`
`Plaintiffs,
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`
`v.
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`MELINTA THERAPEUTICS, LLC,
`a Delaware company
`44 Whippany Road
`Suite 280
`Morristown, NJ 07960,
`
`and
`
`REMPEX PHARMACEUTICALS, INC.,
`a Delaware corporation
`44 Whippany Road
`Suite 280
`Morristown, NJ 07960,
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF COLUMBIA
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`) Civil Action No. 1:22-cv-02190
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`
`U.S. FOOD AND DRUG ADMINISTRATION )
`10903 New Hampshire Avenue
`)
`Silver Spring, MD 20993,
`)
`
`)
`and
`)
`
`)
`U.S. DEPARTMENT OF HEALTH
`)
`AND HUMAN SERVICES,
`)
`200 Independence Avenue SW
`)
`Washington, DC 20201,
`)
`
`)
`and
`)
`
`)
`XAVIER BECERRA,
`)
`)
`In His Official Capacity as Secretary
`)
`of Health and Human Services,
`U.S. Department of Health and Human
`)
`
`Services
`)
`200 Independence Avenue SW
`)
`Washington, DC 20201,
`)
`
`)
`and
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`)
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`
`
`Case 1:22-cv-02190 Document 1 Filed 07/25/22 Page 2 of 20
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`)
`ROBERT M. CALIFF, M.D.,
`)
`In His Official Capacity as
`)
`
`Commissioner of Food and Drugs, United
`)
`States Food and Drug Administration,
`
`U.S. Food and Drug Administration )
`10903 New Hampshire Avenue
`)
`Silver Spring, MD 20993,
`)
`
`)
`)
`)
`
`Defendants.
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`
`
`COMPLAINT
`Plaintiffs Melinta Therapeutics, LLC and Rempex Pharmaceuticals, Inc.
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`(together “Melinta”) bring this action for declaratory, injunctive, and other relief
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`against the U.S. Food and Drug Administration (“FDA”); the U.S. Department of
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`Health and Human Services; Xavier Becerra, in his official capacity as Secretary of
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`Health and Human Services; and Robert Califf, M.D, in his official capacity as
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`Commissioner of Food and Drugs, FDA.
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`The Federal Food, Drug, and Cosmetic Act
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`(“FDCA”) governs the
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`pharmaceutical drug approval process for both innovator and generic drugs. In 1984,
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`Congress amended the act through the Hatch-Waxman Amendments, which sought
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`to strike a balance between inducing pioneering research and the development of new
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`drugs and enabling competitors subsequently to bring generic copies of those drugs
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`to market. See Veloxis Pharms., Inc. v. FDA, 109 F. Supp. 3d 104, 107 (D.D.C. 2015).
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`A key component of that fundamental balance is a regime that requires generic drug
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`companies to notify innovator drug companies of potential patent infringement by a
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`proposed generic drug in order to allow the innovator to protect its patent rights in
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`court before the generic receives FDA approval.
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`2
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`Case 1:22-cv-02190 Document 1 Filed 07/25/22 Page 3 of 20
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`An applicant who files an “abbreviated new drug application,” or ANDA,
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`seeking FDA approval of a generic version of an innovator drug must expressly
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`address patents that cover the innovator drug and explain specifically when FDA can
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`approve the application in light of the patents. 21 U.S.C. § 355(j)(2)(A)(vii). One
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`option to address an innovator patent is by including a “paragraph IV certification,”
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`which states “that such patent is invalid or will not be infringed by the manufacture,
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`use, or sale of the new drug.” 21 U.S.C. § 355(j)(2)(A)(vii)(IV). A successful paragraph
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`IV challenge can clear a patent obstacle to market. In addition, as part of the Hatch-
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`Waxman regime, paragraph IV certification offers a significant incentive: “[T]he first
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`company to file an ANDA containing a paragraph IV certification earns an
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`‘exclusivity’ period of 180 days, during which FDA may not approve for sale any
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`competing generic version of the drug at issue.” Teva Pharm. USA, Inc. v. Sebelius,
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`595 F.3d 1303, 1305 (D.C. Cir. 2010). But this incentive comes with a risk: filing an
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`application with a paragraph IV certification “constitutes an act of patent
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`infringement.” Id. (citing 35 U.S.C. § 271(e)(2)(A)).
