throbber
Case 1:14-cv-01453-LPS Document 99 Filed 04/04/16 Page 1 of 13 PageID #: 2083
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`
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`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`MEDA PHARMACEUTICALS INC. and
`CIPLA LTD.,
`
`
`
`
`
`Plaintiffs,
`
`v.
`
`
`APOTEX INC. and APOTEX CORP.,
`
`)
`)
`)
`)
`)
`C.A. No. 14-1453-LPS
`)
`
`)
`)
`)
`)
`
`PLAINTIFFS MEDA AND CIPLA’S ANSWER TO COUNTERCLAIMS TO FIRST
`AMENDED COMPLAINT
`
`
`
`
`
`
`
`
`
`
`
`Defendants.
`
`Plaintiffs and Counterclaim-Defendants Meda Pharmaceuticals Inc. (“Meda”) and Cipla
`
`Ltd. (“Cipla”) (collectively, “Counterclaim-Defendants”), by their attorneys, answer the
`
`Counterclaims of Defendants Apotex Inc. and Apotex Corp (collectively “Apotex”), as set forth
`
`in Apotex’s Answer and Counterclaims to First Amended Complaint, using the same paragraph
`
`numbers as in Apotex’s Counterclaims as follows:
`
`1.
`
`Counterclaim-Plaintiff Apotex Corp. is a corporation organized and existing
`
`under the laws of the State of Delaware, having a place of business at 2400 North Commerce
`
`Parkway, Suite 400, Weston, Florida 33326. Counterclaim-Plaintiff Apotex Inc. is a corporation
`
`organized and existing under the laws of the Canada, having a place of business at 150 Signet
`
`Drive, Toronto, Ontario M9L 1T9, Canada.
`
`Answer: Upon information and belief, admitted.
`
`2.
`
`On information and belief, Counterclaim-Defendant Meda is a corporation
`
`organized and existing under the laws of the Delaware, having a principal place of business at
`
`265 Davidson Avenue, Suite 300, Somerset, New Jersey 08873-4120.
`
`Answer: Admitted.
`
`{01103918;v1 }
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`
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`

`
`Case 1:14-cv-01453-LPS Document 99 Filed 04/04/16 Page 2 of 13 PageID #: 2084
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`
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`3.
`
`On information and belief, Counterclaim-Defendant Cipla is a corporation
`
`organized and existing under the laws of India and having a principal place of business at Cipla
`
`House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai 400 013,
`
`Maharashtra, India.
`
`Answer: Admitted.
`
`4.
`
`This is a counterclaim for declaratory judgment pursuant to the Declaratory
`
`Judgment Act, 28 U.S.C. §§ 2201 and 2202 for the purpose of determining an actual and
`
`justiciable controversy between the parties.
`
`Answer: Paragraph 4 contains no allegations of fact to which a response is required. To
`
`the extent a response is required, Counterclaim-Defendants deny the allegations of
`
`paragraph 4.
`
`5.
`
`The Court has original jurisdiction over the subject matter of these claims
`
`pursuant to 28 U.S.C. §§ 1331 and 1338(a).
`
`Answer: Paragraph 5 contains no allegations of fact to which a response is required. To
`
`the extent a response is required, Counterclaim-Defendants deny the allegations of
`
`paragraph 5.
`
`6.
`
`Venue is proper in this district under 28 U.S.C. §§ 1391 (b) and (c), 1400(b), and
`
`because Counterclaim-Defendants have consented to venue in this Court by filing the instant
`
`action in this jurisdiction.
`
`Answer: Paragraph 6 contains no allegations of fact to which a response is required. To
`
`the extent a response is required, Counterclaim-Defendants admit that they filed the
`
`instant action in this jurisdiction. They deny the remaining allegations of paragraph 6.
`
`{01103918;v1 }
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`2
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`Case 1:14-cv-01453-LPS Document 99 Filed 04/04/16 Page 3 of 13 PageID #: 2085
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`
`
`7.
`
`Counterclaim-Plaintiffs Apotex submitted Abbreviated New Drug Application
`
`(“ANDA”) No. 207712 to the Food and Drug Administration (“FDA”) seeking approval of
`
`generic nasal spray containing 137 mcg of the active ingredient azelastine hydrochloride and
`
`containing 50 mcg of the active ingredient fluticasone propionate combination nasal spray
`
`(“Apotex’s ANDA product”).
`
`Answer: Upon information and belief, admitted.
`
`8.
`
`Upon information and belief, FDA lists Meda as the holder of New Drug
`
`Application (“NDA”) No. 202236.
`
`Answer: Admitted.
`
`9.
`
`On information and belief, NDA No. 202236 covers DYMISTA®, Counterclaim-
`
`Defendants’ 137 mcg azelastine hydrochloride and 50 mcg fluticasone propionate nasal spray
`
`product.
`
`Answer: Admitted.
`
`10.
`
`On information and belief, the ’723 patent and ’620 patent are both listed in the
`
`FDA’s Approved Drug Products With Therapeutic Equivalence Evaluations (the “Orange
`
`Book”) for the product DYMISTA®. On information and belief, the ’428 patent will be listed in
`
`the Orange Book for the product DYMISTA® within thirty days of its issuance.
`
`Answer: Admitted. Counterclaim-Defendants note that the ’428 patent has been listed in
`
`the Orange Book for the product DYMISTA®.
`
`11.
`
`Counterclaim-Defendant Meda has alleged in the instant action that it is the
`
`exclusive licensee of the ’723 patent, ’620, and ’428 patents.
`
`Answer: Admitted.
`
`{01103918;v1 }
`
`3
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`

