Case 1:14-cv-01453-LPS Document 12 Filed 01/16/15 Page 1 of 10 PageID #: 98
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`MEDA PHARMACEUTICALS INC. and
`CIPLA LTD.,
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`Plaintiffs,
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`C.A. No. 14-1453-LPS
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`PLAINTIFFS MEDA AND CIPLA'S ANSWER TO COUNTERCLAIMS
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`v.
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`APOTEX INC. and APOTEX CORP. ,
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`Defendants.
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`Plaintiffs and Counterclaim Defendants Meda Pharmaceuticals Inc. (“Meda”) and CIPLA
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`Ltd. (“Cipla”) (collectively, “Plaintiffs”), by their attorneys, answer the Counterclaims of
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`Defendants Apotex Inc. and Apotex Corp (collectively “Apotex” or “Defendants”), as set forth
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`in Defendants’ Answer and Counterclaims, using the same paragraph numbers as in Defendants’
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`Counterclaims as follows:
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`1.
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`Counterclaim-Plaintiff Apotex Corp. is a corporation organized and existing
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`under the laws of the State of Delaware, having a place of business at 2400 North Commerce
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`Parkway, Suite 400, Weston, Florida 33326. Counterclaim-Plaintiff Apotex Inc. is a corporation
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`organized and existing under the laws of the Canada, having a place of business at 150 Signet
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`Drive, Toronto, Ontario M9L 1T9, Canada.
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`Answer: Upon information and belief, admitted.
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`2.
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`On information and belief, Counterclaim-Defendant Meda is a corporation
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`organized and existing under the laws of the Delaware, having a principal place of business at
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`265 Davidson Avenue, Suite 300, Somerset, New Jersey 08873-4120.
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`{00934038;v1 }
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`MEDA PHARMACEUTICALS INC. and
`CIPLA LTD.,
`
`Plaintiffs,
`
`
`C.A. No. 14-1453-LPS
`
`
`
`
`
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`PLAINTIFFS MEDA AND CIPLA'S ANSWER TO COUNTERCLAIMS
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`v.
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`APOTEX INC. and APOTEX CORP. ,
`
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`Defendants.
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`
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`Plaintiffs and Counterclaim Defendants Meda Pharmaceuticals Inc. (“Meda”) and CIPLA
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`Ltd. (“Cipla”) (collectively, “Plaintiffs”), by their attorneys, answer the Counterclaims of
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`Defendants Apotex Inc. and Apotex Corp (collectively “Apotex” or “Defendants”), as set forth
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`in Defendants’ Answer and Counterclaims, using the same paragraph numbers as in Defendants’
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`Counterclaims as follows:
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`1.
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`Counterclaim-Plaintiff Apotex Corp. is a corporation organized and existing
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`under the laws of the State of Delaware, having a place of business at 2400 North Commerce
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`Parkway, Suite 400, Weston, Florida 33326. Counterclaim-Plaintiff Apotex Inc. is a corporation
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`organized and existing under the laws of the Canada, having a place of business at 150 Signet
`
`Drive, Toronto, Ontario M9L 1T9, Canada.
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`Answer: Upon information and belief, admitted.
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`2.
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`On information and belief, Counterclaim-Defendant Meda is a corporation
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`organized and existing under the laws of the Delaware, having a principal place of business at
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`265 Davidson Avenue, Suite 300, Somerset, New Jersey 08873-4120.
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`{00934038;v1 }
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`Case 1:14-cv-01453-LPS Document 12 Filed 01/16/15 Page 2 of 10 PageID #: 99
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`Answer: Admitted.
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`3.
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`On information and belief, Counterclaim-Defendant Cipla is a corporation
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`organized and existing under the laws of India and having a principal place of business at Cipla
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`House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai 400 013,
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`Maharashtra, India.
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`Answer: Admitted.
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`4.
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`This is a counterclaim for declaratory judgment pursuant to the Declaratory
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`Judgment Act, 28 U.S.C. §§ 2201 and 2202 for the purpose of determining an actual and
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`justiciable controversy between the parties.
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`Answer: Paragraph 4 contains no allegations of fact to which a response is required. To
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`the extent a response is required, Plaintiffs deny the allegations of paragraph 4.
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`5.
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`The Court has original jurisdiction over the subject matter of these claims
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`pursuant to 28 U.S.C. §§ 1331 and 1338(a).