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`An ANDA applicant that includes a paragraph IV certification must inform
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`both the patent owner and the company that owns the new drug application (“NDA”)
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`for the innovator drug on which the generic drug piggybacks. 21 U.S.C. § 355(j)(2)(B).
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`Receipt of this notice triggers a series of deadlines that are designed to inform the
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`innovator companies and allow them to protect their rights. After the notice is
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`received, the patent owner or innovator drug company has a 45-day window to sue
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`the generic drug company for patent infringement in order to trigger a statutory stay.
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`3
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`Case 1:22-cv-02190 Document 1 Filed 07/25/22 Page 4 of 20
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`21 U.S.C. § 355(j)(5)(B)(iii). If the NDA holder or patent owner sues during that 45-
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`day period following receipt of notice, FDA must wait 30 months after the NDA holder
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`and patent owner’s receipt of notice before approving the ANDA, unless the ANDA
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`applicant wins the suit sooner or the court shortens the 30-month period. 21 U.S.C.
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`§ 355(j)(5)(B)(iii).
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`The ANDA applicant must amend its ANDA to provide documentation of the
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`date of receipt of the required notice “by each person provided the notice.” 21 C.F.R.
`
`§ 314.95(e). For decades, FDA has accepted, as adequate documentation of “the date
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`of receipt,” “a [registered or certified mail] return receipt or a letter acknowledging
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`receipt by the person provided the notice.” 21 C.F.R. § 314.95(a), (e) (1994). Starting
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`in 2016, FDA now also accepts as documentation of “the date of receipt” “signature
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`proof of delivery by a designated delivery service.” 21 C.F.R. § 314.95(e). An
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`applicant may not rely on any other form of documentation to prove the date of receipt
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`unless FDA has agreed to such documentation in advance. Id.
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`Here, Nexus Pharmaceuticals, Inc. (“Nexus”) submitted an ANDA seeking
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`approval to market a generic version of Melinta’s innovator drug. Nexus’s ANDA
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`contained a paragraph IV certification stating that Melinta’s patents were invalid or
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`would not be infringed by Nexus’s generic. But Nexus provided no registered or
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`certified-mail return receipt, signature proof of delivery, or letter acknowledging
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`receipt by Melinta at any point before March 31, 2021. Although Nexus purported to
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`send notice to Melinta in December 2020—in the middle of an unprecedented global
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`4
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`Case 1:22-cv-02190 Document 1 Filed 07/25/22 Page 5 of 20
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`pandemic and before vaccines were widely available—Melinta did not, in fact, receive
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`notice of Nexus’s paragraph IV certification until March 31, 2021.
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`On May 14, 2021, within 45 days of receipt of the notice, Melinta sued Nexus
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`for patent infringement in the Northern District of Illinois. FDA is thus statutorily
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`barred from making its approval of Nexus’s application effective until October 1,
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`2023. Yet despite the ongoing litigation, FDA denied Melinta’s citizen petition asking
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`FDA to refrain from issuing any approval during the 30-month stay in a way that
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`would violate its statutory commands. Shortly thereafter, in the afternoon on July
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`25, 2022, FDA disclosed publicly that it had approved Nexus’s application on July 22,
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`2022. FDA’s denial of Melinta’s citizen petition and approval of Nexus’s ANDA are
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`inconsistent with the statutory scheme, violate its own regulations, and create a path
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`for ANDA applicants to skirt important patent protections. Melinta respectfully
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`requests that the Court set aside FDA’s denial of Melinta’s citizen petition and order
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`FDA to withdraw its approval of Nexus’s application or suspend the approval until
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`the statutory stay expires. In support of its causes of action, Melinta avers as follows:
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`NATURE OF THE ACTION
`This is an action to hold unlawful and set aside as arbitrary, capricious,
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`1.
