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Case 3:13-cv-00091-MLC-DEA Document 63 Filed 03/07/14 Page 1 of 8 PageID: 2858
`
`
`
`
`
`Andrew J. Miller
`Stuart D. Sender
`Alan H. Pollack
`Dmitry Shelhoff
`BUDD LARNER, P.C.
`150 John F. Kennedy Parkway
`Short Hills, New Jersey 07078
`Tel: (973) 379-4800
`
`Attorneys for Defendants
`Dr. Reddy’s Laboratories, Ltd. and
`Dr. Reddy’s Laboratories, Inc.
`
`
`
`
`HORIZON PHARMA, INC. and POZEN
`INC.,
`
`
`Plaintiffs,
`
`v.
`
`DR. REDDY’S LABORATORIES, LTD. and
`DR. REDDY’S LABORATORIES, INC.,
`
`
`Defendants.
` 
`
`
`
`ANSWER OF DR. REDDY’S LABORATORIES, LTD.
`AND DR. REDDY’S LABORATORIES, INC.
`TO FIRST AMENDED COMPLAINT
`
`Defendants Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc.
`
`(collectively “DRL”) by their attorneys, for their Answer to the First Amended Complaint by
`
`Horizon Pharma, Inc. and Pozen Inc. (collectively “Plaintiffs”), respond to allegations as
`
`follows:
`
`
`
`00970219
`
`
`
`
`
`1
`
`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`
`   
`
`Civil Action No. 3:13-cv-00091 (JAP)(DEA)
`
`
` (consolidated for discovery purposes with
` Civ. A. Nos. 3:11-cv-02317 (JAP) (DEA),
` 3:11-cv-04275 (JAP) (DEA), and
` 3:11-cv-06348 (JAP) (DEA))
`
`ELECTRONICALLY FILED 
`
`
`
`

`
`Case 3:13-cv-00091-MLC-DEA Document 63 Filed 03/07/14 Page 2 of 8 PageID: 2859
`
`NATURE OF THE ACTION
`
`1.
`
`DRL admits the allegations contained in paragraph 1 of the First Amended
`
`Complaint.
`
`THE PARTIES
`
`2.
`
`DRL admits the allegations contained in paragraph 2 of the First Amended
`
`Complaint.
`
`3.
`
`DRL admits the allegations contained in paragraph 3 of the First Amended
`
`Complaint.
`
`4.
`
`DRL admits that Dr. Reddy’s Laboratories, Inc. is a corporation operating and
`
`existing under the laws of the State of New Jersey. DRL denies the remaining allegations
`
`contained in paragraph 4 of the First Amended Complaint.
`
`5.
`
`DRL admits the allegations contained in paragraph 5 of the First Amended
`
`Complaint.
`
`6.
`
`DRL admits the allegations contained in paragraph 6 of the First Amended
`
`Complaint.
`
`BACKGROUND
`
`The NDA
`
`7.
`
`DRL admits the allegations contained in paragraph 7 of the First Amended
`
`Complaint.
`
`8.
`
`DRL admits the allegations contained in paragraph 8 of the First Amended
`
`Complaint.
`
`00970219
`
`
`
`2
`
`

`
`Case 3:13-cv-00091-MLC-DEA Document 63 Filed 03/07/14 Page 3 of 8 PageID: 2860
`
`The Patents-in-Suit
`
`9.
`
`DRL denies the allegations of paragraph 9 of the First Amended Complaint,
`
`except admits that U.S. Patent No. 6,926,907 (“the ‘907 patent”), entitled “Pharmaceutical
`
`Compositions for the Coordinated Delivery of NSAIDs,” issued on August 9, 2005, and that the
`
`First Amended Complaint annexes a copy of the ‘907 patent as Exhibit A.
`
`10.
`
`DRL lacks information or knowledge sufficient to admit or deny the allegations
`
`set forth in paragraph 10 of the First Amended Complaint, except that DRL admits that the ‘907
`
`patent states on its face that the assignee of the patent is Pozen Inc.
`
`11.
`
`DRL denies the allegations of paragraph 11 of the First Amended Complaint,
`
`except admits that U.S. Patent No. 8,557,285 (“the ‘285 patent”), entitled “Pharmaceutical
`
`Compositions for the Coordinated Delivery of NSAIDs,” issued on October 15, 2013, and that
`
`the First Amended Complaint annexes a copy of the ‘285 patent as Exhibit B.
`
`12.
`
`DRL lacks information or knowledge sufficient to admit or deny the allegations
`
`set forth in paragraph 12 of the First Amended Complaint, except that DRL admits that the ‘285
`
`patent states on its face that the assignee of the patent is Pozen Inc.
`
`13.
`
`DRL denies the allegations contained in paragraph 13 of the First Amended
`
`The ANDA
`
`Complaint.
`
`14.
`
`DRL admits the allegations contained in paragraph 14 of the First Amended
`
`Complaint.
`
`JURISDICTION AND VENUE
`
`15.
`
`DRL admits the allegations contained in paragraph 15 of the First Amended
`
`Complaint.
`
`00970219
`
`
`
`3
`
`

