
`
`
`
`Civil Action No.:
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`v.
`
`LUPIN, LTD. and LUPIN
`PHARMACEUTICALS, INC.,
`
`
`Defendants.
`
`
`
`
`
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiffs Senju Pharmaceutical Co., Ltd., Bausch & Lomb Incorporated and Bausch &
`
`Lomb Pharma Holdings Corp. (collectively “Plaintiffs”) by way of Complaint against
`
`Defendants Lupin, Ltd. and Lupin Pharmaceuticals, Inc. (collectively “Lupin”) allege as follows:
`
`THE PARTIES
`
`1.
`
`Plaintiff Senju Pharmaceutical Co., Ltd. (“Senju”) is a corporation organized and
`
`existing under the laws of Japan, with a principal place of business at 2-5-8, Hirano-machi,
`
`Chuo-ku, Osaka 541-0046, Japan.
`
`2.
`
`Plaintiff Bausch & Lomb Incorporated (“B+L”) is a corporation organized and
`
`existing under the laws of New York, with a place of business at 1400 North Goodman St.,
`
`Rochester, New York 14609. B+L is the registered holder of approved New Drug Application
`
`No. 203168, which covers Prolensa®.
`
`3.
`
`Plaintiff Bausch & Lomb Pharma Holdings Corp. (“B+L Pharma Holdings”) is a
`
`corporation organized and existing under the laws of Delaware, with a place of business at 700
`
`
`#23581246 v1 (140859.2)
`
`
`
`Case 1:14-cv-00667-JBS-KMW Document 1 Filed 01/31/14 Page 2 of 6 PageID: 2
`
`Route 202/206, Bridgewater, New Jersey 08807. B+L Pharma Holdings is a wholly-owned
`
`subsidiary of B+L.
`
`4.
`
`Upon information and belief, defendant Lupin, Ltd. is a corporation organized and
`
`existing under the laws of India, having a corporate headquarters at C/4 Laxmi Towers, Bandra
`
`Kurla Complex, Bandra (E), Mumbai 400 051.
`
`5.
`
`Upon information and belief, defendant Lupin Pharmaceuticals, Inc. is a
`
`corporation organized and existing under the laws of Virginia, having a principal place of
`
`business at 111 S. Calvert Street, 21st Floor, Baltimore, MD 21202. Upon information and belief,
`
`Lupin Pharmaceuticals, Inc. is a wholly-owned subsidiary of Lupin, Ltd.
`
`NATURE OF THE ACTION
`
`6.
`
`This is an action for infringement of United States Patent No. 8,129,431 (“the
`
`’431 patent”), arising under the United States patent laws, Title 35, United States Code, § 100 et
`
`seq., including 35 U.S.C. §§ 271 and 281. This action relates to Lupin Ltd.’s filing of an
`
`Abbreviated New Drug Application (“ANDA”) under Section 505(j) of the Federal Food, Drug,
`
`and Cosmetic Act (“the Act”), 21 U.S.C. § 355(j), seeking U.S. Food and Drug Administration
`
`(“FDA”) approval to market generic Bromfenac Ophthalmic Solution 0.07% (“Lupin’s generic
`
`bromfenac ophthalmic solution”).
`
`JURISDICTION AND VENUE
`
`7.
`
`8.
`
`This Court has subject matter jurisdiction under 28 U.S.C. §§ 1331 and 1338(a).
`
`Upon information and belief, this Court has jurisdiction over Lupin, Ltd. Upon
`
`information and belief, Lupin Ltd. is in the business of manufacturing, marketing, importing and
`
`selling pharmaceutical drug products, including generic drug products. Upon information and
`
`belief, Lupin Ltd. directly manufactures, markets and sells generic drug products throughout the
`
`United States and in this judicial district, and this judicial district is a likely destination for
`
`
`#23581246 v1 (140859.2)
`
`
`
`Case 1:14-cv-00667-JBS-KMW Document 1 Filed 01/31/14 Page 3 of 6 PageID: 3
`
`Lupin’s generic bromfenac ophthalmic solution. Upon information and belief, Lupin Ltd.
`
`purposefully has conducted and continues to conduct business in this judicial district.
`
`9.
`
`Upon information and belief, this court has jurisdiction over Lupin
`
`Pharmaceuticals, Inc. Upon information and belief, Lupin Pharmaceuticals, Inc. directly, or
`
`indirectly, manufactures, markets and sells generic drug products, including generic drug
`
`products manufactured by Lupin Ltd., throughout the United States and in this judicial district.
`
`Upon information and belief, Lupin Pharmaceuticals, Inc. purposefully has conducted and
`
`continues to conduct business in this judicial district.
`
`10.
`
`Upon information and belief, venue is proper in this judicial district under 28
`
`U.S.C. §§ 1391(c) and (d), and § 1400(b).
`
`COUNT FOR PATENT INFRINGEMENT
`
`11.
`
`The U.S. Patent and Trademark Office (“PTO”) issued the ’431 patent on March
`
`6, 2012. The ’431 patent claims, inter alia, formulations of bromfenac for ophthalmic
`
`administration. Plaintiffs holds all substantial rights in the ’431 patent and have the right to sue
`
`for infringement thereof. Senju is the assignee of the ’431 patent. A copy of the ’431 patent is
`
`attached hereto as Exhibit A.
`
`12.
`
`B+L is the holder of New Drug Application (“NDA”) No. 203168 for Prolensa®,
`
`which the FDA approved on April 5, 2013. In conjunction with NDA No. 203168, the ’431
`
`patent is listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations
`
`(“the Orange Book”).
`
`13.
