American Regent Inc v. Steriscience Pte Ltd

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: American Regent, Inc. (New York)
  • Defendant: Steriscience Pte. Ltd (Singapore)
  • Plaintiff’s Counsel: GIBBONS P.C.
• Case Identification: 2:24-cv-07809, D.N.J., 07/16/2024
• Venue Allegations: Venue is asserted on the basis that the Defendant is a foreign company not residing in any U.S. judicial district and has purposefully availed itself of the rights and benefits of New Jersey.
• Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) for a generic version of Plaintiff's Selenious Acid injection product constitutes an act of infringement of a patent covering stable trace element compositions.
• Technical Context: The technology involves injectable formulations containing trace elements, such as selenium, which are administered as part of parenteral nutrition to patients who are unable to absorb nutrients through the digestive tract.
• Key Procedural History: This Hatch-Waxman action was initiated following Plaintiff's receipt of a Paragraph IV certification notice letter, dated June 26, 2024, in which Defendant sought FDA approval to market its generic product prior to the expiration of Plaintiff's patent listed in the FDA's "Orange Book."

Case Timeline

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 short stability period (typically 24-48 hours) of parenteral nutrition solutions once trace elements are added, which necessitates frequent, costly, and time-consuming admixing under strict aseptic conditions ( '565 Patent, col. 1:56 - col. 2:30).
• The Patented Solution: The invention is a stable, injectable trace element composition that can be added to parenteral nutrition, allowing the final admixture to remain stable for a longer period, such as up to 14 days under refrigeration ('565 Patent, Abstract; col. 18:60-64). This extended stability is achieved through specific formulations that control the concentrations of active ingredients and limit certain impurities ('565 Patent, col. 2:31-44).
• Technical Importance: The claimed solution aims to reduce waste and cost while improving the quality of life for patients and caregivers by enabling the preparation of parenteral nutrition doses in larger, more stable batches ('565 Patent, col. 2:31-44).

Key Claims at a Glance

• The complaint asserts infringement of multiple claims, including independent claim 1 ('Compl. ¶23).
• The essential elements of independent claim 1 include:
  • 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
• The complaint reserves the right to assert numerous other claims, including dependent claims and other independent claims such as 15 and 26 (Compl. ¶23; '565 Patent, col. 71:36 - col. 72:67).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is Defendant Steriscience’s proposed generic drug product, identified in its ANDA No. 219492 (Compl. ¶1). The complaint specifies the product as "Selenious Acid, eq. 600 mcg Selenium/10 mL (eq. 60 mcg Selenium/mL) intravenous solution" (Compl. ¶25).

Functionality and Market Context

• The product is an intravenous solution intended to provide the trace element selenium to patients receiving parenteral nutrition (Compl. ¶25).
• The complaint alleges the ANDA Product is a generic version of Plaintiff's approved Selenious Acid products, containing the same or equivalent active ingredients and possessing the same or equivalent chemical and therapeutic properties (Compl. ¶¶24, 27). It seeks to enter the U.S. market as a lower-cost generic alternative prior to the expiration of the '565 Patent (Compl. ¶1).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint's infringement theory is based on the contents of Steriscience’s ANDA submission, which constitutes a statutory act of infringement under 35 U.S.C. § 271(e)(2). The specific technical details of the accused product are contained within the confidential ANDA, but the complaint alleges that the product, if approved and marketed, would meet all limitations of the asserted claims (Compl. ¶29).

’565 Patent Infringement Allegations

Identified Points of Contention

• Evidentiary Questions: The central dispute will depend on the precise formulation detailed in Steriscience's confidential ANDA. A key factual question is whether the ANDA product's composition, particularly with respect to its impurity profile (chromium, aluminum, iron, fluoride), falls within the specific ranges recited in the asserted claims. The complaint does not present this evidence, relying instead on the act of the ANDA submission itself.
• Scope Questions: The case raises questions about the interpretation of the negative limitations in the claims. For example, the proper construction of "no chromium or chromium in an amount not to exceed 1 µg" will be critical to determining the scope of the claim and, consequently, whether the ANDA product infringes.

V. Key Claim Terms for Construction

• The Term: "no chromium or chromium in an amount not to exceed 1 µg"
• Context and Importance: This term, a negative limitation, defines the upper boundary for an impurity. Its construction is critical because if the ANDA product contains chromium, the amount will determine infringement. Practitioners may focus on this term because the interplay between "no" and the quantitative limit ("not to exceed 1 µg") creates ambiguity.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation (favors Defendant): A defendant might argue that "no chromium" and "chromium in an amount not to exceed 1 µg" are distinct alternatives, where "no" means absolutely zero or undetectable. The specification states that "the injectable composition of this disclosure does not contain any detectable chromium or no chromium at all" ('565 Patent, col. 13:58-61), which could support an argument that "no" is an independent, stringent requirement.
  • Evidence for a Narrower Interpretation (favors Plaintiff): A plaintiff would likely argue the phrase establishes a single permissible range of 0 to 1 µg/mL. Table 4 of the patent, which lists "Elemental Impurities Concentration Limits," specifies a "Control Threshold" and "Specification" for chromium of 1.0 µg/mL ('565 Patent, col. 16), suggesting the inventors contemplated and defined an acceptable level of the impurity, rather than demanding its complete absence.

VI. Other Allegations

• Indirect Infringement: The complaint alleges induced infringement under 35 U.S.C. § 271(b), asserting that Steriscience’s proposed package insert will instruct and encourage medical practitioners to administer the ANDA Product in an infringing manner (Compl. ¶30). It also alleges contributory infringement under § 271(c), claiming the product is especially made for an infringing use and is not suitable for a substantial non-infringing use (Compl. ¶31).
• Willful Infringement: While the complaint does not use the term "willful," it alleges that Steriscience has had knowledge of the '565 patent since at least the date it submitted its ANDA and was aware its submission constituted an act of infringement (Compl. ¶33). Plaintiff seeks a finding that the case is "exceptional" and an award of attorneys' fees under 35 U.S.C. § 285, which is often predicated on conduct akin to willfulness (Compl. ¶34; Prayer for Relief (g)).

VII. Analyst’s Conclusion: Key Questions for the Case

• A central issue will be one of evidentiary proof: does the formulation described in Steriscience's confidential ANDA filing meet every positive and negative limitation of the asserted claims? The dispute will turn on facts not yet on the public record, making discovery into the ANDA's contents the critical next step.
• A dispositive issue will be one of claim construction: how will the court interpret the phrase "no chromium or chromium in an amount not to exceed 1 µg"? The resolution of whether this creates a strict "zero-or-less-than-1-µg" standard or simply defines an acceptable range from zero up to 1 µg will be fundamental to the infringement analysis.