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`an abuse of discretion, and contrary to law FDA’s final decision approving
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`Abbreviated New Drug Application (“ANDA”) No. 214934 submitted by Nexus
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`Pharmaceuticals, Inc. (“Nexus”) seeking to market a purported generic form of
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`Melinta’s innovator drug Minocin® (minocycline) for Injection. The agency’s
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`decision—which would allow ANDA applicants to circumvent the notice requirements
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`5
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`Case 1:22-cv-02190 Document 1 Filed 07/25/22 Page 6 of 20
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`and patent protections set forth in the Hatch-Waxman Act—is inconsistent with the
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`underlying statutory scheme and regulatory restrictions.
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`2. Melinta seeks a declaratory judgment declaring FDA’s action approving
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`Nexus’s ANDA to be arbitrary, capricious, an abuse of discretion, and contrary to law.
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`3. Melinta also seeks a preliminary and permanent injunction ordering
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`FDA to withdraw or suspend its approval of Nexus’s ANDA. In addition, Melinta
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`seeks a preliminary and permanent injunction to require FDA to take whatever
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`action may be necessary to prevent the marketing and distribution of Nexus’s drug
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`until at least after expiration of the 30-month statutory stay.
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`4.
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`Absent injunctive relief, FDA’s decision to approve Nexus’s ANDA will
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`cause serious and irreparable economic and reputational injury to Melinta.
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`JURISDICTION AND VENUE
`This Court has jurisdiction over this action pursuant to 28 U.S.C. § 1331
`
`5.
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`(federal question) and 28 U.S.C. § 1361 (mandamus).
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`6.
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`The relief requested is authorized pursuant to 28 U.S.C. § 1651 (All Writs
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`Act) and 28 U.S.C. § 2201 (Declaratory Judgment Act).
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`7. Melinta has a right to bring this action pursuant to the Administrative
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`Procedure Act (“APA”), 5 U.S.C. §§ 701–706.
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`8.
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`Venue is proper in this District pursuant to 28 U.S.C. § 1391(e) and
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`5 U.S.C. § 703 because this is a civil action in which one of the defendants is an officer
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`or agency of the United States that resides in this judicial District.
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`6
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`Case 1:22-cv-02190 Document 1 Filed 07/25/22 Page 7 of 20
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`9.
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`There is currently an actual, justiciable controversy between the parties
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`concerning whether FDA’s approval of Nexus’s ANDA is consistent with the
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`requirements of the FDCA, 21 U.S.C. § 301 et seq., FDA’s regulations, and the APA.
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`10. Declaratory relief will resolve this controversy and determine whether
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`FDA’s approval of Nexus’s ANDA was lawful, including being consistent with the
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`FDCA, FDA’s regulations, and the APA.
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`11. A preliminary injunction against the defendants requiring FDA to
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`withdraw or suspend its approval of Nexus’s ANDA will shield Melinta from ongoing
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`and irreparable harm while this litigation is pending.
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`12. A permanent injunction against the defendants requiring FDA to
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`withdraw or suspend its approval of Nexus’s ANDA will protect Melinta’s rights
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`prospectively after the final resolution of this matter.
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`PARTIES
`13. Plaintiff Melinta Therapeutics, LLC is a limited liability company
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`organized and existing under the laws of Delaware, having its principal place of
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`business at 44 Whippany Road, Suite 280, Morristown, NJ 07960. Melinta
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`Therapeutics, LLC was formed in November 2020 from a conversion of Melinta
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`Therapeutics, Inc., a Delaware corporation.
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`14. Plaintiff Rempex Pharmaceuticals, Inc. is a corporation organized and
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`existing under the laws of Delaware and has its principal place of business at 44
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`Whippany Road, Suite 280, Morristown, NJ 07960. Rempex Pharmaceuticals, Inc. is
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`a wholly owned subsidiary of Melinta Therapeutics, LLC.
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`7
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`Case 1:22-cv-02190 Document 1 Filed 07/25/22 Page 8 of 20
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`15. Defendant FDA, which has its principal office at 10903 New Hampshire
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`Avenue, Silver Spring, Maryland 20993, is a federal agency headquartered in
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`Maryland. It regulates prescription drugs under authority delegated by Congress
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`and the Secretary of Health and Human Services.
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`16. Defendant U.S. Department of Health and Human Services, which has
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`its principal office at 200 Independence Avenue, S.W., Washington, D.C. 20201, is a
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`federal agency headquartered in the District of Columbia. It has authority over FDA.
