Case 1:16-cv-01221-LPS Document 55 Filed 06/08/18 Page 1 of 4 PageID #: 462
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`Plaintiffs,
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`Defendants.
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`C.A. No. 16-1221 (LPS)
`CONSOLIDATED
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`BAYER HEALTHCARE LLC and BAYER
`HEALTHCARE PHARMACEUTICALS
`INC.,
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`TEVA PHARMACEUTICALS USA, INC.,
`et al.,
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`v.
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`JOINT INTERIM STATUS REPORT
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`Pursuant to paragraph 14 of the Court’s November 13, 2017, Scheduling Order (D.I. 20),
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`Plaintiffs Bayer HealthCare LLC and Bayer HealthCare Pharmaceuticals Inc. (collectively,
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`“Bayer” ), and Defendants Teva Pharmaceuticals USA, Inc. (“Teva”), Apotex Inc. and Apotex
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`Corp. (“Apotex”) respectfully submit this Joint Interim Status Report.
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`Status of the Action
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`This is a Hatch-Waxman patent infringement action involving U.S. Patent Nos. 7,351,834
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`(“the ’834 patent”); 8,637,553 (“the ’553 patent”); 8,680,124 (“the ’124 patent”); and 9,458,107
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`(“the ’107 patent”), which are listed in the U.S. Food and Drug Administration’s Orange Book in
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`connection with Bayer’s anti-cancer drug Stivarga®.
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`On December 16, 2016, Bayer filed a complaint against Teva Pharmaceuticals USA, Inc.
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`and Teva Pharmaceuticals Industries Ltd. in C.A. No. 16-1221-LPS alleging infringement of the
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`’834, ’553, ’124, and ’107 patents in connection with Teva’s filing of Abbreviated New Drug
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`Application (“ANDA”) No. 209728, seeking approval to market a generic version of Stivarga®
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`in the United States prior to the expiration of those patents. Also on December 16, 2016, Bayer
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`)
`)
`)
`
`Plaintiffs,
`
`Defendants.
`
`
`
`
`
`
`C.A. No. 16-1221 (LPS)
`CONSOLIDATED
`
`BAYER HEALTHCARE LLC and BAYER
`HEALTHCARE PHARMACEUTICALS
`INC.,
`
`
`
`
`
`TEVA PHARMACEUTICALS USA, INC.,
`et al.,
`
`
`
`
`
`
`
`
`
`
`
`
`v.
`
`
`
`JOINT INTERIM STATUS REPORT
`
`
`
`Pursuant to paragraph 14 of the Court’s November 13, 2017, Scheduling Order (D.I. 20),
`
`Plaintiffs Bayer HealthCare LLC and Bayer HealthCare Pharmaceuticals Inc. (collectively,
`
`“Bayer” ), and Defendants Teva Pharmaceuticals USA, Inc. (“Teva”), Apotex Inc. and Apotex
`
`Corp. (“Apotex”) respectfully submit this Joint Interim Status Report.
`
`Status of the Action
`
`This is a Hatch-Waxman patent infringement action involving U.S. Patent Nos. 7,351,834
`
`(“the ’834 patent”); 8,637,553 (“the ’553 patent”); 8,680,124 (“the ’124 patent”); and 9,458,107
`
`(“the ’107 patent”), which are listed in the U.S. Food and Drug Administration’s Orange Book in
`
`connection with Bayer’s anti-cancer drug Stivarga®.
`
`On December 16, 2016, Bayer filed a complaint against Teva Pharmaceuticals USA, Inc.
`
`and Teva Pharmaceuticals Industries Ltd. in C.A. No. 16-1221-LPS alleging infringement of the
`
`’834, ’553, ’124, and ’107 patents in connection with Teva’s filing of Abbreviated New Drug
`
`Application (“ANDA”) No. 209728, seeking approval to market a generic version of Stivarga®
`
`in the United States prior to the expiration of those patents. Also on December 16, 2016, Bayer
`
`
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`Case 1:16-cv-01221-LPS Document 55 Filed 06/08/18 Page 2 of 4 PageID #: 463
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`filed a complaint against Apotex in C.A. No. 16-1222-LPS alleging infringement of the ’553
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`patent in connection with Apotex’s filing of ANDA No. 209765.
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`On February 3, 2017, Teva and Bayer stipulated to the dismissal of Teva Pharmaceuticals
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`Industries Ltd. from C.A. No. 16-1221-LPS, leaving Teva Pharmaceuticals USA, Inc. as a
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`defendant (D.I. 9).
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`On March 28, 2017, Bayer filed a second complaint against Apotex in C.A. No. 17-0334-
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`LPS, alleging infringement of the ’107 patent in connection with Apotex’s ANDA No. 209728
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`seeking approval to market a generic version of Stivarga® in the United States prior to the
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`expiration of the ’107 patent.
