Case 1:14-cv-02758-PAC Document 17 Filed 06/10/14 Page 1 of 12
`
`Andrew J. Miller
`Constance S. Huttner
`BUDD LARNER, P.C.
`150 John F. Kennedy Parkway
`Short Hills, NJ 07078-0999
`(973) 379-4800
`
`Attorneys for Defendants
`Amneal Pharmaceuticals, LLC
`
`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF NEW YORK
`
`Civil Action No. 14-cv-2758 (PAC)
`
`Electronically Filed
`
`))))
`
`))))
`
`))))
`
`KOWA COMPANY, LTD., KOWA
`PHARMACEUTICALS AMERICA, INC. and
`NISSAN CHEMICAL INDUSTRIES. LTD.,
`
`Plaintiffs,
`
`AMNEAL PHARMACEUTICALS, LLC
`
`Defendant.
`
`ANSWER, AFFIRMATIVE DEFENSES AND COUNTERCLAIMS
`OF DEFENDANT AMNEAL PHARMACEUTICALS. LLC
`
`Defendant-Counterclaim
`
`Plaintiff Amneal Pharmaceuticals, LLC ("Amneal") by its
`
`attorneys, hereby responds
`
`to the Complaint of Plaintiffs-Counterclaim
`
`Defendants Kowa
`
`Company, Ltd., Kowa Pharmaceuticals America,
`("Plaintiffs" ) as follows:
`
`Inc. and Nissan Chemical
`
`Industries, Ltd
`
`JURISDICTION AND VENUE
`
`1.
`
`Admitted in part and denied in part. Amneal admits that this is an action by
`
`Plaintiffs against Amneal alleging patent
`
`infringement
`
`under 35 U.S.C. )$ 271(e) (2), 271(b),
`
`980169
`
`
`
`Andrew J. Miller
`Constance S. Huttner
`BUDD LARNER, P.C.
`150 John F. Kennedy Parkway
`Short Hills, NJ 07078-0999
`(973) 379-4800
`
`Attorneys for Defendants
`Amneal Pharmaceuticals, LLC
`
`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF NEW YORK
`
`Civil Action No. 14-cv-2758 (PAC)
`
`Electronically Filed
`
`))))
`
`))))
`
`))))
`
`KOWA COMPANY, LTD., KOWA
`PHARMACEUTICALS AMERICA, INC. and
`NISSAN CHEMICAL INDUSTRIES. LTD.,
`
`Plaintiffs,
`
`AMNEAL PHARMACEUTICALS, LLC
`
`Defendant.
`
`ANSWER, AFFIRMATIVE DEFENSES AND COUNTERCLAIMS
`OF DEFENDANT AMNEAL PHARMACEUTICALS. LLC
`
`Defendant-Counterclaim
`
`Plaintiff Amneal Pharmaceuticals, LLC ("Amneal") by its
`
`attorneys, hereby responds
`
`to the Complaint of Plaintiffs-Counterclaim
`
`Defendants Kowa
`
`Company, Ltd., Kowa Pharmaceuticals America,
`("Plaintiffs" ) as follows:
`
`Inc. and Nissan Chemical
`
`Industries, Ltd
`
`JURISDICTION AND VENUE
`
`1.
`
`Admitted in part and denied in part. Amneal admits that this is an action by
`
`Plaintiffs against Amneal alleging patent
`
`infringement
`
`under 35 U.S.C. )$ 271(e) (2), 271(b),
`
`980169
`
`
`
`Case 1:14-cv-02758-PAC Document 17 Filed 06/10/14 Page 2 of 12
`
`271(c), and 281-283. Amneal denies the remaining
`
`allegations of Paragraph 1. Amneal will not
`
`contest subject matter or personal
`
`jurisdiction for purposes of this action only.
`
`PARTIES
`
`2.
`
`Amneal
`
`is without knowledge or information
`
`sufficient
`
`to form a belief as to the
`
`truth of the allegations of Paragraph 2, and therefore denies them.
`
`3.
`
`Amneal
`
`is without knowledge or information
`
`sufficient
`
`to form a belief as to the
`
`truth of the allegations of Paragraph 3, and therefore denies them.
`
`4.
`
`Amneal
`
`is without knowledge or information
`
`sufficient
`
`to form a belief as to the
`
`truth of the allegations of Paragraph 4, and therefore denies them.
`
`5.
`
`6.
`
`Admitted.
`
`Admitted in part and denied in part. Amneal
`
`admits only that
`
`it is registered as a
`
`Pharmacy Establishment
`
`in the State of New York and has facilities located in Hauppauge
`
`and
`
`Brookhaven, New York. Amneal denies the remaining allegations of Paragraph 6.
