DCT
2:24-cv-07791
IN RE SELENIOUS ACID LITIGATION
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: American Regent, Inc. (New York)
- Defendant: Accord Healthcare Inc. (North Carolina)
- Plaintiff’s Counsel: GIBBONS P.C.
- Case Identification: 2:24-cv-07791, D.N.J., 07/16/2024
- Venue Allegations: Plaintiff alleges venue is proper because Defendant transacts substantial business in New Jersey, maintains a permanent and continuous presence in the state, and has consented to jurisdiction and venue for the purposes of this case.
- Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA for generic versions of Plaintiff's Selenious Acid injection products constitutes an act of infringement of a patent covering trace element compositions for parenteral nutrition.
- Technical Context: The technology relates to stable, injectable pharmaceutical compositions of trace elements (such as selenium) used for parenteral (intravenous) nutrition, a critical therapy for patients unable to absorb nutrients through the digestive tract.
- Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant's submission of ANDA No. 218655 with a Paragraph IV certification, asserting that U.S. Patent No. 11,998,565 is invalid or will not be infringed by its proposed generic product. The complaint notes that Defendant has previously been sued in the District of New Jersey and has not challenged personal jurisdiction in those cases.
Case Timeline
| Date | Event |
|---|---|
| 2019-04-30 | Plaintiff's NDA No. 209379 for Selenious Acid approved by FDA |
| 2020-07-02 | ’565 Patent Priority Date |
| 2024-06-04 | ’565 Patent Issued |
| 2024-06-11 | Defendant sends Paragraph IV Notice Letter to Plaintiff |
| 2024-07-16 | Complaint Filed |
| 2041-07-01 | ’565 Patent Expiration Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,998,565 - "Trace element compositions, methods of making and use"
The Invention Explained
- Problem Addressed: The patent's background describes that when trace elements are added to parenteral nutrition (PN) solutions, the resulting admixture often has a short stability period (e.g., 24-48 hours), which necessitates frequent, costly, and time-consuming preparation of new batches ('565 Patent, col. 1:57-2:4). This process can lead to waste and drug supply shortages if a patient's therapy is paused and the admixture must be discarded ('565 Patent, col. 2:16-24).
- The Patented Solution: The invention is a stable, injectable trace element composition that, when added to a PN solution, allows the final admixture to remain stable for a longer period ('565 Patent, Abstract). This extended stability is intended to reduce the frequency of admixing, lower costs, and improve the quality of life for patients and caregivers by allowing PN solutions to be prepared in batches ('565 Patent, col. 2:35-44).
- Technical Importance: By creating trace element formulations with specific compositions and impurity profiles, the invention sought to overcome the stability issues that limited the shelf-life of existing parenteral nutrition admixtures ('565 Patent, col. 2:24-30).
Key Claims at a Glance
- The complaint asserts infringement of "one or more claims" without specifying which ones (Compl. ¶31). Independent claim 1 is representative of the patent's focus on selenium compositions with specific impurity profiles.
- Independent Claim 1:
- An injectable composition comprising water,
- 6 µg or 60 µg of selenium,
- no chromium or chromium in an amount not to exceed 1 µg,
- no aluminum or aluminum in an amount not to exceed 6 µg,
- no iron or iron in an amount up to 10 µg, and
- fluoride in an amount of 0.0001 µg to 2.7 µg per 1 mL of the injectable composition.
- The complaint implicitly reserves the right to assert other independent and dependent claims.
III. The Accused Instrumentality
Product Identification
- The accused products are Accord’s proposed generic "Selenious Acid Injection USP, 60 mcg base/mL single-dose vials and 600 mcg base/10 mL (60 mcg base/mL) Pharmacy Bulk Package" ("ANDA Products"), for which Accord seeks FDA approval via ANDA No. 218655 (Compl. ¶1, ¶27).
Functionality and Market Context
- The complaint alleges the ANDA Products are generic versions of Plaintiff's own Selenious Acid products and are intended to serve as a source of selenium for parenteral nutrition (Compl. ¶17, ¶26). The complaint states that the ANDA Products contain the "same or equivalent ingredients in the same or equivalent amounts" and will have the "same or equivalent chemical and therapeutic properties" as Plaintiff's reference listed drug (Compl. ¶26, ¶28).
No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint does not contain a detailed claim chart. The infringement theory is based on 35 U.S.C. § 271(e)(2), where the filing of the ANDA is the statutory act of infringement. The substantive allegation is that Accord's product, being a generic version of Plaintiff's Orange Book-listed drug, will necessarily meet the limitations of the patent claims that cover that drug. The following chart summarizes this theory based on the allegations.
