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`Case NJ/1:24-cv-08417 Document 11 Filed 02/06/25 Page 1 of 5Case 1:25-md-03138-CPO-EAP Document 1 Filed 02/06/25 Page 1 of 5 PageID: 1
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`UNITED STATES JUDICIAL PANEL
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`MULTIDISTRICT LITIGATION
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`MDL No. 3138
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`IN RE: DENOSUMAB
`PATENT LITIGATION
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`TRANSFER ORDER
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`Before the Panel:* Common plaintiffs Amgen Inc. and Amgen Manufacturing Limited
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`LLC (together Amgen) move under 28 U.S.C. § 1407 to centralize this litigation in the District of
`New Jersey. This litigation consists of four actions, two in the District of New Jersey, one in the
`Northern District of Illinois, and one in the Eastern District of North Carolina, as listed on Schedule
`A. All responding defendants1 oppose centralization.
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`On the basis of the papers filed and the hearing session held, we find that these actions
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`involve common questions of fact and that centralization in the District of New Jersey will serve
`the convenience of the parties and witnesses and promote the just and efficient conduct of this
`litigation. All actions were brought under the Biologics Price Competition and Innovation Act
`(BPCIA).2 In each action, Amgen alleges that the defendant infringed various U.S. patents
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`*
`Judge Matthew F. Kennelly and Judge David C. Norton did not participate in the decision
`of this matter.
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` 1
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`In the Eastern District of North Carolina action, Accord Biopharma, Inc., Accord
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`Healthcare, Inc., and Intas Pharmaceuticals Ltd. In the Northern District of Illinois action,
`Fresenius Kabi USA, LLC, Fresenius Kabi SwissBioSim GmbH, Fresenius Kabi Deutschland
`GmbH, and Fresenius Kabi Austria GmbH. Defendants in the District of New Jersey Celltrion
`action (Celltrion, Inc., and Celltrion USA, Inc.) filed a brief in opposition to centralization. But
`after the conclusion of briefing and before oral argument was held in this matter, the parties to
`Celltrion reached a consent judgment and injunction. The case remains pending at this time.
`Defendants in the District of New Jersey Samsung Bioepis action did not respond to the motion.
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` 2
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`The Biologics Price Competition and Innovation Act of 2009, Pub. L. No. 111-148, §§
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`7001-7003, 124 Stat. 119, 804-21 (2010), was enacted to expedite the entry of follow-on biologic
`drugs into the market. Biologic drugs are larger-molecule drugs or vaccines that are produced by
`manipulating a living tissue or microorganism, such as a virus or protein. See, e.g., Kate S. Gaudry,
`Exclusivity Strategies and Opportunities in View of the Biologics Price Competition and
`Innovation Act, 66 FOOD & DRUG L.J. 587, 587 & n.1 (2011). Submitting an abbreviated
`Biologics License Application (aBLA) constitutes a statutory act of infringement that creates
`subject-matter jurisdiction for a district court to resolve any disputes regarding patent infringement
`or validity prior to the biosimilar drug’s being sold. See, e.g., Sandoz Inc. v. Amgen Inc., 582 U.S.
`1, 8 (2017). Under 42 U.S.C. § 262(l)(2)(A), an aBLA applicant must provide its application and
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`covering its drugs Prolia® and XGEVA®, used in the treatment of certain types of bone disease,
`by submitting aBLAs and seeking to market their follow-on biologic products. Common factual
`questions will include whether the proposed biosimilar products infringe the patents, the evidence
`related to claim construction, and patent validity considerations such as the level of ordinary skill
`in the art, the scope and content of the prior art, and obviousness. Centralization will avoid the
`risk of duplicative discovery and prevent inconsistent rulings as to claim construction, patent
`validity, and other issues.
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`All responding defendants oppose the motion. They argue that each action involves dozens
`of patents—when the motion was filed, a total of 47 across all actions—and that many non-
`overlapping patents are asserted against each defendant. In addition, some of the common patents
`relate to manufacturing methods that defendants contend are unique to each defendant; thus, they
`argue, they may have different invalidity and non-infringement defenses even as to the same
`patents. Defendants also contend that centralization will require special discovery protections
`because defendants are competitors with confidential manufacturing methods. Defendants
`maintain that these complexities make this BPCIA litigation significantly different from litigation
`under the Hatch-Waxman Act3 that the Panel typically centralizes and would result in an
`unmanageable MDL. Given the relatively small number of involved actions, they argue,
`centralization is not appropriate.