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`17. Defendant Xavier Becerra is being sued in his official capacity as
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`Secretary of Health and Human Services. As Secretary, Mr. Becerra has ultimate
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`responsibility for the activities of the Department of Health and Human Services,
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`including those actions complained of herein. Mr. Becerra maintains an office at 200
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`Independence Avenue, S.W., Washington, D.C. 20201.
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`18. Defendant Robert Califf, M.D., is being sued in his official capacity as
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`Commissioner of Food and Drugs, FDA. As Commissioner, Dr. Califf has
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`responsibility for the activities of FDA, including those actions complained of herein.
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`Dr. Califf maintains an office at 10903 New Hampshire Avenue, Silver Spring,
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`Maryland 20993.
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`STATUTORY AND REGULATORY BACKGROUND
`19. The FDCA requires that drug manufacturers (or “sponsors”) demonstrate
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`the safety and effectiveness of their products for their intended use. See 21 U.S.C.
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`§ 355. Innovator drug manufacturers like Melinta demonstrate safety and
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`effectiveness by conducting comprehensive pre-clinical and clinical studies of their
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`8
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`Case 1:22-cv-02190 Document 1 Filed 07/25/22 Page 9 of 20
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`products, producing extensive data that are submitted in New Drug Applications
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`(“NDAs”). 21 U.S.C. § 355(b)(1).
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`20. An NDA must include, among other things, technical data on the
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`composition of the drug, the means for manufacturing it, and data from clinical trials
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`establishing the safety and efficacy of the drug for its intended uses. Id.
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`21.
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`In 1984, Congress passed the Hatch-Waxman Amendments, Pub. L.
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`No. 98-417, 98 Stat. 1585, which amended the FDCA and established an abbreviated
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`process by which drug companies could gain approval from FDA to bring generic
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`versions of innovator drugs to market. 21 U.S.C. § 355(j). The Hatch-Waxman
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`Amendments provide a mechanism—through the filing of an ANDA, an abbreviated
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`new drug application—by which a generic drug company can rely on the costly pre-
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`clinical and clinical data previously generated by an innovator drug manufacturer,
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`rather than having to conduct itself all the studies normally required for approval of
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`an NDA.
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`22. A generic drug company that relies on this data, however, must include
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`in its application a patent certification addressing Orange Book-listed patents that
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`cover the underlying innovator drug. See 21 U.S.C. § 355(j)(2)(vii).
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`23. One type of certification is paragraph IV certification, in which the
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`ANDA applicant certifies that the innovator drug’s “patent is invalid or will not be
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`infringed by the manufacture, use, or sale of the new drug for which the application
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`is submitted.” 21 U.S.C. § 355(j)(2)(A)(vii)(IV).
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`9
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`Case 1:22-cv-02190 Document 1 Filed 07/25/22 Page 10 of 20
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`24. Filing an ANDA with a paragraph IV certification constitutes an act of
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`patent infringement, allowing the patent owner to bring suit under the patent laws
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`and thereby obtain a judicial determination of whether the proposed generic drug
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`would infringe the patent. 35 U.S.C. § 271(e)(2)(A).
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`25. An applicant that makes a paragraph IV certification in its ANDA is
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`statutorily obligated to give notice of the ANDA and the paragraph IV certification to
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`both the innovator drug NDA holder and the patent owner, and the notice must
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`include a “detailed statement of the factual and legal basis” for the applicant’s
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`contention that the patent is invalid or will not be infringed. 21 U.S.C.
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`§ 355(j)(2)(B)(iii)–(iv).
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`26. The applicant must provide this statutorily required notice within a
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`certain time limit. If the paragraph IV certification is made in the application, the
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`applicant must give notice no later than 20 days after the date of the postmark on the
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`notice with which the Secretary informs the applicant that the ANDA has been filed.
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`21 U.S.C. § 355(j)(2)(B)(ii)(I).