`
`7.
`
`Admitted in part and denied in part. Amneal
`
`admits only that
`
`it is registered as a
`
`Foreign Limited Liability Company in New York. Amneal denies the remaining
`
`allegations of
`
`THE NEW DRUG APPLICATION
`
`Paragraph 7.
`
`8,
`
`9.
`
`10.
`
`11.
`
`Admitted.
`
`Admitted.
`
`Admitted.
`
`Admitted.
`
`980169
`
`
`
`Case 1:14-cv-02758-PAC Document 17 Filed 06/10/14 Page 3 of 12
`
`THE PATENTS IN SUIT
`
`12.
`
`Admitted in part and denied in part, Amneal admits that
`
`the '336 patent
`
`is
`
`entitled, "Quinoline Type Mevalonolactones,"
`
`and that the named inventors
`
`are Yoshihiro
`
`Fujikawa, Mikio Suzuki, Hiroshi
`
`Iwasaki, Mitsuaki Sakashita, and Masaki Kitahara. Amneal
`
`further admits that the '336 patent
`
`issued on January 5, 199 and that a purported copy of the '336
`
`patent
`
`is attached to Plaintiffs'omplaint
`
`as Exhibit A. Amneal
`
`states that
`
`the claims of the
`
`patent speak for themselves,
`
`subject to construction by the Court. Amneal
`
`is without knowledge
`
`or information
`
`sufficient
`
`to form a belief as to the remaining
`
`allegations of Paragraph 12, and
`
`therefore denies those allegations.
`
`13.
`
`Admitted in part and denied in part. Amneal admits that the '336 patent will
`
`expire on December 25, 2020. Amneal
`
`is without knowledge
`
`sufficient
`
`to form a belief as to the
`
`remaining
`
`allegations of Paragraph 13, and therefore denies those allegations.
`
`14.
`
`Admitted in part and denied in part. Amneal admits that
`
`the '993 patent
`
`is
`
`entitled "Crystalline Forms of Pitavastatin Calcium," and that the named inventors
`
`are Paul
`
`Adriaan Van Der Schaaf, Fritz Blatter, Martin Szelagiewicz,
`
`and Kai-Uwe Schoening. Amneal
`
`also admits that the '993 patent
`
`issued on October 15, 2013. Amneal
`
`states that the claims of the
`
`'993 patent speaks for themselves,
`
`subject to construction by the Court. Amneal
`
`is without
`
`knowledge or information
`
`sufficient
`
`to form a belief as to the truth of the remaining
`
`allegations
`
`in Paragraph 14, and therefore denies those allegations.
`
`15.
`
`Admitted in part and denied in part. Amneal admits that the '993 patent expires
`
`on February 2, 2024. Amneal
`
`is without knowledge or information
`
`sufficient
`
`to form a belief as
`
`to the truth of the remaining allegations
`
`in Paragraph 15, and therefore denies those allegations.
`
`980169
`
`
`
`Case 1:14-cv-02758-PAC Document 17 Filed 06/10/14 Page 4 of 12
`
`16.
`Amneal admits that KPA sells a pitavastatin
`the trade name Livalo . Amneal
`
`under
`
`drug product
`
`in the United States
`
`is without knowledge or information
`
`sufficient
`
`to form a
`
`belief as to the truth of the remaining
`
`allegations
`
`in Paragraph 16, and therefore denies those
`
`allegations.
`
`17.
`
`Amneal
`
`is without knowledge or information
`
`sufficient
`
`to form a belief as to the
`
`truth of the allegations
`
`in Paragraph 17, and therefore denies those allegations.
`
`18.
`
`Denied.
`
`COUNT I
`
`INFRINGEMENT OF THE '336
`PATENT UNDER 35 U.S.C.S 271(e)(2)(a)
`
`19.
`
`Amneal
`
`repeats its responses
`
`to Paragraphs
`
`1 through 18 above, which are
`
`explicitly incorporated by reference.
`
`20.
`
`21.
`
`Admitted.
`
`Admitted in part and denied in part. Amneal admits that the Amneal ANDA
`
`contains a paragraph
`
`IV certification under 21 U.S.C. ) 355(j)(2)(A)(vii)(IV) respecting the '336
`
`patent. Amneal denies the remaining
`
`allegations of Paragraph 21.
`
`22.
`
`Admitted in part and denied in part. Amneal admits that the Amneal ANDA
`
`contains a paragraph
`
`IV certification under 21 U.S.C. $ 355(j)(2)(A)(vii)(IV) respecting the '336
`
`patent. Amneal denies the remaining allegations of Paragraph 22.