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`Both Teva and Apotex have answered Bayer’s complaints (C.A. No. 16-1221-LPS,
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`D.I. 10; C.A. No. 16-1222, D.I. 10; C.A. No. 17-334-LPS, D.I. 10). Teva asserted defenses and
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`counterclaims of non-infringement and invalidity as to the ’834, ’553, ’124, and ’107 patents.
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`Apotex asserted defenses of non-infringement and invalidity as to the ’553 and ’107 patents.
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`The parties stipulated to the consolidation of the three actions on December 5, 2017,
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`under C.A. No. 16-1221-LPS (D.I. 26).
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`The Joint Claim Construction Chart and Joint Appendix were filed on May 23, 2018
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`(D.I. 52-53).
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`Progress of Discovery
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`Fact discovery is ongoing. The parties’ deadline for substantial completion of document
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`production was May 15, 2018, and fact discovery is scheduled to close on September 4, 2018.
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`All parties have served initial disclosures (D.I. 23, 24, 29). Bayer has served
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`supplemental initial disclosures (D.I. 30). On December 13, 2017, Bayer provided Defendants
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`2
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`Case 1:16-cv-01221-LPS Document 55 Filed 06/08/18 Page 3 of 4 PageID #: 464
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`with an Initial Identification of Asserted Patents and Accused Products and copies of the certified
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`file histories for each of the asserted patents (D.I. 30).
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`On November 22, 2017, Teva notified Bayer that it had completed its production of core
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`technical documents. Apotex notified Bayer that it had completed its production of core
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`technical documents on January 16, 2018.
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`Bayer has served initial infringement claim charts for Teva’s ANDA Product and
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`Apotex’s ANDA Product (D.I. 33, 40).
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`Teva served Initial Invalidity Contentions on January 22, 2018. Apotex served Initial
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`Invalidity Contentions on March 14, 2018 (D.I. 41). Bayer served its final supplementation of
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`the Identification of All Accused Products and Asserted Claims on April 16, 2018 (D.I. 43).
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`Teva and Apotex served their final supplementation of the Identification of All Prior
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`Art/Invalidity References on April 23 and April 24, respectively (D.I. 45, 46).
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`All parties have served and responded to interrogatories and requests for production of
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`documents. Bayer has raised concerns regarding Defendants’ responses to interrogatories and
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`requests for production beginning on February 21, 2018. Defendants have raised concerns with
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`Plaintiffs’ responses to Request for Production beginning February 8, 2018. There have been
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`numerous meet and confers since, but some of the parties’ concerns with respect to the other
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`side’s discovery responses remain. Plaintiffs submit that, to the extent its concerns with
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`Defendants’ discovery responses are not resolved and are ripe for the Court’s attention, Plaintiffs
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`will bring them to the attention of the Court through the Court’s dispute resolution procedures.
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`Defendants’ concerns with Plaintiffs document production remain. To the extent the parties do
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`not resolve these concerns within the next week, Defendants will bring the issues to the Court’s
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`attention through the Court’s dispute resolution procedures.
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`3
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`Case 1:16-cv-01221-LPS Document 55 Filed 06/08/18 Page 4 of 4 PageID #: 465
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`Defendants have requested potential dates and locations for depositions of eleven of the
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`named inventors of the patents-in-suit. In response to this recent request, Bayer responded that
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`ten of the identified individuals are represented by counsel for Bayer, and that it will look into
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`deposition dates and locations for the witnesses. Bayer has not been able to contact the eleventh
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`named inventor identified by Defendants.
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`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
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`/s/ Derek J. Fahnestock
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`
`
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`Jack B. Blumenfeld (#1014)
`Derek J. Fahnestock (#4705)
`Anthony D. Raucci (#5948)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@mnat.com
`dfahnestock@mnat.com
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`Attorneys for Plaintiffs Bayer Healthcare LLC
`and Bayer Healthcare Pharmaceuticals Inc.
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`SHAW KELLER LLP
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`MORRIS JAMES LLP
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`/s/ Kenneth L. Dorsney
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`Kenneth L. Dorsney (#3726)
`500 Delaware Avenue, Suite 1500
`Wilmington, DE 19801-1494
`(302) 888-6855
`kdorsney@morrisjames.com
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`Attorneys for Defendants Apotex Inc. and
`Apotex Corp.
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`/s/ Karen E. Keller
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`John W. Shaw (#3362)
`Karen E. Keller (#4489)
`David M. Fry (#5486)
`1105 North Market Street, 12th Floor
`Wilmington, DE 19801
`(302) 298-0701
`jshaw@shawkeller.com
`kkeller@shawkeller.com
`dfry@shawkeller.com
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`Attorneys for Defendant Teva Pharmaceuticals USA, Inc.
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`June 8, 2018
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`4
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