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`27. This notice provides patent holders and innovator drug companies the
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`opportunity to protect their rights to any disputed patent in court. And to ensure
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`that the opportunity is a meaningful one, the Hatch-Waxman Amendments provide
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`that if, after receiving notice, the patent owner or innovator drug company brings an
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`action for infringement of the patent within 45 days after the date on which the
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`patent owner and innovator receive notice of the ANDA, then FDA’s approval of the
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`ANDA may be made effective only after 30 months from “the date of the receipt of the
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`10
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`Case 1:22-cv-02190 Document 1 Filed 07/25/22 Page 11 of 20
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`notice,” unless the court holds otherwise or resolves the patent infringement action.
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`See 21 U.S.C. § 355(j)(5)(B)(iii).
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`28. After providing this statutorily required notice, the ANDA applicant
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`must amend its application to include “a statement certifying that the notice has been
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`provided to each person” entitled to receive it and “to provide documentation of the
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`date of receipt of the notice … by each person provided the notice.” 21 C.F.R.
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`§ 314.95(b)(3), (e). FDA regulations govern how the ANDA applicant must send the
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`notice and specify what documentation FDA will accept to prove both “sending” and
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`“receipt” of the notice. 21 C.F.R. § 314.95(a), (e).
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`29. An ANDA applicant “must send notice of such [paragraph IV]
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`certification by registered or certified mail, return receipt requested, or by a
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`designated delivery service.” 21 C.F.R. § 314.95(a).
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`30. FDA will accept, as adequate documentation of “the date the notice was
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`sent,” “a copy of the registered mail receipt, certified mail receipt, or receipt from a
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`designated delivery service.” 21 C.F.R. § 314.95(e) (emphasis added).
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`31. Adequate documentation of “the date of receipt” requires “a return
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`receipt, signature proof of delivery by a designated delivery service, or a letter
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`acknowledging receipt by the person provided the notice.” 21 C.F.R. § 314.95(e)
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`(emphasis added). An applicant may not rely on any other form of documentation to
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`prove the date of receipt unless FDA has agreed to such documentation in advance.
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`Id.
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`11
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`Case 1:22-cv-02190 Document 1 Filed 07/25/22 Page 12 of 20
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`32. FDA is not free to ignore either the statutory requirements or its own
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`regulations in the name of expediency or administrative convenience.
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`GENERAL ALLEGATIONS
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`Nexus Submits an ANDA to FDA with a Paragraph IV Certification
`and Purportedly Tries to Notify Melinta
`33. Nexus prepared and submitted ANDA No. 214934 to FDA with a
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`paragraph IV certification seeking approval to manufacture, use, or sell a generic
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`version of Melinta’s product Minocin® for Injection before the expiration of Melinta’s
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`patents.
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`34. Pursuant to the statutory framework, Nexus purported to notify Melinta
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`of the paragraph IV certification through a Notice Letter dated December 7, 2020.
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`35. Nexus sent this letter via Federal Express (“FedEx”) “Priority Overnight”
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`service, attempting to serve Melinta the Notice Letter on December 8, 2020. FedEx
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`offered several “Delivery Signature Options” that Nexus could have selected to
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`require the delivery driver to obtain a recipient signature as proof of delivery. Nexus,
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`however, did not specify that a signature was required when sending the package via
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`FedEx. See Melinta Citizen Petition at 4–5 (Oct. 16, 2021), attached as Exhibit A.
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`36. Due to COVID-19, FedEx had modified its signature policy prior to and
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`including December 8, 2020. According to FedEx policy, if Nexus had requested a
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`recipient signature, the driver would have collected the recipient’s first initial and
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`last name and would have attempted to collect a signature by the recipient. If the
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`recipient had refused to sign for the signature-requested delivery or had not had
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`access to an acceptable stylus or writing instrument for the driver’s device, the driver
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`12
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`Case 1:22-cv-02190 Document 1 Filed 07/25/22 Page 13 of 20
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`would enter “C-19” in the place of a signature image. Because Nexus did not request
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`signature proof of delivery, however, the FedEx driver was not required to—and in
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`fact did not—collect any recipient’s first initial and last name, attempt to obtain the
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`recipient’s signature, or find any Melinta representative to whom to give the Notice
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`Letter. See Citizen Petition at 5–6.
