Opus Genetics Inc v. Sandoz Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Opus Genetics, Inc. (Delaware) and FamyGen Life Sciences, Inc. (Nevada)
  • Defendant: Sandoz Inc. (Delaware)
  • Plaintiff's Counsel: Duane Morris LLP
• Case Identification: 3:26-cv-04811, D.N.J., 04/29/2026
• Venue Allegations: Venue is alleged to be proper in the District of New Jersey as Defendant Sandoz Inc. has a regular and established place of business in Princeton, New Jersey, and has committed acts of infringement in the district, including the submission of the subject Abbreviated New Drug Application (ANDA).
• Core Dispute: Plaintiffs allege that Defendant's filing of an ANDA to market a generic version of Plaintiffs' RYZUMVI™ ophthalmic solution constitutes an act of patent infringement under the Hatch-Waxman Act.
• Technical Context: The technology concerns ophthalmic pharmaceutical compositions, specifically using the alpha-adrenergic antagonist phentolamine to reverse pharmacologically-induced pupil dilation (mydriasis).
• Key Procedural History: This lawsuit is the second filed by the Plaintiffs against Sandoz concerning the same ANDA. A prior action, filed March 14, 2025, asserts a different set of patents. The current complaint was filed following the issuance of the two patents-in-suit on March 17, 2026.

Case Timeline

Date	Event
2018-10-26	Priority Date for '066 and '067 Patents
2023-09-25	FDA approves New Drug Application for RYZUMVI™
2025-03-14	Plaintiffs file first patent infringement suit against Sandoz over the same ANDA
2026-03-17	U.S. Patent No. 12,576,066 issues
2026-03-17	U.S. Patent No. 12,576,067 issues
2026-04-29	Complaint for patent infringement filed

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

U.S. Patent No. 12,576,066 - Methods and Compositions for Treatment of Mydriasis

The Invention Explained

• Problem Addressed: The patent's background section describes that existing treatments for reversing pharmacologically-induced mydriasis, such as dapiprazole (REV-EYES™), can cause undesirable side effects, including a "significant burning sensation upon administration" and "significant eye redness" ʼ066 Patent, col. 2:6-11
• The Patented Solution: The invention proposes using an alpha-adrenergic antagonist, such as phentolamine, in a topical ophthalmic solution to reverse mydriasis ʼ066 Patent, abstract The patent suggests this approach can provide therapeutic benefits, such as pupil diameter reduction, while minimizing the side effects associated with prior treatments ʼ066 Patent, col. 2:12-18
• Technical Importance: This technology offers a method to improve patient comfort and accelerate visual recovery following routine eye examinations that require pupil dilation ʼ066 Patent, col. 1:54-65

Key Claims at a Glance

• The complaint asserts infringement of at least one claim of the '066 patent without specifying which claims Compl. ¶34 Independent claim 1 is representative of the patent's core method claims.
• The essential elements of independent claim 1 are:
  • A method of treating mydriasis in a human patient due to said patient having received tropicamide, phenylephrine, or a pharmaceutically acceptable salt thereof, or a combination of hydroxyamphetamine hydrobromide and tropicamide or a pharmaceutically acceptable salt thereof,
  • comprising administering to an eye of the human patient in need thereof a dosage of phentolamine mesylate to thereby treat the mydriasis,
  • wherein the dosage is topically administered to the patient's eye as one eye drop of a 1% (w/w) phentolamine mesylate solution.
• The complaint does not explicitly reserve the right to assert dependent claims but makes a general allegation against "one or more claims" Compl. ¶36

U.S. Patent No. 12,576,067 - Methods and Compositions for Treatment of Mydriasis

The Invention Explained

• Problem Addressed: The '067 Patent addresses the same technical problem as the '066 Patent: the side effects associated with existing treatments for reversing mydriasis ʼ067 Patent, col. 2:6-11
• The Patented Solution: The '067 Patent proposes the same solution as the '066 Patent: a topical ophthalmic formulation of phentolamine to treat mydriasis while minimizing side effects ʼ067 Patent, abstract ʼ067 Patent, col. 2:12-18
• Technical Importance: As with the '066 Patent, this technology provides an improved method for reversing pupil dilation to enhance patient comfort after eye exams ʼ067 Patent, col. 1:54-65

