Case 1:14-cv-00667-JBS-KMW Document 7 Filed 03/27/14 Page 1 of 12 PageID: 26
`
`
`
`LITE DEPALMA GREENBERG, LLC
`Michael E. Patunas
`Mayra V. Tarantino
`Two Gateway Center, Suite 1201
`Newark, NJ 07102
`(973) 623-3000
`mpatunas@litedepalma.com
`mtarantino@litedepalma.com
`
`Attorneys for Defendant/Counterclaim-Plaintiff
`Lupin Limited and Defendant Lupin Pharmaceuticals, Inc.
`
`
`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`:
`:
`:
`:
`:
`:
`:
`:
`:
`:
`:
`:
`
`
`Civil Action No.: 14-00667 (JBS)(KMW)
`
`
`
`
`
`
`
`
`
`
`
`
`SENJU PHARMACEUTICAL CO., LTD.,
`BAUSCH & LOMB, INC. and BAUSCH &
`LOMB PHARMA HOLDINGS CORP.,
`
`
`
`
`
`LUPIN LIMITED and LUPIN
`PHARMACEUTICALS, INC.,
`
`
`
`
`
`
`
`
`
`
`
`
`v.
`
`
`
`Plaintiffs,
`
`Defendants.
`
`LUPIN LIMITED’S AND LUPIN PHARMACEUTICALS, INC.’S
`ANSWER, DEFENSES, AND COUNTERCLAIMS
`TO COMPLAINT FOR PATENT INFRINGEMENT
`
`
`
`Defendants Lupin Limited (“Lupin Ltd.”) and Lupin Pharmaceuticals, Inc. (“LPI”)
`
`(together, “Lupin” or “Defendants”), through their undersigned counsel, hereby submit the
`
`following answer and defenses in response to the complaint of Senju Pharmaceutical Co., Ltd.,
`
`Bausch & Lomb, Inc., and Bausch & Lomb Pharma Holdings Corp. (together, “Plaintiffs”), and
`
`Lupin Ltd. hereby submits the following counterclaims. The numbered paragraphs below
`
`correspond to the numbered paragraphs in the complaint. To the extent not specifically admitted
`
`herein, the allegations of the complaint are denied.
`
`
`
`410196.1
`
`
`
`
`
`
`
`LITE DEPALMA GREENBERG, LLC
`Michael E. Patunas
`Mayra V. Tarantino
`Two Gateway Center, Suite 1201
`Newark, NJ 07102
`(973) 623-3000
`mpatunas@litedepalma.com
`mtarantino@litedepalma.com
`
`Attorneys for Defendant/Counterclaim-Plaintiff
`Lupin Limited and Defendant Lupin Pharmaceuticals, Inc.
`
`
`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`:
`:
`:
`:
`:
`:
`:
`:
`:
`:
`:
`:
`
`
`Civil Action No.: 14-00667 (JBS)(KMW)
`
`
`
`
`
`
`
`
`
`
`
`
`SENJU PHARMACEUTICAL CO., LTD.,
`BAUSCH & LOMB, INC. and BAUSCH &
`LOMB PHARMA HOLDINGS CORP.,
`
`
`
`
`
`LUPIN LIMITED and LUPIN
`PHARMACEUTICALS, INC.,
`
`
`
`
`
`
`
`
`
`
`
`
`v.
`
`
`
`Plaintiffs,
`
`Defendants.
`
`LUPIN LIMITED’S AND LUPIN PHARMACEUTICALS, INC.’S
`ANSWER, DEFENSES, AND COUNTERCLAIMS
`TO COMPLAINT FOR PATENT INFRINGEMENT
`
`
`
`Defendants Lupin Limited (“Lupin Ltd.”) and Lupin Pharmaceuticals, Inc. (“LPI”)
`
`(together, “Lupin” or “Defendants”), through their undersigned counsel, hereby submit the
`
`following answer and defenses in response to the complaint of Senju Pharmaceutical Co., Ltd.,
`
`Bausch & Lomb, Inc., and Bausch & Lomb Pharma Holdings Corp. (together, “Plaintiffs”), and
`
`Lupin Ltd. hereby submits the following counterclaims. The numbered paragraphs below
`
`correspond to the numbered paragraphs in the complaint. To the extent not specifically admitted
`
`herein, the allegations of the complaint are denied.