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`Answer: Paragraph 5 contains no allegations of fact to which a response is required. To
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`the extent a response is required, Plaintiffs deny the allegations of paragraph 5.
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`6.
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`Venue is proper in this district under 28 U.S.C. §§ 1391 (b) and (c), 1400(b), and
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`because Counterclaim-Defendants have consented to venue in this Court by filing the instant
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`action in this jurisdiction.
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`Answer: Paragraph 6 contains no allegations of fact to which a response is required. To
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`the extent a response is required, Plaintiffs admit that it filed the instant action in this
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`jurisdiction. They deny the remaining allegations of paragraph 6.
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`7.
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`Counterclaim-Plaintiffs Apotex submitted Abbreviated New Drug Application
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`(“ANDA”) No. 207712 to the Food and Drug Administration (“FDA”) seeking approval of
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`Case 1:14-cv-01453-LPS Document 12 Filed 01/16/15 Page 3 of 10 PageID #: 100
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`generic nasal spray containing 137 mcg of the active ingredient azelastine hydrochloride and
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`containing 50 mcg of the active ingredient fluticasone propionate combination nasal spray
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`(“Apotex’s ANDA product”).
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`Answer: Upon information and belief, admitted.
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`8.
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`Upon information and belief, FDA lists Meda as the holder of New Drug
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`Application (“NDA”) No. 202236.
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`Answer: Admitted.
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`9.
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`On information and belief, NDA No. 202236 covers DYMISTA®, Counterclaim-
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`Defendants’ 137 mcg azelastine hydrochloride and 50 mcg fluticasone propionate nasal spray
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`product.
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`Answer: Admitted.
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`10.
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`On information and belief, the ’723 patent and ’620 patent are both listed in the
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`FDA’s Approved Drug Products With Therapeutic Equivalence Evaluations (the “Orange
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`Book”) for the product DYMISTA®.
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`Answer: Admitted.
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`11.
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`Counterclaim-Defendant Meda has alleged in the instant action that it is the
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`exclusive licensee of the ’723 patent and ’620 patent.
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`Answer: Admitted.
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`12.
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`On information and belief, Counterclaim-Defendant Cipla is the present owner of
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`the ’723 patent and the ’620 patent.
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`Answer: Admitted.
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`13.
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`Counterclaim-Plaintiff Apotex sent Counterclaim-Defendants a letter dated
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`October 20, 2014 notifying Counterclaim-Defendants of its paragraph IV certification that the
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`Case 1:14-cv-01453-LPS Document 12 Filed 01/16/15 Page 4 of 10 PageID #: 101
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`claims of the ’723 patent, and the ’620 patent are invalid and/or will not be infringed by the
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`product that is the subject of ANDA No. 207712. The Notice Letter included an offer of
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`confidential access (“the Notice Letter”).
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`Answer: The Notice Letter referenced in paragraph 13 speaks for itself and is the best
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`evidence of its contents. To the extent a response is required, Plaintiffs admit that they
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`received a letter dated October 20, 2014 notifying them of Apotex's paragraph IV
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`certification. Plaintiffs admit that Notice Letter included an offer of confidential access.
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`Plaintiff deny the remaining allegations of paragraph 13.
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`14.
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`On December 2, 2014, Counterclaim-Defendants filed an action against
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`Counterclaim-Plaintiff Apotex for infringement of the ’723 patent, and the ’620 patent.
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`Answer: Admitted.
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`15.
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`As a consequence of the foregoing, there is an actual and justiciable controversy
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`between Counterclaim-Plaintiff Apotex and Counterclaim-Defendants Meda and Cipla as to
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`whether the claims of the ’723 patent and ’620 patent are invalid and whether those claims are
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`being infringed or will be infringed by Apotex’s ANDA No. 207712 or by the manufacture, use,
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`or sale of the product described therein.
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`Answer: Paragraph 15 contains no allegations of fact to which a response is required. To
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`the extent a response is required, Plaintiffs deny the allegations of paragraph 15.
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`COUNT I
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`(Declaration of Invalidity of the ’723 Patent)
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`16.
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`Counterclaim-Plaintiff Apotex re-alleges and incorporates the allegations of
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`paragraphs 1-15 as if fully set forth herein.
