Case 1:22-cv-00023-JPB Document 22 Filed 05/06/22 Page 1 of 7 PageID #: 612
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`BEFORE THE UNITED STATES
`JUDICIAL PANEL ON MULTIDISTRICT LITIGATION
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`In re Ozempic® (Semaglutide) Patent
`Litigation
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`MDL No. ________________
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`PLAINTIFFS’ MOTION FOR TRANSFER OF ACTION TO THE DISTRICT OF
`DELAWARE PURSUANT TO 28 U.S.C. § 1407 FOR COORDINATED AND
`CONSOLIDATED PRETRIAL PROCEEDINGS
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`NOW COMES Novo Nordisk Inc. and Novo Nordisk A/S (collectively “Novo
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`Nordisk”), Plaintiffs in:
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`a)
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`b)
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`c)
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`d)
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`e)
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`f)
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`Novo Nordisk Inc. and Novo Nordisk A/S v. Rio Biopharmaceuticals, Inc. and
`EMS S/A, 1:22-cv-00294-CFC (D. Del.);
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`Novo Nordisk Inc. and Novo Nordisk A/S v. Sun Pharmaceutical Industries Ltd.
`and Sun Pharmaceuticals Industries, Inc., 1:22-cv-00296-CFC (D. Del.);
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`Novo Nordisk Inc. and Novo Nordisk A/S v. Zydus Worldwide DMCC, Zydus
`Pharmaceuticals (USA) Inc., and Cadila Healthcare Ltd., 1:22-cv-00297-CFC
`(D. Del.);
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`Novo Nordisk Inc. and Novo Nordisk A/S v. Dr. Reddy’s Laboratories, Ltd. and
`Dr. Reddy’s Laboratories, Inc., 1:22-cv-00298-CFC (D. Del.);
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`Novo Nordisk Inc. and Novo Nordisk A/S v. Alvogen, Inc., 1:22-cv-00299-CFC
`(D. Del.);1 and
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`Novo Nordisk Inc. and Novo Nordisk A/S v. Mylan Pharmaceuticals Inc., 1:22-
`cv-00023-JPB (N.D. W. Va.).
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`Novo Nordisk, by and through its undersigned counsel, respectfully moves the Judicial
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`Panel on Multidistrict Litigation to enter an order pursuant to 28 U.S.C. § 1407 and Rule 6.2
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`of the Rules of Procedure of the Judicial Panel on Multidistrict Litigation, to transfer
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`1 Novo Nordisk filed, but subsequently voluntarily dismissed without prejudice, an additional
`action in the District of Delaware. See Novo Nordisk Inc. and Novo Nordisk A/S v. Aurobindo
`Pharma USA, Inc. et al., 1:22-cv-00295-CFC, ECF No. 7 (D. Del. Mar. 28, 2022) (voluntarily
`dismissing the action under Rule 41(a)(1)(A)(i)).
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`Case 1:22-cv-00023-JPB Document 22 Filed 05/06/22 Page 2 of 7 PageID #: 613
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`Novo Nordisk Inc. and Novo Nordisk A/S v. Mylan Pharmaceuticals Inc., 1:22-cv-00023-JPB,
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`which is pending before Judge John Preston Bailey in the United States District Court for the
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`Northern District of West Virginia, to Chief Judge Colm Connolly in the United States District
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`Court for the District of Delaware, for coordinated and consolidated pretrial proceedings with
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`five related actions already pending in that District.
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`Transfer for pretrial consolidation and coordination is proper and necessary for the
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`following reasons, as set forth more fully in the accompanying memorandum:
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`1.
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`This motion seeks transfer of one action and consolidation of that action with
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`five other actions for patent infringement brought under the patent laws of the United States,
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`Title 35, United States Code, by Novo Nordisk against the following entities: Rio
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`Biopharmaceuticals Inc. and EMS S/A (collectively, “Rio”); Sun Pharmaceutical Industries
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`Ltd. and Sun Pharmaceutical Industries, Inc. (collectively, “Sun”); Zydus Worldwide DMCC,
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`Zydus Pharmaceuticals (USA) Inc., and Cadila Healthcare Ltd. (collectively, “Zydus”);
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`Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories,
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`Inc.
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`(collectively,
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`“Dr. Reddy’s”); Alvogen, Inc. (“Alvogen”); and Mylan Pharmaceuticals Inc. (“Mylan”). Rio,
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`Sun, Zydus, Dr. Reddy’s, Alvogen, and Mylan are collectively referred to herein as
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`“Defendants.”
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`2.
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`All six actions arise under the Hatch-Waxman Act. Specifically, the actions
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`arise from Defendants’ submissions of Abbreviated New Drug Applications (“ANDAs”) to the
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`United States Food and Drug Administration (“FDA”) seeking approval to manufacture and
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`sell generic versions of Ozempic® (semaglutide) prior to expiration of patents listed in the
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`FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange
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`Book”) for Novo Nordisk’s Ozempic® drug product.