`
`
`
`410196.1
`
`
`
`
`
`Case 1:14-cv-00667-JBS-KMW Document 7 Filed 03/27/14 Page 2 of 12 PageID: 27
`
`
`
`THE PARTIES1
`
`Lupin is without information sufficient to form a belief as to the allegations of this
`
`1.
`
`paragraph, and therefore denies them.
`
`2.
`
`Upon information and belief, Lupin admits that Bausch & Lomb, Inc. is the
`
`holder of approved New Drug Application (“NDA”) No. 203168. Lupin is without information
`
`sufficient to form a belief as to the remaining allegations of this paragraph, and therefore denies
`
`them.
`
`3.
`
`Lupin is without information sufficient to form a belief as to the allegations of this
`
`paragraph, and therefore denies them.
`
`4.
`
`Lupin admits that Lupin Ltd. is a corporation organized and existing under the
`
`laws of India, having a place of business at C/4 Laxmi Towers, Bandra Kurla Complex, Bandra
`
`(E), Mumbai 400 051. The allegations of this paragraph are otherwise denied.
`
`5.
`
`Lupin admits that LPI is a corporation organized and existing under the laws of
`
`Virginia, having a place of business at 111 S. Calvert Street, 21st Floor, Baltimore, MD 21202.
`
`Lupin further admits that LPI is a wholly-owned subsidiary of Lupin Ltd. The allegations of this
`
`paragraph are otherwise denied. By way of further response, Lupin denies that LPI is a proper
`
`defendant in this action.
`
`NATURE OF THE ACTION
`
`6.
`
`Lupin admits that this is an action for alleged infringement of U.S. Patent No.
`
`8,129,431 (the “’431 patent”). Lupin further admits that Lupin Ltd. filed an Abbreviated New
`
`Drug Application (“ANDA”) seeking U.S. Food and Drug Administration (“FDA”) approval to
`
`market Bromfenac Ophthalmic Solution 0.07%. The allegations of this paragraph are otherwise
`
`denied.
`
`1 Lupin has included the headings set forth in the complaint merely for convenience. By so
`doing, Lupin is not admitting any express or implied statements set forth in those headings.
`2
`
`410196.1
`
`
`
`Case 1:14-cv-00667-JBS-KMW Document 7 Filed 03/27/14 Page 3 of 12 PageID: 28
`
`
`
`JURISDICTION AND VENUE
`
`Lupin admits that this Court has subject matter jurisdiction over claims against
`
`7.
`
`Lupin Ltd. under 35 U.S.C. § 271(e)(2) set forth in the complaint. The allegations of this
`
`paragraph are otherwise denied.
`
`8.
`
`Lupin admits that Lupin Ltd. manufactures pharmaceutical products. Lupin does
`
`not contest personal jurisdiction as to Lupin Ltd. in this judicial district for the limited purpose of
`
`this action only. The allegations of this paragraph are otherwise denied.
`
`9.
`
`Lupin admits that LPI sells and distributes pharmaceutical products, including
`
`pharmaceutical products manufactured by Lupin Ltd. Lupin does not contest personal
`
`jurisdiction as to LPI in this judicial district for the limited purpose of this action only. The
`
`allegations of this paragraph are otherwise denied.
`
`10.
`
`Lupin does not contest venue in this judicial district for the limited purpose of this
`
`action only. The allegations of this paragraph are otherwise denied.
`
`COUNT FOR PATENT INFRINGEMENT
`
`11.
