DCT
2:23-cv-03830
Azurity Pharma Inc v. Cosette Pharma Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Azurity Pharmaceuticals, Inc. (Delaware)
- Defendant: Cosette Pharmaceuticals, Inc. (Delaware)
- Plaintiff’s Counsel: Saiber LLC
- Case Identification: 2:23-cv-03830, D.N.J., 07/18/2023
- Venue Allegations: Venue is alleged to be proper as Defendant has its principal place of business in the District of 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 Plaintiff's FIRVANQ® oral solution constitutes an act of infringement of a patent covering stable liquid formulations of vancomycin.
- Technical Context: The technology concerns pharmaceutical compositions of vancomycin, an antibiotic used to treat serious bacterial infections like Clostridium difficile-associated diarrhea, formulated as a stable oral liquid to improve administration for pediatric and geriatric patients.
- Key Procedural History: This is a patent infringement action filed under the Hatch-Waxman Act. The patent-in-suit is listed in the FDA's "Approved Drug Products with Therapeutic Equivalence Evaluations" (the "Orange Book") for Plaintiff's FIRVANQ® product. The suit was triggered by Defendant's ANDA filing seeking to market a generic version of FIRVANQ® prior to the patent's expiration.
Case Timeline
| Date | Event |
|---|---|
| 2014-03-14 | Earliest Priority Date for '692 Patent |
| 2022-10-03 | Date of Defendant's "Notice Letter" for other patents |
| 2023-05-02 | '692 Patent Issue Date |
| 2023-07-18 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,638,692 - "Composition and Method for Vancomycin Oral Liquid"
- Patent Identification: U.S. Patent No. 11,638,692, "Composition and Method for Vancomycin Oral Liquid", issued May 2, 2023.
The Invention Explained
- Problem Addressed: The patent describes challenges in administering vancomycin to certain patient populations, such as children and the elderly, who may have difficulty swallowing solid oral capsules (’692 Patent, col. 5:1-9). The alternative, compounding an oral liquid from vancomycin powder intended for injection, is described as cumbersome, time-consuming for pharmacists, and resulting in an unpalatable formulation that lacks preservatives, creating a risk of contamination (’692 Patent, col. 5:15-39).
- The Patented Solution: The invention provides a stable, non-sterile liquid formulation of vancomycin hydrochloride, or a kit for its preparation (’692 Patent, Abstract). The solution is created by combining a pre-measured amount of vancomycin powder with a specially formulated diluent containing components such as buffering agents, preservatives, and sweeteners (’692 Patent, col. 2:55-65; col. 3:50-56). This process results in a homogenous liquid that is stable for at least 30 days, simplifying administration and improving safety and patient compliance (’692 Patent, col. 1:26-34; col. 6:7-15).
- Technical Importance: The invention aims to provide a standardized, shelf-stable, and palatable oral liquid version of vancomycin, which was not previously commercially available, thereby offering a safer and more convenient treatment option than ad-hoc pharmacy compounding (’692 Patent, col. 6:1-6).
Key Claims at a Glance
- The complaint asserts infringement of one or more unspecified claims. The patent contains two independent claims, 1 and 5.
- Independent Claim 1 recites a non-sterile stable liquid formulation for oral administration consisting of:
- a buffering agent selected from a specified list;
- water;
- optionally a sweetener;
- a preservative selected from a specified list;
- optionally a flavoring agent;
- vancomycin hydrochloride; and
- a "wherein" clause requiring the formulation to be homogenous, stable for at least 1 week, and have a pH of 2.5-4.5.
- Independent Claim 5 is similar but specifically requires "citric acid" as the buffering agent, rather than an agent from a broader list.
- The complaint does not explicitly reserve the right to assert dependent claims.
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is "Cosette's ANDA Product," a generic version of Azurity's FIRVANQ® for which Defendant Cosette has sought FDA approval via ANDA No. 214237 (Compl. ¶1, ¶7).
Functionality and Market Context
- The complaint alleges that by filing an ANDA, Defendant has represented to the FDA that its product has the same active ingredient (vancomycin hydrochloride), dosage form, strength, and route of administration as FIRVANQ®, and is bioequivalent (Compl. ¶22).
- The product is intended for the same medical indications as FIRVANQ®, namely the treatment of C. difficile-associated diarrhea and enterocolitis caused by S. aureus (Compl. ¶11).
- The complaint alleges that the proposed label for Cosette's product will be substantially similar to the FIRVANQ® label, which instructs a healthcare provider to reconstitute a supplied powder to produce the final oral solution (Compl. ¶23-¶24).