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`3.
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`Novo Nordisk filed the above-listed actions against Rio, Sun, Zydus,
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`Dr. Reddy’s, and Alvogen in the District of Delaware on March 4, 2022 (collectively, the
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`2
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`Case 1:22-cv-00023-JPB Document 22 Filed 05/06/22 Page 3 of 7 PageID #: 614
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`“Delaware Actions”). Dr. Reddy’s filed its Answer, Defenses, and Counterclaims on May 3,
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`2022. Novo Nordisk Inc. et al. v. Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories,
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`Inc., Case No. 22-cv-298-CFC, ECF No. 10 (D. Del. May 3, 2022). All remaining Defendants
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`in the Delaware Actions are due to respond to Novo Nordisk’s complaints by May 9, 2022.
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`Novo Nordisk expects that the Delaware Actions will be consolidated for all purposes,
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`including discovery, claim construction proceedings, and trial.
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`4.
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`Because Mylan refused to consent to venue in Delaware, Novo Nordisk filed
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`the sixth action, against Mylan, in the Northern District of West Virginia, where Mylan is
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`located and incorporated, on March 18, 2022 (the “West Virginia Action”). The West Virginia
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`Action is pending before Judge John Preston Bailey in the Northern District of West Virginia.
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`Mylan filed its Answer, Separate Defenses, and Counterclaims in the West Virginia Action on
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`April 8, 2022. Mylan did not contest personal jurisdiction or venue in the West Virginia
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`Action. Novo Nordisk Inc. et al. v. Mylan Pharmaceuticals Inc., Case No. 22-cv-00023-JPB,
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`ECF No. 19, ¶¶ 5-8 (N.D. W. Va. Apr. 8, 2022).
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`5.
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`Novo Nordisk filed the above-listed actions in response to separate notice letters
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`received from each Defendant notifying Novo Nordisk that the Defendant had submitted an
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`ANDA to the FDA seeking approval to engage in the commercial manufacture, use, offer for
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`sale, sale, or importation of a generic version of Ozempic® prior to the expiration of certain
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`patents identified in the Defendant’s notice letter. The six ANDAs giving rise to the actions
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`are referred to collectively as “Defendants’ ANDAs.”
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`6.
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`Each Defendant informed Novo Nordisk in its notice letter that the Defendant’s
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`ANDA included a certification pursuant to 21 U.S.C. § 355(i)(2)(A)(vii)(IV) (a “Paragraph IV
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`certification”), asserting that certain Orange Book-listed patents for Ozempic® are invalid,
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`unenforceable, and/or will not be infringed by the manufacture, use, offer for sale, sale, and/or
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`3
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`Case 1:22-cv-00023-JPB Document 22 Filed 05/06/22 Page 4 of 7 PageID #: 615
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`importation of the product that is the subject of the Defendant’s ANDA (collectively,
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`“Defendants’ ANDA Products”).
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`7.
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`In each action, Novo Nordisk alleges, among other things, patent infringement
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`under 35 U.S.C. § 271(e)(2)(A), which makes submission of the Defendant’s ANDA with a
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`Paragraph IV certification against an Orange Book-listed patent an act of infringement.
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`8.
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`All six actions involve the same core issue: whether Defendants’ ANDA
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`Products infringe Novo Nordisk’s patents listed in the Orange Book for Ozempic®. While the
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`patents asserted in each action vary to some extent, depending on which patents each Defendant
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`challenged in its notice letter, there is considerable overlap, which will lead to a high level of
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`commonality of claims, defenses, and other issues. U.S. Patent Nos. 9,132,239 and 10,335,462
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`are common to all six actions, and the Delaware Actions against Dr. Reddy’s and Alvogen
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`share ten patents in common with the West Virginia Action against Mylan. Additionally, there
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`is almost complete overlap in “patent families” between the Delaware Actions and the West
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`Virginia Action, as discussed in more detail in the accompanying memorandum.
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`9.
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`The actions present numerous common issues of fact and law, including without
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`limitation the research and development underlying the claimed inventions; the prosecution
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`history of the asserted patents; the construction of claim terms; the level of ordinary skill in the
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`art; the scope and content of the prior art; the differences between the claimed inventions and
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`the prior art; Orange Book listability of certain asserted patents; and secondary indicia of non-
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`obviousness, such as the unexpected properties of the claimed inventions, the long felt need for
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`the claimed inventions, and the commercial success of the claimed inventions, among others.
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`10.
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`All six actions are in their early stages. As of the date of filing of this motion,
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`neither Court has held a conference, neither Court has issued a substantive order, and the parties
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`have not served any discovery requests.
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`Case 1:22-cv-00023-JPB Document 22 Filed 05/06/22 Page 5 of 7 PageID #: 616
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`11.
