DCT
2:24-cv-07803
American Regent Inc v. Hikma Pharma USA Inc
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: American Regent, Inc. (New York)
- Defendant: Hikma Pharmaceuticals USA Inc. (Delaware)
- Plaintiff’s Counsel: Gibbons P.C.
- Case Identification: 2:24-cv-07803, D.N.J., 07/16/2024
- Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant maintains a regular and established place of business in Berkeley Heights, New Jersey, from which it purportedly submitted the Abbreviated New Drug Application (ANDA) that gives rise to this action.
- Core Dispute: Plaintiff alleges that Defendant’s submission of an ANDA to the FDA seeking approval to market generic versions of Plaintiff's Selenious Acid injectable products constitutes an act of infringement of a patent covering trace element compositions.
- Technical Context: The technology concerns stable, injectable solutions of trace elements, such as selenium, which are used in parenteral nutrition for patients who cannot receive nutrients through normal digestion.
- Key Procedural History: This lawsuit was initiated under the Hatch-Waxman Act after Defendant filed an ANDA containing a Paragraph IV Certification, which asserts that the patent-in-suit is either invalid or will not be infringed by Defendant's proposed generic product. The patent-in-suit is listed in the FDA's "Orange Book" in connection with Plaintiff's Selenious Acid products.
Case Timeline
| Date | Event |
|---|---|
| 2019-04-30 | Plaintiff's New Drug Application (NDA 209379) for Selenious Acid approved by FDA. |
| 2020-07-02 | '565 Patent Priority Date. |
| 2024-06-04 | '565 Patent Issue Date. |
| 2024-06-10 | Defendant sends Paragraph IV Notice Letter to Plaintiff. |
| 2024-07-16 | Complaint Filing 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 section describes the problem of instability in parenteral nutrition (PN) solutions once trace elements are added. Such admixtures often have a short shelf-life of 24 to 48 hours due to issues like particulate formation, which leads to product waste, increased costs, and logistical burdens for patients and healthcare providers (’565 Patent, col. 1:46-col. 2:14). Additionally, existing multi-element formulations are not easily customized for specific patient needs (’565 Patent, col. 2:15-24).
- The Patented Solution: The invention provides for stable, injectable trace element compositions that are designed to remain stable for longer periods (e.g., at least 3 to 14 days) after being added to a PN solution (’565 Patent, col. 4:3-5). This enhanced stability allows the compositions to be prepared in batches, reducing waste and improving convenience, and enables the creation of formulations with specific, customized dosages of elements like selenium (’565 Patent, Abstract; col. 2:31-44).
- Technical Importance: This technology aims to improve the efficiency, cost-effectiveness, and safety of administering essential trace elements as part of parenteral nutrition therapy (’565 Patent, col. 2:31-44).
Key Claims at a Glance
- The complaint does not identify specific claims, but based on the accused product, independent claim 15 is representative.
- Essential elements of independent claim 15:
- 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
- iodine in an amount of 0.0001 µg to 0.2 µg
- per 1 mL of the injectable composition.
- The complaint reserves the right to assert other claims of the ’565 patent (Compl. ¶29).
III. The Accused Instrumentality
Product Identification
Defendant’s proposed generic Selenious Acid products ("the ANDA Products") described in ANDA No. 217680 (Compl. ¶1).
