Case 1:17-cv-00399-LPS Document 8 Filed 05/04/17 Page 1 of 15 PageID #: 379
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`BRISTOL-MYERS SQUIBB COMPANY
`AND PFIZER INC.,
` Plaintiffs,
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` v.
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`APOTEX INC. AND APOTEX CORP.,
`
` Defendants.
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`C.A. No. 17-399-LPS
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`
`ANSWER, AFFIRMATIVE DEFENSES AND COUNTERCLAIMS
`OF THE APOTEX DEFENDANTS
`
`Defendants Apotex Inc. and Apotex Corp. (collectively, the “Apotex Defendants” or
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`“Apotex”), by and through their undersigned counsel, respond to the Complaint filed by
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`Plaintiffs Bristol-Myers Squibb Company (“BMS”) and Pfizer Inc. (“Pfizer”) (collectively, the
`
`“Plaintiffs”) as follows:
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`NATURE OF THE ACTION1
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`1.
`
`The Apotex Defendants admit that Plaintiffs brought this action for patent
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`infringement. The Apotex Defendants further admit that Plaintiffs brought this action as related
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`to ANDA No. 210091 filed by Apotex with FDA. The Apotex Defendants deny any remaining
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`allegations of paragraph 1.
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`2.
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`Apotex admits that it filed ANDA No. 210091, seeking FDA approval to market
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`2.5 mg and 5 mg tablets of apixaban. Apotex denies any remaining allegations of paragraph 2.
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`
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`
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`1 The Apotex Defendants deny any allegation that may be implied or inferred from the headings
`of Plaintiffs’ Complaint.
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`

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`PARTIES
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`3.
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`The Apotex Defendants lack knowledge and information to form a belief as to the
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`truthfulness of the allegations of paragraph 3 of the Complaint, and therefore deny them.
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`4.
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`The Apotex Defendants lack knowledge and information to form a belief as to the
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`truthfulness of the allegations of paragraph 4 of the Complaint, and therefore deny them.
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`5.
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`The Apotex Defendants lack knowledge and information to form a belief as to the
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`truthfulness of the allegations of paragraph 5 of the Complaint, and therefore deny them.
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`6.
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`7.
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`8.
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`The Apotex Defendants admit the allegations of paragraph 6 of the Complaint.
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`The Apotex Defendants admit the allegations of paragraph 7 of the Complaint.
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`The Apotex Defendants admit that Apotex Inc. and Apotex Corp. have cooperated
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`and assisted in the preparation and filing of ANDA No. 210091. The Apotex Defendants admit
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`that Apotex Inc. will be involved in the manufacture, importation, marketing and sale of the
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`Apotex ANDA product in the United States. The Apotex Defendants lack knowledge and
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`information to form a belief as to the truthfulness of the remaining allegations of paragraph 8 of
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`the Complaint, and therefore deny them.
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`JURISDICTION AND VENUE
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`9.
`
`The Apotex Defendants state that the allegations set forth in paragraph 9 of the
`
`Complaint are legal conclusions to which no responsive pleading is necessary. To the extent any
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`response is required, the Apotex Defendants admit for purposes of the instant case only that this
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`Court has subject matter jurisdiction over Plaintiffs’ claims.
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`10.
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`The Apotex Defendants state that the allegations set forth in paragraph 10 of the
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`Complaint are legal conclusions to which no responsive pleading is necessary. To the extent any
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`2
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`

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`response is required, the Apotex Defendants admit for purposes of the instant case only that they
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`do not contest venue or personal jurisdiction in this Court.
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`PATENTS-IN-SUIT
`
`11.
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`The Apotex Defendants admit that the ’980 patent was issued on July 2, 2002, and
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`is entitled “Nitrogen Containing Heterobicycles as Factor Xa Inhibitors.” The Apotex
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`Defendants further admit that, according to the electronic records of the U.S. Patent and
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`Trademark Office (the “PTO”), BMS is the assignee of the ’980 patent. The Apotex Defendants
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`admit that what appears to be an uncertified copy of the ’980 patent was attached to Plaintiffs’
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`Complaint as Exhibit A. The Apotex Defendants admit that, according to the FDA’s publication
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`Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”), the
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`’980 patent is not expired. The Apotex Defendants deny that the claims of the ’980 patent are
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`valid and enforceable. The Apotex Defendants lack knowledge and information sufficient to
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`form a belief as to whether BMS is now the owner of the ’980 patent and/or has the right to
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`enforce it, and therefore deny those allegations. The Apotex Defendants deny the remaining
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`allegations of paragraph 11.