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`37. The tracking information from FedEx states only that the package was
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`“signed for” on December 8, 2020 by “A.MELNTA.” No employee at Melinta had that
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`name at the time, indicating that the FedEx employee merely wrote a version of
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`Melinta’s name instead of finding an actual person to whom to give the delivery. See
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`Citizen Petition at 5.
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`38. Nexus thus did not obtain, and did not provide to FDA through an
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`amendment to its ANDA, the “signature proof of delivery” required by FDA’s
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`regulation (or any other acceptable documentation of receipt by Melinta on or around
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`December 8, 2020).
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`Melinta Receives Notice on March 31, 2021
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`39.
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`In fact, Melinta did not receive notice, and FedEx had no contact with
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`any Melinta agent, employee or officer, on December 8, 2020.
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`40. Like many other businesses in the United States and around the world,
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`Melinta’s corporate offices were effectively closed to the public in December 2020 due
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`to the COVID-19 pandemic, and employees had been directed to work from home. At
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`the time Nexus tried to send notice, Melinta’s offices had been locked and were
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`accessible only by access card. To accommodate the shut-down, Melinta arranged to
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`13
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`Case 1:22-cv-02190 Document 1 Filed 07/25/22 Page 14 of 20
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`receive mail and other deliveries through a formal procedure that ensured designated
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`employees would timely open, review, and appropriately route electronic and hard
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`copies of inbound correspondence. Melinta’s internal process for handling mail and
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`other deliveries correctly took in and routed hundreds of letters and packages during
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`the pandemic shut-down, including a significant number of legal notices.
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`41. The Notice Letter did not go through this established process and was
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`not sorted or organized with the remainder of received business and legal
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`correspondence.
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`42. The Notice Letter was first received by Melinta on March 31, 2021, when
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`Melinta’s General Counsel discovered the letter.
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`Melinta Sues Nexus for Patent Infringement
`within Forty-Five Days of Receipt of Notice
`43. Melinta filed an action for patent infringement against Nexus on May 14,
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`2021, within 45 days of receipt of the letter, thereby triggering the 30-month period
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`during which FDA is statutorily barred from approving Nexus’s ANDA. That period
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`runs from March 31, 2021 until October 1, 2023.
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`44. The patent infringement litigation is currently pending in the United
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`States District Court for the Northern District of Illinois. See Melinta Therapeutics,
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`LLC v. Nexus Pharmaceuticals, Inc., No. 1:21-cv-02636.
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`Melinta Explains the Situation to FDA in a Citizen Petition
`45. At the time it approved Nexus’s ANDA, FDA knew that Nexus had not
`
`amended the ANDA to provide an acceptable form of documentation of Melinta’s
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`14
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`Case 1:22-cv-02190 Document 1 Filed 07/25/22 Page 15 of 20
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`receipt of the Notice Letter. FDA also knew that Melinta had not in fact received the
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`Notice Letter until March 31, 2021.
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`46.
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`In addition to Nexus’s failure to amend its ANDA to provide the requisite
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`documentation, Melinta submitted a citizen petition to FDA regarding the date of
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`receipt.
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`47. Melinta advised FDA on May 7, 2021 of Nexus’s deficient paragraph IV
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`certification. And on August 11, 2021, Melinta notified FDA of Melinta’s initiation of
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`patent litigation within 45 days against Nexus. On October 16, 2021, Melinta filed a
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`citizen petition with FDA, further alerting FDA to the date Melinta received the
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`notice and asking FDA to, inter alia, determine that the statutory 30-month stay
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`under 21 U.S.C. § 355(j)(5)(B)(iii) had been triggered by the filing of the patent
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`infringement action. See generally Citizen Petition.
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`48.
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`In the Petition, Melinta pointed out that Nexus sent the notice without
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`requiring a signature. Citizen Petition at 5. Melinta also explained that while FedEx
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`had modified its signature processes due to COVID-19, if Nexus had required a
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`signature, FedEx would have attempted to collect one and would not have delivered
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`the package without at least collecting the first initial and last name of an actual
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`human recipient who accepted delivery of the package. See Citizen Petition at 5–6.
