Case 1:17-cv-00399-LPS Document 10 Filed 05/23/17 Page 1 of 6 PageID #: 395
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`BRISTOL-MYERS SQUIBB COMPANY
`AND PFIZER INC.,
`
`
` Plaintiffs and
`Counterclaim-Defendants,
`
`v.
`
`
`
`
`APOTEX, INC. AND APOTEX CORP.,
`
`
` Defendants and
`Counterclaim-Plaintiffs.
`
`
`
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
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`
`C.A. No. 17-cv-399-LPS
`
`PLAINTIFFS’ REPLY TO DEFENDANTS’ COUNTERCLAIMS
`
`Plaintiffs and Counterclaim-Defendants Bristol-Myers Squibb Company (“BMS”) and
`
`Pfizer Inc. (“Pfizer,” together with BMS, “Plaintiffs”) hereby reply to the Counterclaims of
`
`Defendants and Counterclaim-Plaintiffs Apotex, Inc. and Apotex Corp. (collectively, “Apotex”),
`
`D.I. 8, as follows. Plaintiffs deny any allegation contained in Apotex’s Answer and
`
`Counterclaims not expressly admitted in this Reply.
`
`COUNTERCLAIMS1
`
`PARTIES
`
`1.
`
`Plaintiffs lack knowledge or information sufficient to form a belief about the truth
`
`of the allegations in this Paragraph.
`
`2.
`
`Plaintiffs lack knowledge or information sufficient to form a belief about the truth
`
`of the allegations in this Paragraph.
`
`
`1
`Plaintiffs have incorporated the headings that appear in Apotex’s Counterclaims. Plaintiffs
`do not necessarily agree with the characterization of such headings and do not waive any right to
`object to those characterizations.
`
`
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`BRISTOL-MYERS SQUIBB COMPANY
`AND PFIZER INC.,
`
`
` Plaintiffs and
`Counterclaim-Defendants,
`
`v.
`
`
`
`
`APOTEX, INC. AND APOTEX CORP.,
`
`
` Defendants and
`Counterclaim-Plaintiffs.
`
`
`
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`C.A. No. 17-cv-399-LPS
`
`PLAINTIFFS’ REPLY TO DEFENDANTS’ COUNTERCLAIMS
`
`Plaintiffs and Counterclaim-Defendants Bristol-Myers Squibb Company (“BMS”) and
`
`Pfizer Inc. (“Pfizer,” together with BMS, “Plaintiffs”) hereby reply to the Counterclaims of
`
`Defendants and Counterclaim-Plaintiffs Apotex, Inc. and Apotex Corp. (collectively, “Apotex”),
`
`D.I. 8, as follows. Plaintiffs deny any allegation contained in Apotex’s Answer and
`
`Counterclaims not expressly admitted in this Reply.
`
`COUNTERCLAIMS1
`
`PARTIES
`
`1.
`
`Plaintiffs lack knowledge or information sufficient to form a belief about the truth
`
`of the allegations in this Paragraph.
`
`2.
`
`Plaintiffs lack knowledge or information sufficient to form a belief about the truth
`
`of the allegations in this Paragraph.
`
`
`1
`Plaintiffs have incorporated the headings that appear in Apotex’s Counterclaims. Plaintiffs
`do not necessarily agree with the characterization of such headings and do not waive any right to
`object to those characterizations.
`
`
`
`
`
`Case 1:17-cv-00399-LPS Document 10 Filed 05/23/17 Page 2 of 6 PageID #: 396
`
`3.
`
`4.
`
`5.
`
`Admitted.
`
`Admitted.
`
`JURISDICTION AND VENUE
`
`This Paragraph contains legal conclusions to which no answer is required. To the
`
`extent an answer is required, Plaintiffs do not contest that the Court has jurisdiction over the
`
`subject matter of the Counterclaims.
`
`6.
