DCT

3:25-cv-01895

Opus Genetics Inc v. Sandoz Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:25-cv-01895, D.N.J., 03/14/2025
  • Venue Allegations: Venue is asserted based on Defendant Sandoz having a regular and established place of business in Princeton, New Jersey, and having committed the alleged act of infringement—the filing of an Abbreviated New Drug Application (ANDA)—within the judicial district.
  • Core Dispute: Plaintiffs allege that Defendant’s submission of an ANDA to the FDA seeking approval to market a generic version of Plaintiffs' RYZUMVIT™ ophthalmic solution constitutes an act of patent infringement.
  • Technical Context: The technology relates to stable, aqueous ophthalmic solutions containing phentolamine, a drug used to reverse pharmacologically-induced mydriasis (pupil dilation) following eye examinations.
  • Key Procedural History: The litigation was initiated under the Hatch-Waxman Act following Plaintiffs' receipt of Paragraph IV Notice Letters from Sandoz, dated January 31, 2025, and February 27, 2025. In these letters, Sandoz certified that the patents-in-suit are invalid, unenforceable, and/or will not be infringed by its proposed generic product. The asserted patents are part of an extended family, and the front page of U.S. Patent No. 10,278,918 notes that it is subject to a terminal disclaimer, which may limit its enforceable term to that of its parent patent, U.S. Patent No. 9,795,560.

Case Timeline

Date Event
2013-02-01 '560, '918, '829, '261, '858 Patents - Earliest Priority Date
2017-10-24 U.S. Patent No. 9,795,560 Issued
2018-10-26 '077 Patent - Earliest Priority Date
2019-05-07 U.S. Patent No. 10,278,918 Issued
2019-10-25 '615, '616 Patents - Earliest Priority Date
2020-09-15 U.S. Patent No. 10,772,829 Issued
2021-08-17 U.S. Patent No. 11,090,261 Issued
2022-08-02 U.S. Patent No. 11,400,077 Issued
2023-09-25 FDA Approval of RYZUMVIT™ (NDA 217064)
2023-12-19 U.S. Patent No. 11,844,858 Issued
2025-01-21 U.S. Patent No. 12,201,615 Issued
2025-01-21 U.S. Patent No. 12,201,616 Issued
2025-01-31 Sandoz First Notice Letter Date
2025-02-27 Sandoz Second Notice Letter Date
2025-03-14 Complaint Filing Date

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

U.S. Patent No. 9,795,560 - "Aqueous Ophthalmic Solutions of Phentolamine and Medical Uses Thereof," Issued October 24, 2017

The Invention Explained

  • Problem Addressed: The patent background describes the difficulty in preparing stable, aqueous formulations of phentolamine salts without using a chelating agent, such as disodium ethylenediaminetetraacetic acid (EDTA), which was previously believed necessary to maintain stability ('918 Patent, col. 1:49-56).
  • The Patented Solution: The invention is described as a stable, aqueous ophthalmic solution of phentolamine that is "free of a chelating agent" ('918 Patent, Abstract; col. 2:22-24). The stability is purportedly achieved through the surprising discovery that a specific combination of phentolamine, at least one polyol compound (e.g., mannitol), and a buffer in water creates a stable formulation suitable for eye drops without the need for a chelator ('918 Patent, col. 1:59-63).
  • Technical Importance: The patented solution provides for a stable phentolamine eye drop formulation that avoids chelating agents, which can be a source of irritation for some patients ('918 Patent, col. 2:15-20).

Key Claims at a Glance

  • The complaint alleges infringement of at least one claim without specifying which claims will be asserted (Compl. ¶55). Independent claim 1 is representative of the formulation patents.
  • The essential elements of a representative independent claim include:
    • An aqueous ophthalmic solution, consisting of:
    • about 0.5% (w/v) to about 2% (w/v) of phentolamine mesylate;
    • about 1% (w/v) to about 6% (w/v) of one or more polyol compounds;
    • about 1 mM to about 6 mM of an alkali metal acetate;
    • acetic acid; and
    • water;
    • wherein the solution has a pH in the range of 4.5 to 5.5.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 10,278,918 - "Aqueous Ophthalmic Solutions of Phentolamine and Medical Uses Thereof," Issued May 7, 2019

The Invention Explained

  • Problem Addressed: The '918 Patent, a continuation of the application leading to the '560 Patent, addresses the same technical problem: the difficulty of creating stable aqueous phentolamine formulations without a chelating agent ('918 Patent, col. 1:49-52).
  • The Patented Solution: The solution is identical to that described in the '560 Patent: a stable, aqueous ophthalmic phentolamine solution that is free of a chelating agent ('918 Patent, col. 2:22-24). This is achieved by combining the active ingredient with a polyol (like mannitol) and a buffer ('918 Patent, col. 1:59-63; Abstract).
  • Technical Importance: The invention offers a formulation for ophthalmic use that avoids chelating agents, which may minimize potential stinging or burning sensations associated with prior art formulations ('918 Patent, col. 2:15-20).