`
`Case 1:14-cv-01453-LPS Document 99 Filed 04/04/16 Page 4 of 13 PageID #: 2086
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`
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`12.
`
`On information and belief, Counterclaim-Defendant Cipla is the present owner of
`
`the ’723 patent, ’620, and ’428 patents.
`
`Answer: Admitted.
`
`13.
`
`Counterclaim-Plaintiff Apotex sent Counterclaim-Defendants a letter dated
`
`October 20, 2014 notifying Counterclaim-Defendants of its paragraph IV certification that the
`
`claims of the ’723 patent, and the ’620 patent are invalid and/or will not be infringed by the
`
`product that is the subject of ANDA No. 207712. The Notice Letter included an offer of
`
`confidential access (“the Notice Letter”).
`
`Answer: The Notice Letter referenced in paragraph 13 speaks for itself and is the best
`
`evidence of its contents. To the extent a response is required, Counterclaim-Defendants
`
`admit that they received a letter dated October 20, 2014 notifying them of Apotex’s
`
`paragraph IV certification. Counterclaim-Defendants admit that Notice Letter included
`
`an offer of confidential access. Counterclaim-Defendants deny the remaining allegations
`
`of paragraph 13.
`
`14.
`
`On December 2, 2014, Counterclaim-Defendants filed an action against
`
`Counterclaim-Plaintiff Apotex for infringement of the ’723 patent, and the ’620 patent. On
`
`February 26, 2016, Counterclaim-Defendants filed an amended complaint alleging infringement
`
`of the ’428 patent.
`
`Answer: Admitted.
`
`15.
`
`As a consequence of the foregoing, there is an actual and justiciable controversy
`
`between Counterclaim-Plaintiff Apotex and Counterclaim-Defendants Meda and Cipla as to
`
`whether the claims of the ’723, ’620, and ’428 patents are invalid and whether those claims are
`
`{01103918;v1 }
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`4
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`

`
`Case 1:14-cv-01453-LPS Document 99 Filed 04/04/16 Page 5 of 13 PageID #: 2087
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`
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`being infringed or will be infringed by Apotex’s ANDA No. 207712 or by the manufacture, use,
`
`or sale of the product described therein.
`
`Answer: Paragraph 15 contains no allegations of fact to which a response is required. To
`
`the extent a response is required, Counterclaim-Defendants deny the allegations of
`
`paragraph 15.
`
`COUNT I
`
`(Declaration of Invalidity of the ’723 Patent)
`
`16.
`
`Counterclaim-Plaintiff Apotex re-alleges and incorporates the allegations of
`
`
`
`paragraphs 1-15 as if fully set forth herein.
`
`Answer: Paragraph 16 contains no allegations of fact to which a response is required. To
`
`the extent a response is required, Counterclaim-Defendants incorporate the answers to
`
`paragraph 1-15 fully.
`
`17.
`
`Counterclaim-Defendants allege ownership of and exclusive license to the ’723
`
`patent and have brought claims against Counterclaim-Plaintiff Apotex alleging infringement of
`
`the ’723 patent.
`
`Answer: Cipla owns the ’723 patent. Meda is the exclusive licensee to the ’723 patent.
`
`Counterclaim-Defendants have brought claims against Apotex alleging infringement of
`
`the ’723 patent. Counterclaim-Defendants deny the remaining allegations in paragraph
`
`17.
`
`18.
`
`One or more claims of the ’723 patent are invalid under one or more provisions of
`
`35 U.S.C. §§ 101, 102, 103, and/or 112.
`
`Answer: Denied.
`
`{01103918;v1 }
`
`5
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`