`
`This Paragraph contains legal conclusions to which no answer is required. To the
`
`extent an answer is required, BMS does not contest personal jurisdiction in this Court for purposes
`
`of the Counterclaims.
`
`7.
`
`This Paragraph contains legal conclusions to which no answer is required. To the
`
`extent an answer is required, Pfizer does not contest personal jurisdiction in this Court for purposes
`
`of the Counterclaims.
`
`8.
`
`This Paragraph contains legal conclusions to which no answer is required. To the
`
`extent an answer is required, Plaintiffs do not contest that venue with respect to the Counterclaims
`
`is proper in this judicial district.
`
`FACTUAL BACKGROUND
`
`9.
`
`10.
`
`11.
`
`12.
`
`13.
`
`14.
`
`15.
`
`Admitted.
`
`Admitted.
`
`Admitted.
`
`Admitted.
`
`Admitted.
`
`Admitted.
`
`Admitted.
`
`
`
`- 2 -
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`
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`Case 1:17-cv-00399-LPS Document 10 Filed 05/23/17 Page 3 of 6 PageID #: 397
`
`16.
`
`Plaintiffs admit that they have alleged that the FDA approved NDA No. 202155.
`
`Plaintiffs further admit that they have alleged Eliquis® is indicated: (1) to reduce the risk of
`
`stroke and systemic embolism in patients with nonvalvular atrial fibrillation; (2) for the
`
`prophylaxis of deep vein thrombosis (“DVT”), which may lead to pulmonary embolism (“PE”), in
`
`patients who have undergone hip or knee replacement surgery; and (3) for the treatment of DVT
`
`and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy.
`
`Plaintiffs also admit that they have alleged that they market apixaban tablets under the trade name
`
`Eliquis®.
`
`17.
`
`Plaintiffs lack knowledge or information sufficient to form a belief about the truth
`
`of the allegations in this Paragraph. Plaintiffs state, however, that Apotex sent Plaintiffs a letter
`
`dated March 13, 2017, notifying Plaintiffs that Apotex had submitted ANDA No. 210091 to the
`
`FDA, seeking approval to market 2.5 mg and 5 mg tablets of apixaban, generic versions of
`
`Plaintiffs’ Eliquis® drug product (the “Apotex ANDA product”).
`
`18.
`
`This Paragraph contains legal conclusions to which no answer is required. To the
`
`extent an answer is required, denied.
`
`19.
`
`Plaintiffs lack knowledge or information sufficient to form a belief about the truth
`
`of the allegations in this Paragraph. Plaintiffs deny, however, that the patents-in-suit are invalid
`
`and/or would not be infringed by Apotex’s commercial manufacture, use, offer to sell, sale, or
`
`importation of the Apotex ANDA product prior the expiration of the patents-in-suit.
`
`20.
`
`This Paragraph contains legal conclusions to which no answer is required. To the
`
`extent an answer is required, Plaintiffs admit that there is currently a justiciable controversy
`
`between the parties regarding the patents-in-suit.
`
`
`
`- 3 -
`
`
`
`Case 1:17-cv-00399-LPS Document 10 Filed 05/23/17 Page 4 of 6 PageID #: 398
`
`COUNT I
`(Declaratory Judgment of Invalidity of the ’980 Patent)
`
`21.
`
`Plaintiffs hereby incorporate the answers set forth in response to Paragraphs 1
`
`through 20.
`
`22.
`
`Plaintiffs admit that Apotex purports to seek a judicial declaration that the claims of
`
`the ’980 patent are invalid, and that Apotex sent a letter to Plaintiffs dated March 13, 2017 (the
`
`“Notice Letter”), asserting that certain claims of the ’980 patent are invalid under 35 U.S.C. §§ 101
`
`and/or 112. Otherwise, denied.
`
`COUNT II
`(Declaratory Judgment of Non-Infringement of the ’980 Patent)
`
`23.