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`Because the six actions assert infringement based on the submission of ANDAs
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`referencing the same drug product, the effect of inconsistent rulings on claim construction,
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`patent validity, and/or infringement would be significant, harmful, and unnecessarily strain
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`court resources. Transfer of the West Virginia Action and consolidation with the Delaware
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`Actions is therefore necessary to: (a) eliminate the potential for inconsistent rulings on pretrial
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`motions, including but not limited to claim construction rulings; (b) eliminate the burden of
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`duplicative discovery on common issues; (c) avoid the unnecessary use of judicial resources;
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`and (d) reduce the overall costs and burdens on all parties.
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`12.
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`Chief Judge Connolly has experience presiding over complex patent litigation
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`cases and has substantial experience with cases involving patent infringement claims against
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`multiple defendants arising under the Hatch-Waxman Act. See, e.g., Genzyme Corp. et al. v.
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`Apotex Corp. et al., Case No. 18-cv-1795-CFC, ECF No. 18 (D. Del. Feb. 4, 2019)
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`(consolidating Hatch-Waxman litigations against five ANDA-filers concerning the drug
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`Cerdelga®); Boehringer Ingelheim Pharm. Inc. et al. v. Mankind Pharma Ltd. et al., Case No.
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`18-cv-1689-CFC, ECF No. 20 (D. Del. Mar. 5, 2019) (consolidating Hatch-Waxman litigations
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`against 16 ANDA-filers concerning the drug Jardiance®); UCB, Inc. et al. v. Annora Pharma
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`Private Ltd. et al., Case No. 20-cv-00987-CFC, ECF No. 99 (D. Del. July 7, 2021)
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`(consolidating Hatch-Waxman litigations against eight ANDA-filers concerning the drug
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`Briviact®). Notably, Chief Judge Connolly has previously presided over Hatch-Waxman
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`litigations involving Novo Nordisk’s drug product Victoza®, which, like Ozempic®, is an
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`injectable GLP-1 product indicated for the treatment of type 2 diabetes, giving Judge Connolly
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`valuable background on the relevant technology. See Novo Nordisk Inc. et al. v. Sandoz Inc.,
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`20-cv-00747 (D. Del.) and Novo Nordisk Inc. et al. v. Mylan Institutional LLC, 19-cv-1551 (D.
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`Del.). Chief Judge Connolly is additionally currently presiding over a case involving Victoza®,
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`which is still in early stages and also involves the ’833 patent, which is asserted against Mylan
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`5
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`Case 1:22-cv-00023-JPB Document 22 Filed 05/06/22 Page 6 of 7 PageID #: 617
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`in the West Virginia Action. See Novo Nordisk Inc. et al. v. Hikma Pharmaceuticals USA Inc.,
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`21-cv-01783 (D. Del.). Finally, Chief Judge Connolly is presiding over a Hatch-Waxman
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`litigation in its early stages involving Novo Nordisk’s drug product, Saxenda® (the “Saxenda®
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`Litigation”). As a further reason for consolidation of the West Virginia Action before Chief
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`Judge Connolly, the Saxenda® Litigation involves 15 of the 18 patents asserted against Mylan
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`in the West Virginia Action. See Novo Nordisk Inc. et al. v. Teva Pharmaceuticals, Inc. et al.,
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`21-cv-01782-CFC (D. Del.). Chief Judge Connolly’s familiarity with these patents and the
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`underlying technology due to the Saxenda® Litigation is another reason why consolidation of
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`the West Virginia Action in Delaware would be an efficient use of judicial resources.
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`13.
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`Based on the foregoing, and for the reasons set forth more fully in the
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`accompanying memorandum, Novo Nordisk respectfully requests that the West Virginia
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`Action be transferred to Chief Judge Connolly in the District of Delaware for consolidated and
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`coordinated pretrial proceedings with the five above-captioned cases already pending in that
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`District.
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`6
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`Case 1:22-cv-00023-JPB Document 22 Filed 05/06/22 Page 7 of 7 PageID #: 618
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`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`
`/s/ Brian P. Egan
`_____________________________________
`Jack B. Blumenfeld (#1014)
`Brian P. Egan (#6227)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@morrisnichols.com
`began@morrisnichols.com
`
`James F. Companion (W. Va. Bar No. 790)
`Sandra K. Law (W. Va. Bar No. 6071)
`SCHRADER COMPANION DUFF & LAW, PLLC
`401 Main Street Wheeling, WV 26003
`(304) 233-3390
`jfc@schraderlaw.com
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`skl@schraderlaw.com
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`Attorney for Novo Nordisk Inc. and
`Novo Nordisk A/S
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`OF COUNSEL:
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`Jeffrey J. Oelke
`Ryan P. Johnson
`Robert E. Counihan
`Laura T. Moran
`FENWICK & WEST LLP
`902 Broadway, Suite 14
`New York, NY 10010-6035
`(212) 430-2600
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`May 6, 2022
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`7
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