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`Case 1:14-cv-01289-RGA Document 189 Filed 02/21/19 Page 1 of 3 PageID #: 7135
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. 14-1043-RGA
`C.A. No. 16-431-RGA
`C.A. No. 17-420-RGA
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`C.A. No. 14-1289-RGA
`C.A. No. 14-1494-RGA
`C.A. No. 15-78-RGA
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`C.A. No. 14-1196-RGA
`C.A. No. 14-1508-RGA
`C.A. No. 15-128-RGA
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`Plaintiffs,
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`Defendant.
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`Plaintiffs,
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`Defendant.
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`Plaintiffs,
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`Defendant.
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`NOVARTIS PHARMACEUTICALS
`CORPORATION and NOVARTIS AG,
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`BRECKENRIDGE PHARMACEUTICAL, INC.,
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`NOVARTIS PHARMACEUTICALS
`CORPORATION and NOVARTIS AG,
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`PAR PHARMACEUTICAL, INC.,
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`NOVARTIS PHARMACEUTICALS
`CORPORATION and NOVARTIS AG,
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`WEST-WARD PHARMACEUTICALS
`INTERNATIONAL LIMITED,
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`NOVARTIS’S OPPOSITION TO DEFENDANTS’ MOTION
`FOR EXTENSION OF TIME TO SUBMIT JOINT STATUS REPORT
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`Plaintiffs Novartis Pharmaceuticals and Novartis AG (collectively “Novartis”) oppose the
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`motion by Defendants Breckenridge Pharmaceutical, Inc., Par Pharmaceutical, Inc., and West-
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`Ward Pharmaceuticals International Limited n/k/a Hikma Pharmaceuticals International Limited
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`Case 1:14-cv-01289-RGA Document 189 Filed 02/21/19 Page 2 of 3 PageID #: 7136
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`(collectively, “Defendants”) for a 7 day extension to file a joint status report, see, e.g., Case 1:14-
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`cv-01043-RGA, D. I. 202. Defendants’ motion fails to provide any basis to grant the extension
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`Defendants seek, and glaringly omits that there is an urgency to resolve the outstanding § 103
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`challenge to U.S. Patent No. 5,665,772 (“the ’772 patent”), as the 30-month stay has now
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`expired, at least one Defendant has approval for its Zortress® generic product and will not agree
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`to forgo an at-risk launch until the matter is resolved, and the other Defendants may obtain
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`approval at any point.
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`Although the Mandate issued on February 15, 2019, the underlying decision on the merits
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`issued on December 7, 2018, and Defendants’ request for rehearing was denied on February 8,
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`2019, so Defendants have known that remand was imminent. Novartis was preparing to contact
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`the Court on the heels of the Mandate’s issuance when it received the Court’s Order directing the
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`parties to file a joint status report within five (5) days.
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`In reliance on the Court’s Order, instead of filing its own submission, Novartis sent
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`Defendants a draft of the joint status report on February 16, 2019, asking for comments by noon
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`on Tuesday February 19, 2019 (Exhibit 1). Shortly before noon on Tuesday, the Defendants
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`asked if Novartis would agree to a 7 day extension, citing the holiday weekend as the basis for
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`the request (Exhibit 2 at 2). Novartis agreed subject to two straightforward conditions: (1)
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`Defendants would agree not to launch while this Court considered the validity of the ’772 patent,
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`and (2) Defendants would provide their comments on the joint letter by close of business on
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`Friday February 22, 2019 (Exhibit 2 at 1-2). Defendants refused to agree to Novartis’s
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`conditions, offered no counter-proposal and instead filed the instant motion (Exhibit 2 at 1).
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`Defendants’ motion fails to offer any explanation as to why any extension, let alone a 7
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`day extension, is necessary. The intervening 3 day weekend, which the Court presumably was
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`Case 1:14-cv-01289-RGA Document 189 Filed 02/21/19 Page 3 of 3 PageID #: 7137
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`well-aware of when issuing its order, does not justify a 7 day extension. Novartis even suggested
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`that Defendants could include as their position in the joint status report that Defendants were
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`considering their options and would provide a further update later (Exhibit 3), but Defendants
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`did not respond to that suggestion. This is not a matter of Novartis refusing to extend a courtesy;
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`rather, Novartis believes this matter needs to be brought before the Court promptly to address
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`(and preclude) any potential launch at risk. Thus far, none of the Defendants has agreed to not
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`launch its respective Zortress® products before this Court issues a decision on the validity of the
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`’772 patent, and accordingly, there is a need to quickly resolve the outstanding ’772 patent issue.
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`That issue can be quickly resolved because the Defendants are estopped from pursing their § 103
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`obviousness challenge—the sole challenge remaining on remand—under 35 U.S.C. § 315(e)(2).
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`Accordingly, Novartis respectfully requests that this Court deny Defendants’ motion and
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`schedule an in person or telephonic status conference at the Court’s earliest convenience.
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`Dated: February 21, 2019
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`McCARTER & ENGLISH, LLP
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`/s/ Daniel M. Silver
`Daniel M. Silver (#4758)
`Renaissance Centre
`405 N. King Street, 8th Floor
`Wilmington, Delaware 19801
`(302) 984-6300
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`dsilver@mccarter.com
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`Of Counsel:
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`Nicholas N. Kallas
`VENABLE FITZPATRICK
`1290 Avenue of the Americas
`New York, NY 10104-3800
`(212) 218-2100
`nkallas@venable.com
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`Attorneys for Plaintiffs
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