`
`Case 1:14-cv-01453-LPS Document 99 Filed 04/04/16 Page 6 of 13 PageID #: 2088
`
`
`
`19.
`
`A present, genuine, and justiciable controversy exists between Counterclaim-
`
`Plaintiff Apotex and Counterclaim-Defendants regarding the validity of the ’723 patent.
`
`Answer: Paragraph 19 contains no allegations of fact to which a response is required.
`
`20.
`
`Counterclaim-Plaintiff Apotex is entitled to a declaration that claims of the ’723
`
`patent are invalid.
`
`Answer: Denied.
`
`
`
`
`
`COUNT II
`
`(Declaration of Non-Infringement of the ’723 Patent)
`
`21.
`
`Counterclaim-Plaintiff Apotex re-alleges and incorporates the allegations of
`
`paragraphs 1-20 as if fully set forth herein.
`
`Answer: Paragraph 21 contains no allegations of fact to which a response is required. To
`
`the extent a response is required, Counterclaim-Defendants incorporate the answers to
`
`paragraph 1-20 fully.
`
`22.
`
`Counterclaim-Defendants allege ownership of and exclusive license to the ’723
`
`patent and have brought claims against Counterclaim-Plaintiff Apotex alleging infringement of
`
`the ’723 patent.
`
`Answer: Cipla owns the ’723 patent. Meda is the exclusive licensee to the ’723 patent.
`
`Counterclaim-Defendants have brought claims against Apotex alleging infringement of
`
`the ’723 patent. Counterclaim-Defendants deny the remaining allegations in paragraph
`
`22.
`
`23.
`
`The manufacture, use, or sale of Counterclaim-Plaintiff Apotex’s ANDA product
`
`would not infringe any valid or enforceable claim of the ’723 patent, either directly or indirectly,
`
`and either literally or under the doctrine of equivalents.
`
`{01103918;v1 }
`
`6
`
`

`
`Case 1:14-cv-01453-LPS Document 99 Filed 04/04/16 Page 7 of 13 PageID #: 2089
`
`
`
`Answer: Denied.
`
`24.
`
`A present, genuine, and justiciable controversy exists between Counterclaim-
`
`Plaintiff Apotex and Counterclaim-Defendants regarding the issue of whether the manufacture,
`
`use, or sale of Counterclaim-Plaintiff Apotex’s ANDA product would infringe any valid or
`
`enforceable claim of the ’723 patent.
`
`Answer: Paragraph 24 contains no allegations of fact to which a response is required.
`
`25.
`
`Counterclaim-Plaintiff Apotex is entitled to a declaration that the manufacture,
`
`use, or sale of its ANDA product would not infringe any valid or enforceable claim of the ’723
`
`patent.
`
`Answer: Denied.
`
`COUNT III
`
`(Declaration of Invalidity of the ’620 Patent)
`
`26.
`
`Counterclaim-Plaintiff Apotex re-alleges and incorporates the allegations of
`
`paragraphs 1-25 as if fully set forth herein.
`
`Answer: Paragraph 26 contains no allegations of fact to which a response is required. To
`
`the extent a response is required, Counterclaim-Defendants incorporate the answers to
`
`paragraph 1-25 fully.
`
`27.
`
`Counterclaim-Defendants allege ownership of and exclusive license to the ’620
`
`patent and have brought claims against Counterclaim-Plaintiff Apotex alleging infringement of
`
`the ’620 patent.
`
`Answer: Cipla owns the ’620 patent. Meda is the exclusive licensee to the ’620 patent.
`
`Counterclaim-Defendants have brought claims against Apotex alleging infringement of
`
`{01103918;v1 }
`
`7
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`