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`Case 1:14-cv-01453-LPS Document 12 Filed 01/16/15 Page 5 of 10 PageID #: 102
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`Answer: Paragraph 16 contains no allegations of fact to which a response is required. To
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`the extent a response is required, Plaintiffs incorporate the answers to paragraph 1-15
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`fully.
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`17.
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`Counterclaim-Defendants allege ownership of and exclusive license to the ’723
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`patent and have brought claims against Counterclaim-Plaintiff Apotex alleging infringement of
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`the ’723 patent.
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`Answer: Cipla owns the ’723 patent. Meda is an exclusive licensee to the ’723 patent.
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`Plaintiffs have brought claims against Apotex alleging infringement of the ’723 patent.
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`Plaintiffs deny the remaining allegations in paragraph 17.
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`18.
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`One or more claims of the ’723 patent are invalid under one or more provisions of
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`35 U.S.C. §§ 101, 102, 103, and/or 112.
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`Answer: Denied.
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`19.
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`A present, genuine, and justiciable controversy exists between Counterclaim-
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`Plaintiff Apotex and Counterclaim-Defendants regarding the validity of the ’723 patent.
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`Answer: Paragraph 19 contains no allegations of fact to which a response is required.
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`20.
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`Counterclaim-Plaintiff Apotex is entitled to a declaration that claims of the ’723
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`patent are invalid.
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`Answer: Denied.
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`COUNT II
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`(Declaration of Non-Infringement of the ’723 Patent)
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`21.
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`Counterclaim-Plaintiff Apotex re-alleges and incorporates the allegations of
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`paragraphs 1-20 as if fully set forth herein.
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`Case 1:14-cv-01453-LPS Document 12 Filed 01/16/15 Page 6 of 10 PageID #: 103
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`Answer: Paragraph 21 contains no allegations of fact to which a response is required. To
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`the extent a response is required, Plaintiffs incorporate the answers to paragraph 1-20
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`fully.
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`22.
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`Counterclaim-Defendants allege ownership of and exclusive license to the ’723
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`patent and have brought claims against Counterclaim-Plaintiff Apotex alleging infringement of
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`the ’723 patent.
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`Answer: Cipla owns the ’723 patent. Meda is an exclusive licensee to the ’723 patent.
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`Plaintiffs have brought claims against Apotex alleging infringement of the ’723 patent.
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`Plaintiffs deny the remaining allegations in paragraph 22.
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`23.
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`The manufacture, use, or sale of Counterclaim-Plaintiff Apotex’s ANDA product
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`would not infringe any valid or enforceable claim of the ’723 patent, either directly or indirectly,
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`and either literally or under the doctrine of equivalents.
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`Answer: Denied.
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`24.
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`A present, genuine, and justiciable controversy exists between Counterclaim-
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`Plaintiff Apotex and Counterclaim-Defendants regarding the issue of whether the manufacture,
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`use, or sale of Counterclaim-Plaintiff Apotex’s ANDA product would infringe any valid or
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`enforceable claim of the ’723 patent.
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`Answer: Paragraph 24 contains no allegations of fact to which a response is required.
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`25.
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`Counterclaim-Plaintiff Apotex is entitled to a declaration that the manufacture,
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`use, or sale of its ANDA product would not infringe any valid or enforceable claim of the ’723
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`patent.
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`Answer: Denied.
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`{00934038;v1 }
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`Case 1:14-cv-01453-LPS Document 12 Filed 01/16/15 Page 7 of 10 PageID #: 104
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`COUNT III
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`(Declaration of Invalidity of the ’620 Patent)
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`26.
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`Counterclaim-Plaintiff Apotex re-alleges and incorporates the allegations of
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`paragraphs 1-25 as if fully set forth herein.
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`Answer: Paragraph 26 contains no allegations of fact to which a response is required. To
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`the extent a response is required, Plaintiffs incorporate the answers to paragraph 1-25
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`fully.
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`27.
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`Counterclaim-Defendants allege ownership of and exclusive license to the ’620
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`patent and have brought claims against Counterclaim-Plaintiff Apotex alleging infringement of
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`the ’620 patent.
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`Answer: Cipla owns the ’620 patent. Meda is an exclusive licensee to the ’620 patent.
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`Plaintiffs have brought claims against Apotex alleging infringement of the ’620 patent.
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`Plaintiffs deny the remaining allegations in paragraph 27.
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`28.
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`One or more claims of the ’620 patent are invalid under one or more provisions of
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`35 U.S.C. §§ 101, 102, 103, and/or 112.
