`
`Douglass C. Hochstetler (dhochstetler@kelleydrye.com)
`(pro hac vice application forthcoming)
`Christine A. Dudzik (cdudzik@kelleydrye.com)
`(pro hac vice application forthcoming)
`KELLEY DRYE & WARREN LLP
`
`333 W. Wacker Drive, Suite 2600
`
`Chicago, IL 60606
`Telephone: 312-857-7000
`Facsimile: 312-857-7095
`
`Beth D. Jacob (b'acob@kelleydrye.com)
`(pro hac vice application forthcoming)
`Clifford Katz (ckatz@kelleydrye.com)
`KELLEY DRYE & WARREN LLP
`101 Park Avenue
`
`New York, NY 10178
`
`Telephone: 212-808-7800
`Facsimile: 212-808-7897
`
`Michael A. Innes (minnes@kelleydrye.com)
`KELLEY DRYE & WARREN LLP
`200 Kimball Drive
`
`Parsippany, New Jersey 07054
`Telephone: (973) 503-5900
`Facsimile: (973) 503-5950
`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF NEW JERSEY
`
`C.A. No. 1:14-cv-07105-JBS-KMW
`
`) ) ) ) ) )
`
`) ) )
`
`) ) )
`
`OTSUKA PHARMACEUTICAL CO., LTD.,
`
`Plaintiff,
`
`v.
`
`LUPIN LIMITED, LUPIN ATLANTIS
`
`HOLDING SA, LUPIN
`
`PHARMACEUTICALS, INC., and HETERO
`
`LABS LIMITED,
`
`Defendants.
`
`LUPIN’S ANSWER TO AMENDED COMPLAINT
`
`FOR PATENT INFRINGMENT
`
`NY01\KatzC\3961976.1
`
`Janssen Ex. 2034
`
`Lupin Ltd. v. Janssen Sciences Ireland UC
`|PR2015-01030
`
`(Page 1 of 12)
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`
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`Case 1:14—cv—O7105—JBS—KMW Document 37 Filed 03/09/15 Page 2 of 12 Page|D: 651
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`Defendants Lupin Limited, Lupin Atlantis Holdings SA and Lupin
`
`Pharmaceuticals, Inc. (collectively, “Lupin”), by and through their attorneys, respond to each of
`
`the numbered paragraphs in the Amended Complaint filed against them by Plaintiff Otsuka
`
`Pharmaceutical Co., Ltd. (“Plaintiff ’ or “Otsuka”) as follows:
`
`Lupin denies all allegations contained in headings, unnumbered paragraphs, and
`
`the “Wherefore” clause in the Amended Complaint. Otuska does not distinguish Lupin from
`
`Hetero Labs Limited (“Hetero”) in certain allegations, and instead makes allegations against
`
`“Defendants” generally; Lupin denies any explicit or implicit allegations that Lupin acted on
`
`behalf of, or jointly with, Hetero. Lupin further denies all allegations set forth in the Amended
`
`Complaint that are not specifically admitted.
`
`THE PARTIES
`
`l.
`
`Lupin lacks knowledge or information sufficient to form a belief about the
`
`truth of the allegations set forth in paragraph 1 of the Amended Complaint.
`
`2.
`
`Lupin admits the allegations set forth in paragraph 2 of the Amended
`
`Complaint.
`
`Complaint.
`
`Complaint.
`
`3.
`
`Lupin admits the allegations set forth in paragraph 3 of the Amended
`
`4.
`
`Lupin admits the allegations set forth in paragraph 4 of the Amended
`
`5.
`
`Lupin lacks knowledge or information sufficient to form a belief about the
`
`truth of the allegations set forth in paragraph 5 of the Amended Complaint.
`
`NY0l\KatzC\396l976.l
`
`Janssen Ex. 2034
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`Lupin Ltd. v. Janssen Sciences Ireland UC
`|PR2015-01030
`
`(Page 2 of 12)
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`
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`Case 1:14—cv—O7105—JBS—KMW Document 37 Filed 03/09/15 Page 3 of 12 Page|D: 652
`
`NATURE OF THE ACTION
`
`6.
`
`Lupin admits that Plaintiffs purport to bring an action for patent
`
`infringement under the patent laws of the United States, but otherwise denies the allegations set
`
`forth in Paragraph 6 of the Amended Complaint.
`
`JURISDICTION AND VENUE
`
`7.
`
`Lupin admits the allegations set forth in paragraph 7 of the Amended
`
`Complaint.
`
`8.