`
`23.
`
`Admitted in part and denied in part. Amneal admits that it notified Plaintiffs by
`
`letter dated March 5, 2014 that Amneal had submitted the Amneal ANDA containing a
`
`Paragraph IV certification respecting the '336 patent. Amneal
`
`is without knowledge or
`
`information
`
`sufficient
`
`to form a belief as to the truth of the remaining allegations of Paragraph
`
`23, and therefore denies those allegations.
`
`980169
`
`
`
`Case 1:14-cv-02758-PAC Document 17 Filed 06/10/14 Page 5 of 12
`
`24.
`
`Amneal
`
`states that its March 5, 2014 Notice Letter speaks for itself and
`
`respectfully refers the Court to that
`
`letter for its contents.
`
`25.
`
`26.
`
`27.
`
`Denied.
`
`Denied.
`
`Amneal
`
`states that
`
`its proposed labeling material
`
`is a part of its ANDA and that
`
`such material
`
`speaks for itself. Amneal
`
`respectfully refers the Court
`
`to that material
`
`for its
`
`contents.
`
`28.
`
`Denied.
`
`COUNT II
`
`INFRINGEMENT OF THE METHOD CLAIM
`OF THE '336 PATENT UNDER 35 U.S.C. 5 271(b)
`
`29.
`
`Amneal
`
`repeats its responses
`
`to Paragraph 1-28 above which are explicitly
`
`incorporated by reference.
`
`30.
`
`31.
`
`Denied.
`
`Amneal
`
`states that
`
`its proposed labeling material are a part of its ANDA and that
`
`such material
`
`speaks for itself. Amneal
`
`respectfully refers the Court to that material
`
`for its
`
`contents.
`
`32.
`
`Admitted in part and denied in part. Amneal
`
`states that it is aware of the label
`
`indications
`
`for Livalo, which include the use of pitavastatin
`
`as an adjunct
`
`therapy to diet to
`
`treat primary hyperlipidemia
`
`and mixed dyslipidemia. Amneal denies the remaining
`
`allegations
`
`in Paragraph 32.
`
`33.
`
`Denied.
`
`980169
`
`
`
`Case 1:14-cv-02758-PAC Document 17 Filed 06/10/14 Page 6 of 12
`
`COUNT III
`
`INFRINGEMENT OF THK METHOD CLAIM
`OF THE '336 PATENT UNDER 35 U.S.C.5271(c)
`
`34.
`
`Amneal
`
`repeats its responses
`
`to Paragraphs
`
`1 through 33 above, which are
`
`explicitly incorporated by reference.
`
`35,
`
`Admitted in part and denied in part. Amneal admits that its proposed pitavastatin
`
`drug product comprises pitavastatin
`
`calcium. Amneal denies the remaining allegations
`
`in
`
`Paragraph 35.
`
`36.
`
`37.
`
`38.
`
`39.
`
`40.
`
`41.
`
`42.
`
`Denied.
`
`Denied.
`
`Denied.
`
`Denied.
`
`Denied.
`
`Denied.
`
`Denied.
`
`COUNT IV
`
`INFRINGEMENT OF THE '993
`PATENT UNDER 35 U.S.C.5271(e)(2)(A)
`
`43.
`
`Amneal
`
`repeats its responses
`
`to Paragraphs
`
`1 through 42 above, which are
`
`explicitly incorporated by reference.
`
`44.
`
`Amneal
`
`states that
`
`its Notice Letter speaks for itself and respectfully refers the
`
`Court
`
`to that Letter for its contents.
`
`45.
`
`Amneal
`
`states that
`
`its Notice Letter speaks for itself and respectfully refers the
`
`Court to that Letter for its contents.
`
`980169
`
`
`
`Case 1:14-cv-02758-PAC Document 17 Filed 06/10/14 Page 7 of 12
`
`46.
`
`47.
`
`48.
`
`Denied.
`
`Denied.
`
`Denied.
`
`REOIJESTED RELIEF
`
`Amneal denies that Plaintiffs are entitled to any of the relief sought
`
`in paragraphs
`
`(a)
`
`through (g) on pages 10-11 of the Complaint.
`
`AFFIRMATIVE DEFENSES
`
`First Affirmative Defense - Noninfrineement
`
`of the '336 and '993 Patents
`
`Amneal has not infringed,
`
`is not infringing, will not infringe,
`
`and will not contribute to or
`
`induce infiingement
`
`of, literally or under
`
`the Doctrine of Equivalents,
`
`any valid and enforceable
`
`claim of the '336 or '993 patents.
