DCT
2:25-cv-14927
Nexus Pharma LLC v. Saba Ilac Sanayi Ve Ticaret As
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Nexus Pharmaceuticals, LLC (Illinois)
- Defendant: Saba Ilac Sanayi ve Ticaret A.S. (Turkey)
- Plaintiff’s Counsel: Robinson Miller LLC; Marshall, Gerstein & Borun LLP
- Case Identification: 2:25-cv-14927, D.N.J., 08/26/2025
- Venue Allegations: Venue is alleged to be proper as Defendant is a foreign corporation subject to personal jurisdiction in the District of New Jersey.
- Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's EMERPHED® product constitutes infringement of four U.S. patents directed to ready-to-use ephedrine sulfate injection compositions.
- Technical Context: The technology concerns stable, sterile, injectable pharmaceutical formulations of ephedrine sulfate that do not require dilution before administration, intended to treat hypotension in clinical settings such as anesthesia.
- Key Procedural History: The action was initiated under the Hatch-Waxman Act following Defendant’s submission of ANDA No. 218622 to the U.S. Food and Drug Administration (FDA). The ANDA included a Paragraph IV Certification asserting that Plaintiff's Orange Book-listed patents are invalid or will not be infringed by Defendant's proposed generic product.
Case Timeline
| Date | Event |
|---|---|
| 2019-05-16 | Priority Date for ’278, ’400, ’436, and ’369 Patents |
| 2021-08-17 | U.S. Patent No. 11,090,278 Issues |
| 2022-02-08 | U.S. Patent No. 11,241,400 Issues |
| 2022-08-30 | U.S. Patent No. 11,426,369 Issues |
| 2022-10-25 | U.S. Patent No. 11,478,436 Issues |
| 2025-07-14 | Defendant Notifies Plaintiff of ANDA Filing via Notice Letter |
| 2025-08-26 | Complaint Filed |
| 2028-01-15 | Earliest Potential Date for Final Approval of Defendant's ANDA |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,090,278 - "Compositions comprising ephedrine or an ephedrine salt and methods of making and using same"
The Invention Explained
- Problem Addressed: The patent’s background describes how all previously FDA-approved ephedrine sulfate formulations required a ten-fold dilution before being administered to a patient. This mandatory dilution step is described as inconvenient, a cause of treatment delays, and a significant source of potential medication errors and microbial contamination in clinical settings (Compl. ¶20; ’278 Patent, col. 1:16-34).
- The Patented Solution: The invention is a sterile, premixed, "ready-to-use" pharmaceutical composition of ephedrine sulfate that does not require dilution prior to administration. The formulation, comprising ephedrine sulfate, an isotonic agent such as sodium chloride, and water, is designed to be stable for prolonged periods without the need for preservatives or chelating agents, which can pose risks of allergic reactions (’278 Patent, Abstract; col. 2:50-61).
- Technical Importance: By providing a stable, pre-diluted, ready-to-use formulation, the invention aims to improve patient safety by eliminating the risks associated with bedside dilution of concentrated drugs (’278 Patent, col. 1:40-49).
Key Claims at a Glance
- The complaint asserts infringement of one or more claims; independent claim 1 is representative of the asserted methods of administration.
- Essential Elements of Claim 1:
- A method of administering ephedrine sulfate to a subject with or at risk of hypotension.
- The method consists essentially of drawing a composition from a sterile premixed product into a syringe and injecting it.
- The composition itself consists essentially of: 5 mg/mL +/-5% ephedrine sulfate; 9 mg/mL sodium chloride; no preservative; and water.
- The composition is prepared by a specified multi-step process.
- The complaint reserves the right to assert additional claims (Compl. ¶50).
U.S. Patent No. 11,241,400 - "Compositions comprising ephedrine or an ephedrine salt and methods of making and using same"
The Invention Explained
- Problem Addressed: The ’400 Patent, which shares a common specification with the ’278 Patent, addresses the same problems of inconvenience, delay, error, and contamination risk associated with the required dilution of concentrated ephedrine sulfate injections (’400 Patent, col. 1:21-34).
- The Patented Solution: The invention provides a method for making a stable, ready-to-use pharmaceutical composition of ephedrine sulfate. The method involves combining the active ingredient with sodium chloride and water, placing the solution into vials, sealing them, and terminally sterilizing them to ensure a safe and stable final product that does not require dilution (’400 Patent, Abstract; col. 16:43-52).
- Technical Importance: The claimed manufacturing method produces a standardized, pre-diluted, and sterile ephedrine sulfate product, which obviates the need for on-site compounding or dilution by healthcare professionals, thereby enhancing safety and efficiency (’400 Patent, col. 1:40-49).
Key Claims at a Glance
- The complaint asserts infringement of one or more claims; independent claim 1 is representative of the asserted methods of making the composition.