`
`Lupin Limited states that it does not contest personal jurisdiction in this
`
`District solely for the purposes of this action, but otherwise denies the allegations set forth in
`
`Paragraph 8 of the Amended Complaint, except admits that Lupin Limited manufactures
`
`pharmaceutical products and refers to the Annual Report and the cited Lupin websites for a
`
`complete and accurate statement of their contents.
`
`9.
`
`Lupin Atlantis Holdings SA states that it does not contest personal
`
`jurisdiction in this District solely for the purposes of this action, but otherwise denies the
`
`allegations set forth in Paragraph 9 of the Amended Complaint.
`
`10.
`
`Lupin Pharmaceuticals, Inc. states that it does not contest personal
`
`jurisdiction in this District, solely for the purposes of this action, but otherwise denies the
`
`allegations set forth in Paragraph 10 of the Amended Complaint, except admits that Lupin
`
`Pharmaceuticals, Inc. distributes generic pharmaceutical products in the United States, including
`
`generic pharmaceutical products manufactured by Lupin Limited, and refers to the cited Lupin
`
`websites for a complete and accurate statement of their contents.
`
`ll.
`
`Lupin denies the allegations set forth in Paragraph 11 of the Amended
`
`Complaint, and refers to the cited Lupin websites for a complete and accurate statement of their
`
`contents.
`
`NY0l\KatzC\396l976.l
`
`Janssen Ex. 2034
`
`Lupin Ltd. v. Janssen Sciences Ireland UC
`|PR2015-01030
`
`(Page 3 of 12)
`
`
`
`Case 1:14—cv—O7105—JBS—KMW Document 37 Filed 03/09/15 Page 4 of 12 Page|D: 653
`
`12.
`
`Lupin lacks knowledge or information sufficient to form a belief about the
`
`truth of the allegations set forth in paragraph 12 of the Amended Complaint
`
`13.
`
`Lupin states that it does not contest Venue in this District solely for the
`
`purposes of this action, but otherwise denies the allegations set forth in Paragraph 13 of the
`
`Amended Complaint.
`
`FIRST COUNT FOR PATENT INFRINGEMENT
`
`14.
`
`Lupin admits the allegations in Paragraph 14 of the Amended Complaint
`
`that, according to the face of the patent, U.S. Patent No. 8,017,615 (‘"615 patent”) was issued by
`
`the U.S. Patent and Trademark Office (“PTO”) on September 13, 2011, that it is entitled “Low
`
`Hygroscopic Aripiprazole Drug Substance and Processes for the Preparation Thereof,” and that a
`
`copy of the patent is attached to the Amended Complaint, but denies that the patent was duly and
`
`legally issued.
`
`15.
`
`Lupin lacks knowledge or information sufficient to form a belief about the
`
`truth of the allegations in Paragraph 15 of the Amended Complaint.
`
`16.
`
`Lupin lacks knowledge or information sufficient to form a belief about the
`
`truth of the allegations in Paragraph 16 of the Amended Complaint.
`
`17.
`
`Lupin denies the allegations in Paragraph 17 of the Amended Complaint,
`
`and refers to the ’615 patent for a complete and accurate statement of its terms.
`
`18.
`
`Lupin lacks knowledge or information sufficient to form a belief about the
`
`truth of the allegations in Paragraph 18 of the Amended Complaint, except admits that, upon
`
`information and belief, Otsuka is the holder of New Drug Application No. 21-436.
`
`19.
`
`Lupin lacks knowledge or information sufficient to form a belief about the
`
`truth of the allegations in Paragraph 19 of the Amended Complaint, except admits that, the ’615
`
`NY01\KatzC\3961976.1
`
`Janssen Ex. 2034
`
`Lupin Ltd. v. Janssen Sciences Ireland UC
`|PR2015-01030
`
`(Page 4 of 12)
`
`
`
`Case 1:14—cv—O7105—JBS—KMW Document 37 Filed 03/09/15 Page 5 of 12 Page|D: 654
`
`patent is listed in the FDA’s Orange Book: Approved Drug Products with Therapeutic
`
`Equivalence Evaluations in connection with NDA No. 21-436.
`
`20.
`
`Upon information and belief, Lupin admits the allegations in Paragraph 20
`
`of the Amended Complaint.
`
`21.
`
`Lupin Atlantis Holdings SA admits that it submitted ANDA No. 205589
`
`to the FDA, under Section 505(j) of the Act, 21 U.S.C § 355(j). The allegations of Paragraph 21
`
`of the Amended Complaint are otherwise denied.
`
`22.
`
`Lupin admits the allegations in Paragraph 22 of the Amended Complaint.
`
`23.
`
`Lupin admits the allegations in Paragraph 23 of the Amended Complaint.
`
`24.