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`49. Although the FedEx courier inputted the typed phrase “A.MELNTA” in
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`the tracking information, Melinta highlighted to FDA that no employee worked at
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`that time with that name or initials. Citizen Petition at 5. Melinta also explained
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`that it had interviewed each of its employees who were in the office on December 8,
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`15
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`Case 1:22-cv-02190 Document 1 Filed 07/25/22 Page 16 of 20
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`2020, as well as additional administrative staff assigned to receive and process
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`incoming correspondence, and confirmed that the FedEx courier had not made
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`contact with any of those employees. Id. Melinta noted that the recorded name
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`“A.MELNTA” was a misspelling of Melinta’s corporate name and was likely entered
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`by the courier because no actual person’s name was available. Id.
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`50. FDA never sought additional information from Melinta on this topic.
`
`FDA Denies Melinta’s Citizen Petition
`and Approves ANDA No. 214934
`51. On July 22, 2022, FDA notified Melinta that it had denied Melinta’s
`
`citizen petition. See FDA Denial, attached as Exhibit B.
`
`52. FDA acknowledged that an ANDA applicant must amend its ANDA to
`
`provide documentation of the date of receipt of the notice, that this documentation
`
`requires signature proof of delivery by a designated delivery service, and that the
`
`date of receipt triggers the 45-day period to file a patent infringement suit to start
`
`the statutory 30-month stay. See FDA Denial at 5.
`
`53. FDA determined, however, that FedEx’s proof-of-delivery information
`
`constituted “signature proof of delivery,” despite the fact that it contained no
`
`signature by the intended recipient and that no person at Melinta signed for or
`
`received the notice when delivered. See FDA Denial at 7; see also Citizen Petition at
`
`Attachment 7.
`
`54. FDA failed to identify any evidence that Melinta actually received the
`
`notice prior to March 31, 2021. FDA also failed to identify any evidence that
`
`contradicts Melinta’s statements that the Notice Letter was not received by Melinta
`
`
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`16
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`
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`Case 1:22-cv-02190 Document 1 Filed 07/25/22 Page 17 of 20
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`and that FedEx did not attempt to contact anyone at Melinta regarding the Notice
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`letter. See Citizen Petition at 5.
`
`55. FDA also determined that, despite the fact that no one at Melinta
`
`received notice on December 8, 2020, this would count as the date on which the notice
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`was “received” for purposes of the 45-day period in which to file a patent infringement
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`action and trigger the statutory 30-month stay. FDA Denial at 8.
`
`56. FDA concluded that the 30-month statutory “stay does not apply.” FDA
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`Denial at 8.
`
`57. FDA also denied Melinta’s request for advance notice of any approval of
`
`ANDA 214934. FDA Denial at 8.
`
`58. On July 25, 2022, at approximately 2:00 p.m., FDA disclosed publicly
`
`that it had approved Nexus’s ANDA No. 214934.
`
`CLAIM FOR RELIEF
`(Declaratory and Injunctive Relief)
`
`Violation of the Administrative Procedure Act
`and Statutory and Regulatory Notice and Stay Obligations
`for Approving an ANDA Application
`(5 U.S.C. § 706(2)(A); 21 U.S.C. § 355(j)(5)(B); 21 C.F.R. § 314.95(e))
`59. Melinta realleges and incorporates by reference the allegations set forth
`
`in paragraphs 1 through 58 of this Complaint as if fully set forth herein.
`
`60. Where a patent holder brings an action for patent infringement within
`
`45 days of receipt of notice of the paragraph IV certification and ANDA, FDA’s
`
`approval may be made effective only after a 30-month period from the date of receipt,
`
`
`
`17
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`
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`Case 1:22-cv-02190 Document 1 Filed 07/25/22 Page 18 of 20
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`unless the court holds otherwise or resolves the patent infringement action. See 21
`
`U.S.C. § 355(j)(5)(B)(iii).
`
`61. FDA regulations govern what documentation is required to prove the
`
`date of receipt of the notice.
`
`62. Adequate documentation of the date of receipt requires a registered or
`
`certified-mail return receipt, signature proof of delivery by a designated delivery
`
`service, or a letter acknowledging receipt by the person provided the notice. 21 C.F.R.
`
`§ 314.95(a), (e).
`
`63. An application may not rely on any other form of documentation to prove
`
`the date of receipt unless FDA has agreed to such documentation in advance. Id.
