DCT
2:24-cv-09017
Rayner Surgical Inc v. Somerset Therap LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Rayner Surgical Inc. (Delaware) and Rayner Intraocular Lenses Ltd. (England)
- Defendant: Somerset Therapeutics, LLC (Delaware)
- Plaintiff’s Counsel: Saul Ewing LLP
- Case Identification: 2:24-cv-09017, D.N.J., 09/06/2024
- Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant Somerset Therapeutics, LLC maintains its principal place of business in Somerset, New Jersey.
- Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of the ophthalmic surgical product OMIDRIA® constitutes an act of infringement of three patents related to stable, preservative-free drug formulations.
- Technical Context: The technology involves stable, injectable liquid pharmaceutical formulations containing a mydriatic agent (phenylephrine) and an anti-inflammatory agent (ketorolac) for use during cataract and other ophthalmic surgeries.
- Key Procedural History: The litigation was initiated under the Hatch-Waxman Act following Defendant’s submission of ANDA No. 219384 with a Paragraph IV certification, asserting that the patents-in-suit are invalid, unenforceable, or will not be infringed by the proposed generic product. The patents are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book") for OMIDRIA®.
Case Timeline
| Date | Event |
|---|---|
| 2012-10-24 | Earliest Priority Date for ’856, ’406, and ’246 Patents |
| 2014-05-01 | FDA Approval of New Drug Application for OMIDRIA® |
| 2015-06-30 | U.S. Patent No. 9,066,856 Issues |
| 2016-11-08 | U.S. Patent No. 9,486,406 Issues |
| 2018-01-02 | U.S. Patent No. 9,855,246 Issues |
| 2024-07-26 | Defendant Mails Paragraph IV Certification Notice Letter |
| 2024-09-06 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,066,856 - Stable Preservative-Free Mydriatic and Anti-Inflammatory Solutions for Injection
- Issued: June 30, 2015
The Invention Explained
- Problem Addressed: The patent’s background section describes the need for a stable liquid formulation combining a mydriatic agent (to dilate the pupil) and an anti-inflammatory agent for use in ophthalmic surgery. Prior art solutions often included preservatives and antioxidants (e.g., sodium metabisulfite), which have been associated with potential toxicity to ocular tissues and complications like Toxic Anterior Segment Syndrome (TASS) ('856 Patent, col. 2:1-11).
- The Patented Solution: The invention is a liquid pharmaceutical formulation containing phenylephrine and ketorolac that achieves long-term stability without the use of preservatives or antioxidants ('856 Patent, Abstract). This stability is achieved by combining the active ingredients in a specific aqueous buffer system, such as a sodium citrate buffer, maintained within a defined pH range ('856 Patent, col. 9:15-22). Stability data presented in the patent, such as in FIG. 4, illustrates that a formulation with a citrate buffer at pH 6.5 and no additives shows minimal degradation over time compared to formulations with antioxidants ('856 Patent, col. 13:40-54; Fig. 4).
- Technical Importance: The invention provides a single, pre-mixed, injectable solution for use during surgery that both maintains pupil dilation and reduces inflammation, while avoiding the potential for ocular toxicity linked to preservatives and antioxidants commonly used in earlier formulations ('856 Patent, col. 1:13-19).
Key Claims at a Glance
- The complaint asserts independent Claim 1 ('856 Patent, col. 27:12-18; Compl. ¶38).
- The essential elements of Claim 1 are:
- A sterile liquid pharmaceutical formulation
- consisting essentially of phenylephrine, ketorolac and a buffer system in an aqueous carrier,
- wherein the formulation is stable for at least six months when stored at a temperature of from 5+/-3° C. to 25 +/-2° C.
- The complaint reserves the right to assert other claims of the ’856 Patent (Compl. ¶36).
U.S. Patent No. 9,486,406 - Stable Preservative-Free Mydriatic and Anti-Inflammatory Solutions for Injection
- Issued: November 8, 2016
The Invention Explained
- Problem Addressed: The ’406 Patent addresses the same technical problem as the ’856 Patent: the need for a stable ophthalmic formulation of phenylephrine and ketorolac that avoids the use of potentially toxic preservatives and antioxidants ('406 Patent, col. 1:15-19).
- The Patented Solution: The invention is a liquid formulation that is stable specifically "without the inclusion of preservatives and antioxidants" (’406 Patent, Abstract). The specification discloses experimental data showing that the addition of several common antioxidants (ascorbic acid, cysteine, glutathione) surprisingly increased the degradation of the active ingredients, highlighting that their exclusion is a critical inventive step ('406 Patent, col. 15:35-52). The claimed solution achieves stability by combining the active ingredients in an aqueous carrier with a buffer system ('406 Patent, col. 27:26-33).