`
`Lupin denies the allegations in Paragraph 24 of the Amended Complaint.
`
`25.
`
`Lupin denies the allegations in Paragraph 25 of the Amended Complaint.
`
`26.
`
`Lupin denies the allegations in Paragraph 26 of the Amended Complaint,
`
`except admits that, as indicated on its Form FDA 356h, Lupin Pharmaceuticals, Inc. is
`
`designated as Lupin Atlantis Holdings SA’s “Authorized U.S. Agent” for ANDA No. 205589.
`
`SECOND COUNT FOR PATENT INFRINGEMENT
`
`27.
`
`Lupin incorporates herein its answers to the allegations made in
`
`Paragraphs 18 through 23 of the Amended Complaint, as if those answers had been realleged and
`
`set forth again in full.
`
`28.
`
`Lupin admits the allegations in Paragraph 28 of the Amended Complaint
`
`that, according to the face of the patent, U.S. Patent No. 8,580,796 (‘"796 patent”) was issued by
`
`the PTO on November 12, 2013, that it is entitled “Low Hygroscopic Aripiprazole Drug
`
`Substance and Processes for the Preparation Thereof,” and that a copy of the patent is attached to
`
`the Amended Complaint, but denies that the patent was duly and legally is sued.
`
`NY0l\KatzC\396l976.l
`
`Janssen Ex. 2034
`
`Lupin Ltd. v. Janssen Sciences Ireland UC
`|PR2015-01030
`
`(Page 5 of 12)
`
`
`
`Case 1:14—cv—O7105—JBS—KMW Document 37 Filed 03/09/15 Page 6 of 12 Page|D: 655
`
`29.
`
`Lupin lacks knowledge or information sufficient to form a belief about the
`
`truth of the allegations in Paragraph 29 of the Amended Complaint.
`
`30.
`
`Lupin lacks knowledge or information sufficient to form a belief about the
`
`truth of the allegations in Paragraph 30 of the Amended Complaint.
`
`31.
`
`Lupin denies the allegations in Paragraph 31 of the Amended Complaint,
`
`and refers to the ’796 patent for a complete and accurate statement of its terms.
`
`32.
`
`Lupin lacks knowledge or information sufficient to form a belief about the
`
`truth of the allegations in Paragraph 32 of the Amended Complaint, except admits that, the ’796
`
`patent is listed in the FDA’s Orange Book: Approved Drug Products with Therapeutic
`
`Equivalence Evaluations in connection with NDA No. 21-436.
`
`33.
`
`Lupin admits the allegations in Paragraph 33 of the Amended Complaint.
`
`34.
`
`Lupin denies the allegations in Paragraph 34 of the Amended Complaint.
`
`35.
`
`Lupin denies the allegations in Paragraph 35 of the Amended Complaint.
`
`36.
`
`Lupin denies the allegations in Paragraph 36 of the Amended Complaint,
`
`except admits that, as indicated on its Form FDA 356h, Lupin Pharmaceuticals, Inc. is
`
`designated as Lupin Atlantis Holdings SA’s “Authorized U.S. Agent” for ANDA No. 205589.
`
`THIRD COUNT FOR PATENT INFRINGEMENT
`
`37.
`
`Lupin incorporates herein its answers to the allegations made in
`
`Paragraphs 18 through 23 of the Amended Complaint, as if those answers had been realleged and
`
`set forth again in full.
`
`38.
`
`Lupin admits the allegations in Paragraph 38 of the Amended Complaint
`
`that, according to the face of the patent, U.S. Patent No. 8,642,760 (‘"760 patent”) was issued by
`
`the PTO on February 4, 2014, that it is entitled “Low Hygroscopic Aripiprazole Drug Substance
`
`NY01\KatzC\3961976.1
`
`Janssen Ex. 2034
`
`Lupin Ltd. v. Janssen Sciences Ireland UC
`|PR2015-01030
`
`(Page 6 of 12)
`
`
`
`Case 1:14—cv—O7105—JBS—KMW Document 37 Filed 03/09/15 Page 7 of 12 Page|D: 656
`
`and Processes for the Preparation Thereof,” and that a copy of the patent is attached to the
`
`Amended Complaint, but denies that the patent was duly and legally issued.
`
`39.
`
`Lupin lacks knowledge or information sufficient to form a belief about the
`
`truth of the allegations in Paragraph 39 of the Amended Complaint.
`
`40.
`
`Lupin lacks knowledge or information sufficient to form a belief about the
`
`truth of the allegations in Paragraph 40 of the Amended Complaint.
`
`41.
