DCT

2:24-cv-07799

American Regent Inc v. DR Reddy's Laboratories Inc

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:24-cv-07799, D.N.J., 07/16/2024
  • Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because Defendant Dr. Reddy's Laboratories, Inc. is incorporated in, resides in, and has a regular and established place of business in the district. It is further alleged that both defendants have committed acts of infringement in New Jersey and intend to market the accused product in the state.
  • Core Dispute: Plaintiff alleges that Defendants’ filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's Selenious Acid injection product constitutes an act of infringement of a patent covering stable trace element compositions for parenteral use.
  • Technical Context: The lawsuit concerns injectable pharmaceutical formulations used in parenteral nutrition, which provides nutrients intravenously to patients who cannot eat or absorb food through the digestive tract.
  • Key Procedural History: The action was triggered by Defendants' submission of ANDA No. 218639 to the U.S. Food and Drug Administration (FDA) with a Paragraph IV Certification. This certification asserts that U.S. Patent No. 11,998,565 is invalid, unenforceable, or will not be infringed by the manufacture and sale of the proposed generic product. Plaintiff received a Notice Letter from Defendants regarding the ANDA filing on June 10, 2024.

Case Timeline

Date Event
2019-04-30 FDA approval for Plaintiff's NDA No. 209379 (Selenious Acid)
2020-07-02 Earliest Priority Date for ’565 Patent
2024-06-04 U.S. Patent No. 11,998,565 Issued
2024-06-10 Date of Defendants' Notice Letter regarding ANDA filing
2024-07-16 Complaint Filed

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

U.S. Patent No. 11,998,565 - Trace element compositions, methods of making and use

  • Issued: June 4, 2024

The Invention Explained

  • Problem Addressed: The patent's background describes a significant limitation with conventional parenteral nutrition (PN): once trace elements like zinc or copper are added to a PN solution, the mixture has a very short stability period, typically only 24 to 48 hours at room temperature (’565 Patent, col. 1:56-2:4). This short shelf-life leads to waste, increased costs, and logistical burdens for patients and healthcare providers, who must frequently prepare fresh admixtures (’565 Patent, col. 2:5-15).
  • The Patented Solution: The invention provides stable, injectable trace element compositions that, when added to parenteral nutrition, allow the final mixture to remain stable for a longer period (’565 Patent, Abstract; col. 2:31-35). This extended stability is intended to reduce waste and improve convenience by allowing PN bags to be prepared in batches or less frequently (’565 Patent, col. 2:35-44). The specification describes specific formulations of elements like selenium, zinc, copper, and manganese designed to achieve this stability (’565 Patent, col. 3:1-4:65).
  • Technical Importance: The invention addresses a practical and economic challenge in clinical nutrition by aiming to extend the usable life of admixed parenteral nutrition solutions, thereby reducing costs and improving the quality of life for patients dependent on intravenous feeding (’565 Patent, col. 2:31-44).

Key Claims at a Glance

  • The complaint asserts infringement of claims 1-2, 4-11, 13-17, 19-20, 22-26, and 28-29 of the ’565 patent (Compl. ¶31). The lead independent claims are 1 and 15.
  • 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
  • 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

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are the generic drug products described in Defendants' ANDA No. 218639 ("the ANDA Products") (Compl. ¶1).

Functionality and Market Context

  • The complaint identifies the ANDA Products as generic versions of Plaintiff's Selenious Acid products, specifically "selenious acid, intravenous solution, EQ 600 mcg Selenium/10 mL and EQ 60 mcg Selenium/mL" (Compl. ¶32-33).
  • The complaint alleges that the ANDA Products contain the "same or equivalent ingredients in the same or equivalent amounts" as Plaintiff's FDA-approved products and will feature the "same or equivalent chemical and therapeutic properties" (Compl. ¶32, ¶34-35). As generic drugs, they are intended to be therapeutically equivalent and thus directly compete with Plaintiff's branded product (Compl. ¶1).
  • 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 the allegation that Defendants' ANDA Products are generic versions of Plaintiff's own products, which are covered by the ’565 Patent, and will therefore necessarily meet the limitations of the asserted claims (Compl. ¶24, ¶32, ¶35).

