DCT

2:25-cv-00694

Merck Sharp & Dohme BV v. USV Pvt Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:25-cv-00694, D.N.J., 01/23/2025
  • Venue Allegations: Venue is alleged to be proper because Defendant is a foreign corporation that may be sued in any judicial district and has purposefully availed itself of the New Jersey forum through systematic and continuous business contacts.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) for a generic version of the anesthetic reversal agent Bridion® (sugammadex) constitutes an act of infringement of a patent covering the sugammadex compound.
  • Technical Context: The technology relates to modified cyclodextrins used as chemical chelating agents to reverse the effects of neuromuscular blocking agents administered during surgery.
  • Key Procedural History: This complaint follows prior litigation between the same parties over the same patent and ANDA (IN RE SUGAMMADEX, No. 20-2576, D.N.J.). In that case, the court entered a final judgment and injunction against Defendant USV after a trial where USV admitted infringement but unsuccessfully challenged the patent’s term. That judgment is currently on appeal. This new action was triggered by Defendant’s subsequent "Notice of Recertification" under Paragraph IV of the Hatch-Waxman Act for the same ANDA. The patent-in-suit was granted a five-year Patent Term Extension (PTE) and is set to expire on January 27, 2026.

Case Timeline

Date Event
1999-11-29 U.S. RE44,733 Patent Priority Date
2003-12-30 Original U.S. Patent No. 6,670,340 Issued
2014-01-28 U.S. Patent No. RE44,733 Issued
2015-12-15 FDA Approved Merck's Bridion® (sugammadex)
2020-02-04 USPTO Issued Final Determination on Patent Term Extension for ’733 Patent
2020-02-13 USV Sent Initial Paragraph IV Notice Letter to Merck
2023-06-29 Final Judgment Entered in Prior Litigation (In re Sugammadex)
2024-12-11 USV Sent New "Notice of Recertification" to Merck
2025-01-23 Complaint Filed
2026-01-27 '733 Patent Expiration Date (with PTE)

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. RE44,733 - "6-Mercapto-Cyclodextrin Derivatives: Reversal Agents For Drug-Induced Neuromuscular Block," Issued January 28, 2014

The Invention Explained

  • Problem Addressed: The patent describes the clinical problem of reversing drug-induced neuromuscular blockade after surgery. Traditional reversal agents, known as anticholinesterases, work by increasing levels of the neurotransmitter acetylcholine. This mechanism is non-selective and can cause significant side effects like bradycardia and hypotension, requiring the co-administration of other drugs which have their own adverse effects. Further, these agents are not reliably effective in cases of "profound block," where neuromuscular function is completely suppressed ('733 Patent, col. 2:1-27).
  • The Patented Solution: The invention proposes using a specific class of molecules—6-mercapto-cyclodextrin derivatives—as "chemical chelators" to solve this problem ('733 Patent, col. 2:28-34). These molecules have a three-dimensional, cage-like structure that allows them to directly capture and encapsulate neuromuscular blocking agents in the bloodstream, forming an inactive complex. This novel mechanism of action neutralizes the blocking agent without affecting neurotransmitter levels, thereby avoiding the side effects of prior art agents ('733 Patent, Abstract; col. 4:26-51). The general structure of these derivatives is depicted in Formula I ('733 Patent, col. 3:5-12).
  • Technical Importance: This direct encapsulation approach represented a new paradigm for reversing anesthesia, offering the potential for faster, more predictable, and safer reversal of neuromuscular blockade across all depths, including profound block (Compl. ¶¶28-29).

Key Claims at a Glance

  • The complaint asserts one or more claims, including at least independent claim 1 (Compl. ¶39). Other independent claims include claim 5 (pharmaceutical composition), claim 6 (kit), and claim 9 (method of reversal).
  • The essential elements of independent claim 1 are:
    • A 6-mercapto-cyclodextrin derivative defined by a general chemical structure (Formula I) or its pharmaceutically acceptable salts.
    • The cyclodextrin core is specified as a β-cyclodextrin (m+n=7) or a γ-cyclodextrin (m+n=8).
    • The derivative has specific side chains attached via a sulfur atom (mercapto-), where the side chains are defined by variables R (a linker) and X (a terminal chemical group).
    • The claim explicitly excludes a specific list of six previously known β-cyclodextrin derivatives and two γ-cyclodextrin derivatives.
  • The complaint notes that USV has previously admitted that its product infringes claims 1-5, 9, 11-14, 20, and 21 (Compl. ¶40).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is Defendant USV's proposed generic sugammadex injection, for which it submitted Abbreviated New Drug Application (ANDA) No. 214276 to the FDA (Compl. ¶5). The products are identified as "Sugammadex Injection 200 mg/2 ml (100 mg/ml) and 500 mg/5 ml (100 mg/ml)" ("USV ANDA Products") (Compl. ¶8).

Functionality and Market Context

  • The USV ANDA Products are a generic version of Merck’s branded drug, Bridion®, and contain the same active ingredient, sugammadex (Compl. ¶¶28, 31).
  • Sugammadex is described as a modified cyclodextrin that functions by directly encapsulating, binding, and inactivating neuromuscular blocking agents (specifically rocuronium and vecuronium) used during surgery (Compl. ¶28).
  • The complaint alleges that USV seeks FDA approval to commercially manufacture and sell these products in the United States prior to the expiration of the '733 patent (Compl. ¶31).