`
`Bromfenac Ophthalmic Solution 0.07% is sold in the United States under the
`
`trademark Prolensa®.
`
`14.
`
`Upon information and belief, Lupin Ltd. filed with the FDA ANDA No. 206027,
`
`under Section 505(j) of the Act and 21 U.S.C. § 355(j).
`
`
`#23581246 v1 (140859.2)
`
`
`
`Case 1:14-cv-00667-JBS-KMW Document 1 Filed 01/31/14 Page 4 of 6 PageID: 4
`
`15.
`
`Upon information and belief, Lupin Ltd.’s ANDA No. 206027 seeks FDA
`
`approval to sell in the United States Lupin’s generic bromfenac ophthalmic solution, intended to
`
`be a generic version of Prolensa®.
`
`16.
`
`Bausch & Lomb received a letter from Lupin Ltd. dated December 19, 2013,
`
`purporting to be a Notice of Certification for ANDA No. 206027 (“Lupin’s notice letter”) under
`
`Section 505(j)(2)(B)(ii) of the Act, 21 U.S.C. § 355(j)(2)(B)(ii), and 21 § C.F.R. 314.95(c).
`
`17.
`
`Lupin’s notice letter alleges that Lupin Ltd. has submitted to the FDA ANDA No.
`
`206027 seeking FDA approval to sell generic bromfenac ophthalmic solution, intended to be a
`
`generic version of Prolensa®.
`
`18.
`
`Upon information and belief, ANDA No. 206027 seeks approval of Lupin’s
`
`generic bromfenac ophthalmic solution that is the same, or substantially the same, as Prolensa®.
`
`19.
`
`Under 35 U.S.C. § 271(e)(2), Lupin Ltd. has infringed at least one claim of the
`
`’431 patent by submitting, or causing to be submitted to the FDA, ANDA No. 206027 seeking
`
`approval for the commercial marketing of Lupin’s generic bromfenac ophthalmic solution before
`
`the expiration date of the ’431 patent.
`
`20.
`
`Upon information and belief, Lupin’s generic bromfenac ophthalmic solution
`
`will, if approved and marketed, infringe at least one claim of the ’431 patent.
`
`21.
`
`Upon information and belief, Lupin Ltd. will, through the manufacture, use
`
`import, offer for sale and/or sale of Lupin’s generic bromfenac ophthalmic solution, directly
`
`infringe, contributorily infringe and/or induce infringement of at least one claim of the ’431
`
`patent.
`
`
`#23581246 v1 (140859.2)
`
`
`
`Case 1:14-cv-00667-JBS-KMW Document 1 Filed 01/31/14 Page 5 of 6 PageID: 5
`
`22.
`
`Upon information and belief, Lupin Ltd.’s actions relating to ANDA No. 206027
`
`complained of herein were done with the cooperation, the participation, the assistance of, and at
`
`least in part for the benefit of Lupin Pharmaceuticals, Inc.
`
`WHEREFORE, Plaintiffs respectfully request that the Court enter judgment in their
`
`favor and against Defendants on the patent infringement claim set forth above and respectfully
`
`request that this Court:
`
`1.
`
`enter judgment that, under 35 U.S.C. § 271(e)(2), Lupin has infringed at least one
`
`claim of the ’431 patent through Lupin Ltd.’s submission of ANDA No. 206027 to the FDA to
`
`obtain approval for the commercial manufacture, use, import, offer for sale and/or sale in the
`
`United States of Lupin’s generic bromfenac ophthalmic solution before the expiration of the ’431
`
`patent;
`
`2.
`
`order that the effective date of any approval by the FDA of Lupin’s generic
`
`bromfenac ophthalmic solution be a date that is not earlier than the expiration of the ’431 patent,
`
`or such later date as the Court may determine;
`
`3.
`
`enjoin Lupin from the commercial manufacture, use, import, offer for sale and/or
`
`sale of Lupin’s generic bromfenac ophthalmic solution until expiration of the ’431 patent, or
`
`such later date as the Court may determine;
`
`4.
`
`enjoin Lupin and all persons acting in concert with Lupin from seeking, obtaining
`
`or maintaining approval of Lupin Ltd.’s ANDA No. 206027 until expiration of the ’431 patent;
`
`5.
`
`declare this to be an exceptional case under 35 U.S.C. §§ 285 and 271(e)(4) and
`
`award Plaintiffs costs, expenses and disbursements in this action, including reasonable attorneys
`
`fees;
`
`
`#23581246 v1 (140859.2)
`
`
`
`Case 1:14-cv-00667-JBS-KMW Document 1 Filed 01/31/14 Page 6 of 6 PageID: 6
`
`6.
`
`award Plaintiff such further and additional relief as this Court deems just and
`
`proper.
`
`Dated: January 31, 2014
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`
`
`s/ John F. Brenner
`John F. Brenner
`PEPPER HAMILTON, LLP
`Suite 400
`301 Carnegie Center
`Princeton, New Jersey, 08543-5276
`(609) 951-4193
`brennerj@pepperlaw.com
`
`Attorneys for Plaintiffs
`SENJU PHARMACEUTICAL CO., LTD.,
`BAUSCH & LOMB, INC. and BAUSCH & LOMB
`PHARMA HOLDINGS CORP.
`
`
`
`
`
`
`
`
`
`
`Of Counsel:
`Bryan C. Diner
`Justin J. Hasford
`FINNEGAN, HENDERSON,
`FARABOW, GARRETT & DUNNER, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`(202) 408-4000
`
`
`
`
`
`
`#23581246 v1 (140859.2)
`
`
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