Key Claims at a Glance

  • The complaint alleges infringement of at least one claim without specifying which claims will be asserted (Compl. ¶73). Independent claim 1 is representative.
  • The essential elements of independent claim 1 include:
    • An aqueous ophthalmic solution, consisting of:
    • phentolamine or a pharmaceutically acceptable salt thereof;
    • at least one polyol compound;
    • at least one buffer;
    • water; and
    • optionally, one or more other specified excipients;
    • wherein the solution has a pH in the range of 4.0 to 7.5.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 10,772,829 - "Aqueous Ophthalmic Solutions of Phentolamine and Medical Uses Thereof," Issued September 15, 2020

  • Technology Synopsis: This patent is in the same family as the lead patents and is directed to the same core technology: stable, aqueous ophthalmic solutions of phentolamine formulated without a chelating agent. The claims appear directed to specific formulations consisting of phentolamine, a polyol, a buffer, and water within defined concentration and pH ranges.
  • Asserted Claims: At least one claim of the '829 Patent (Compl. ¶91).
  • Accused Features: Sandoz's ANDA Product, intended to be a generic version of RYZUMVIT™ (Compl. ¶87).

U.S. Patent No. 11,090,261 - "Aqueous Ophthalmic Solutions of Phentolamine and Medical Uses Thereof," Issued August 17, 2021

  • Technology Synopsis: This patent continues the same theme as the prior formulation patents, claiming specific compositions of phentolamine, a polyol, and a buffer that are stable without a chelating agent.
  • Asserted Claims: At least one claim of the '261 Patent (Compl. ¶109).
  • Accused Features: Sandoz's ANDA Product (Compl. ¶105).

U.S. Patent No. 11,844,858 - "Aqueous Ophthalmic Solutions of Phentolamine and Medical Uses Thereof," Issued December 19, 2023

  • Technology Synopsis: This patent continues the same theme as the prior formulation patents, claiming specific compositions of phentolamine, a polyol, and a buffer that are stable without a chelating agent.
  • Asserted Claims: At least one claim of the '858 Patent (Compl. ¶148).
  • Accused Features: Sandoz's ANDA Product (Compl. ¶144).

U.S. Patent No. 11,400,077 - "Methods and Compositions for Treatment of Presbyopia, Mydriasis, and Other Ocular Disorders," Issued August 2, 2022

  • Technology Synopsis: This patent is directed to methods of treating ocular disorders, such as mydriasis, by administering an alpha-adrenergic antagonist like phentolamine. The claims are distinct from the pure formulation patents and cover the act of using the composition for a therapeutic purpose.
  • Asserted Claims: At least one claim of the '077 Patent (Compl. ¶127).
  • Accused Features: Sandoz's ANDA Product and its proposed package insert, which Plaintiffs allege will instruct medical professionals and patients to use the generic product in an infringing manner (Compl. ¶¶ 131, 132).

U.S. Patent No. 12,201,615 - "Methods and Compositions for Treatment of Mydriasis," Issued January 21, 2025

  • Technology Synopsis: This patent is directed specifically to methods of treating mydriasis by administering an ophthalmic solution containing phentolamine.
  • Asserted Claims: At least one claim of the '615 Patent (Compl. ¶166).
  • Accused Features: Sandoz's ANDA Product and its proposed package insert, which is alleged to induce infringement (Compl. ¶¶ 170, 171).

U.S. Patent No. 12,201,616 - "Methods and Compositions for Treatment of Mydriasis," Issued January 21, 2025

  • Technology Synopsis: This patent, issued the same day as the '615 patent, is also directed to methods of treating mydriasis with phentolamine ophthalmic solutions.
  • Asserted Claims: At least one claim of the '616 Patent (Compl. ¶187).
  • Accused Features: Sandoz's ANDA Product and its proposed package insert (Compl. ¶¶ 191, 192).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is Sandoz's proposed generic phentolamine ophthalmic solution, 0.75%, for which it submitted ANDA No. 219888 to the FDA ("Sandoz's ANDA Product") (Compl. ¶¶1, 41).

Functionality and Market Context

  • The complaint alleges that Sandoz's ANDA Product is a generic version of Plaintiffs' branded drug, RYZUMVIT™, and is intended for the same indication: the treatment of pharmacologically-induced mydriasis (Compl. ¶¶15, 42). Based on FDA bioequivalence requirements, the complaint asserts that Sandoz's ANDA Product is "the same, or substantially the same" as RYZUMVIT™ and is "pharmaceutically and therapeutically equivalent" to it (Compl. ¶¶48, 53). RYZUMVIT™ is a sterile solution containing 1% phentolamine mesylate, which is equivalent to 0.75% phentolamine (Compl. ¶14).
  • The basis for the infringement action is the submission of the ANDA itself, which under 35 U.S.C. § 271(e)(2) is an act of infringement if the proposed product would infringe an existing patent upon commercialization (Compl. ¶55). Sandoz is a generic pharmaceutical company seeking to market its product prior to the expiration of the patents-in-suit (Compl. ¶5).
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide or reference a claim chart exhibit. The infringement allegations are based on the statutory framework of the Hatch-Waxman Act.