`
`64. Nexus did not provide FDA with a return receipt, signature proof of
`
`delivery from a designated delivery service, or a letter acknowledging receipt by
`
`Melinta that would prove receipt of the Notice Letter earlier than March 31, 2021.
`
`65. Melinta, in fact, did not receive the Notice Letter until March 31, 2021.
`
`66. Melinta filed a patent infringement suit against Nexus within 45 days of
`
`this date of receipt, triggering the statutory 30-month stay of FDA approval.
`
`67. Despite Melinta’s satisfying the statutory and regulatory requirements
`
`for the 30-month stay, FDA denied Melinta’s citizen petition and denied Melinta that
`
`stay. See FDA Denial at 8. FDA’s denial injures Melinta by improperly denying it
`
`the statutory rights and protections of the Hatch-Waxman regime.
`
`68. FDA’s denial of Melinta’s citizen petition was therefore arbitrary,
`
`capricious, and contrary to law within the meaning of 5 U.S.C. § 706(2)(A), in excess
`
`
`
`18
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`
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`Case 1:22-cv-02190 Document 1 Filed 07/25/22 Page 19 of 20
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`of statutory authority within the meaning of 5 U.S.C. § 706(2)(C), and in violation of
`
`the FDCA and FDA’s regulations.
`
`69. Despite the statutory 30-month stay, FDA publicly disclosed on July 25,
`
`2022 that it had approved Nexus’s ANDA on July 22, 2022.
`
`70. FDA’s approval of Nexus’s ANDA was therefore arbitrary, capricious,
`
`and contrary to law within the meaning of 5 U.S.C. § 706(2)(A), in excess of statutory
`
`authority within the meaning of 5 U.S.C. § 706(2)(C), and in violation of the FDCA
`
`and FDA’s regulations.
`
`PRAYER FOR RELIEF
`WHEREFORE, Melinta requests that the Court:
`
`A.
`
`Enter a declaratory judgment declaring that FDA’s denial of Melinta’s
`
`citizen petition was arbitrary, capricious, an abuse of discretion, and contrary to law.
`
`B.
`
`Enter a preliminary and permanent injunction that directs FDA to grant
`
`the citizen petition’s request for relief by determining that the 30-month statutory
`
`stay has been triggered.
`
`C.
`
`Enter a declaratory judgment declaring that FDA’s approval of Nexus’s
`
`ANDA was arbitrary, capricious, an abuse of discretion, and contrary to law.
`
`D.
`
`Enter a preliminary and permanent injunction that (1) directs FDA to
`
`withdraw or suspend its approval of Nexus’s ANDA; and (2) directs FDA to take
`
`whatever actions may be necessary to prevent the marketing and distribution of
`
`Nexus’s purported generic drug product until the 30-month period has ended or until
`
`
`
`19
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`
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`Case 1:22-cv-02190 Document 1 Filed 07/25/22 Page 20 of 20
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`the court has resolved the patent infringement litigation or set forth a different time
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`period.
`
`E.
`
`Vacate any additional agency action found to be arbitrary, capricious,
`
`an abuse of discretion, or otherwise not in accordance with law, and remand any
`
`matters herein to FDA for further proceedings in accord with any legal instructions
`
`the Court may deem proper and just.
`
`F.
`
`Order such other and further relief as the Court deems just and proper.
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`Dated: July 25, 2022
`
`
`
`
`
`Respectfully submitted,
`
`
`
`
`
`/s/Jeffrey S. Bucholtz
`Jeffrey S. Bucholtz
` D.C. Bar No. 452385
`Paul Alessio Mezzina
` D.C. Bar No. 999325
`Amy R. Upshaw
` D.C. Bar No. 888156455
`KING & SPALDING LLP
`1700 Pennsylvania Avenue NW
`Suite 900
`Washington, DC 20006
`Telephone: (202) 737-0500
`Facsimile: (202) 626-3737
`jbucholtz@kslaw.com
`pmezzina@kslaw.com
`aupshaw@kslaw.com
`
`Counsel for Plaintiffs Melinta
`Therapeutics, LLC and Rempex
`Pharmaceuticals, Inc.
`
`20
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`