`
`Upon information and belief, Lupin admits that the U.S. Patent and Trademark
`
`Office (“PTO”) issued the ’431 patent on or about March 6, 2012. Lupin further admits that
`
`Senju Pharmaceutical Co., Ltd. is listed as the assignee on the face of the ’431 patent. Lupin
`
`admits that Exhibit A to the complaint purports to be a copy of the ’431 patent. The second
`
`sentence of this paragraph states legal conclusions to which no response is required, and in any
`
`event, the claims of the ’431 patent speak for themselves. Lupin is without information
`
`sufficient to form a belief as to the remaining allegations of this paragraph, and therefore denies
`
`them.
`
`12.
`
`13.
`
`Upon information and belief, admitted.
`
`Upon information and belief, admitted.
`
`410196.1
`
`3
`
`
`
`Case 1:14-cv-00667-JBS-KMW Document 7 Filed 03/27/14 Page 4 of 12 PageID: 29
`
`
`
`14.
`
`15.
`
`Admitted.
`
`Lupin admits that Lupin Ltd.’s ANDA No. 206027 seeks FDA approval to market
`
`in the United States Bromfenac Ophthalmic Solution 0.07%. The allegations of this paragraph
`
`are otherwise denied.
`
`16.
`
`Lupin admits that, by letter dated December 19, 2013, Lupin Ltd. provided a
`
`Notification of Certification of Invalidity, Unenforceability, and/or Noninfringement for U.S.
`
`Patent No. 8,129,431 to Bausch & Lomb, Inc. for ANDA No. 206027 (“Lupin Ltd.’s notice
`
`letter”) under Sections 505(j)(2)(B)(ii) and (iv) of the Federal Food, Drug, and Cosmetic Act, 21
`
`U.S.C. §§ 355(j)(2)(B)(ii) and (iv), and 21 C.F.R. § 314.95. Lupin is without information
`
`sufficient to form a belief as to the remaining allegations of this paragraph, and therefore denies
`
`them.
`
`17.
`
`Lupin admits that Lupin Ltd.’s notice letter states that Lupin Ltd. has submitted
`
`ANDA No. 206027 to FDA to obtain FDA approval to market Bromfenac Ophthalmic Solution
`
`0.07%. The allegations of this paragraph are otherwise denied.
`
`18.
`
`Lupin admits that Lupin Ltd.’s ANDA No. 206027 seeks FDA approval for
`
`Bromfenac Ophthalmic Solution 0.07%. The allegations of this paragraph are otherwise denied.
`
`19.
`
`20.
`
`21.
`
`22.
`
`Denied.
`
`Denied.
`
`Denied.
`
`Lupin admits that LPI is designated as Lupin Ltd.’s U.S. agent in Lupin Ltd.’s
`
`ANDA No. 206027. The allegations of this paragraph are otherwise denied.
`
`PRAYER FOR RELIEF
`
`23.
`
`Lupin denies that Plaintiffs are entitled to the judgment and relief requested in the
`
`complaint.
`
`410196.1
`
`4
`
`
`
`Case 1:14-cv-00667-JBS-KMW Document 7 Filed 03/27/14 Page 5 of 12 PageID: 30
`
`
`
`DEFENSES
`
`Lupin, without any admission as to burden of proof and without prejudice to the denials
`
`set forth in its answer, alleges the following defenses to the allegations in the complaint. Lupin
`
`reserves the right to supplement this answer, including the right to assert additional defenses, as
`
`more information is learned through discovery.
`
`First Defense
`(Lack of Subject Matter Jurisdiction as to LPI)
`
`24.
`
`The claims in the complaint against LPI should be dismissed for lack of subject
`
`matter jurisdiction because LPI did not submit ANDA No. 206027 to FDA.
`
`Second Defense
`(LPI Not Proper Defendant)
`
`25.
`
`LPI is not a proper defendant in this action.
`
`Third Defense
`(Failure to State a Claim)
`
`26.