Key Claims at a Glance

• The complaint asserts infringement of at least one claim of the '067 patent without specifying which claims Compl. ¶52 Independent claim 1 is representative.
• The essential elements of independent claim 1 are identical to those of claim 1 of the '066 Patent, with one exception in the final element:
  • A method of treating mydriasis in a human patient due to said patient having received [a specified mydriatic agent],
  • comprising administering to an eye of the human patient in need thereof a dosage of phentolamine mesylate to thereby treat the mydriasis,
  • wherein the dosage is topically administered to the patient's eye as two eye drops of a 1% (w/w) phentolamine mesylate solution.
• The complaint does not explicitly reserve the right to assert dependent claims but makes a general allegation against "one or more claims" Compl. ¶54

III. The Accused Instrumentality

Product Identification

The accused instrumentality is Sandoz's proposed generic version of RYZUMVI™, which is the subject of ANDA No. 219888 ("Sandoz's ANDA Product") Compl. ¶1 Compl. ¶27

Functionality and Market Context

The complaint alleges that Sandoz's ANDA Product is a phentolamine ophthalmic solution, 0.75% Compl. ¶1 Compl. ¶17 It is alleged to be "pharmaceutically and therapeutically equivalent" to Plaintiffs' RYZUMVI™ product Compl. ¶32 Compl. ¶50 The complaint further alleges that the proposed generic product will have a label and indications that are the same or substantially the same as RYZUMVI™ Compl. ¶28, which is indicated for the treatment of pharmacologically-induced mydriasis Compl. ¶18

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The infringement action is brought under 35 U.S.C. § 271(e)(2), where the filing of an ANDA to obtain approval for a generic drug prior to the expiration of a patent is a statutory act of infringement. The analysis centers on whether the product Sandoz seeks to market would infringe the asserted patents.

12,576,066 Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
A method of treating mydriasis in a human patient due to said patient having received tropicamide, phenylephrine... or a combination of hydroxyamphetamine hydrobromide and tropicamide...	The complaint alleges Sandoz's ANDA Product has a label and indications that are the same, or substantially the same, as RYZUMVI™, which is indicated for treating pharmacologically-induced mydriasis.	¶28	col. 1:54-56
...comprising administering to an eye of the human patient in need thereof a dosage of phentolamine mesylate to thereby treat the mydriasis,	Sandoz's ANDA Product is a phentolamine ophthalmic solution. The proposed label will presumably instruct administration for the treatment of mydriasis.	¶1; ¶28	col. 2:20-28
...wherein the dosage is topically administered to the patient's eye as one eye drop of a 1% (w/w) phentolamine mesylate solution.	The complaint alleges Sandoz's product is a generic version of RYZUMVI™, which contains "1% phentolamine mesylate (equivalent to 0.75% phentolamine)." The proposed label will instruct users how to administer the product.	¶17; ¶28	col. 71:18-21

12,576,067 Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
A method of treating mydriasis in a human patient due to said patient having received tropicamide, phenylephrine... or a combination of hydroxyamphetamine hydrobromide and tropicamide...	The complaint alleges Sandoz's ANDA Product has a label and indications that are the same, or substantially the same, as RYZUMVI™, which is indicated for treating pharmacologically-induced mydriasis.	¶28	col. 1:54-56
...comprising administering to an eye of the human patient in need thereof a dosage of phentolamine mesylate to thereby treat the mydriasis,	Sandoz's ANDA Product is a phentolamine ophthalmic solution. The proposed label will presumably instruct administration for the treatment of mydriasis.	¶1; ¶28	col. 2:20-28
...wherein the dosage is topically administered to the patient's eye as two eye drops of a 1% (w/w) phentolamine mesylate solution.	The complaint alleges Sandoz's product is a generic version of RYZUMVI™, which contains "1% phentolamine mesylate (equivalent to 0.75% phentolamine)." The proposed label will instruct users how to administer the product.	¶17; ¶28	col. 71:20-23

