Case 1:20-cv-00747-CFC-JLH Document 123 Filed 10/04/21 Page 1 of 3 PageID #: 3428Case 1:20-cv-00747-CFC-JLH Document 126 Filed 10/12/21 Page 1 of 3 PageID #: 3446
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`HEYMAN ENERJO
`GATTUSO& HlrtZEL
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`- - - - - - - 1.l.P
`l'RJ\LI ICINC I I IL J\R I 0 1 LJ\W
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`300 Delaware Avenue • Suite 200 • Wilmington, Delaware 19801
`Tel: (302) 472 7300 • Fax: (302) 472.7320 • WWW.HEGH.LAW
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`October 4, 2021
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`DD: (302) 472-7311
`Email: dgattuso@email.com
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`Public Version Filed October 12, 2021
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`Via CM-ECF
`The Honorable Colm F. Connolly
`J. Caleb Boggs Federal Building
`844 N. King Street
`Unit 31
`Room 4124
`Wilmington, DE 19801
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`Re: Novo Nordisk v. Sandoz, 20-cv-747 (D. Del.)
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`Dear Chief Judge Connolly,
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`I write as counsel to Defendant Sandoz Inc., along with Steptoe & Johnson LLP, to
`respectfully request permission to file a motion for partial summary judgment only as to
`non-infringement of U.S. Patent No. 8,114,833 (the “’833 patent”) in the above-referenced
`matter. Good cause for such a motion exists for the following reasons:
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`(1)
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`(2)
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`(3)
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`Plaintiffs are not asserting infringement of the ʼ833 patent and there is
`no genuine dispute of material fact;
`Resolving the ʼ833 patent on summary judgment will conserve judicial
`resources, particularly at trial; and,
`Sandoz requires a judgment (as opposed to dismissal) to protect its
`ability to launch its generic product as early as possible in view of
`Hatch-Waxman law and related FDA procedures.
`First, there is no infringement dispute in this litigation as to the asserted claims of
`the ʼ833 patent, which relate to formulation. Therefore, the motion for summary judgment
`may be resolved with little expenditure of the Court’s and the parties’ resources. Plaintiffs
`did not provide an opening expert report as to infringement of the ʼ833 patent. Their expert
`stated that “I understand that, based on the formulation of Sandoz’s Product as currently
`described in Sandoz’s ANDA, Novo Nordisk is not asserting infringement of the ʼ833
`patent, and I have not been asked to opine on infringement of the ʼ833 patent.” Thus, there
`is no genuine dispute as to infringement of the ʼ833 patent and Sandoz is entitled to
`summary judgment.
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`FRESENIUS EXHIBIT 1078
`Page 1 of 3
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`Case 1:20-cv-00747-CFC-JL Document 126 Filed 10/12/21 Page 2 of 3 PageID #: 3447
`Filed 10/04/21 Page 2 of 3 PagelD #: 3429
`ITTse 1:20-cv-00747-CFC-JLH Document 123
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`G&HThe Honorable Colm F. Connolly
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`October 4, 2021
`2 1Page
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`Second, the filing of the requested motion is the most expedient, economical way to
`proceed, given that Plaintiffs have twice refused to enter into a consent judgment on the
`atent des ite their clear intention not to ursue a claim of infrin ement. 1
`'833
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`Thus, only the '833 patent, which relates to formulation, and U.S.
`Patent No. 9,265,893 ('"893 Patent"), which relates to the injection device, remain in this
`litigation. Judgment of non-infringement as to the '833 formulation patent will reduce this
`case to the one remaining patent-the '893 device patent, significantly narrowing the issues
`and time of trial for the Court. For example, the formulation and device patents involve
`different inventors and different expert witnesses. Narrowing the case to the device patent
`will avoid future expert discovery on formulation and composition patent issues,
`significantly reduce the number of witnesses presented at trial, and generally narrow the
`issues to be decided .
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`Third, Sandoz is not the first ANDA filer against the drug product that is the subject
`of this litigation. Under FDA provisions of forfeiture of exclusivity granted to the first
`ANDA filer, Sandoz must obtain a judgment of non-infringement as to the '833 patent to
`avoid risks of the FDA refusing to provide final approval of the Sandoz drug product. For
`example, under Hatch-Waxman law, a judgment of no infringement is required to trigger
`the forfeiture of the first ANDA filer exclusivity period in the event that the first ANDA
`filer does not launch or is otherwise not eligible to launch for various reasons. Without a
`judgment, Hatch-Waxman law precludes Sandoz from triggering that exclusivity period
`and thus will prevent Sandoz from gaining final approval to enter the generic market for
`an undetermined time. See, e.g., Caraco Pharm. Lab 'ys, Ltd. v. Forest Lab 'ys, Inc., 527
`F.3d 1278, 1287, 1297 (Fed. Cir. 2008). Plaintiffs have offered to dismiss their claims of
`infringement via a stipulated dismissal and a covenant not to sue but have refused to enter
`a consent judgment of no infringement by Sandoz. Thus, Sandoz now seeks Court
`intervention to obtain a judgment of no infringement. See id. at 1297 ( subsequent ANDA
`filer can trigger exclusivity only with a judgment; a covenant not to sue is insufficient).
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`Sandoz has worked diligently for the past several months in an effort to resolve this
`issue without Court intervention. Plaintiffs have offered to dismiss their claims of
`infringement via a stipulated dismissal and a covenant not to sue, but have refused to enter
`into a consent judgment. However, as discussed above, a covenant not to sue is
`insufficient; a judgment is required. See id. at 1297 (subsequent ANDA filer can trigger
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`1 Provided the Comi enters summa1y judgment of non-infringement of the '833 patent, Sandoz will not
`pm-sue its counterclaim for declarato1y judgment of invalidity of the '833 patent.
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`FRESENIUS EXHIBIT 1078
`Page 2 of 3
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`Case 1:20-cv-00747-CFC-JLH Document 123 Filed 10/04/21 Page 3 of 3 PageID #: 3430Case 1:20-cv-00747-CFC-JLH Document 126 Filed 10/12/21 Page 3 of 3 PageID #: 3448
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`HE
`The Honorable Colm F. Connolly
`GH -
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` October 4, 2021
` 3 | P a g e
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`exclusivity only with a judgment; a covenant not to sue is insufficient). Thus, the Court’s
`judgment of no infringement will efficiently reduce this case to the sole remaining ’893
`device patent.
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`Counsel for Sandoz are available at the convenience of the Court if Your Honor
`would find a status conference helpful.
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`DTG/ram
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`cc: All Counsel of Record (via CM-ECF)
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`Respectfully,
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`/s/ Dominick T. Gattuso
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`Dominick T. Gattuso (# 3630)
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`FRESENIUS EXHIBIT 1078
`Page 3 of 3
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