`
`Second Affirmative Defense - Invaliditv of the '336 and '993 Patents
`
`Upon information
`
`and belief, each claim of the '336 and '993 patents is invalid for failure
`
`to comply with the conditions
`
`and requirements of the patent
`
`laws of the United States, including
`
`without
`
`limitation, 35 U.S.C. $ $ 101, 102, 103 and/or 112.
`
`Reservation of Rights
`
`Amneal
`
`reserves the right
`
`to assert such other defenses and damages
`
`that may appear as
`
`discovery proceeds in this case.
`
`980169
`
`
`
`Case 1:14-cv-02758-PAC Document 17 Filed 06/10/14 Page 8 of 12
`
`COUNTERCLAIMS
`
`JURISDICTION AND VENUE
`
`Amneal counterclaims
`
`against Plaintiffs pursuant
`
`to the patent
`
`laws of the United
`
`States, 35 U.S.C. ( 1, et seq., and the Declaratory Judgment Act, 28 U.S.C. ( 2201, et seq.
`arise out of the same transactions
`
`and occurrences
`
`that are
`
`2.
`
`These Counterclaims
`
`the subject of the claims asserted in the Complaint
`
`in the above-captioned
`
`action.
`
`Jurisdiction of this Court is based upon 28 U.S,C. $ $ 1331, 1338(a), 2201 and
`
`2202 and Rule 13 of the Federal Rules of Civil Procedure.
`
`4.
`
`Venue is proper in this Court under 28 U.S.C. $ 1391(b) and (c). Plaintiffs have
`
`submitted to personal
`
`jurisdiction in this Court, having brought
`
`the instant
`
`suit against Amneal.
`
`PARTIES
`
`5.
`
`Counterclaim Plaintiff Amneal
`
`is a limited liability company organized and
`
`existing under
`
`the laws of the State of Delaware, having a principal place of business at 440 US
`
`Highway 22 East, Suite 104, Bridgewater, NJ 08807.
`
`6.
`
`Upon information
`
`and belief, as alleged in Counterclaim Defendants'omplaint,
`
`Counterclaim Defendant Kowa is a Japanese corporation having its corporate headquarters
`
`and
`
`principal place of business
`
`in Aichi, Japan.
`
`7.
`
`Upon information
`
`and belief, as alleged in Counterclaim Defendants'omplaint,
`
`Counterclaim Defendant KPA is a wholly owned U.S. subsidiary of Kowa with principal place
`
`of business and headquarters
`
`in Montgomery, Alabama.
`
`8.
`
`Upon information
`
`and belief, as alleged in Counterclaim Defendants'omplaint,
`
`Counterclaim Defendant Nissan is a Japanese corporation having its principal place of business
`
`in Tokyo, Japan.
`
`980169
`
`
`
`Case 1:14-cv-02758-PAC Document 17 Filed 06/10/14 Page 9 of 12
`
`THK PATENTS-IN-SUIT
`
`11.
`
`U.S. Patent No. 5,856,336 ('the '336 patent"), entitled "Quinoline Type
`
`Mevalonolactones,"
`
`issued on January 5, 1999.
`
`12.
`
`U.S. Patent No. 8,557,993 ("the '993 patent"), entitled "Crystalline Forms of
`
`Pitavastatin Calcium," issued on October 15, 2013.
`
`15.
`
`This is an action based on an actual controversy between Plaintiffs and Amneal
`
`concerning the noninfringement
`
`and/or
`
`invalidity of the '336 and '993 patents
`
`(collectively,
`
`the
`
`"patents-in-suit").
`
`16.
`
`Amneal
`
`submitted ANDA No. 20-5961 to the FDA seeking approval
`
`to engage in
`
`the commercial manufacture,
`
`use, and/or
`
`sale of its 1 mg, 2 mg and 4 mg pitavastatin
`
`calcium
`
`tablets.
`
`17.
`
`Plaintiffs
`
`filed their Complaint
`
`in this Court alleging that Amneal's
`
`act of
`
`submitting ANDA No. 20-5961 infringes
`
`the patents-in-suit.
`
`18.
`
`Amneal denies that it infringes
`
`any valid and enforceable claim of the patents-in
`
`suit.
`
`19.
`
`Based on Plaintiffs'iling of the Complaint,
`
`and Amneal's denial
`
`thereof,
`
`there is
`
`an actual, substantial,
`
`and continuing justiciable controversy between Amneal and Plaintiffs
`
`having adverse legal
`
`interests of sufficient
`
`immediacy and reality to warrant
`
`the issuance of a
`
`declaratory judgment
`
`regarding whether Amneal has infringed any valid and enforceable claim
`
`of the patents-in-suit.