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`12.
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`The Apotex Defendants admit that the ’208 patent was issued on November 22,
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`2005, and is entitled “Lactam-Containing Compounds and Derivatives Thereof as Factor Xa
`
`Inhibitors.” The Apotex Defendants further admit that according to the PTO’s electronic records,
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`BMS is the assignee of the ’208 patent, and that what appears to be an uncertified copy of the
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`’208 patent was attached to Plaintiffs’ Complaint as Exhibit B. The Apotex Defendants admit
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`that, according to the Orange Book, the ’208 patent is not expired. The Apotex Defendants deny
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`that the claims of the ’208 patent are valid and enforceable. The Apotex Defendants lack
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`knowledge and information sufficient to form a belief as to whether BMS is now the owner of
`
`
`
`3
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`

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`Case 1:17-cv-00399-LPS Document 8 Filed 05/04/17 Page 4 of 15 PageID #: 382
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`the ’208 patent and/or has the right to enforce it, and therefore deny those allegations. The
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`Apotex Defendants deny the remaining allegations of paragraph 12.
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`13.
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`The Apotex Defendants admit that the ’945 patent was issued on May 3, 2016,
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`and is titled “Apixaban Formulations.” The Apotex Defendants further admit that according to
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`the PTO’s electronic records, Plaintiffs are the assignees of the ’945 patent, and that what
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`appears to be an uncertified copy of the ’945 patent was attached to Plaintiffs’ Complaint as
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`Exhibit C. The Apotex Defendants admit that, according to the Orange Book, the ’945 patent is
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`not expired. The Apotex Defendants deny that the claims of the ’945 patent are valid and
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`enforceable. The Apotex Defendants lack knowledge and information sufficient to form a belief
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`as to whether the Plaintiffs are now the owners of the ’945 patent and/or have the right to enforce
`
`it, and therefore deny those allegations. The Apotex Defendants deny the remaining allegations
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`of paragraph 13.
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`14.
`
`The Apotex Defendants admit the allegations of paragraph 14.
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`INFRINGEMENT BY APOTEX
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`The Apotex Defendants admit the allegations of paragraph 15.
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`The Apotex Defendants admit that the Eliquis Notice Letter states, inter alia, that
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`15.
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`16.
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`Apotex seeks approval from the FDA to engage in the commercial manufacture, use or sale of
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`the Apotex ANDA product before the expiration of the patents-in-suit, for the reasons stated
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`within the Eliquis Notice Letter. The Apotex Defendants lack knowledge or information
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`sufficient to form a belief as to the truthfulness of the remaining allegations of paragraph 16, and
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`therefore deny them.
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`4
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`

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`17.
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`The Apotex Defendants admit that the Apotex ANDA product has the active
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`ingredient apixaban, is an oral tablet in 2.5 mg and 5 mg, and is bioequivalent to Eliquis®. The
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`Apotex Defendants deny the remaining allegations of paragraph 17.
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`18.
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`19.
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`20.
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`The Apotex Defendants admit the allegations of paragraph 18.
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`The Apotex Defendants admit the allegations of paragraph 19.
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`The Apotex Defendants admit that the Eliquis Notice Letter included an Offer of
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`Confidential Access pursuant to 21 U.S.C. § 355(j)(5)(C)(i)(III). The Apotex Defendants deny
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`the remaining allegations of paragraph 20.
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`21.
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`The Apotex Defendants admit the allegations of paragraph 21.
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`COUNT I
`
`(INFRINGEMENT OF THE ’980 PATENT)
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`22.
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`The Apotex Defendants incorporate their responses to paragraphs 1–21 set forth
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`above as if fully set forth herein.
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`23.
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`24.
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`25.
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`26.
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`The Apotex Defendants deny the allegations of paragraph 23.
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`The Apotex Defendants deny the allegations of paragraph 24.
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`The Apotex Defendants deny the allegations of paragraph 25.
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`The Apotex Defendants deny the allegations of paragraph 26.
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`COUNT II
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`(INFRINGEMENT OF THE ’208 PATENT)
`
`27.