`
`The complaint fails to state a claim upon which relief can be granted.
`
`Fourth Defense
`(Invalidity of the ’431 Patent)
`
`27.
`
`The claims of the ’431 patent are invalid for failure to comply with one or more of
`
`the requirements of 35 U.S.C. § 100 et seq., including but not limited to §§ 101, 102, 103, and/or
`
`112, and/or for obviousness-type double patenting.
`
`Fifth Defense
`(Non-infringement of the ’431 Patent)
`
`28.
`
`Lupin has not infringed, either directly or indirectly, any valid and enforceable
`
`claim of the ’431 patent, either literally or under the doctrine of equivalents, and Lupin’s
`
`manufacture, sale, use, offer for sale, and/or importation of the drug product that is the subject of
`
`ANDA No. 206027 would not infringe, either directly or indirectly, any valid and enforceable
`
`claim of the ’431 patent, either literally or under the doctrine of equivalents.
`5
`
`410196.1
`
`
`
`Case 1:14-cv-00667-JBS-KMW Document 7 Filed 03/27/14 Page 6 of 12 PageID: 31
`
`
`
`Sixth Defense
`(Other Defenses)
`
`29.
`
`Any additional defenses that discovery may reveal.
`
`COUNTERCLAIMS
`
`Lupin Limited (“Lupin Ltd.”) counterclaims against Senju Pharmaceuticals Co., Ltd.,
`
`Bausch & Lomb, Inc. and Bausch & Lomb Pharma Holdings Corp. (together, “Counterclaim
`
`Defendants”) as follows:
`
`PARTIES
`
`1.
`
`Lupin Ltd. is a corporation organized and existing under the laws of India, having
`
`a place of business at C/4 Laxmi Towers, Bandra Kurla Complex, Bandra (E), Mumbai 400 051
`
`India.
`
`2.
`
`Senju Pharmaceutical Co., Ltd. purports to be 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.
`
`3.
`
`Bausch & Lomb, Inc. purports to be 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.
`
`4.
`
`Bausch & Lomb Pharma Holdings Corp. purports to be a corporation organized
`
`and existing under the laws of Delaware, with a place of business at 700 Route 202/206,
`
`Bridgewater, NJ 08807.
`
`5.
`
`Bausch & Lomb Pharma Holdings Corp. purports to be a wholly-owned
`
`subsidiary of Bausch & Lomb, Inc.
`
`JURISDICTION AND VENUE
`
`6.
`
`These declaratory judgment counterclaims arise under the patent laws of the
`
`United States, Title 35, United States Code. This Court has subject matter jurisdiction pursuant
`6
`
`410196.1
`
`
`
`Case 1:14-cv-00667-JBS-KMW Document 7 Filed 03/27/14 Page 7 of 12 PageID: 32
`
`
`
`to 28 U.S.C. §§ 1331, 1338(a), 2201 and 2202. The requested relief is authorized by the
`
`Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202.
`
`7.
`
`Counterclaim Defendants are subject to the personal jurisdiction of this Court
`
`because they initiated and are prosecuting this action, and because they, either directly or through
`
`agents, transact business in, and derive substantial revenue from, New Jersey.
`
`8.
`
`Venue is proper in this Court pursuant to 28 U.S.C. §§ 1391(b) and 1400(b).
`
`BACKGROUND
`
`9.
`
`Upon information and belief, Bausch & Lomb, Inc. is the holder of NDA No.
`
`203168 for Bromfenac Ophthalmic Solution 0.07%. Upon information and belief, the FDA
`
`approved NDA No. 203168 on or about April 5, 2013. Upon information and belief,
`
`Counterclaim Defendants sell this drug product under the brand name Prolensa®.
`
`10.
`
`Upon information and belief, the PTO issued the ’431 patent on or about March 6,
`
`2012.
`
`11.