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`Case 3:13-cv-00091-MLC-DEA Document 63 Filed 03/07/14 Page 4 of 8 PageID: 2861
`
`16.
`
`DRL admits the allegations contained in paragraph 16 of the First Amended
`
`Complaint.
`
`17.
`
`DRL admits jurisdiction and venue in this case and denies the remaining
`
`allegations in paragraph 17 of the First Amended Complaint.
`
`18.
`
`DRL admits jurisdiction and venue in this case and denies the remaining
`
`allegations in paragraph 18 of the First Amended Complaint.
`
`19.
`
`DRL admits jurisdiction and venue in this case and denies the remaining
`
`allegations in paragraph 19 of the First Amended Complaint.
`
`20.
`
`DRL admits jurisdiction and venue in this case and denies the remaining
`
`allegations in paragraph 20 of the First Amended Complaint.
`
`21.
`
`DRL admits the allegations contained in paragraph 21 of the First Amended
`
`Complaint.
`
`22.
`
`DRL admits the allegations contained in paragraph 22 of the First Amended
`
`Complaint.
`
`23.
`
`DRL admits the allegations contained in paragraph 23 of the First Amended
`
`Complaint.
`
`24.
`
`DRL admits jurisdiction and venue in this case, with the balance being legal
`
`points which require no response.
`
`25.
`
`DRL admits jurisdiction and venue in this case and denies the remaining
`
`allegations in paragraph 25 of the First Amended Complaint.
`
`26.
`
`27.
`
`28.
`
`DRL admits the allegations in paragraph 26 of the First Amended Complaint.
`
`DRL admits the allegations in paragraph 27 of the First Amended Complaint.
`
`DRL admits the allegations in paragraph 28 of the First Amended Complaint.
`
`00970219
`
`
`
`4
`
`

`
`Case 3:13-cv-00091-MLC-DEA Document 63 Filed 03/07/14 Page 5 of 8 PageID: 2862
`
`29.
`
`DRL admits jurisdiction and venue in this case and denies the remaining
`
`allegations in paragraph 29 of the First Amended Complaint.
`
`30.
`
`DRL admits the allegations in paragraph 30 of the First Amended Complaint.
`
`COUNT I
`(INFRINGEMENT OF THE ‘907 PATENT UNDER 35 U.S.C. § 271(e)(2)(A))
`
`DRL incorporates by reference and repeats its responses to paragraphs 1-30 above
`
`31.
`
`as if fully set forth here.
`
`32.
`
`DRL denies the allegations of paragraph 32 of the First Amended Complaint,
`
`except admits that it sent a Notice of Paragraph IV Certification, dated November 20, 2012.
`
`33.
`
`DRL admits that it was aware of the text of 21 U.S.C. § 355(j)(2) and 21 C.F.R. §
`
`314.95(c) and denies the remaining allegations in paragraph 33 of the First Amended Complaint.
`
`34.
`
`DRL denies the allegations contained in paragraph 34 of the First Amended
`
`Complaint.
`
`35.
`
`DRL denies the allegations contained in paragraph 35 of the First Amended
`
`Complaint.
`
`36.
`
`DRL denies the allegations contained in paragraph 36 of the First Amended
`
`Complaint.
`
`37.
`
`DRL denies the allegations contained in paragraph 37 of the First Amended
`
`Complaint.
`
`38.
`
`DRL denies the allegations contained in paragraph 38 of the First Amended
`
`Complaint.
`
`00970219
`
`
`
`
`
`5
`
`

`
`Case 3:13-cv-00091-MLC-DEA Document 63 Filed 03/07/14 Page 6 of 8 PageID: 2863
`
`COUNT II
`(INFRINGEMENT OF THE ‘285 PATENT UNDER 35 U.S.C. § 271(e)(2)(A))
`
`39.
`
`DRL incorporates by reference and repeats its responses to paragraphs 1-30 above
`
`
`
`as if fully set forth here.
`
`40.
`
`41.
`
`42.
`
`43.
`
`DRL denies the allegations of paragraph 40 of the First Amended Complaint.
`
`DRL denies the allegations of paragraph 41 of the First Amended Complaint.
`
`DRL denies the allegations of paragraph 42 of the First Amended Complaint.
`
`DRL admits that it has previously filed patent certifications in association with
`
`their ANDA No. 204206. DRL denies the remaining allegations contained in paragraph 43 of
`
`the First Amended Complaint.
`
`44.
`
`DRL denies the allegations contained in paragraph 44 of the First Amended
`
`Complaint.
`
`45.
`
`DRL denies the allegations contained in paragraph 45 of the First Amended
`
`Complaint.
`
`46.
`
`DRL denies the allegations contained in paragraph 50 [sic] of the First Amended
`
`Complaint.
`
`PRAYER FOR RELIEF
`
`47.
`
`DRL denies that Plaintiffs are entitled to any of the judgments and relief prayed
`
`for in paragraphs A through G of the First Amended Complaint.
`
`AFFIRMATIVE DEFENSES
`
`48.
`
`DRL alleges and asserts the following affirmative defenses in response to the
`
`allegations contained in Plaintiffs’ First Amended Complaint:
`
`00970219
`
`
`
`6
`
`