Identified Points of Contention

• Scope Questions: The complaint states that RYZUMVI™ (and by extension, the accused generic product) is a "0.75% phentolamine" solution that contains "1% phentolamine mesylate" Compl. ¶17 The asserted claims require a "1% (w/w) phentolamine mesylate solution." A central issue for the court will be whether the accused 0.75% phentolamine solution meets the "1% (w/w) phentolamine mesylate solution" limitation. The dispute raises the question of whether the claim term refers to the concentration of the mesylate salt form of the molecule or the phentolamine base equivalent.
• Technical Questions: The complaint does not provide the proposed product label for Sandoz's ANDA product. This raises an evidentiary question as to what administration instructions the label will contain. The label's instructions will be critical for determining infringement of the '066 Patent, which claims administration of "one eye drop," versus the '067 Patent, which claims administration of "two eye drops."

V. Key Claim Terms for Construction

• The Term: "1% (w/w) phentolamine mesylate solution"
• Context and Importance: This term is the lynchpin of the literal infringement analysis. The accused product is identified as a "0.75%" phentolamine solution Compl. ¶1, while the claims require a "1%" solution. However, the complaint alleges the branded product contains "1% phentolamine mesylate (equivalent to 0.75% phentolamine)" Compl. ¶17 The construction of this term-whether it is defined by the concentration of the phentolamine mesylate salt or the phentolamine base-will likely be dispositive of infringement. Practitioners may focus on this term because the numerical difference between the claim language and the common description of the accused product creates a clear-cut issue for construction.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: Plaintiffs may argue that the plain language of the claim, "1% (w/w) phentolamine mesylate solution," is clear and unambiguous, referring to the weight-by-weight concentration of the mesylate salt. The patent specification consistently refers to concentrations in terms of the phentolamine mesylate salt (e.g., '066 Patent, col. 47:1-52). The fact that Plaintiffs' own product is described in the complaint as containing "1% phentolamine mesylate" supports this reading Compl. ¶17
  • Evidence for a Narrower Interpretation: Defendant may argue that a person of ordinary skill in the art would understand concentration in terms of the active phentolamine base (0.75%). They may point to the parenthetical "(equivalent to 0.75% phentolamine)" in the complaint's own description of RYZUMVI™ as evidence of industry convention and intent Compl. ¶17 However, the patent specification appears to lack explicit definitions or examples that would equate the claimed "1% (w/w) phentolamine mesylate solution" with a 0.75% phentolamine base concentration for the purpose of claim scope.

VI. Other Allegations

• Indirect Infringement: The complaint alleges that upon FDA approval, Sandoz will induce and/or contribute to infringement by marketing and selling its ANDA Product with a label that instructs users to perform the patented methods Compl. ¶36 Compl. ¶45 Compl. ¶54 Compl. ¶63
• Willful Infringement: The complaint does not use the word "willful," but it alleges that Sandoz has "actual knowledge" of the patents-in-suit no later than their issue date Compl. ¶33 Compl. ¶51 It also seeks attorneys' fees for an "exceptional case" under 35 U.S.C. § 285 Compl. ¶40 Compl. ¶58 These allegations lay a foundation for a potential willfulness claim based on post-issuance conduct.

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

• A core issue will be one of definitional scope: Can the claim term "1% (w/w) phentolamine mesylate solution" be construed to read on the accused generic product, which is a 0.75% phentolamine solution? The case may turn on whether the claim is interpreted based on the concentration of the phentolamine salt form (1%) or the active base (0.75%).
• A key evidentiary question will be one of instructed use: What specific dosage administration-"one eye drop" or "two eye drops"-will be recited on the proposed product label for Sandoz's ANDA Product? The answer will be critical for determining which, if either, of the asserted method patents is infringed.