`
`Counterclaim Defendants allege in the complaint that they hold all substantial
`
`rights in the ’431 patent and have the right to sue for infringement thereof, and that Senju
`
`Pharmaceutical Co., Ltd. is the assignee of the ’431 patent.
`
`12.
`
`13.
`
`The ’431 patent is listed in the Orange Book for Prolensa®.
`
`Lupin Ltd. submitted ANDA No. 206027 to FDA under 21 U.S.C. § 355(j)
`
`seeking approval to market the Bromfenac Ophthalmic Solution 0.07% that is the subject of
`
`ANDA No. 206027 in the United States. ANDA No. 206027 includes a certification under 21
`
`U.S.C. §355(j)(2)(A)(vii)(IV) of the Federal Food, Drug, and Cosmetic Act that the ’431 patent
`
`is invalid, unenforceable and/or not infringed by the manufacture, use or sale of the drug product
`
`that is the subject of ANDA No. 206027.
`
`14.
`
`Lupin Ltd. sent notice of that certification to Counterclaim Defendants on or
`
`410196.1
`
`7
`
`
`
`Case 1:14-cv-00667-JBS-KMW Document 7 Filed 03/27/14 Page 8 of 12 PageID: 33
`
`
`
`about December 19, 2013. Counterclaim Defendants allege in the complaint that Bausch &
`
`Lomb, Inc. received this notification.
`
`15.
`
`A justiciable controversy exists as to the infringement and validity of the ’431
`
`patent because Counterclaim Defendants have brought an action against Lupin Ltd. alleging that
`
`Lupin Ltd. has infringed at least one claim of the ’431 patent, and that the manufacture, use, sale,
`
`offer for sale, and/or importation of the drug product that is the subject of ANDA No. 206027
`
`would infringe at least one claim of the ’431 patent, and Lupin Ltd. has denied that it has
`
`infringed any valid and enforceable claim of the ’431 patent and has denied that the manufacture,
`
`use, sale, offer for sale, and/or importation of the drug product that is the subject of ANDA No.
`
`206027 would infringe any valid and enforceable claim of that patent, and Lupin Ltd. has further
`
`alleged that the claims of the ’431 patent are invalid. This controversy is of sufficient
`
`immediacy and reality to warrant the issuance of a Declaratory Judgment.
`
`FIRST COUNTERCLAIM
`(Declaratory Judgment of Invalidity of the ’431 Patent)
`
`16.
`
`Lupin Ltd. repeats and incorporates herein by reference the allegations set forth in
`
`paragraphs 1-15 of its counterclaims.
`
`17.
`
`The claims of the ’431 patent are invalid for failure to comply with one or more
`
`provisions of 35 U.S.C. § 100 et seq., including but not limited to §§ 101, 102, 103, and/or 112,
`
`and/or for obviousness-type double patenting.
`
`SECOND COUNTERCLAIM
`(Declaratory Judgment of Non-infringement of the ’431 Patent)
`
`Lupin Ltd. repeats and incorporates herein by reference the allegations set forth in
`
`18.
`
`paragraphs 1-17 of its counterclaims.
`
`19.
`
`Lupin Ltd. has not infringed, either directly or indirectly, any valid and
`
`enforceable claim of the ’431 patent, either literally or under the doctrine of equivalents. Lupin
`
`410196.1
`
`8
`
`
`
`Case 1:14-cv-00667-JBS-KMW Document 7 Filed 03/27/14 Page 9 of 12 PageID: 34
`
`
`
`Ltd.’s manufacture, sale, use, offer for sale, and/or importation of the drug product that is the
`
`subject of ANDA No. 206027 would not infringe, either directly or indirectly, any valid and
`
`enforceable claim of the ’431 patent, either literally or under the doctrine of equivalents.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Lupin respectfully requests the following relief:
`
`A.
`
`B.
`
`A judgment dismissing the complaint against Lupin with prejudice;
`
`A judgment denying Plaintiffs any of the relief they have requested in the
`
`complaint against Lupin;
`
`C.