`
`20.
`
`Unless Plaintiffs are enjoined, Amneal believes that Plaintiffs will continue to
`
`assert
`
`that Amneal
`
`infringes
`
`the claims of the patents-in-suit
`
`and will continue to interfere with
`
`Amneal's business with respect
`
`to pitavastatin
`
`calcium tablets.
`
`980169
`
`
`
`Case 1:14-cv-02758-PAC Document 17 Filed 06/10/14 Page 10 of 12
`
`21.
`
`Amneal will be irreparably harmed if Plaintiffs are not enjoined from asserting the
`
`patents-in-suit
`
`and interfering with Amneal's business.
`
`First Counterclaim - Noninfrineement
`
`of the '336 and '993 Patents
`
`22.
`
`Amneal
`
`repeats,
`
`realleges and incorporates Paragraphs
`
`1-21 of these
`
`Counterclaims
`
`as if fully set forth herein.
`
`23.
`
`Amneal has not infringed,
`
`is not infringing, will not infringe,
`
`and will not
`
`contribute to or induce infringement
`
`of, literally or under
`
`the Doctrine of Equivalents,
`
`any valid
`
`and enforceable claim of the '336 and '993 patents.
`
`Second Counterclaim - Invalidity of the '336 and '993 Patents
`
`24.
`
`Amneal
`
`repeats,
`
`realleges and incorporates Paragraphs
`
`1-21 of these
`
`Counterclaims
`
`as if fully set forth herein.
`
`25.
`
`Upon information
`
`and belief, each claim of the patents in suit is invalid for failure
`
`to comply with the conditions
`
`and requirements of the patent
`
`laws of the United States, including
`
`without
`
`limitation, 35 U.S,C, )$ 101, 102, 103 and/or 112.
`
`DEMAND FOR JUDGMENT
`
`WHEREFORE, Amneal
`
`respectfully prays that
`
`this Court enter judgment
`
`in its favor
`
`and grant
`
`the following relief:
`
`a.
`
`Dismiss Plaintiffs'omplaint
`
`with prejudice and deny each and every prayer
`
`for
`
`relief contained therein;
`
`b.
`
`Declare that Amneal has not in&inged,
`
`is not infringing,
`
`and will not infringe, nor
`
`contribute to or induce infringement
`
`of, literally or under
`
`the Doctrine of Equivalents,
`
`any valid
`
`and enforceable claim of the patents-in-suit
`
`and that Amneal has a lawful
`
`right
`
`to obtain FDA
`
`approval of its ANDA No. 20-5961 for pitavastatin
`
`calcium tablets;
`
`980169
`
`10
`
`
`
`Case 1:14-cv-02758-PAC Document 17 Filed 06/10/14 Page 11 of 12
`
`c.
`
`d.
`
`Declare that the claims of the '336 and '993 patents are invalid;
`
`Enjoin Plaintiffs,
`
`their officers, employees,
`
`agents,
`
`representatives,
`
`attorneys
`
`and
`
`others acting on their behalf,
`
`from threatening
`
`or initiating infringement
`
`litigation against
`
`Amneal or its customers, dealers or suppliers, or any prospective or present sellers, dealers,
`
`distributors or customers of Amneal, or charging them either verbally or in writing with
`
`infringement of any patent asserted against Amneal;
`
`Declare that this is an exceptional case, and that Amneal be awarded its
`
`attorneys'ees
`
`and costs pursuant
`
`to 35 U.S.C. g 285; and
`
`f.
`
`Award Amneal
`
`such further
`
`relief as this Court may deem necessary,
`
`just and
`
`Respect
`
`mitted,
`
`Andrew J. Miller
`Constance S. Huttner
`(chuttner@buddlarner.corn)
`BUDD LARNER, PC
`150 John F. Kennedy Parkway
`Short Hills, NJ 07078-2703
`t: (973) 379-4800
`f: (973) 379-7734
`
`proper.
`
`Dated: June/P 2014
`
`980169
`
`
`
`Case 1:14-cv-02758-PAC Document 17 Filed 06/10/14 Page 12 of 12
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that
`
`the within ANSWER, AFFIRMATIVE DEFENSES AND
`
`COUNTERCLAIMS OF DEFENDANT AMNEAL PHARMACEUTICALS, LLC
`
`has been filed electronically and is available for viewing and downloading
`
`from the ECF System,
`
`and is being served upon all counsel of record via ECF transmission
`
`in accordance with the
`
`Electronic Filing System of the Court,
`
`this 10th day of June, 2014.
`
`Cons(ance S. tuner
`
`980169
`
`12
`
`
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