U.S. Patent No. 11,998,565 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An injectable composition comprising water... | Accord’s ANDA Products are injectable compositions containing the same or equivalent ingredients as Plaintiff's product, which is an aqueous solution. | ¶26, ¶27 | col. 10:59-65 |
| 6 µg or 60 µg of selenium, | Accord’s ANDA Products are identified as "Selenious Acid Injection USP, 60 mcg base/mL," which allegedly meets the "60 µg of selenium" limitation. | ¶27 | col. 11:1-4 |
| no chromium or chromium in an amount not to exceed 1 µg... | The complaint alleges Accord’s ANDA Products contain the "same or equivalent ingredients" as Plaintiff's product, which is covered by the patent, suggesting on information and belief that the ANDA product meets the claimed impurity profile for chromium. | ¶18, ¶26 | col. 17:1-2 |
| no aluminum or aluminum in an amount not to exceed 6 µg... | The complaint alleges Accord’s ANDA Products contain the "same or equivalent ingredients" as Plaintiff's product, which is covered by the patent, suggesting on information and belief that the ANDA product meets the claimed impurity profile for aluminum. | ¶18, ¶26 | col. 17:4-8 |
| no iron or iron in an amount up to 10 µg... | The complaint alleges Accord’s ANDA Products contain the "same or equivalent ingredients" as Plaintiff's product, which is covered by the patent, suggesting on information and belief that the ANDA product meets the claimed impurity profile for iron. | ¶18, ¶26 | col. 17:10-15 |
| and fluoride in an amount of 0.0001 µg to 2.7 µg per 1 mL... | The complaint alleges Accord’s ANDA Products contain the "same or equivalent ingredients" as Plaintiff's product, which is covered by the patent, suggesting on information and belief that the ANDA product meets the claimed impurity profile for fluoride. | ¶18, ¶26 | col. 17:5-8 |
Identified Points of Contention
- Evidentiary Questions: The complaint relies on the premise that the ANDA product is a bioequivalent copy of the reference drug. A primary point of contention will be whether discovery of Accord's confidential ANDA submission confirms that its product formulation actually meets every quantitative and negative limitation of the asserted claims, particularly the specified upper limits for impurities like chromium, aluminum, iron, and fluoride.
- Scope Questions: The interpretation of the negative limitations (e.g., "no chromium or chromium in an amount not to exceed 1 µg") will be critical. The parties may dispute whether "no chromium" requires absolute absence or merely a level below a certain limit of detection, and how that impacts the infringement analysis.
V. Key Claim Terms for Construction
- The Term: "no chromium or chromium in an amount not to exceed 1 µg"
- Context and Importance: This negative limitation is central to defining the purity of the claimed composition. Infringement will depend on whether the accused product falls within this specific purity window. Practitioners may focus on this term because proving a negative (the absence or near-absence of a substance) is an evidentiary focal point, and the interpretation of "no" versus a specific threshold is a common area for claim construction disputes.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party arguing for a broader scope (i.e., that any amount under 1 µg infringes) may point to the plain language of the full phrase, suggesting the disjunctive "or" makes the specific numerical limit the controlling factor.
- Evidence for a Narrower Interpretation: A party arguing for a narrower scope could focus on the term "no chromium," potentially arguing it creates a separate requirement of absolute absence that is distinct from the alternative "not to exceed 1 µg." However, the patent specification itself appears to contemplate the potential presence of chromium as an impurity. For example, Table 2 ("Specifications and Properties of Trace Elements Injectable Composition") lists a target for "Chromium (Cr)" of "Not more than 1.0 µg/mL," which may suggest the patentee's own understanding was that the critical aspect is keeping the impurity below the specified cap ('565 Patent, col. 14, row "Chromium (Cr)").
VI. Other Allegations
Indirect Infringement
- The complaint alleges induced infringement under 35 U.S.C. § 271(b), asserting that Accord's proposed package insert for its ANDA Products will actively instruct and encourage medical practitioners and patients to administer the product in a manner that directly infringes one or more claims of the ’565 Patent (Compl. ¶31). The complaint alleges Accord possesses the requisite knowledge and specific intent for this conduct (Compl. ¶31).
Willful Infringement
- The complaint alleges that Accord has had knowledge of the ’565 patent since at least the date it submitted its ANDA with the Paragraph IV certification (Compl. ¶34). It further pleads that the case is "exceptional" and seeks enhanced damages and attorneys' fees, which implies an allegation of willful infringement (Compl. ¶35, ¶(g)).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of evidentiary proof: Will the chemical composition and impurity profile detailed in Accord’s confidential ANDA filing, once revealed in discovery, fall squarely within the precise quantitative limitations of the asserted claims, especially the upper limits for impurities like chromium, aluminum, and iron?
- A key legal question will be one of claim scope: How will the court construe the negative limitation "no chromium or chromium in an amount not to exceed 1 µg"? The interpretation of this phrase will define the purity standard the accused product must meet to infringe and will likely be a focal point of claim construction.