`
`D.
`
`A judgment declaring that the claims of the ’431 patent are invalid;
`
`A judgment declaring that Lupin Ltd. has not infringed, either directly or
`
`indirectly, any valid and enforceable claim of the ’431 patent, either literally or under the
`
`doctrine of equivalents, and that Lupin Ltd.’s manufacture, sale, use, offer for sale, and/or
`
`importation of the drug product that is the subject of ANDA No. 206027 would not infringe,
`
`either directly or indirectly, any valid and enforceable claim of the ’431 patent, either literally or
`
`under the doctrine of equivalents;
`
`E.
`
`A judgment declaring this to be an exceptional case under 35 U.S.C. § 285 and
`
`awarding Lupin its reasonable attorneys’ fees in defending this action;
`
`F.
`
`G.
`
`Lupin’s costs and expenses in defending this action; and
`
`Such other and further relief as the Court may deem just and proper.
`
`Dated: March 27, 2014
`
`
`410196.1
`
`
`
`
`
`LITE DEPALMA GREENBERG, LLC
`
`
`
`
`
` /s/ Michael E. Patunas
`Michael E. Patunas
`Mayra V. Tarantino
`Two Gateway Center, Suite 1201
`Newark, NJ 07102
`(973) 623-3000
`mpatunas@litedepalma.com
`mtarantino@litedepalma.com
`9
`
`
`
`Case 1:14-cv-00667-JBS-KMW Document 7 Filed 03/27/14 Page 10 of 12 PageID: 35
`
`
`
`
`Of Counsel:
`KENYON & KENYON LLP
`Elizabeth J. Holland
`Daniel P. Margolis
`Sarah Fink
`One Broadway
`New York, New York 10004-1050
`(212) 425-7200
`eholland@kenyon.com
`dmargolis@kenyon.com
`sfink@kenyon.com
`
`KENYON & KENYON LLP
`John W. Bateman
`1500 K Street, NW
`Washington, DC 20005-1257
`(202) 220-4200
`jbateman@kenyon.com
`
`Attorneys for Defendant/Counterclaim-Plaintiff
`Lupin Limited and Defendant Lupin
`Pharmaceuticals, Inc.
`
`
`
`410196.1
`
`10
`
`
`
`Case 1:14-cv-00667-JBS-KMW Document 7 Filed 03/27/14 Page 11 of 12 PageID: 36
`
`
`
`CERTIFICATION PURSUANT TO LOCAL CIVIL RULE 11.2
`
`Lupin Limited and Lupin Pharmaceuticals, Inc., by their undersigned counsel, hereby
`
`certify pursuant to Local Civil Rule 11.2 that the matter in controversy is not the subject of any
`
`other action pending in any court, nor of any pending arbitration or administrative proceeding.
`
`
`Dated: March 27, 2014
`
`
`
`
`
`
`
`
`LITE DEPALMA GREENBERG, LLC
`
`
`
`
`
` /s/ Michael E. Patunas
`Michael E. Patunas
`Mayra V. Tarantino
`Two Gateway Center, Suite 1201
`Newark, NJ 07102
`(973) 623-3000
`mpatunas@litedepalma.com
`mtarantino@litedepalma.com
`
`410196.1
`
`11
`
`
`
`Case 1:14-cv-00667-JBS-KMW Document 7 Filed 03/27/14 Page 12 of 12 PageID: 37
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`I, Michael E. Patunas, hereby certify that on this day, I served a copy of Lupin Limited’s
`
`
`
`and Lupin Pharmaceuticals, Inc.’s Answer, Defenses, and Counterclaims to Complaint For
`
`Patent Infringement to be served on counsel for Plaintiffs via the Court’s ECF system.
`
`
`
`March 27, 2014
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`/s/Michael E. Patunas
`Michael E. Patunas
`
`410196.1
`
`
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
