American Regent Inc v. DR Reddy's Laboratories Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: American Regent, Inc. (New York)
  • Defendant: Dr. Reddy's Laboratories, Inc. (New Jersey) and Dr. Reddy's Laboratories, Ltd. (India)
  • Plaintiff’s Counsel: Gibbons P.C.; Sterne, Kessler, Goldstein & Fox P.L.L.C.
• Case Identification: 2:24-cv-11114, D.N.J., 12/13/2024
• Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant Dr. Reddy's Laboratories, Inc. is a New Jersey corporation with a principal place of business in the district, and Defendant Dr. Reddy's Laboratories, Ltd. is a foreign corporation that may be sued in any judicial district.
• Core Dispute: Plaintiff alleges that Defendants' submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of Plaintiff's Selenious Acid products is an act of patent infringement under the Hatch-Waxman Act.
• Technical Context: The technology concerns stable, injectable trace element compositions used to supplement parenteral nutrition for patients who cannot receive nourishment through normal digestion.
• Key Procedural History: This action was triggered by Defendants' submission of ANDA No. 218639 containing a Paragraph IV Certification, asserting that the patent-in-suit is invalid or will not be infringed by the proposed generic product. The complaint notes a related case (24-cv-7799) involving the same ANDA but a different patent. The patent-in-suit is listed in the FDA's "Orange Book" as covering Plaintiff's Selenious Acid products.

Case Timeline

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 12,150,957 - "Trace element compositions, methods of making and use"

Issued November 26, 2024. (Compl. ¶25).

The Invention Explained

• Problem Addressed: The patent describes that when trace elements are added to parenteral nutrition (PN) solutions, the resulting mixture has a short stability period of 24 to 48 hours, after which precipitation or other issues may occur. This necessitates frequent, costly, and time-consuming admixing for patients, increases waste, and can contribute to drug supply shortages. (’957 Patent, col. 1:56 - 2:30).
• The Patented Solution: The invention provides stable injectable trace element compositions that, when added to PN solutions, result in a mixture that is stable for a longer period. This allows the PN solutions to be prepared in larger batches and less frequently, which is intended to reduce costs and improve the quality of life for patients and caregivers. (’957 Patent, Abstract; col. 2:31-44). The patent also discloses compositions with reduced or eliminated amounts of certain elements, such as chromium, compared to then-currently available products. (’957 Patent, col. 2:40-44).
• Technical Importance: By creating longer-lasting parenteral nutrition admixtures, the invention aimed to reduce the logistical and financial burden on patients requiring long-term intravenous feeding and on the healthcare facilities that serve them. (’957 Patent, col. 2:35-39).

Key Claims at a Glance

• The complaint asserts infringement of one or more unspecified claims of the '957 Patent. (Compl. ¶¶38-39). Independent claim 29 is representative of the method of use for the accused product category.
• The essential elements of independent claim 29 are:
  • A method of providing an injectable composition to a human patient in need thereof, comprising:
  • administering the injectable composition to the human patient,
  • wherein the injectable composition comprises water,
  • and per 1 mL of the composition:
    • selenious acid 98 µg,
    • 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 not to exceed 10 µg, and
    • either fluoride in an amount of 0.0001 µg to 2.7 µg, or iodine in an amount of 0.0001 µg to 0.2 µg.
• The complaint reserves the right to assert infringement of other claims, including dependent claims. (Compl. ¶¶38-39).

III. The Accused Instrumentality

Product Identification

Defendants' proposed generic versions of American Regent's Selenious Acid products, submitted to the FDA under ANDA No. 218639 ("the ANDA Products"). (Compl. ¶¶1, 32).

Functionality and Market Context

• The complaint alleges the ANDA Products are "selenious acid, intravenous solution" in concentrations of "EQ 600 mcg Selenium/10 mL and EQ 60 mcg Selenium/mL." (Compl. ¶33). These products are intended for administration to patients as a supplement for parenteral nutrition, according to instructions that will be provided in a proposed package insert. (Compl. ¶38).
• The complaint alleges that the ANDA Products contain the "same or equivalent ingredients in the same or equivalent amounts" and will feature the "same or equivalent chemical and therapeutic properties" as Plaintiff's corresponding approved drug products. (Compl. ¶¶34-35).
• No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not contain a detailed claim chart. The infringement allegations are based on the assertion that the ANDA Products are generic versions of Plaintiff's products and that their use, as instructed by the proposed label, will meet the limitations of the patent's claims. (Compl. ¶¶32-35, 38).

'957 Patent Infringement Allegations

Identified Points of Contention

• Technical Questions: The central dispute will likely be factual and evidentiary. A key question is: Does the composition detailed in Defendants' ANDA actually meet the strict negative limitations of Claim 29? The complaint alleges equivalence but does not provide specific data on the levels of chromium, aluminum, iron, fluoride, or iodine in the ANDA Products. Proving infringement will require evidence from the ANDA itself that these elements are absent or below the claimed thresholds.
• Scope Questions: The interpretation of the negative limitations (e.g., "no chromium") may become a point of contention. The court may need to determine if "no" means an absolute absence or is defined by the limits of detection technology.

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 critical to defining the scope of the invention and the boundary of infringement. The case may turn on whether Defendants' product, the exact formulation of which is not public, meets this purity standard. Practitioners may focus on this term because infringement requires proving the absence or near-absence of a substance, which can create significant evidentiary challenges for the plaintiff and opportunities for non-infringement or invalidity arguments for the defendant.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The plain language of the claim, "no chromium or chromium in an amount not to exceed 1 µg," presents two alternative ways to meet the limitation. This disjunctive phrasing could be argued to explicitly permit a de minimis amount of chromium up to the specified cap. ('957 Patent, col. 73:52-54).
  • Evidence for a Narrower Interpretation: The specification repeatedly emphasizes the complete removal of chromium as a key feature. It states, "the injectable composition of this disclosure does not contain any detectable chromium or no chromium at all" and distinguishes the invention from prior art products that intentionally include chromium. (’957 Patent, col. 17:49-51; col. 68, Table 35). This context could support an argument that the "not to exceed 1 µg" language is intended to account only for unavoidable trace impurities or limitations of detection, rather than a permissibly added amount.

VI. Other Allegations

• Indirect Infringement: The complaint alleges induced infringement, stating that Defendants intend for patients and medical professionals to use the ANDA Product in an infringing manner and that the proposed package insert will provide instructions for such use. (Compl. ¶38). It further alleges contributory infringement, claiming the product is especially made for an infringing use and is not suitable for substantial non-infringing use. (Compl. ¶39).
• Willful Infringement: While the term "willful" is not explicitly used, the complaint alleges that Defendants had knowledge of the '957 Patent since at least October 11, 2024, when Plaintiff notified them that the patent would be issuing. (Compl. ¶41). This allegation of pre-suit knowledge, combined with the act of filing the ANDA, may form the basis for a later claim of willful infringement. The complaint seeks a finding that the case is "exceptional" and an award of attorneys' fees, which is consistent with an allegation of willfulness. (Compl. ¶42; Prayer for Relief ¶(g)).

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

• A central issue will be one of evidentiary proof: As a notice pleading, the complaint asserts that the accused generic product will have a composition that infringes. The case will depend on whether discovery confirms this assertion, specifically regarding the negative limitations on impurities like chromium, aluminum, and iron, which are central to the asserted claim.
• A key legal question will be one of claim construction: The court's interpretation of the negative limitations, such as "no chromium or chromium in an amount not to exceed 1 µg," will be decisive. The dispute will likely focus on whether this language requires absolute absence or permits a defined tolerance, a determination that will shape the entire infringement analysis.