- Essential Elements of Claim 1:
- A method of making a shelf-stable, ready-to-use ephedrine sulfate composition.
- The method comprises combining ephedrine sulfate, sodium chloride, and water to form a solution consisting essentially of 5 mg/mL +/-5% ephedrine sulfate and 9 mg/mL sodium chloride.
- The method further comprises placing the solution into depyrogenated glass vials, sealing the vials, and terminally sterilizing the sealed vials.
- The complaint reserves the right to assert additional claims (Compl. ¶62).
U.S. Patent No. 11,478,436 - "Compositions comprising ephedrine or an ephedrine salt and methods of making and using same"
- Technology Synopsis: This patent, part of the same family, is directed to ready-to-use packaged pharmaceutical compositions of ephedrine sulfate. The invention addresses the clinical problem of medication errors and contamination by providing a stable, pre-diluted formulation that eliminates the need for bedside dilution of the drug before administration (Compl. ¶¶20, 26).
- Asserted Claims: The complaint alleges infringement of one or more unspecified claims (Compl. ¶74).
- Accused Features: Defendant's proposed generic "ANDA Product" is accused of infringing, based on allegations that its composition, packaging, and intended use mirror those of the patented invention (Compl. ¶¶34-38, 72-74).
U.S. Patent No. 11,426,369 - "Compositions Comprising Ephedrine or and Ephedrine Salt and Methods of Making and Using Same"
- Technology Synopsis: This patent, also in the same family, is directed to methods of making a shelf-stable, ready-to-use ephedrine sulfate composition. The disclosed method is intended to solve the problem of instability and short shelf-life in diluted ephedrine solutions by providing a specific formulation and terminal sterilization process that yields a product ready for immediate clinical use (Compl. ¶¶20, 29).
- Asserted Claims: The complaint alleges infringement of one or more unspecified claims (Compl. ¶86).
- Accused Features: Defendant's manufacturing process for its proposed generic product is accused of infringing, based on allegations that it will use the "same or equivalent methods" as those used for Plaintiff's commercial product (Compl. ¶¶39, 84-86).
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is "Saba's ANDA Product," a proposed generic Ephedrine Sulfate Injection, USP, 50mg/10mL (5 mg/mL) in single-dose vials, for which Defendant seeks FDA approval via ANDA No. 218622 (Compl. ¶¶32, 34).
Functionality and Market Context
- The complaint alleges the ANDA Product is a "ready-to-use pre-mixed composition" that contains ephedrine sulfate, sodium chloride, and water in amounts "the same or equivalent" to Plaintiff's EMERPHED® product (Compl. ¶¶36, 37). The product is alleged not to contain a preservative (Compl. ¶37). The proposed labeling for the product allegedly instructs administration to patients for treating hypotension without requiring prior dilution (Compl. ¶¶43, 45).
- By filing an ANDA with a Paragraph IV certification, Defendant seeks to market its product as a generic equivalent to EMERPHED® prior to the expiration of the patents-in-suit (Compl. ¶¶32-33).
- No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
11,090,278 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of administering ephedrine sulfate to a subject having hypotension...the method consisting essentially of: | The proposed labeling for Defendant’s ANDA Product allegedly recommends, instructs, and promotes its administration to patients for the treatment of clinically important hypotension occurring in the setting of anesthesia. | ¶44 | col. 15:9-14 |
| drawing a shelf-stable ready-to-use ephedrine sulfate composition from a sterile premixed pharmaceutical product into a syringe; and injecting the composition into the subject using the syringe... | The proposed labeling for the ANDA Product allegedly instructs administration by drawing the composition into a syringe and injecting it into a patient without dilution. | ¶45 | col. 15:11-14 |
| wherein the shelf-stable ready-to-use ephedrine sulfate composition consists essentially of: 5 mg/mL+/-5% ephedrine sulfate; 9 mg/mL sodium chloride; no preservative; and water... | Defendant’s ANDA Product is alleged to be a ready-to-use composition containing ephedrine sulfate, sodium chloride, and water in the same or equivalent amounts as Plaintiff's product, and allegedly does not contain a preservative. | ¶¶36, 37 | col. 15:15-18 |
| and wherein the shelf-stable ready-to-use ephedrine sulfate composition is prepared by a process comprising: combining ephedrine sulfate, sodium chloride, and water...placing the solution into...vials; sealing...; and terminally sterilizing... | Defendant’s ANDA Product is alleged to be manufactured using the same or equivalent methods as Plaintiff’s product, which embodies the patented process. | ¶¶39, 41 | col. 15:19-24 |
11,241,400 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of making a shelf-stable, ready-to-use ephedrine sulfate composition... | Defendant is alleged to have submitted an ANDA seeking approval to manufacture a generic product that is a shelf-stable, ready-to-use ephedrine sulfate composition. | ¶¶31, 36 | col. 16:11-13 |
| the method comprising: combining ephedrine sulfate, sodium chloride, and water to form a solution consisting essentially of 5 mg/mL+/-5% of ephedrine sulfate and 9 mg/mL sodium chloride; | Defendant’s ANDA Product is alleged to contain ephedrine sulfate, sodium chloride, and water in the "same or equivalent amounts" as the formulation claimed in the patent. | ¶37 | col. 16:14-17 |
