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Lundbeck v. Apotex Inc.

United States District Court, D. Delaware

November 15, 2019

H. LUNDBECK A/S, et al. Plaintiffs,
v.
APOTEX INC., et al, Defendants.

          Megan E. Dellinger and Jack B. Blumenfeld, MORRIS, NICHOLS, ARSHT & TUNNELL LLP, Wilmington, DE George F. Pappas, Einar Stole, Christopher N. Sipes, Brianne Bharkhda, Priscilla G. Dodson, Alaina Whitt, Allison Schmitt, and Yiye Fu, COVINGTON & BURLING LLP, Washington, DC Attorneys for Plaintiffs.

          Dominick T. Gattuso, HEYMAN ENERIO GATTUSO & HIRZEL LLP, Wilmington, DE Laura A. Lydigsen, Joshua E. Ney, and Judy K. He, BRINKS GILSON & LIONE, Chicago, IL Attorneys for Defendants Sandoz Inc. and Lek Pharmaceuticals d.d.

          MEMORANDUM ORDER

          Stark, U.S. District Judge.

         Pending before the Court is Defendants Sandoz Inc. and Lek Pharmaceuticals d.d.'s ("Defendants") motion for certification of an interlocutory appeal pursuant to 28 U.S.C. § 1292(b) (D.I. 378). For the reasons stated below, the motion is denied.

         BACKGROUND

         Plaintiffs H. Lundbeck A/S, Takeda Pharmaceutical Company Ltd., Takeda Pharmaceuticals U.S.A., Inc., Takeda Pharmaceuticals International AG, and Takeda Pharmaceuticals America, Inc. ("Plaintiffs") brought this patent infringement case against Defendants based on Defendants' Abbreviated New Drug Applications ("ANDA"), which seek approval from the U.S. Food and Drug Administration ("FDA") to market generic versions of Plaintiffs' Trintellix drug product prior to the expiration of certain of Plaintiffs' patents. Trintellix is indicated for treating Major Depressive Disorder ("MDD").

         When Plaintiffs initiated this suit, they alleged that Defendants' proposed ANDA product would infringe three patents: U.S. Patent Nos. 8, 722, 684 ("the '684 patent"), 8, 969, 355 ("the '355 patent"), and 9, 227, 946 ("the '946 patent'"). Thereafter, Plaintiffs made two FDA-approved changes to their Trintellix label. First, Plaintiffs included information related to Trintellix's positive effects on cognitive impairment. Consequently, Plaintiffs also added U.S. Patent 9, 125, 910 ("the '910 patent") to Trintellix's entry in the FDA's "Orange Book." The '910 patent claims a "method of treating cognitive impairment involving a decline in speed of processing, executive function, attention, or verbal learning and memory in a patient diagnosed with depression." (D.I. 387 Ex. O at 39:31-34) Second, Plaintiffs added data related to Trintellix's positive effects on treatment of emergent sexual dysfunction. Correspondingly, they also added U.S. Patent 9, 278, 096 ("the '096 patent") to Trintellix's Orange Book entry. The '096 patent claims (in part) a "method for the treatment of a disease selected from the group consisting of depression, anxiety, abuse and chronic pain . . . wherein [a] patient has previously received medication or is still receiving medication for the treatment of said disease, [and] the medication is ceased or reduced or has to be ceased or reduced due to sexually related adverse events." (D.I. 387 Ex. L at 20:30-43)

         Plaintiffs then moved to amend to their complaints, seeking to add claims for a declaratory judgment that Defendants would be liable for contributory infringement of the '910 and '096 patents. (See D.I. 224) After considering Defendants' opposition (D.I. 234), the Court granted Plaintiffs' motion to amend (D.I. 260). Defendants then filed their pending motion for certification of an interlocutory appeal of the Court's order granting the motion to amend. (D.I. 378)

         LEGAL STANDARDS

         Under 28 U.S.C. § 1292(b), the Court has discretion to certify orders for interlocutory review where "exceptional circumstances" merit a departure from the final judgment rule. See Coopers & Lybrand v. Livesay, 437 U.S. 463, 475 (1978); see also Microsoft Mobile Inc. v. Interdigital, Inc., 2016 WL 8302609, at *1 (D. Del. June 13, 2016) ("Interlocutory appeal is meant to be used sparingly and only in exceptional cases where the interests cutting in favor of immediate appeal overcome the presumption against piecemeal litigation."). The Court can certify orders that (i) address a "controlling question of law" as to which there is (ii) "substantial ground for difference of opinion" if (iii) an immediate appeal "may materially advance the ultimate termination of the litigation." 28 U.S.C. § 1292(b); see also Katz v. Carte Blanche Corp., 496 F.2d 747, 754-55 (3d Cir. 1974). The decision to certify an order for appeal under § 1292(b) lies within the sound discretion of the District Court. See St. Clair Intellectual Prop. Consultants, Inc. v. Samsung Elecs. Co., 2010 WL 1213367, at *4 (D. Del. Mar. 28, 2010).

         A question presented for certification is a "controlling question of law" when it "would result in a reversal of judgment after a final hearing." Katz, 496 F.2d at 755. Such questions should not require the appellate court to make "factual determinations better left to the district court." Miller v. Bolger, 802 F.2d 660, 666-67 (3d Cir. 1986).

         DISCUSSION

         Defendants request certification of the following question:

Whether Plaintiffs can state a cognizable claim for contributory infringement of an Orange Book-listed patent based on the filing of Sandoz Inc.'s ANDA where Sandoz Inc. has submitted a section viii ...

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