`
`The Apotex Defendants incorporate their responses to paragraphs 1–26 set forth
`
`above as if fully set forth herein.
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`28.
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`29.
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`
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`The Apotex Defendants deny the allegations of paragraph 28.
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`The Apotex Defendants deny the allegations of paragraph 29.
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`5
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`

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`Case 1:17-cv-00399-LPS Document 8 Filed 05/04/17 Page 6 of 15 PageID #: 384
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`30.
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`31.
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`32.
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`The Apotex Defendants deny the allegations of paragraph 30.
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`The Apotex Defendants deny the allegations of paragraph 31.
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`The Apotex Defendants deny the allegations of paragraph 32.
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`COUNT III
`
`(INFRINGEMENT OF THE ’945 PATENT)
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`33.
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`The Apotex Defendants incorporate their responses to paragraphs 1–32 set forth
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`above as if fully set forth herein.
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`34.
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`35.
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`36.
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`37.
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`The Apotex Defendants deny the allegations of paragraph 34.
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`The Apotex Defendants deny the allegations of paragraph 35.
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`The Apotex Defendants deny the allegations of paragraph 36.
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`The Apotex Defendants deny the allegations of paragraph 37.
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`
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`ANSWER TO PLAINTIFFS’ PRAYER FOR RELIEF
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`The remainder of Plaintiffs’ Complaint is a prayer for relief, and does not require a
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`response. To the extent any response is required, the Apotex Defendants deny that the Plaintiffs
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`are entitled to any relief whatsoever against the Apotex Defendants in this action, either as
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`prayed for in their Complaint or otherwise.
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`THE APOTEX DEFENDANTS’ AFFIRMATIVE DEFENSES
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`The Apotex Defendants assert the following defenses to the Plaintiffs’ Complaint,
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`without prejudice to the denials in this Answer, and without admitting any allegations of the
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`Complaint not otherwise admitted. The Apotex Defendants reserve the right to assert additional
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`defenses, as warranted by facts learned through investigation and discovery. Assertion of a
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`defense is not a concession that the Apotex Defendants have the burden of proving the matter
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`asserted.
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`6
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`

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`FIRST DEFENSE
`(Failure to State a Claim)
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`The Plaintiffs’ claims are barred in whole or in part because the Plaintiffs have not stated
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`a claim upon which relief can be granted.
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`SECOND DEFENSE
`(Invalidity of the ’980 Patent)
`
`Upon information and belief, the claims of the ’980 patent are invalid under 35 U.S.C. §§
`
`101, 102, 103, and/or 112 and general principles of patent law.
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`THIRD DEFENSE
`(Non-Infringement of the ’980 Patent)
`
`No acts by any entity related to the Apotex Defendants have infringed, infringe, or will
`
`infringe any valid claim of the ’980 patent.
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`FOURTH DEFENSE
`(Invalidity of the ’208 Patent)
`
`Upon information and belief, the claims of the ’208 patent are invalid under 35 U.S.C. §§
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`101, 102, 103, and/or 112 and general principles of patent law.
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`FIFTH DEFENSE
`(Non-Infringement of the ’208 Patent)
`
`No acts by any entity related to the Apotex Defendants have infringed, infringe, or will
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`infringe any valid claim of the ’208 patent.
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`SIXTH DEFENSE
`(Invalidity of the ’945 Patent)
`
`Upon information and belief, the claims of the ’945 patent are invalid under 35 U.S.C. §§
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`101, 102, 103, and/or 112 and general principles of patent law.
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`SEVENTH DEFENSE
`(Non-Infringement of the ’945 Patent)
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`
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`7
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`

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`No acts by any entity related to the Apotex Defendants have infringed, infringe, or will
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`infringe any valid claim of the ’945 patent.
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`EIGHTH DEFENSE
`
`Any additional defenses that discovery may reveal.
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`COUNTERCLAIMS
`
`For their counterclaims against Counterclaim-Defendants Bristol-Myers Squibb
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`Company (“BMS”) and Pfizer Inc. (“Pfizer”) (collectively, the “Counterclaim-Defendants”),
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`Counterclaim-Plaintiffs Apotex Inc. and Apotex Corp. (collectively, “Apotex”) allege as follows:
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`PARTIES
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`Apotex Inc. is a company organized under the laws of Canada with its principal
`
`1.