| placing the solution into depyrogenated glass vials; | Defendant's ANDA Product is alleged to use the "same or an equivalent container" as Plaintiff's EMERPHED®, which is supplied in vials. | ¶40 | col. 16:18 |
| sealing the filled glass vials; and | Defendant’s manufacturing process for its ANDA Product is alleged to be the same or equivalent to the method for EMERPHED®, which includes sealing vials. | ¶39 | col. 16:19 |
| terminally sterilizing the sealed glass vials. | Defendant's manufacturing process is alleged to include sterilizing its product in the "same or an equivalent method" as EMERPHED®, which embodies the claimed terminal sterilization step. | ¶41 | col. 16:20 |
- Identified Points of Contention:
- Scope Questions: The infringement allegations rely heavily on the Defendant’s product and process being the "same or equivalent" to Plaintiff’s. A central question will be whether the specific formulation in Defendant's confidential ANDA literally meets limitations such as "5 mg/mL+/-5% ephedrine sulfate" and "consisting essentially of," or whether Plaintiff will need to rely on the doctrine of equivalents.
- Technical Questions: A primary factual question is what Saba’s ANDA specifies for its formulation, excipients, and manufacturing process. The complaint does not provide these details, stating they are based on "information and belief." The case may turn on whether discovery reveals Defendant’s product contains unlisted components or is made by a process that differs materially from the one claimed.
V. Key Claim Terms for Construction
The Term: "consisting essentially of"
Context and Importance: This transitional phrase appears in asserted claims of both the ’278 and ’400 patents. Its construction is critical because it defines the scope of the claimed composition. It permits the presence of unlisted ingredients that do not materially affect the basic and novel properties of the invention. The dispute will likely center on what those properties are (e.g., stability, safety, being preservative-free) and whether any unlisted components in Defendant’s product materially affect them.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: Parties may argue that the "basic and novel" property is simply being a ready-to-use, injectable solution, allowing for minor, conventional excipients that do not alter this fundamental function.
- Evidence for a Narrower Interpretation: The specification emphasizes achieving stability without preservatives or chelating agents (’278 Patent, col. 1:35-40). Language describing the composition as consisting of ephedrine sulfate, sodium chloride, and water could be used to argue that the "basic and novel" property is this specific minimalist formulation, and thus the scope should be narrow.
The Term: "ready-to-use"
Context and Importance: This term is used throughout the patents to describe the final product. Its definition is key to the invention's stated purpose of eliminating pre-administration dilution. Practitioners may focus on this term because any ambiguity could allow a defendant to argue its product, while requiring some minor handling, is not "ready-to-use" in the sense required by the claims.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification defines the term functionally, stating the formulation "does not require reconstitution or dilution prior to administration" (’278 Patent, col. 2:58-60). This suggests any product not requiring dilution would meet the definition.
- Evidence for a Narrower Interpretation: The patent background extensively criticizes any pre-administration step, including dilution, as a source of error and contamination (’278 Patent, col. 1:19-29). This context may support an interpretation where "ready-to-use" means immediately injectable from the container with no manipulation other than drawing it into a syringe.
VI. Other Allegations
- Indirect Infringement: The complaint alleges active inducement of infringement for all four patents. The alleged basis for inducement is Defendant's proposed product labeling, which will allegedly instruct and encourage healthcare professionals to administer the ANDA Product in a manner that directly infringes the method claims (e.g., Compl. ¶¶52, 64).
- Willful Infringement: While not using the term "willful," the complaint alleges that Defendant acted with "full knowledge" of the patents-in-suit and "without a reasonable basis for believing that it would not be liable for infringing" (e.g., Compl. ¶¶56, 68). This allegation is based on Defendant's Paragraph IV certification, which establishes pre-suit knowledge of the patents.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of evidentiary proof: does the chemical composition and manufacturing process detailed in Defendant's confidential ANDA submission literally meet the specific concentrations and components recited in the claims? The complaint's reliance on allegations of "same or equivalent" functionality suggests that the case will depend heavily on facts developed during discovery.
- A key legal question will be one of claim scope: how will the court construe the term "consisting essentially of"? This will determine whether any additional, unlisted ingredients in Defendant's product are permissible, a determination that could be dispositive of the infringement analysis.