Case 1:20-cv-00747-CFC-JLH Document 127 Filed 10/15/21 Page 1 of 3 PagelD #: 3449
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`MoRRIS, NICHOLS, ARsHT & TuNNELL LLP
`Original Filing Date: October 8, 2021
`Redacted Filing Date: October 15, 2021
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`1201 NORTH MARKET STREET
`P .O. Box 1347
`,vrLMINGTON, DELAWARE 19899-1347
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`(302) 658-9200
`(302) 658-3989 FAX
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`October 8, 2021
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`JACKB. BLUMl!NFEU)
`(302) 351-9291
`(302) 425-3012 FAX
`jblumenfeld@morrisnichols.com
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`The Honorable Cohn F. Connolly
`United States District Court
`for the Disti·ict of Delaware
`844 No1i h King Street
`Wilmington, DE 19801
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`VIA ELECTRONIC FILING
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`REDACTED-
`PUBLIC VERSION
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`Re:
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`Novo Nordisk Inc. et al. v. Sandoz Inc., C.A. No. 20-747-CFC
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`Dear Chief Judge Connolly:
`We represent the Novo Nordisk Plaintiffs in this matter. We write in response to Defendant
`Sandoz's October 4 letter (D.I. 123) seeking leave to move for summaiy judgment of non(cid:173)
`infringement of Novo Nordisk's '833 patent. Novo Nordisk opposes that request.
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`There is no pressing need to dive1i the Comi and the pa1iies from other matters with
`summa1y judgment proceedings on the '833 patent. A bench ti·ial in this Hatch-Waxman case is
`scheduled for A ril 2022 and the 30-month sta extends to October 21 2022.
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`There is therefore no mgency to
`Sandoz's request. The pa1iies can address the '833 patent as pa1i of the preti·ial process.
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`Moreover, on October 4, Novo Nordisk provided Sandoz a covenant not-to-sue on the '833
`patent, which eliminated any conti·oversy between the paii ies concerning that patent. After
`granting the covenant, Novo Nordisk asked Sandoz to stipulate to the dismissal of the paii ies'
`claims and counterclaims concerning the '833 patent, the easiest and most efficient way to remove
`it from the case. Sandoz declined and instead asked the Comi to initiate summaiy judgment
`proceedings. With no infringement issue, the only remaining issue regai·ding the '833 patent is
`whether the Comi has subject matter jurisdiction to rnle on it.
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`According to Sandoz, Novo Nordisk's covenant is insufficient because only a judgment on
`the '833 patent can "ti·igger" a third-paiiy "first ANDA filer's" 180-day generic exclusivity, which
`might someday block Sandoz from "enter[ing] the generic market" for the product-in-question.
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`FRESENIUS EXHIBIT 1079
`Page 1 of 3
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`Case 1:20-cv-00747-CFC-JLH Document 127 Filed 10/15/21 Page 2 of 3 PageID #: 3450
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`The Honorable Cohn F. Connolly
`October 8, 2021
`Page2
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`See D.I. 123 at 2. Sandoz contends that it needs to pursue this hypothetical "trigger" to cause the
`third ai
`to forfeit its exclusivi and ensure that Sandoz can launch promptly i n (cid:173)
`Othe1wise, Sandoz's theo1y goes, the first-filer's exclusivity
`·om ma y approving Sandoz's ANDA product, delaying Sandoz's launch.
`rmg t prevent FDA
`Id. In other words, Sandoz is asking the Comi to hear smnmaiy judgment on a patent that Novo
`Nordisk cannot asse1i against Sandoz, in hopes of targeting a third-pa1iy generic competitor's
`hypothetical statuto1y exclusivity-
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`Settled precedent establishes that the Comi does not have subject matter jurisdiction over
`Sandoz's demand for a judgment on the '833 patent because there is no justiciable "case or
`controversy." Novo Nordisk's covenant eliminates any potential injmy to Sandoz relating to
`infringement of the '833 patent. The only injmy Sandoz com lains of- otential dela
`launchin its eneric roduct-is of Sandoz's own makin
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`at e ay was San oz's c 01ce, an
`therefore any launch delay injmy is traceable to Sandoz itself, not to Novo Nordisk or the '833
`patent. Under these circumstances, no justiciable controversy exists. Janssen Phann., NV v.
`Apotex, Inc., 540 F.3d 1353, 1361-62 (Fed. Cir. 2008).
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`Moreover, whether Sandoz will ever experience any launch delay is hi hi
`For that dela to occur the first-filer would need to have eneric exclusivi
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`r the product-
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`, an FDA were to cone u e t at t e irst(cid:173)
`filer had somehow maintained unexpired generic exclusivity, Sandoz would also need to convince
`the Federal Circuit that yet another Novo Nordisk patent asse1i ed in this case (the '893 patent) is
`invalid or not infringed before Sandoz could trigger the first-filer's hypothetical exclusivity.
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`Thus, the injmy Sandoz claims it urgently needs summa1y judgment to address-delayed
`launch of its generic product-is impossible until- at the ve1y earliest due to Sandoz's own
`actions, and is highly speculative after that, as it is contingent on several other events that may
`never occur. That contingent, future alleged injmy is far from the so1i of real, immediate, and
`concrete controversy that this Comi has jurisdiction to hear. Janssen , 540 F.3d at 1363. Novo
`Nordisk respectfully submits that the Comi may defer a decision on the '833 patent until the
`pretrial phase of this case, rather than initiating summa1y judgment proceedings not contemplated
`in the Scheduling Order. If, however, the Comi wishes to heai· Sandoz's request for SllllllllaIY
`judgment, Novo Nordisk requests that the Court first consider the critical threshold issue of
`whether the Comi retains subject matter jurisdiction over the '833 patent to decide the issue.2 See
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`2 Specifically, if the Comi wishes to address the '833 patent at this time, Novo Nordisk would seek
`dismissal of the '833 patent for lack of subject matter jurisdiction. But rather than burden the
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`FRESENIUS EXHIBIT 1079
`Page 2 of 3
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`Case 1:20-cv-00747-CFC-JLH Document 127 Filed 10/15/21 Page 3 of 3 PageID #: 3451
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`The Honorable Colm F. Connolly
`October 8, 2021
`Page 3
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`Vanda Pharm. Inc. v. West-Ward Pharm. Int’l Ltd., 887 F.3d 1117, 1123 (Fed. Cir. 2018) (“We
`must first address whether the district court properly exercised [subject matter] jurisdiction . . . .”).
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`Respectfully,
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`/s/ Jack B. Blumenfeld
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`Jack B. Blumenfeld (#1014)
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`cc:
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`All Counsel of Record (via CM/ECF and electronic mail)
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`Court with motion practice on dismissal, this too can be deferred until the pretrial phase for the
`same reasons that summary judgment can be deferred. Both forms of relief rise and fall on whether
`the Court retains subject matter jurisdiction over the ’833 patent.
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`FRESENIUS EXHIBIT 1079
`Page 3 of 3
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