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`Case 1:14-cv-01453-LPS Document 99 Filed 04/04/16 Page 8 of 13 PageID #: 2090
`
`
`
`the ’620 patent. Counterclaim-Defendants deny the remaining allegations in paragraph
`
`27.
`
`28.
`
`One or more claims of the ’620 patent are invalid under one or more provisions of
`
`35 U.S.C. §§ 101, 102, 103, and/or 112.
`
`Answer: Denied.
`
`29.
`
`A present, genuine, and justiciable controversy exists between Counterclaim-
`
`Plaintiff Apotex and Counterclaim-Defendants regarding the validity of the ’620 patent.
`
`Answer: Paragraph 29 contains no allegations of fact to which a response is required.
`
`30.
`
`Counterclaim-Plaintiff Apotex is entitled to a declaration that claims of the ’620
`
`patent are invalid.
`
`Answer: Denied.
`
`COUNT IV
`
`(Declaration of Non-Infringement of the ’620 Patent)
`
`
`
`31.
`
`Counterclaim-Plaintiff Apotex re-alleges and incorporates the allegations of
`
`paragraphs 1-30 as if fully set forth herein.
`
`Answer: Paragraph 31 contains no allegations of fact to which a response is required. To
`
`the extent a response is required, Counterclaim-Defendants incorporate the answers to
`
`paragraph 1-30 fully.
`
`32.
`
`Counterclaim-Defendants allege ownership of and exclusive license to the ’620
`
`patent and have brought claims against Counterclaim-Plaintiff Apotex alleging infringement of
`
`the ’620 patent.
`
`Answer: Cipla owns the ’620 patent. Meda is the exclusive licensee to the ’620 patent.
`
`Counterclaim-Defendants have brought claims against Apotex alleging infringement of
`
`{01103918;v1 }
`
`8
`
`

`
`Case 1:14-cv-01453-LPS Document 99 Filed 04/04/16 Page 9 of 13 PageID #: 2091
`
`
`
`the ’620 patent. Counterclaim-Defendants deny the remaining allegations in paragraph
`
`32.
`
`33.
`
`The manufacture, use, or sale of Counterclaim-Plaintiff Apotex’s ANDA product
`
`would not infringe any valid or enforceable claim of the ’620 patent, either directly or indirectly,
`
`and either literally or under the doctrine of equivalents.
`
`Answer: Denied.
`
`34.
`
`A present, genuine, and justiciable controversy exists between Counterclaim-
`
`Plaintiff Apotex and Counterclaim-Defendants regarding the issue of whether the manufacture,
`
`use, or sale of Counterclaim-Plaintiff Apotex’s ANDA product would infringe any valid or
`
`enforceable claim of the ’620 patent.
`
`Answer: Paragraph 34 contains no allegations of fact to which a response is required.
`
`35.
`
`Counterclaim-Plaintiff Apotex is entitled to a declaration that the manufacture,
`
`use, or sale of its ANDA product would not infringe any valid or enforceable claim of the ’620
`
`patent.
`
`Answer: Denied.
`
`COUNT V
`
`(Declaration of Invalidity of the ’428 Patent)
`
`
`
`36.
`
`Counterclaim-Plaintiff Apotex re-alleges and incorporates the allegations of
`
`paragraphs 1-35 as if fully set forth herein.
`
`Answer: Paragraph 36 contains no allegations of fact to which a response is required. To
`
`the extent a response is required, Counterclaim-Defendants incorporate the answers to
`
`paragraph 1-35 fully.
`
`{01103918;v1 }
`
`9
`
`

`
`Case 1:14-cv-01453-LPS Document 99 Filed 04/04/16 Page 10 of 13 PageID #: 2092
`
`
`
`37.
`
`Counterclaim-Defendants allege ownership of and exclusive license to the ’428
`
`patent and have brought claims against Counterclaim-Plaintiff Apotex alleging infringement of
`
`the ’428 patent.
`
`Answer: Cipla owns the ’428 patent. Meda is the exclusive licensee to the ’428 patent.
`
`Counterclaim-Defendants have brought claims against Apotex alleging infringement of
`
`the ’428 patent. Counterclaim-Defendants deny the remaining allegations in paragraph
`
`37.
`
`38.
`
`One or more claims of the ’428 patent are invalid under one or more provisions of
`
`35 U.S.C. §§ 101, 102, 103, and/or 112.
`
`Answer: Denied.
`
`39.
`
`A present, genuine, and justiciable controversy exists between Counterclaim-
`
`Plaintiff Apotex and Counterclaim-Defendants regarding the validity of the ’428 patent.
`
`Answer: Paragraph 39 contains no allegations of fact to which a response is required.
`
`40.
`
`Counterclaim-Plaintiff Apotex is entitled to a declaration that claims of the ’428
`
`patent are invalid.
`
`Answer: Denied.
`
`COUNT VI
`
`(Declaration of Non-Infringement of the ’428 Patent)
`
`41.
`
`Counterclaim-Plaintiff Apotex re-alleges and incorporates the allegations of
`
`paragraphs 1-40 as if fully set forth herein.
`
`Answer: Paragraph 41 contains no allegations of fact to which a response is required. To
`
`the extent a response is required, Counterclaim-Defendants incorporate the answers to
`
`paragraph 1-40 fully.
`
`{01103918;v1 }
`
`10
`
`