`
`Lupin denies the allegations in Paragraph 41 of the Amended Complaint,
`
`and refers to the ’760 patent for a complete and accurate statement of its terms.
`
`42.
`
`Lupin lacks knowledge or information sufficient to form a belief about the
`
`truth of the allegations in Paragraph 42 of the Amended Complaint, except admits that, the ’760
`
`patent is listed in the FDA’s Orange Book: Approved Drug Products with Therapeutic
`
`Equivalence Evaluations in connection with NDA No. 21-436.
`
`43.
`
`Lupin admits the allegations in Paragraph 43 of the Amended Complaint.
`
`44.
`
`Lupin denies the allegations in Paragraph 44 of the Amended Complaint.
`
`45.
`
`Lupin denies the allegations in Paragraph 45 of the Amended Complaint.
`
`46.
`
`Lupin denies the allegations in Paragraph 46 of the Amended Complaint,
`
`except admits that, as indicated on its Form FDA 356h, Lupin Pharmaceuticals, Inc. is
`
`designated as Lupin Atlantis Holdings SA’s “Authorized U.S. Agent” for ANDA No. 205589.
`
`FOURTH COUNT FOR PATENT INFRINGEMENT
`
`47.
`
`Lupin incorporates herein its answers to the allegations made in
`
`Paragraphs 18 through 23 of the Amended Complaint, as if those answers had been realleged and
`
`set forth again in full.
`
`48.
`
`Lupin admits the allegations in Paragraph 48 of the Complaint that,
`
`according to the face of the patent, U.S. Patent No. 8,759,350 (‘"350 patent”) was issued by the
`
`NY0l\KatzC\396l976.l
`
`7
`
`Janssen Ex. 2034
`
`Lupin Ltd. v. Janssen Sciences Ireland UC
`|PR2015-01030
`
`(Page 7 of 12)
`
`
`
`Case 1:14—cv—O7105—JBS—KMW Document 37 Filed 03/09/15 Page 8 of 12 Page|D: 657
`
`PTO on June 24, 2014, that it is entitled “Carbostyril Derivatives and Serotonin Reuptake
`
`Inhibitors for Treatment of Mood Disorders,” and that a copy of the patent is attached to the
`
`Complaint, but denies that the patent was duly and legally issued.
`
`49.
`
`Lupin lacks knowledge or information sufficient to form a belief about the
`
`truth of the allegations in Paragraph 49 of the Amended Complaint.
`
`50.
`
`Lupin lacks knowledge or information sufficient to form a belief about the
`
`truth of the allegations in Paragraph 50 of the Amended Complaint.
`
`51.
`
`Lupin denies the allegations in Paragraph 51 of the Amended Complaint,
`
`and refers to the ’350 patent for a complete and accurate statement of its terms.
`
`52.
`
`Lupin lacks knowledge or information sufficient to form a belief about the
`
`truth of the allegations in Paragraph 52 of the Amended Complaint, except admits that, the ’35O
`
`patent is listed in the FDA’s Orange Book: Approved Drug Products with Therapeutic
`
`Equivalence Evaluations in connection with NDA No. 21-436.
`
`53.
`
`Lupin admits the allegations in Paragraph 53 of the Amended Complaint.
`
`54.
`
`Lupin denies the allegations in Paragraph 54 of the Amended Complaint.
`
`55.
`
`Lupin denies the allegations in Paragraph 55 of the Amended Complaint.
`
`56.
`
`Lupin denies the allegations in Paragraph 56 of the Amended Complaint,
`
`except admits that, as indicated on its Form FDA 356h, Lupin Pharmaceuticals, Inc. is
`
`designated as Lupin Atlantis Holdings SA’s “Authorized U.S. Agent” for ANDA No. 205589.
`
`57.
`
`Lupin denies all allegations not specifically admitted herein, and further
`
`denies that Plaintiffs are entitled to the judgment and relief requested in the Wherefore clause set
`
`forth in the Amended Complaint or to any relief whatsoever.
`
`NY0l\KatzC\396l976.l
`
`Janssen Ex. 2034
`
`Lupin Ltd. v. Janssen Sciences Ireland UC
`|PR2015-01030
`
`(Page 8 of 12)
`
`
`
`Case 1:14—cv—O7105—JBS—KMW Document 37 Filed 03/09/15 Page 9 of 12 Page|D: 658
`
`AFFIRMATIVE AND OTHER 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 Amended
`
`Complaint. Lupin reserves the right to supplement this Answer, including the right to assert
`
`additional defenses.
`
`(Non-infringement of the ’615, ’796, ’760, and ’350 patents)
`
`FIRST DEFENSE
`
`5 8.