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`We recently rejected similar arguments. See In re Aflibercept Pat. Litig., 730 F. Supp. 3d
`1374 (J.P.M.L. 2024). Now that the District of New Jersey Celltrion action has reached a
`settlement, Amgen states that it asserts a common set of 24 patents in the three remaining actions
`here, three of which (the Dillon ’205 patent, the Boyle ’736 patent, and the Huang ’514 patent)
`were the subject of a six-day preliminary injunction hearing in a previously-pending action in the
`District of New Jersey. See Amgen Inc. et al. v. Sandoz Inc. et al., No. 1:23-cv-02406-CPO-EAP
`(D.N.J.). Certain defendants concede that the Boyle ’736 patent is directed to the denosumab
`antibody itself.4 “Even if there is some variation among defendants’ defenses to certain patents, it
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`manufacturing information to the branded drug sponsor within 20 days of the date the U.S. Federal
`Drug Administration notifies the applicant that it has accepted the aBLA for review. This
`commences an exchange between the applicant and the branded drug sponsor of lists of potentially
`relevant patents and the companies’ respective arguments regarding those patents. Id. § 262(l)(3).
`The BPCIA provides two paths for patent litigation. First, the parties may negotiate to identify
`patents on the lists for immediate litigation or, if agreement is not reached, the branded drug
`sponsor may bring an action alleging infringement of all patents on the lists. Id. § 262(l)(6).
`Second, when a biosimilar applicant gives the branded drug sponsor 180-days’ notice that it
`intends to begin commercially marketing the biosimilar product, as required under § 262(l)(8)(A),
`the branded drug sponsor may seek a preliminary injunction to prevent the marketing of the
`biosimilar product. Id. § 262(l)(8)(B).
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` 3
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`The Drug Price Competition and Patent Term Restoration Act of 1984 (“Hatch-Waxman
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`Act”), Pub. L. No. 98-417, 98 Stat. 1585 (1984).
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` 4
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`These defendants argue that certain overlapping patents are expired or soon will expire,
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`but Amgen argues it may seek damages for past infringement after the patents’ expirations.
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`seems far more efficient to allow a single court to construe the patents at issue and to decide
`whether injunctive relief is warranted.” In re Aflibercept, 730 F. Supp. 3d at 1376. Defendants
`argue that Amgen will narrow the patents asserted in each action, and there may be even fewer
`overlapping patents. But each defendant’s product is asserted to be “highly similar” to Amgen’s
`Prolia® and XGEVA® products, and it seems unlikely that ultimately no patents will overlap.
`These are highly complex patent disputes and, contrary to the argument that defendants’ status as
`competitors weighs against centralization, Amgen argues that there already is a demonstrated need
`for a single judge to coordinate disclosures of requested confidential information across the
`different actions. Allowing these actions to proceed before a judge who already has familiarity
`with the products at issue, relevant manufacturing processes and technologies, and previous
`litigation that already has involved overlapping discovery is likely to streamline resolution of the
`litigation. It may be, on further refinement of the issues and close scrutiny by the transferee judge,
`that some actions can be remanded in advance of the other actions in the transferee district. If the
`transferee judge deems Section 1407 remand of any claims or actions appropriate, this can be
`accomplished with minimal delay. See Panel Rules 10.1-10.3.
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`In opposing centralization, certain defendants also argued that the District of New Jersey
`Celltrion action is in a different procedural posture than the other three actions, and transfer might
`delay progress in Celltrion. That action has reached a consent judgment and injunction. While it
`currently remains open, its resolution appears imminent. Given that we are assigning this litigation
`to the district where Celltrion is pending, we leave to the discretion of the transferee judge whether
`it is necessary to coordinate any remaining proceedings in Celltrion with the three other actions
`on the motion, each of which are in a similar early procedural posture.
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`The District of New Jersey is the most appropriate transferee district for this litigation. The
`Honorable Christine P. O’Hearn presides over the Samsung Bioepis action, as well as Celltrion,
`and previously presided over the Sandoz action. In Sandoz, she held a technical tutorial on
`denosumab and the manufacturing processes and technologies involved in producing Prolia® and
`XGEVA®, and she presided over a preliminary injunction motion. She therefore has substantial
`familiarity with the drugs at issue and at least some of the asserted patents.
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`IT IS THEREFORE ORDERED that the actions listed on Schedule A and pending outside
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`the District of New Jersey are transferred to the District of New Jersey and, with the consent of
`that court, assigned to the Honorable Christine P. O’Hearn for coordinated or consolidated pretrial
`proceedings.
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` PANEL ON MULTIDISTRICT LITIGATION
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` Karen K. Caldwell
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` Chair
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`Nathaniel M. Gorton
`Dale A. Kimball
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` Roger T. Benitez
` Madeline Cox Arleo
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`IN RE: DENOSUMAB
`PATENT LITIGATION
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`MDL No. 3138
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`SCHEDULE A
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`Northern District of Illinois
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`AMGEN, INC., ET AL. v. FRESENIUS KABI USA, LLC, ET AL.,
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`C.A. No. 1:24−09555
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`District of New Jersey
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`AMGEN, INC., ET AL. v. CELLTRION, INC., ET AL., C.A. No. 1:24−06497
`AMGEN, INC., ET AL. v. SAMSUNG BIOEPIS CO., LTD., ET AL.,
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`C.A. No. 1:24−08417
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`Eastern District of North Carolina
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`AMGEN, INC., ET AL. v. ACCORD BIOPHARMA, INC., ET AL.,
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`C.A. No. 5:24−00642
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