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`place of business at 150 Signet Drive, Toronto, Ontario, M9L 1T9, Canada.
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`2.
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`Apotex Corp. is a company organized under the laws of the State of Delaware
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`with its principal place of business at 2400 Commerce Parkway, Suite 400, Weston, Florida
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`33326.
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`3.
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`BMS is a corporation organized and existing under the laws of Delaware, having
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`a place of business at Route 206 and Province Line Road, Princeton, New Jersey 08540.
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`4.
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`Pfizer is a corporation organized and existing under the laws of Delaware, having
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`its principal place of business at 235 East 42nd Street, New York, New York 10017.
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`JURISDICTION AND VENUE
`
`This Court has subject matter jurisdiction over this Counterclaim under 28 U.S.C.
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`5.
`
`§§ 1331, 1338(a), 2201, and 2202.
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`8
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`

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`6.
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`This Court has personal jurisdiction over BMS because BMS has availed itself to
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`the rights and privileges of this forum by suing Apotex Inc. and Apotex Corp. in this Court and
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`because BMS is incorporated in Delaware.
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`7.
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`This Court has personal jurisdiction over Pfizer because Pfizer has availed itself
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`to the rights and privileges of this forum by suing Apotex Inc. and Apotex Corp. in this Court
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`and because Pfizer is incorporated in Delaware.
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`8.
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`Venue is proper in this judicial district under 28 U.S.C. §§ 1391, 1400(b).
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`FACTUAL BACKGROUND
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`On or about July 2, 2002, the U.S. Patent and Trademark Office (the “PTO”)
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`9.
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`issued U.S. Patent No. 6,413,980 (the “’980 patent”), attached to the Complaint (D.I. 1) as
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`Exhibit A, titled “Nitrogen Containing Heterobicycles as Factor Xa Inhibitors.”
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`10.
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`BMS has alleged that BMS is the owner of the ’980 patent. See Complaint (D.I.
`
`1), ¶ 11.
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`11. On or about November 22, 2005, the PTO issued U.S. Patent No. 6,967,208 (the
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`“’208 patent”), attached to the Complaint (D.I. 1) as Exhibit B, titled “Lactam-Containing
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`Compounds and Derivatives Thereof as Factor Xa Inhibitors.”
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`12.
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`BMS has alleged that BMS is the owner of the ’208 patent. See Complaint (D.I.
`
`1), ¶ 12.
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`13.
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`On or about May 3, 2016, the PTO issued U.S. Patent No. 9,326,945 (the “’945
`
`patent”), attached to the Complaint (D.I. 1) as Exhibit C, titled “Apixaban Formulations.”
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`14.
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`BMS and Pfizer alleged that BMS and Pfizer are the joint owners of the ’945
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`patent. See Complaint (D.I. 1), ¶ 13.
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`
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`9
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`

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`15.
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`Each of the ’980 patent, the ’208 patent, and the ’945 patent has been listed in
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`connection with Eliquis® in the FDA’s publication, Approved Drug Products with Therapeutic
`
`Equivalence Evaluations, commonly referred to as the “Orange Book.”
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`16.
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`BMS and Pfizer have alleged that Eliquis® is approved by the FDA in NDA No.
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`202155 and is indicated to reduce the risk of and/or prevent certain thromboembolic diseases in
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`some patients. BMS and Pfizer have alleged that the active ingredient in Eliquis® is apixaban.
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`See Complaint (D.I. 1), ¶ 14.
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`17.
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`Apotex Inc. is the current owner of FDA Abbreviated New Drug Application
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`(“ANDA”) No. 210091 seeking approval for the commercial manufacture, use, sale, offer for
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`sale, and/or importation of apixaban oral tablet, 2.5 mg and 5 mg.
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`18.
`
`As a result of the Counterclaim-Defendants’ actions in listing the ’980, ’208, and
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`’945 patents in the Orange Book and in suing Apotex for alleged infringement of the ’980, ’208,
`
`and ’945 patents, Apotex is presently prevented from selling apixaban oral tablet, 2.5 mg and 5
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`mg, and is thus being injured.
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`19.