`
`The manufacture, use, offer for sale, sale, or importation of Lupin’s
`
`Aripiprazole Tablets, 2—mg, 5—mg,
`
`lO—mg, l5—mg, 20—mg, and 30—mg (“Lupin’s ANDA
`
`Products”) does not and will not infringe any valid claim of the ’6l5, ’796, ’760, and ’350
`
`patents, either literally or under the doctrine of equivalents. Lupin further does not indirectly
`
`infringe any method of use claim in these patents because, inter alia, there exists substantial non-
`
`infringing uses and Lupin has a good faith basis that the claims of these patents are invalid
`
`and/or not infringed.
`
`SECOND DEFENSE
`
`(Invalidity of the ’615, ’796, ’760, and ’350 patents)
`
`59.
`
`The claims of the ’6l5, ’796, ’760, and ’35O patents are invalid for failing
`
`to meet a condition for patentability set forth in 35 U.S.C. § 101 et seq. By way of example and
`
`not of limitation, one or more of the claims of the ’6l5, ’796, ’760, and ’35O patents are invalid
`
`for indefiniteness under 35 USC § 112 if such claims are construed to encompass Lupin’s
`
`ANDA Products.
`
`THIRD DEFENSE
`
`gFailure to State a Claim)
`
`60.
`
`The Amended Complaint fails to state a claim against Lupin upon which
`
`relief can be granted with respect to the ’350 patent (Fourth Count).
`
`NY0l\KatzC\396l976.l
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`Janssen Ex. 2034
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`Lupin Ltd. v. Janssen Sciences Ireland UC
`|PR2015-01030
`
`(Page 9 of 12)
`
`
`
`Case 1:14—cv—O7105—JBS—KMW Document 37 Filed 03/09/15 Page 10 of 12 Page|D: 659
`
`61.
`
`Additionally, to the extent that Plaintiff alleges that Lupin’s actions make
`
`this case exceptional under 35 U.S.C. § 285, the Amended Complaint further fails to state a
`
`claim upon which relief can be granted.
`
`FOURTH DEFENSE
`
`62.
`
`Any additional defenses that discovery may reveal.
`
`WHEREFORE, Lupin respectfully requests the Court to enter judgment against
`
`Plaintiff as follows:
`
`(a)
`
`dismissing the Amended Complaint in its entirety with prejudice and
`
`entering judgment in favor of Lupin against Plaintiff;
`
`(b)
`
`that this is an exceptional case under 35 U.S.C. § 285, and an award to
`
`Lupin of its costs and fees incurred in defending this action;
`
`(c)
`
`and such other and further relief as the Court may deem just and proper.
`
`Dated: March 9, 2015
`
`Respectfully submitted,
`
`KELLEY DRYE & WARREN LLP
`
`s/ Michael A. Innes
`
`Michael A. Innes
`
`200 Kimball Drive
`
`Parsippany, New Jersey 07054
`(973) 503-5900
`
`Beth D. Jacob
`
`(pro hac vice application forthcoming)
`Clifford Katz
`
`101 Park Avenue
`
`New York, NY 10178
`
`(212) 808-7800
`
`Douglass C. Hochstetler
`(pro hac vice application forthcoming)
`Christine A. Dudzik
`
`(pro hac vice application forthcoming)
`10
`
`Janssen Ex. 2034
`
`Lupin Ltd. v. Janssen Sciences Ireland UC
`|PR2015-01030
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`(Page 10 of 12)
`
`NY01\KatzC\3961976.1
`
`
`
`Case 1:14—cv—O7105—JBS—KMW Document 37 Filed 03/09/15 Page 11 of 12 Page|D: 660
`
`333 W. Wacker Drive, Suite 2600
`
`Chicago, IL 60606
`(312) 857-7000
`
`Attorneys for Defendants Lapin Limited,
`Lapin Atlantis Holdings SA and
`
`Lapin Pharmaceuticals, Inc.
`
`NY01\KatzC\3961976.1
`
`11
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`|PR2015-01030
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`(Page 11 of 12)
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`
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`Case 1:14—cv—O7105—JBS—KMW Document 37 Filed 03/09/15 Page 12 of 12 Page|D: 661
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`CERTIFICATE OF SERVICE
`
`I hereby certify that on March 9, 2015, I caused a copy of the foregoing Lupin’s Answer
`
`to Amended Complaint for Patent Infringement to be served Via the Court’s ECF system upon all
`
`counsel of record
`
`By:
`
`s/ Michael A. Innes
`Michael A. Innes
`
`NY0l\KatzC\396l976.l
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`12
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`|PR2015-01030
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`(Page 12 of 12)