- Technical Importance: The invention established that for this particular combination of active pharmaceutical ingredients, long-term stability is best achieved by omitting traditional antioxidants, a counterintuitive finding relative to standard pharmaceutical formulation practices.
Key Claims at a Glance
- The complaint asserts independent Claim 2 (’406 Patent, col. 27:26-33; Compl. ¶57).
- The essential elements of Claim 2 are:
- A liquid pharmaceutical formulation
- comprising phenylephrine, ketorolac and a buffer system in an aqueous carrier,
- wherein the formulation is stable without the inclusion of preservatives and antioxidants for at least six months when stored at a temperature of from 5+/-3° C. to 25+/-2° C.
- The complaint reserves the right to assert other claims of the ’406 Patent (Compl. ¶55).
U.S. Patent No. 9,855,246 - Stable Preservative-Free Mydriatic and Anti-Inflammatory Solutions for Injection
- Issued: January 2, 2018
Technology Synopsis
- The ’246 Patent is directed to a specific liquid intraocular ophthalmic solution dosage form that is free of preservatives, antioxidants, and solubilizing agents (’246 Patent, col. 4:18-24). The claims require specific concentration ranges for both phenylephrine and ketorolac and further require the solution to be packaged in a single-use container with a nitrogen gas overlay, a feature intended to further enhance product stability by displacing oxygen (’246 Patent, col. 27:32-48).
Asserted Claims & Accused Features
- Asserted Claims: Claim 1 (independent) (Compl. ¶76).
- Accused Features: The complaint alleges that Somerset's ANDA product is a liquid solution dosage form in a single-use container that contains phenylephrine and ketorolac at the claimed concentrations, is free of the excluded agents, and includes a nitrogen gas overlay (Compl. ¶77).
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is the drug product described in Somerset Therapeutics, LLC’s Abbreviated New Drug Application No. 219384 (the "ANDA Product") (Compl. ¶1).
Functionality and Market Context
- The ANDA Product is a generic version of Rayner’s OMIDRIA®, which is a combination of phenylephrine hydrochloride and ketorolac tromethamine in a solution for injection (Compl. ¶¶1, 18). It is intended for use during ophthalmic procedures such as cataract surgery to maintain pupil size (preventing miosis) and to reduce postoperative pain (Compl. ¶18). The complaint alleges that, to gain FDA approval as a generic, the ANDA product must be bioequivalent and contain the same active and inactive ingredients in the same concentrations as the branded OMIDRIA® product (Compl. ¶¶37, 56, 75).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
'9,066,856 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A sterile liquid pharmaceutical formulation... | Somerset's ANDA product is alleged to be a sterile liquid pharmaceutical formulation. | ¶39 | col. 7:46-50 |
| ...consisting essentially of phenylephrine, ketorolac and a buffer system in an aqueous carrier,... | The ANDA product is alleged to consist essentially of phenylephrine, ketorolac, and a buffer system in an aqueous carrier, based in part on FDA regulations requiring generic equivalence. | ¶¶37, 39 | col. 7:51-54 |
| ...wherein the formulation is stable for at least six months when stored at a temperature of from 5+/-3° C. to 25 +/-2° C. | The complaint alleges that Somerset's Notice Letter does not dispute that the ANDA product meets the claimed stability requirement. | ¶39 | col. 8:19-24 |
'9,486,406 Infringement Allegations
| Claim Element (from Independent Claim 2) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A liquid pharmaceutical formulation comprising phenylephrine, ketorolac and a buffer system in an aqueous carrier,... | Somerset's ANDA product is alleged to be a liquid pharmaceutical formulation comprising phenylephrine, ketorolac, and a buffer system in an aqueous carrier. | ¶58 | col. 7:54-57 |
| ...wherein the formulation is stable without the inclusion of preservatives and antioxidants for at least six months when stored at a temperature of from 5+/-3° C. to 25+/-2° C. | The ANDA product is alleged to be formulated without preservatives and antioxidants and to meet the stability requirement. | ¶58 | col. 8:24-30 |
Identified Points of Contention
- Scope Questions: A central issue for the ’856 Patent may be the scope of the transitional phrase "consisting essentially of." The analysis will question whether any unlisted ingredients in the ANDA product materially alter the formulation's basic and novel characteristics (i.e., stability without traditional preservatives/antioxidants). For the ’406 Patent, the negative limitation "without the inclusion of...antioxidants" raises the question of whether an ingredient that serves as a buffer (e.g., citrate) but also possesses secondary antioxidant properties falls within the scope of the exclusion.