`
`Case 3:13-cv-00091-MLC-DEA Document 63 Filed 03/07/14 Page 7 of 8 PageID: 2864
`
`First Affirmative Defense
`(Non-infringement of Valid and Enforceable Claims)
`
`The manufacture, use, offer for sale, sale or importation of the product described
`
`49.
`
`in DRL’s ANDA 204206 does not and will not infringe (either literally or under the doctrine of
`
`equivalents), directly or indirectly (either by inducement or contributorily), any valid or
`
`enforceable claim of the ‘907 or ‘285 patents (collectively “patents-in- suit”).
`
`Second Affirmative Defense
`(Invalidity)
`
`At least claims 1, 5, 9-17, 21-24, 28-29, 32-35, 37, 41-42, 45-48, and 50-55 of the
`
`50.
`
`‘907 patent are invalid under Title 35, United States Code, including, inter alia, §§ 101, 102,
`
`103, 112, and for double patenting.
`
`51.
`
`All claims of the ‘285 patent are invalid under Title 35, United States Code,
`
`including, inter alia, §§ 101, 102, 103, 112, and for double patenting.
`
`Third Affirmative Defense
`(Non-Infringement)
`
`The manufacture, use, sale, offer to sell in the United States or the importation
`
`52.
`
`into the United States of the product described in DRL’s ANDA 204206 does not and would not
`
`infringe any of the claims of the ‘907 patent.
`
`
`
`53.
`
`The manufacture, use, sale, offer to sell in the United States or the importation
`
`into the United States of the product described in DRL’s ANDA 204206 does not and would not
`
`infringe any claim of the ‘285 patent.
`
`Fourth Affirmative Defense
`(Prosecution History Estoppel)
`
`54.
`
`Claims of the patents in suit are so limited as not to cover the manufacture, use,
`
`offer for sale, sale or importation of the product described in DRL’s ANDA 204206 due to the
`
`00970219
`
`
`
`7
`
`

`
`Case 3:13-cv-00091-MLC-DEA Document 63 Filed 03/07/14 Page 8 of 8 PageID: 2865
`
`arguments, statements, representations and/or amendments made by Plaintiffs to the United
`
`States Patent and Trademark Office during the prosecution of the respective applications leading
`
`to issuance of each of the patents in suit.
`
`Fifth Affirmative Defense
`
`55.
`
`Each of Plaintiffs’ allegations of infringement of each of the patents in suit under
`
`35 U.S.C. § 271(a), (b) and/or (c) fails to state a claim upon which relief can be granted.
`
`WHEREFORE, DRL prays for relief as follows:
`
`PRAYER FOR RELIEF
`
`(a)
`
`(b)
`
`That the Complaint against DRL be dismissed in its entirety and with prejudice;
`
`That the Court permanently enjoin Plaintiffs from asserting either the ‘907 and/or
`
`the ‘285 patent against DRL or the purchasers of its Proposed Product;
`
`(c)
`
`That this case be deemed to be an exceptional case within the meaning of 35
`
`U.S.C. § 285;
`
`(d)
`
`(e)
`
`
`
`
`
`That DRL be awarded its attorney fees and costs and expenses of the suit, and;
`
`That the Court award other and further relief as it deems just and proper.
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`Dated: March 7, 2014 By:
`
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`s/ Alan H. Pollack
`Andrew J. Miller (amiller@budlarner.com)
`Stuart D. Sender (ssender@buddlarner.com)
`Alan H. Pollack (apollack@buddlarner.com
`Dmitry Shelhoff (dshelhoff@buddlarner.com)
`BUDD LARNER, P.C.
`150 John F. Kennedy Parkway
`Short Hills, New Jersey 07078
`Tel: (973) 379-4800
`
`
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`Attorneys for Defendants
`Dr. Reddy’s Laboratories, Ltd. and
`Dr. Reddy’s Laboratories, Inc.
`
`
`
`
`
`
`
`00970219
`
`
`
`8

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