For the formulation patents (e.g., the '560 and '918 Patents), the complaint’s theory of infringement rests on the allegation that Sandoz’s ANDA Product is necessarily covered by the asserted claims because, as a generic drug, it is required by the FDA to be "pharmaceutically and therapeutically equivalent" to the branded RYZUMVIT™ product (Compl. ¶¶ 53, 71). The complaint alleges that Plaintiffs' own RYZUMVIT™ product is covered by the patents-in-suit, and therefore Sandoz's bioequivalent product will also contain a formulation that meets the limitations of at least one claim of each asserted formulation patent (Compl. ¶¶ 48, 55).

For the method patents (e.g., the '077, '615, and '616 Patents), the infringement theory is one of inducement. The complaint alleges that Sandoz knows of the patents and that its proposed package insert for the ANDA Product "will recommend, suggest, encourage and/or instruct" healthcare professionals and patients to use the generic product in a manner that directly infringes the claimed methods of treatment (Compl. ¶¶ 132, 171, 192).

  • Identified Points of Contention:
    • Scope Questions: For the formulation claims reciting the transitional phrase "consisting of" (e.g., '560 Patent, claim 1), a central question may be whether Sandoz’s formulation contains any unrecited excipients. The presence of any additional, unrecited substance not classifiable as an ordinary impurity could form a basis for a non-infringement argument.
    • Technical Questions: A key technical question, rooted in the patent's own disclosure, is whether the Sandoz formulation is truly "free of a chelating agent" ('918 Patent, Abstract). The dispute may turn on the technical definition of a "chelating agent" and whether any excipient in the Sandoz formulation, even if included for another purpose, possesses sufficient chelating properties to fall outside the claim's negative limitation.

V. Key Claim Terms for Construction

  • The Term: "consisting of"

    • Context and Importance: This transitional phrase appears in independent claims of the asserted patents (e.g., '560 Patent, claim 1) and is highly restrictive. It closes the claim to any elements not explicitly recited, except for impurities. The infringement analysis for these claims will depend on whether Sandoz's ANDA Product contains any additional excipients beyond those listed in the claims.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: There is little intrinsic evidence to broaden this term, as its meaning is well-established in patent law. An argument could be made that certain processing aids or trace elements are "impurities ordinarily associated therewith" and do not vitiate the "consisting of" limitation.
      • Evidence for a Narrower Interpretation: The specification's repeated emphasis on the "surprising discovery" of a stable solution free of a chelating agent suggests a strong intent to exclude other active or stabilizing components ('918 Patent, col. 1:59-63). This supports a strict interpretation where only the recited components are present.

  • The Term: "free of a chelating agent"

    • Context and Importance: This negative limitation is presented as a key point of novelty in the patent specifications ('918 Patent, col. 2:22-24). The definition of "chelating agent" is therefore critical. A dispute could arise if Sandoz's formulation contains an excipient with secondary chelating properties.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation (i.e., narrower exclusion): The background specifically names EDTA as an example of a chelating agent used in the prior art ('918 Patent, col. 1:50-52). A party might argue the term should be limited to such conventional, strong chelators added specifically for that purpose.
      • Evidence for a Narrower Interpretation (i.e., broader exclusion): The patent's summary states, "one aspect of the invention provides an aqueous ophthalmic solution free of a chelating agent" ('918 Patent, col. 2:22-24). This broad statement, without qualification, may support an interpretation that excludes any compound with meaningful chelating activity, regardless of its primary purpose in the formulation.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement of the asserted method patents ('077, '615, '616 Patents). This allegation is based on Sandoz’s knowledge of the patents and its intent for others to infringe, as evidenced by its proposed product label, which will allegedly instruct users to perform the patented methods of treating mydriasis (Compl. ¶¶ 131-132, 170-171, 191-192).
  • Willful Infringement: While not pleaded as a separate count, the complaint lays the groundwork for a willfulness allegation by asserting that Sandoz has "actual knowledge" of the patents-in-suit, citing Sandoz's Paragraph IV Notice Letters (Compl. ¶¶ 54, 72). Plaintiffs also request attorneys' fees on the basis that the case is "exceptional" under 35 U.S.C. § 285 (Compl. ¶61).

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

  • A central validity question will be one of non-obviousness: was it a "surprising discovery," as the patents contend, that a stable aqueous phentolamine solution could be formulated without a chelating agent using a polyol and a buffer, or would this have been an obvious formulation strategy to a person of ordinary skill in the art at the time of the invention?
  • A key infringement question will be one of compositional scope: does the restrictive "consisting of" language in several formulation claims read on Sandoz’s proposed ANDA Product, or does the generic product contain any unrecited excipients that place it outside the claims' literal scope?
  • For the method claims, a primary issue will be one of induced infringement: does the language of Sandoz's proposed product label provide sufficient instruction and encouragement to healthcare providers and patients to perform the steps of the patented methods of treatment, thereby demonstrating Sandoz's specific intent to induce infringement?