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`Apotex seeks certainty with respect to the ’980, ’208, and ’945 patents and
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`certainty regarding the legal rights relating to ANDA No. 210091 through a judicial declaration
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`that the ’980, ’208, and ’945 patents are invalid and/or not infringed by selling the apixaban oral
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`tablet, 2.5 mg and 5 mg, in ANDA No. 210091.
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`20.
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`A real, actual, and justiciable controversy exists between Apotex and the
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`Counterclaim-Defendants regarding the invalidity and/or non-infringement of the ’980, ’208, and
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`’945 patents constituting a case or actual controversy within the jurisdiction of this Court under
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`the Declaratory Judgment Act, 28 U.S.C. §§ 2201–2202.
`
`COUNT I
`(Declaratory Judgment of Invalidity of the ’980 Patent)
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`10
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`

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`21.
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`Apotex re-alleges and incorporates the allegations in paragraphs 1–20 as if fully
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`set forth herein.
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`22.
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`Apotex seeks judicial declaration that the claims of the ’980 patent are invalid
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`under 35 U.S.C. §§ 101, 102, 103, and/or 112 and general principles of patent law for, at least,
`
`the reasons stated in the Apotex’s Notice Letter dated March 13, 2017 (“Eliquis Notice Letter”).
`
`COUNT II
`(Declaratory Judgment of Non-Infringement of the ’980 Patent)
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`23.
`
`Apotex re-alleges and incorporates the allegations in paragraphs 1–22 as if fully
`
`set forth herein.
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`24.
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`The manufacture, use, sale, offer for sale, or importation into the United States of
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`the apixaban oral tablet, 2.5 mg and 5 mg, that are the subject of ANDA No. 210091 have not
`
`infringed, do not infringe, and would not, if marketed, infringe any valid or enforceable claim of
`
`the ’980 patent. The apixaban oral tablet, 2.5 mg and 5 mg, described in ANDA No. 210091 does
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`not meet each and every limitation of any valid or enforceable claim of the ’980 patent and
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`therefore does not infringe the ’980 patent.
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`25.
`
`Apotex is entitled to a declaration that the manufacture, use, sale, offer for sale, or
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`importation into the United States of the apixaban oral tablet, 2.5 mg and 5 mg, that are the
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`subject of ANDA No. 210091 have not infringed, do not infringe, and would not, if marketed,
`
`infringe any valid or enforceable claim of the ’980 patent for, at least, the reasons stated in the
`
`Eliquis Notice Letter.
`
`COUNT III
`(Declaratory Judgment of Invalidity of the ’208 Patent)
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`26.
`
`Apotex re-alleges and incorporates the allegations in paragraphs 1–25 as if fully
`
`set forth herein.
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`11
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`27.
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`Apotex seeks judicial declaration that the claims of the ’208 patent are invalid
`
`under 35 U.S.C. §§ 101, 102, 103, and/or 112 and general principles of patent law for, at least,
`
`the reasons stated in the Eliquis Notice Letter.
`
`COUNT IV
`(Declaratory Judgment of Non-Infringement of the ’208 Patent)
`
`28.
`
`Apotex re-alleges and incorporates the allegations in paragraphs 1–27 as if fully
`
`set forth herein.
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`29.
`
`The manufacture, use, sale, offer for sale, or importation into the United States of
`
`the apixaban oral tablet, 2.5 mg and 5 mg, that are the subject of ANDA No. 210091 have not
`
`infringed, do not infringe, and would not, if marketed, infringe any valid or enforceable claim of
`
`the ’208 patent. The apixaban oral tablet, 2.5 mg and 5 mg, described in ANDA No. 210091 does
`
`not meet each and every limitation of any valid or enforceable claim of the ’208 patent and
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`therefore does not infringe the ’208 patent.
`
`30.
`
`Apotex is entitled to a declaration that the manufacture, use, sale, offer for sale, or
`
`importation into the United States of the apixaban oral tablet, 2.5 mg and 5 mg, that are the
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`subject of ANDA No. 210091 have not infringed, do not infringe, and would not, if marketed,
`
`infringe any valid or enforceable claim of the ’208 patent for, at least, the reasons stated in the
`
`Eliquis Notice Letter.
`
`COUNT V
`(Declaratory Judgment of Invalidity of the ’945 Patent)
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`31.
`
`Apotex re-alleges and incorporates the allegations in paragraphs 1–30 as if fully
`
`set forth herein.