IV. Analysis of Infringement Allegations

The complaint’s infringement theory is based on the chemical identity between the accused product and the patented compound. Significantly, the complaint alleges that USV previously admitted in prior litigation that its ANDA product infringes the asserted claims and did not contest infringement in its recent Notice of Recertification (Compl. ¶40). The infringement analysis is therefore straightforward. No probative visual evidence provided in complaint.

RE44,733 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A 6-mercapto-cyclodextrin derivative having the general formula I... or pharmaceutically acceptable salts thereof The USV ANDA Product's active ingredient is sugammadex, specifically 6-per-deoxy-6-per-(2-carboxyethyl)thio-γ-cyclodextrin, which is a derivative of a γ-cyclodextrin (m=0, n=8) covered by Formula I. ¶39, ¶25 col. 3:5-12
wherein... m+n=7 or 8 Sugammadex is derived from γ-cyclodextrin, for which m+n=8, satisfying this limitation. ¶25 col. 5:14-15
R is (C1-6)alkylene... For sugammadex, the linker between the sulfur atom and the carboxy group is an ethyl group (-CH2-CH2-), which is a (C1-6)alkylene. ¶24 col. 5:21-27
X is COOH... For sugammadex, the terminal group X is a carboxy group (COOH), which is an enumerated option for X. ¶24 col. 5:20

Identified Points of Contention

  • Legal Question: The central issue is not a technical dispute over infringement, which USV has reportedly admitted (Compl. ¶40). The primary question raised by the filing of this new complaint is the legal significance of USV's "Notice of Recertification." The court will have to determine what legal or factual basis, if any, USV has for recertifying its ANDA while an injunction from a prior proceeding on the same patent and product remains in effect and on appeal.
  • Procedural Question: This action raises the question of whether it is a procedurally proper lawsuit or a duplicative action intended to protect Merck’s rights against any new arguments USV might raise following its appeal. The complaint itself is filed "to avoid any uncertainty" (Compl. p. 2).

V. Key Claim Terms for Construction

Given USV's alleged admission of infringement, claim construction is not presented as a central point of dispute in the complaint. The technology involves a specific chemical compound, where infringement is typically determined by identity. However, in a hypothetical dispute, the following term would be fundamental.

The Term: "6-mercapto-cyclodextrin derivative"

  • Context and Importance: This term defines the core chemical structure of the invention. Its scope is foundational to any infringement analysis. Practitioners may focus on this term because it establishes the genus of compounds covered by the patent, and any potential non-infringement argument would have to assert that an accused compound falls outside this definition.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification defines a "derivative" broadly through the variable components of Formula I, which allows for different cyclodextrin cores (β or γ), various linkers (R), and multiple terminal groups (X) ('733 Patent, col. 3:13-28). The patent describes "a class of cyclic molecules containing six or more α-D-glucopyranose units," suggesting flexibility in the core structure ('733 Patent, col. 4:61-64).
    • Evidence for a Narrower Interpretation: An argument for a narrower construction could point to the specific list of excluded prior art compounds, suggesting the invention is limited to derivatives not previously known ('733 Patent, col. 4:1-19). Furthermore, arguments could be made to limit the scope to the specific embodiments and examples detailed in the specification, such as those based on γ-cyclodextrin with carboxy-terminated side chains.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon approval of its ANDA, USV will actively induce infringement by marketing its generic product with a label that instructs healthcare professionals on its use, where such use will directly infringe the patent's method claims. USV's proposed label is alleged to be "substantially similar" to the label for Merck's Bridion® (Compl. ¶46).
  • Willful Infringement: Willfulness is alleged based on USV's "full knowledge of the '733 patent," gained from the extensive prior litigation (Compl. ¶51). The complaint alleges that USV's continued pursuit of FDA approval for its generic product, despite the prior judgment and existing injunction, constitutes willful and deliberate infringement, rendering the case "exceptional" under 35 U.S.C. § 285 (Compl. ¶51).

VII. Analyst’s Conclusion: Key Questions for the Case

This litigation appears to be less about a technical dispute over patent infringement and more a strategic legal maneuver in a long-running conflict. The key questions are therefore primarily legal and procedural.

  • A core issue will be one of legal justification: Given the prior judgment, injunction, and USV's reported admission of infringement, what is the legal basis for USV’s new Paragraph IV recertification? The litigation will likely probe whether this filing is a permissible procedural step to preserve rights pending appeal or an improper attempt to relitigate settled issues.
  • A second key question will be one of willfulness and remedies: Will USV’s decision to file a new certification for an already-adjudicated product be deemed willful infringement, particularly while the prior judgment is on appeal? This will be central to Merck's request for a finding that this is an "exceptional case" warranting an award of attorney's fees.
  • Finally, the case raises a question of judicial economy and preclusion: To what extent are the issues in this new action precluded by the final judgment in the In re Sugammadex litigation? The court will need to determine how the pending appeal of that judgment affects the proceedings in this new, parallel case.