- Technical Questions: While the complaint alleges that the ANDA product's composition is equivalent to OMIDRIA® and meets the claim limitations, discovery will be required to confirm the precise formulation. A key evidentiary question will be whether the ANDA product's formulation, as specified in its confidential ANDA submission, contains any components that could be characterized as a preservative or antioxidant under the language of the ’406 Patent.
V. Key Claim Terms for Construction
The Term: "consisting essentially of" (’856 Patent, Claim 1)
Context and Importance
- This transitional phrase is critical for defining the scope of infringement. Its construction will determine whether Somerset’s ANDA product can include any unlisted ingredients without falling outside the claim. The dispute will likely focus on whether any such additional components materially affect the formulation's stability, which the patent identifies as a key characteristic.
Intrinsic Evidence for Interpretation
- Evidence for a Broader Interpretation: The patent does not provide a special definition, which may support applying the standard legal interpretation where unlisted ingredients are permitted so long as they do not materially affect the invention's "basic and novel" properties.
- Evidence for a Narrower Interpretation: The specification emphasizes the purity of the formulation, stating that preferred formulations "consist essentially of the two APIs and the buffering system in water for injection, yielding a very pure formulation" ('856 Patent, col. 9:45-49). This language could be used to argue that the patentee envisioned a very simple composition and that the addition of almost any other functional ingredient would be a material alteration.
The Term: "without the inclusion of preservatives and antioxidants" (’406 Patent, Claim 2)
Context and Importance
- This negative limitation creates a potential point of non-infringement if the accused product contains any substance that can be classified as a preservative or antioxidant. Practitioners may focus on this term because the patent’s preferred buffer, sodium citrate, is known to have chelating properties that can inhibit oxidation. The interpretation of whether a multi-functional ingredient is "included" as an "antioxidant" will be central to the dispute.
Intrinsic Evidence for Interpretation
- Evidence for a Broader Interpretation: The patent specification distinguishes between the "buffering system" (which may include citrate) and other "antioxidants" that were tested and found to be detrimental (e.g., ascorbic acid, L-cysteine) (’406 Patent, col. 15:35-52, Example 3). This may support an interpretation that the exclusion applies only to agents added for the primary purpose of acting as an antioxidant, not to buffering agents with incidental antioxidant properties.
- Evidence for a Narrower Interpretation: The patent itself acknowledges that "citric acid in the citrate buffer, which has the ability to chelate divalent cations and can thus also prevent oxidation, provides an antioxidant effect as well as a buffering effect" (’406 Patent, col. 9:31-34). This statement could be cited to argue that the patentee understood citrate to be an antioxidant, and therefore a formulation containing it would not be "without the inclusion of" an antioxidant, regardless of its primary purpose as a buffer.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Somerset will induce infringement by marketing and selling its ANDA product with proposed prescribing information and product inserts that will instruct healthcare professionals and others on how to use the product in an infringing manner (Compl. ¶¶41, 60, 79).
- Willful Infringement: The complaint alleges that Somerset had actual and constructive notice of the patents-in-suit prior to filing its ANDA (Compl. ¶¶42, 61, 80). It further alleges that Somerset’s conduct in certifying that the patents are invalid or not infringed was "without adequate justification," rendering the case "exceptional" under 35 U.S.C. § 285 (Compl. ¶¶43, 62, 81).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: does the phrase "consisting essentially of" in the ’856 Patent permit the inclusion of any unlisted excipients in the accused generic formulation, or does the specification constrain its meaning to a composition of only the named components? This will be contrasted with the more explicit negative limitation in the ’406 Patent.
- A central factual question will be one of chemical characterization: does any component in the accused product, such as the citrate buffer, function as an "antioxidant" within the meaning of the ’406 Patent's claims, even if its primary purpose is buffering? The case may turn on whether the phrase "without the inclusion of...antioxidants" is an absolute prohibition or one limited to agents added specifically for that purpose.
- A key legal question will concern exceptionality: what evidence did Somerset possess to form a good-faith belief that the asserted patents were invalid or not infringed when it filed its Paragraph IV certification, and will that justification be sufficient to defend against a claim for enhanced damages and attorneys' fees?