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`Answer: Denied.
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`29.
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`A present, genuine, and justiciable controversy exists between Counterclaim-
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`Plaintiff Apotex and Counterclaim-Defendants regarding the validity of the ’620 patent.
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`Answer: Paragraph 29 contains no allegations of fact to which a response is required.
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`30.
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`Counterclaim-Plaintiff Apotex is entitled to a declaration that claims of the ’620
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`patent are invalid.
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`Answer: Denied.
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`{00934038;v1 }
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`Case 1:14-cv-01453-LPS Document 12 Filed 01/16/15 Page 8 of 10 PageID #: 105
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`COUNT IV
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`(Declaration of Non-Infringement of the ’620 Patent)
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`31.
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`Counterclaim-Plaintiff Apotex re-alleges and incorporates the allegations of
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`paragraphs 1-30 as if fully set forth herein.
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`Answer: Paragraph 31 contains no allegations of fact to which a response is required. To
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`the extent a response is required, Plaintiffs incorporate the answers to paragraph 1-30
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`fully.
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`32.
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`Counterclaim-Defendants allege ownership of and exclusive license to the ’620
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`patent and have brought claims against Counterclaim-Plaintiff Apotex alleging infringement of
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`the ’620 patent.
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`Answer: Cipla owns the ’620 patent. Meda is an exclusive licensee to the ’620 patent.
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`Plaintiffs have brought claims against Apotex alleging infringement of the ’620 patent.
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`Plaintiffs deny the remaining allegations in paragraph 32.
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`33.
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`The manufacture, use, or sale of Counterclaim-Plaintiff Apotex’s ANDA product
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`would not infringe any valid or enforceable claim of the ’620 patent, either directly or indirectly,
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`and either literally or under the doctrine of equivalents.
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`Answer: Denied.
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`34.
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`A present, genuine, and justiciable controversy exists between Counterclaim-
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`Plaintiff Apotex and Counterclaim-Defendants regarding the issue of whether the manufacture,
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`use, or sale of Counterclaim-Plaintiff Apotex’s ANDA product would infringe any valid or
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`enforceable claim of the ’620 patent.
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`Answer: Paragraph 34 contains no allegations of fact to which a response is required.
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`Case 1:14-cv-01453-LPS Document 12 Filed 01/16/15 Page 9 of 10 PageID #: 106
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`35.
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`Counterclaim-Plaintiff Apotex is entitled to a declaration that the manufacture,
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`use, or sale of its ANDA product would not infringe any valid or enforceable claim of the ’620
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`patent.
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`Answer: Denied.
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`PRAYER FOR RELIEF
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`Plaintiffs deny that Defendants are entitled to judgment in its favor and deny that
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`Defendants are entitled to any relief as set forth in its Counterclaims, Affirmative
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`Defenses, and/or Prayer for Relief. Plaintiffs respectfully request the Court enter
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`judgment:
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`a) Dismissing Defendants’ Counterclaims with prejudice;
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`b) Awarding Plaintiffs the relief that is requested in its Complaint; and
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`c) Awarding Plaintiffs such other relief as the Court deems just and proper.
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`DEFENSES
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`First Defense
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`The Counterclaims fail to state a claim for which relief can be granted.
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`Second Defense
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`The Counterclaims must be dismissed and denied because Defendants have committed an
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`act of infringement of the ’620 and ’723 patents by filing its Abbreviated New Drug Application
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`(“ANDA”) that is the subject of the Complaint and intends to further infringe if its ANDA is
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`approved by making, using, selling, offering to sell, and/or importing into the United States the
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`product that is described in its ANDA. Unless enjoined by the Court from doing so, Defendants
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`will commit acts of infringement, inducement to infringe and/or contributory infringement of the
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`’620 and ’723 patents, either literally or under the doctrine of equivalents.
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`Case 1:14-cv-01453-LPS Document 12 Filed 01/16/15 Page 10 of 10 PageID #: 107
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`Third Defense
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`Plaintiffs reserve the right to assert such other defenses that may appear as discovery
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`proceeds in this case.
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`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
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`Attorneys for Plaintiffs Meda Pharmaceuticals Inc.
`and Cipla Ltd.
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`Of Counsel:
`
`H. Keeto Sabharwal
`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
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`Dated: January 16, 2015
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`{00934038;v1 }
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