`
`Case 1:14-cv-01453-LPS Document 99 Filed 04/04/16 Page 11 of 13 PageID #: 2093
`
`
`
`42.
`
`Counterclaim-Defendants allege ownership of and exclusive license to the ’428
`
`patent and have brought claims against Counterclaim-Plaintiff Apotex alleging infringement of
`
`the ’428 patent.
`
`Answer: Cipla owns the ’428 patent. Meda is the exclusive licensee to the ’428 patent.
`
`Counterclaim-Defendants have brought claims against Apotex alleging infringement of
`
`the ’428 patent. Counterclaim-Defendants deny the remaining allegations in paragraph
`
`42.
`
`43.
`
`The manufacture, use, or sale of Counterclaim-Plaintiff Apotex’s ANDA product
`
`would not infringe any valid or enforceable claim of the ’428 patent, either directly or indirectly,
`
`and either literally or under the doctrine of equivalents.
`
`Answer: Denied.
`
`44.
`
`A present, genuine, and justiciable controversy exists between Counterclaim-
`
`Plaintiff Apotex and Counterclaim-Defendants regarding the issue of whether the manufacture,
`
`use, or sale of Counterclaim-Plaintiff Apotex’s ANDA product would infringe any valid or
`
`enforceable claim of the ’428 patent.
`
`Answer: Paragraph 44 contains no allegations of fact to which a response is required.
`
`45.
`
`Counterclaim-Plaintiff Apotex is entitled to a declaration that the manufacture,
`
`use, or sale of its ANDA product would not infringe any valid or enforceable claim of the ’428
`
`patent.
`
`Answer: Denied.
`
`PRAYER FOR RELIEF
`
`Counterclaim-Defendants deny that Apotex is entitled to judgment in its favor and deny
`
`that Apotex is entitled to any relief as set forth in its Counterclaims, Affirmative Defenses,
`
`{01103918;v1 }
`
`11
`
`

`
`Case 1:14-cv-01453-LPS Document 99 Filed 04/04/16 Page 12 of 13 PageID #: 2094
`
`
`
`and/or Prayer for Relief. Counterclaim-Defendants respectfully request the Court enter
`
`judgment:
`
`a) Dismissing Apotex’s Counterclaims with prejudice;
`
`b) Awarding Counterclaim-Defendants the relief that is requested in its Complaint;
`
`and
`
`c) Awarding Counterclaim-Defendants such other relief as the Court deems just and
`
`proper.
`
`DEFENSES
`
`First Defense
`
`The Counterclaims fail to state a claim for which relief can be granted.
`
`Second Defense
`
`The Counterclaims must be dismissed and denied because Apotex has committed an act
`
`of infringement of the ’620, ’723, and ’428 patents by filing its Abbreviated New Drug
`
`Application (“ANDA”) that is the subject of the Complaint and intends to further infringe if its
`
`ANDA is approved by making, using, selling, offering to sell, and/or importing into the United
`
`States the product that is described in its ANDA. Unless enjoined by the Court from doing so,
`
`Apotex will commit acts of infringement, inducement to infringe and/or contributory
`
`infringement of the ’620, ’723, and ’428 patents, either literally or under the doctrine of
`
`equivalents.
`
`Third Defense
`
`Counterclaim-Defendants reserve the right to assert such other defenses that may appear
`
`as discovery proceeds in this case.
`
`{01103918;v1 }
`
`12
`
`

`
`Case 1:14-cv-01453-LPS Document 99 Filed 04/04/16 Page 13 of 13 PageID #: 2095
`
`
`
`ASHBY & GEDDES
`
`/s/ Andrew C. Mayo
`_________________________________
`Steven J. Balick (#2114)
`John G. Day (#2403)
`Andrew C. Mayo (#5207)
`500 Delaware Ave., 8th Floor
`P.O. Box 1150
`Wilmington, DE 19899
`(302) 654-1888
`sbalick@ashby-geddes.com
`jday@ashby-geddes.com
`amayo@ashby-geddes.com
`
`Attorneys for Plaintiffs Meda Pharmaceuticals Inc.
`and Cipla Ltd.
`
`
`
`Of Counsel:
`
`Uma N. Everett
`Dennies Varughese
`STERNE, KESSLER, GOLDSTEIN & FOX
`PLLC
`1100 New York Ave., N.W., Suite 800
`Washington, DC 20005-3934
`(202) 371-2600
`
`
`Dated: April 4, 2016
`
`
`{01103918;v1 }
`
`13

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