`
`Plaintiffs hereby incorporate the answers set forth in response to Paragraphs 1
`
`through 22.
`
`24.
`
`25.
`
`Denied.
`
`Denied.
`
`COUNT III
`(Declaratory Judgment of Invalidity of the ’208 Patent)
`
`26.
`
`Plaintiffs hereby incorporate the answers set forth in response to Paragraphs 1
`
`through 25.
`
`27.
`
`Plaintiffs admit that Apotex purports to seek a judicial declaration that the claims of
`
`the ’208 patent are invalid, and that Apotex sent the Notice Letter asserting that certain claims of
`
`the ’208 patent are invalid under 35 U.S.C. §§ 101, 103 and/or 112. Otherwise, denied.
`
`COUNT IV
`(Declaratory Judgment of Non-Infringement of the ’208 Patent)
`
`28.
`
`Plaintiffs hereby incorporate the answers set forth in response to Paragraphs 1
`
`through 27.
`
`29.
`
`Denied.
`
`
`
`- 4 -
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`
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`Case 1:17-cv-00399-LPS Document 10 Filed 05/23/17 Page 5 of 6 PageID #: 399
`
`30.
`
`Denied.
`
`COUNT V
`(Declaratory Judgment of Invalidity of the ’945 Patent)
`
`31.
`
`Plaintiffs hereby incorporate the answers set forth in response to Paragraphs 1
`
`through 30.
`
`32.
`
`Plaintiffs admit that Apotex purports to seek a judicial declaration that the claims of
`
`the ’945 patent are invalid, and that Apotex sent the Notice Letter asserting that certain claims of
`
`the ’945 patent are invalid under 35 U.S.C. §§ 103 and/or 112. Otherwise, denied.
`
`
`
`COUNT VI
`(Declaratory Judgment of Non-Infringement of the ’945 Patent)
`
`33.
`
`Plaintiffs hereby incorporate the answers set forth in response to Paragraphs 1
`
`through 32.
`
`34.
`
`35.
`
`Denied.
`
`Denied.
`
`PRAYER FOR RELIEF
`
`Plaintiffs deny that Apotex is entitled to any of the relief sought in its Counterclaims or to
`
`any relief whatsoever.
`
`Dated: May 23, 2017
`
`
`
`
`
`Respectfully submitted,
`
`FARNAN, LLP
`
`/s/ Michael J. Farnan
`Joseph J. Farnan, Jr. (Bar No. 100245)
`Brian E. Farnan (Bar No. 4089)
`Michael J. Farnan (Bar No. 5165)
`919 N. Market Str., 12th Floor
`Wilmington, DE 19801
`Tel: (302) 777-0300
`Fax: (302) 777-0301
`farnan@farnanlaw.com
`
`- 5 -
`
`
`
`Case 1:17-cv-00399-LPS Document 10 Filed 05/23/17 Page 6 of 6 PageID #: 400
`
`bfarnan@farnanlaw.com
`mfarnan@farnanlaw.com
`
`Amy K. Wigmore (admitted pro hac vice)
`Gregory H. Lantier (admitted pro hac vice)
`Tracey C. Allen (admitted pro hac vice)
`Heather M. Petruzzi (admitted pro hac vice)
`Jeffrey T. Hantson (admitted pro hac vice)
`Wilmer Cutler Pickering Hale and Dorr LLP
`1875 Pennsylvania Ave, NW
`Washington, DC 20006
`202-663-6000
`202-663-6363
`
`Andrew J. Danford (admitted pro hac vice)
`Timothy A. Cook (admitted pro hac vice)
`Kevin M. Yurkerwich (admitted pro hac vice)
`Wilmer Cutler Pickering Hale and Dorr LLP
`60 State Street
`Boston, MA 02109
`617-526-6000
`617-526-5000
`
`Counsel for Plaintiffs Bristol-Myers Squibb
`Company and Pfizer Inc.
`
`- 6 -
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