’565 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
An injectable composition comprising water, [and] 6 µg or 60 µg of selenium... The complaint alleges the ANDA Products are "selenious acid, intravenous solution" containing "EQ 60 mcg Selenium/mL," which corresponds to the "60 µg of selenium" limitation. The product is also alleged to contain the same or equivalent ingredients as Plaintiff's product. ¶32-34 col. 23:1-9
...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 does not provide specific data regarding the impurity profile of the ANDA Products. Infringement of these negative limitations is asserted on the basis that the ANDA Products are generic versions of Plaintiff's products and will have the "same or equivalent chemical and therapeutic properties," which are alleged to be covered by the claims of the '565 patent. ¶35, ¶37 col. 16:52-17:2

Identified Points of Contention

  • Scope Questions: A primary question for the court will be the proper construction of the negative limitations, such as "no chromium." Does this require an absolute absence of the element, or does it mean "not containing any detectable chromium" as the specification suggests at col. 16:60-61? The claim's alternative phrasing ("no chromium or chromium in an amount not to exceed 1 µg") introduces ambiguity as to whether these are two distinct standards.
  • Technical Questions: The complaint's infringement theory rests on the premise of bioequivalence. A key factual question will be whether Defendants' ANDA Product, upon chemical analysis, actually meets the specific quantitative limits for selenium and the recited impurities (chromium, aluminum, iron, fluoride, and iodine) as required by the asserted claims. The complaint does not provide this direct evidence.

V. Key Claim Terms for Construction

  • The Term: "no chromium" (Claim 1)
  • Context and Importance: This is a negative limitation, and its construction is critical for determining infringement. If construed to mean an absolute absence, proving infringement could be difficult. If construed to mean "non-detectable" or simply anything below the 1 µg/mL threshold also recited, the standard for infringement changes. Practitioners may focus on this term because the claim language "no chromium or chromium in an amount not to exceed 1 µg" creates an interpretive puzzle.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation (favoring Defendant): A defendant may argue that "no chromium" is an alternative to, and not stricter than, the "not to exceed 1 µg" limitation, effectively setting a single upper boundary.
    • Evidence for a Narrower Interpretation (favoring Plaintiff): The specification states, "In many cases, the injectable composition of this disclosure does not contain any detectable chromium or no chromium at all" (’565 Patent, col. 16:60-61). Plaintiff may argue this language supports a construction requiring chromium levels to be non-existent or below the level of detection, a standard potentially stricter than the explicit 1 µg/mL limit.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement, stating that Defendants' proposed package insert will instruct and encourage medical practitioners to administer the ANDA Product in a manner that infringes the ’565 patent (Compl. ¶38). Contributory infringement is alleged on the basis that the ANDA Products are "especially made or adapted for use in infringing the '565 patent" and are "not suitable for substantial non-infringing use" (Compl. ¶39).
  • Willful Infringement: Willfulness is alleged based on Defendants' knowledge of the ’565 patent, which the complaint asserts existed "since at least the date DRL submitted the ANDA with a Paragraph IV Certification" (Compl. ¶41). The complaint also pleads that the case is "exceptional," seeking an award of attorneys' fees (Compl. ¶42).

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

This Hatch-Waxman action will likely center on two fundamental issues for the court's determination:

  • A core issue will be one of claim construction and proof: What is the precise meaning of the negative limitation "no chromium" in the context of the full claim language, and can Plaintiff produce evidence that Defendants' proposed generic product actually meets this and the other stringent impurity limits?
  • A key evidentiary question will be one of compositional fact: Beyond the legal presumption of equivalence, what does a chemical analysis of the ANDA product reveal? The case will depend on whether the specific formulation that Dr. Reddy's intends to market falls within the literal scope of the asserted claims, particularly with respect to the quantified amounts of selenium and various specified impurities.