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`12
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`32.
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`Apotex seeks judicial declaration that the claims of the ’945 patent are invalid
`
`under 35 U.S.C. §§ 101, 102, 103, and/or 112 and general principles of patent law for, at least,
`
`the reasons stated in the Eliquis Notice Letter.
`
`COUNT VI
`(Declaratory Judgment of Non-Infringement of the ’945 Patent)
`
`33.
`
`Apotex re-alleges and incorporates the allegations in paragraphs 1–32 as if fully
`
`set forth herein.
`
`34.
`
`The manufacture, use, sale, offer for sale, or importation into the United States of
`
`the apixaban oral tablet, 2.5 mg and 5 mg, that are the subject of ANDA No. 210091 have not
`
`infringed, do not infringe, and would not, if marketed, infringe any valid or enforceable claim of
`
`the ’945 patent. The apixaban oral tablet, 2.5 mg and 5 mg, described in ANDA No. 210091 does
`
`not meet each and every limitation of any valid or enforceable claim of the ’945 patent and
`
`therefore does not infringe the ’945 patent.
`
`35.
`
`Apotex is entitled to a declaration that the manufacture, use, sale, offer for sale, or
`
`importation into the United States of the apixaban oral tablet, 2.5 mg and 5 mg, that are the
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`subject of ANDA No. 210091 have not infringed, do not infringe, and would not, if marketed,
`
`infringe any valid or enforceable claim of the ’945 patent for, at least, the reasons stated in the
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`Eliquis Notice Letter.
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`PRAYER FOR RELIEF
`
`WHEREFORE, Apotex Inc. and Apotex Corp. pray for relief as follows:
`
`A.
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`Dismissing the Complaint with prejudice, and denying all relief sought in the
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`Complaint;
`
`B.
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`C.
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`
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`Judgment in their favor for all claims for relief;
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`A declaration that the claims of the ’980, ’208, and ’945 patents are invalid;
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`13
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`D.
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`A declaration that the manufacture, use, sale, offer for sale, or importation into the
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`United States of the apixaban oral tablet, 2.5 mg and 5 mg, that are the subject of ANDA No.
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`210091 have not infringed, do not infringe, and would not, if marketed, infringe any valid or
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`enforceable claim of the ’980, ’208, and ’945 patents;
`
`E.
`
`A declaration that the Food & Drug Administration may approve Abbreviated
`
`New Drug Application No. 210091 concerning apixaban oral tablet, 2.5 mg and 5 mg, whenever
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`that application is otherwise in condition for approval, without awaiting any further order,
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`judgment, or decree of this Court; that the judgment entered in this case is a judgment reflecting
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`a decision that the ’980, ’208, and ’945 patents are invalid or not infringed pursuant to 21 U.S.C.
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`§ 355(j)(5)(B)(iii)(I)(aa); and that the thirty-month period referred to in 21 U.S.C. §
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`355(j)(5)(B)(iii) and any other marketing exclusivity periods to which the Plaintiffs/
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`Counterclaim-Defendants might otherwise be entitled (including any pediatric exclusivity) are
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`shortened to expire upon the date of entry of judgment in this case;
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`F.
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`A declaration that this case is exceptional pursuant to 35 U.S.C. § 285, and an
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`award of attorneys’ fees and costs; and
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`G.
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`For an award of such other and further relief as the Court may deem just and
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`proper.
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`Of Counsel:
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`Dated: May 4, 2017
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`PHILLIPS GOLDMAN MCLAUGHLIN & HALL, P.A.
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`/s/ John C. Phillips, Jr.______________________
`John C. Phillips, Jr. (#110)
`John Josef Molenda
`David A. Bilson (#4986)
`Vishal C. Gupta
`1200 North Broom Street
`STEPTOE & JOHNSON LLP
`Wilmington, DE 19806
`1114 Avenue of the Americas, 35th Floor
`(302) 655-4200
`New York, NY 10036
`jcp@pgmhlaw.com
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`14
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`Case 1:17-cv-00399-LPS Document 8 Filed 05/04/17 Page 15 of 15 PageID #: 393
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`Phone: (212) 506-3900
`Facsimile: (212) 506-3950
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`dab@pgmhlaw.com
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`Attorneys for Defendants Apotex Inc. and
`Apotex Corp.
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`15
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