Functionality and Market Context
The accused products are injectable solutions intended as generic equivalents to Plaintiff’s approved Selenious Acid products, which are used as a source of selenium in parenteral nutrition (Compl. ¶¶1, 23). The complaint identifies three formulations in the ANDA: Selenious Acid Injection, USP (1) 12 mcg/2 mL (equivalent to 6 mcg/mL); (2) 60 mcg/mL in a single dose vial; and (3) 600 mcg/10 mL (equivalent to 60 mcg/mL) in a pharmacy bulk package (Compl. ¶24). The complaint alleges these products contain the same or equivalent ingredients and will have the same or equivalent chemical and therapeutic properties as Plaintiff's patented products (Compl. ¶¶25-26).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
’565 Patent Infringement Allegations
| Claim Element (from Independent Claim 15) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An injectable composition comprising water... | The ANDA Products are described as aqueous "Selenious Acid Injection, USP" solutions. | ¶24 | col. 14:45-50 |
| ...6 µg or 60 µg of selenium... per 1 mL of the injectable composition. | The complaint states the ANDA Products are formulated at concentrations of 6 mcg/mL and 60 mcg/mL. | ¶24 | col. 15:20-22 |
| ...no chromium or chromium in an amount not to exceed 1 µg... | The complaint alleges the ANDA Products contain the "same or equivalent ingredients" as Plaintiff’s products, which are covered by the patent claims, thereby implying this purity level is met. | ¶¶23, 25 | col. 16:Table 4 |
| ...no aluminum or aluminum in an amount not to exceed 6 µg... | The complaint alleges the ANDA Products contain the "same or equivalent ingredients" as Plaintiff’s products, which are covered by the patent claims, thereby implying this purity level is met. | ¶¶23, 25 | col. 16:Table 4 |
| ...no iron or iron in an amount up to 10 µg... | The complaint alleges the ANDA Products contain the "same or equivalent ingredients" as Plaintiff’s products, which are covered by the patent claims, thereby implying this purity level is met. | ¶¶23, 25 | col. 16:Table 4 |
| ...and iodine in an amount of 0.0001 µg to 0.2 µg... | The complaint alleges the ANDA Products contain the "same or equivalent ingredients" as Plaintiff’s products, which are covered by the patent claims, thereby implying the presence of this element. | ¶¶23, 25 | col. 17:1-9 |
Identified Points of Contention
- Evidentiary Questions: The complaint’s infringement theory rests on the allegation that the ANDA Products are generic equivalents to Plaintiff's patented products (Compl. ¶¶23, 25). A central evidentiary question will be whether discovery confirms that Defendant’s proposed formulation, as detailed in its ANDA, meets all limitations of the asserted claims. This includes not only the selenium concentration but also the specific negative limitations for chromium, aluminum, and iron, and the positive limitation for iodine.
- Technical Questions: The negative limitations (e.g., "no chromium or chromium in an amount not to exceed 1 µg") raise technical questions regarding the threshold for detection and whether unavoidable trace impurities would constitute infringement. The resolution may depend on the analytical methods used to assess the composition of the ANDA products.
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 a defining feature of the claim, establishing a specific purity standard. The construction of this term is critical because infringement will depend on proving the absence, or near-absence, of this element in the accused product. The outcome will determine whether any detectable amount of chromium, however small, voids an infringement claim.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation (favoring patentee): A party might argue the phrase establishes a clear ceiling of 1 µg/mL, and any product with a chromium concentration at or below this level, including zero, falls within the claim's scope. This reading treats "no chromium" as the ideal and "not to exceed 1 µg" as the permissible upper bound.
- Evidence for a Narrower Interpretation (favoring accused infringer): A party may point to the patent's own specification, which lists a "Control Threshold" for chromium impurities and a specific limit of 1.0 µg/mL in its product specifications (’565 Patent, col. 16:Table 4; col. 17:Table 4). This could support an argument that the claim term is not merely aspirational but defines a precise, measurable purity requirement that must be proven.
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement, stating that Defendant’s proposed package insert will instruct and encourage medical professionals and patients to administer the ANDA Products in a manner that directly infringes the ’565 patent (Compl. ¶29). It further alleges contributory infringement, asserting that the ANDA Products are especially made for an infringing use and are not suitable for substantial non-infringing use (Compl. ¶30).
- Willful Infringement: The complaint alleges that Defendant has had knowledge of the ’565 patent since at least the date it submitted its ANDA with the Paragraph IV certification (Compl. ¶32). It seeks a finding that the case is "exceptional" and an award of attorneys' fees, which is predicated on a high degree of culpability such as willful infringement (Compl. ¶33).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of evidentiary confirmation: Will discovery of Defendant's confidential ANDA submission reveal a product formulation that meets every limitation of the asserted claims? The case's viability depends on whether Plaintiff can prove that the accused product contains the specified selenium and iodine concentrations while simultaneously meeting the stringent purity requirements for chromium, aluminum, and iron.
- A key legal question will be one of definitional interpretation: How will the court construe the negative limitations, such as "no chromium or chromium in an amount not to exceed 1 µg"? The determination of whether this language requires absolute absence versus adherence to a specific impurity threshold, as potentially defined by the patent's own specification, will be central to the infringement analysis.