- No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint does not provide a detailed infringement analysis or claim chart. The infringement theory is premised on the act of filing the ANDA, which seeks approval for a product that, if manufactured and sold, would allegedly infringe the '692 Patent. The allegation is that Cosette's ANDA product, being a bioequivalent generic of FIRVANQ®, will necessarily meet the limitations of the asserted claims upon reconstitution as directed by its proposed label.
- ’692 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A non-sterile stable liquid formulation formulated for oral administration, consisting of: (a) a buffering agent... (d) a preservative... (f) vancomycin hydrochloride | The complaint alleges that the product described in Cosette's ANDA, which is a generic version of FIRVANQ®, will, upon reconstitution, be a liquid formulation containing these components. | ¶22, ¶28 | col. 10:48-51 |
| wherein the non-sterile stable liquid formulation is homogenous and stable for at least 1 week at ambient and refrigerated temperature | The complaint alleges that Cosette's ANDA product is bioequivalent to FIRVANQ® and that its manufacture and sale will result in an infringing product, implying it will meet the claimed stability and homogeneity requirements. | ¶22, ¶27 | col. 10:59-62 |
| and has a pH of 2.5-4.5 | This functional property is alleged to be met by the ANDA product, which is represented as bioequivalent to the Orange Book-listed drug. | ¶22, ¶27 | col. 10:62-63 |
- Identified Points of Contention:
- Scope Questions: A central dispute may arise over the term "consisting of" in the independent claims. This creates a strong presumption that the claims are closed to any additional, unrecited ingredients. The litigation may turn on whether Cosette's ANDA product contains any excipients not classifiable as a "buffering agent," "sweetener," "preservative," or "flavoring agent."
- Technical Questions: The complaint lacks any specific factual allegations about the composition of Cosette's proposed generic product. A key evidentiary question is whether the precise formulation and performance characteristics detailed in Cosette's confidential ANDA submission meet every limitation of the asserted claims, including the specific pH range and stability criteria.
V. Key Claim Terms for Construction
- The Term: "consisting of"
- Context and Importance: This transitional phrase is typically interpreted in patent law to be closed, meaning the claimed formulation cannot include other ingredients besides those explicitly recited (or impurities). Its construction is critical because if Defendant's ANDA product contains any additional, unrecited excipient, it may fall outside the literal scope of the claims. Practitioners may focus on this term as it presents a primary potential avenue for a non-infringement defense.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party might argue that the categories of ingredients (e.g., "sweetener," "preservative") should be interpreted broadly, or that certain trace ingredients are merely impurities and do not count as additional elements. The patent provides extensive lists of exemplary ingredients for each category, which could be argued to support a broad reading of what falls within the recited classes (’692 Patent, col. 9:15-34, 9:50-10:2).
- Evidence for a Narrower Interpretation: The term "consisting of" is a well-established term of art with a strong exclusionary meaning. The patent’s detailed description of specific embodiments (e.g., the formulation at col. 4:6-15) could be used to argue that the claims are strictly limited to formulations containing only the types of components listed.
VI. Other Allegations
- Indirect Infringement: The complaint alleges inducement of infringement. The factual basis for this claim is that Cosette's proposed product labeling will instruct healthcare providers (e.g., pharmacists) to reconstitute the product, an act that allegedly directly infringes the claims of the ’692 Patent (Compl. ¶28-¶29).
- Willful Infringement: The complaint alleges that Cosette "had or should have had actual and constructive knowledge of the '692 Patent" and acted with "specific intent to infringe" (Compl. ¶29). While the word "willful" is not used, these allegations, combined with the request for a finding of an "exceptional case" under 35 U.S.C. § 285, lay the groundwork for a future claim of willful infringement and enhanced damages (Prayer for Relief ¶e).
VII. Analyst’s Conclusion: Key Questions for the Case
- A primary issue will be one of claim scope: Can the phrase "consisting of" be overcome? The case may depend on whether Defendant's proposed generic formulation, as detailed in its confidential ANDA, contains any excipient that is not classifiable within the specific categories recited in the independent claims.
- A central question will be evidentiary and factual: Does the product that would result from following the instructions in Defendant's ANDA meet every technical limitation of the asserted claims? This will require a detailed comparison of the ANDA's contents with the patent's requirements for composition, pH, stability, and homogeneity.
- A potential procedural question may arise from the complaint's allegation that Cosette has not yet provided a Paragraph IV certification with respect to the '692 Patent. While the suit is predicated on the ANDA filing itself, the specific procedural posture may be a point of early motion practice.