DCT

2:24-cv-07810

American Regent Inc v. Sun Pharmaceutical Industries Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:24-cv-07810, D.N.J., 07/16/2024
  • Venue Allegations: Venue is asserted based on Defendant Sun Pharmaceutical Industries, Inc.’s principal place of business, headquarters, offices, and laboratories located within the District of New Jersey.
  • Core Dispute: Plaintiff alleges that Defendants’ filing of an Abbreviated New Drug Application (ANDA) to market a generic Selenious Acid injection constitutes an act of infringement of a patent covering stable trace element compositions for parenteral nutrition.
  • Technical Context: The technology relates to injectable trace element formulations used in parenteral nutrition, which provides intravenous nutrients to patients who cannot ingest food orally.
  • Key Procedural History: This is a patent infringement action under the Hatch-Waxman Act, triggered by Defendants' submission of ANDA No. 219547 with a Paragraph IV Certification. This certification asserts that U.S. Patent No. 11,998,565, which is listed in the FDA’s Orange Book for Plaintiff’s Selenious Acid products, is invalid or will not be infringed by the proposed generic product. Plaintiff was notified of the ANDA filing via a letter dated June 11, 2024.

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 Issue Date
2024-06-11 Defendant sends Paragraph IV Notice Letter to Plaintiff
2024-07-16 Complaint Filing Date
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"

  • Issued: June 4, 2024

The Invention Explained

  • Problem Addressed: The patent describes that when trace elements are added to parenteral nutrition (PN) solutions, the resulting admixtures have a short stability period, often just 24 to 48 hours. This necessitates frequent, costly, and time-consuming preparation of PN bags under aseptic conditions, limiting the ability to prepare doses in larger, more efficient batches. (’565 Patent, col. 2:1-17).
  • The Patented Solution: The invention is a stable, injectable trace element composition that can be added to parenteral nutrition, extending the stability of the final admixture. This allows the admixed PN solution to be prepared in batches and stored for a longer period, which is intended to reduce costs, improve efficiency for healthcare providers, and enhance the quality of life for a patient. (’565 Patent, col. 2:46-54). The patent discloses specific formulations, including those containing selenium, with defined concentrations and low levels of certain impurities. (’565 Patent, Abstract).
  • Technical Importance: The invention provides a solution to the practical clinical challenges of administering long-term parenteral nutrition, aiming to make the therapy safer, more convenient, and more cost-effective. (’565 Patent, col. 2:35-44).

Key Claims at a Glance

  • While the complaint does not specify which claims are asserted, Claim 1 is the first independent claim of the '565 Patent.
  • Essential elements of 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 alleges infringement of "one or more claims," reserving the right to assert other claims, including dependent claims. (Compl. ¶37).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is Defendants' proposed generic drug product identified in ANDA No. 219547: "Selenious Acid Injection, USP, 600 mcg/10 mL (60 mcg/mL) of selenium in a 10 mL pharmacy bulk package" ("the ANDA Product"). (Compl. ¶¶1, 32).

Functionality and Market Context

  • The ANDA Product is a generic version of Plaintiff's approved Selenious Acid products and is intended for use as a source of the trace element selenium in patients requiring parenteral nutrition. (Compl. ¶¶31, 34). The complaint alleges the ANDA Product contains the "same or equivalent ingredients in the same or equivalent amounts" as Plaintiff's reference listed drug and will have the same therapeutic properties. (Compl. ¶¶33-34). It seeks to enter the U.S. market as a lower-cost generic alternative prior to the expiration of the '565 Patent. (Compl. ¶1).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement 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, The ANDA Product is an injectable solution containing water. ¶32, ¶36 col. 4:11-19
6 µg or 60 µg of selenium, The ANDA Product is specifically identified as a "Selenious Acid Injection, USP, 600 mcg/10 mL (60 mcg/mL) of selenium." ¶32 col. 15:20-22
no chromium or chromium in an amount not to exceed 1 µg, The complaint alleges the ANDA product will infringe Claim 1, which requires this limitation regarding chromium content. ¶36 col. 13:55-61
no aluminum or aluminum in an amount not to exceed 6 µg, The complaint alleges the ANDA product will infringe Claim 1, which requires this limitation regarding aluminum content. ¶36 col. 18:1-3
no iron or iron in an amount up to 10 µg, and The complaint alleges the ANDA product will infringe Claim 1, which requires this limitation regarding iron content. ¶36 col. 13:55-61
fluoride in an amount of 0.0001 µg to 2.7 µg per 1 mL of the injectable composition. The complaint alleges the ANDA product will infringe Claim 1, which requires this limitation regarding fluoride content. ¶36 col. 17:5-9

Identified Points of Contention

  • Technical Questions: A primary point of contention will be factual: what is the precise chemical composition of the ANDA Product? The complaint does not provide details from Sun's ANDA submission. The infringement analysis will depend entirely on whether the ANDA Product meets the negative limitations for chromium, aluminum, and iron, as well as the positive limitation for fluoride, as recited in Claim 1.
  • Scope Questions: The case raises the question of whether being a "generic version" that is therapeutically equivalent is sufficient to meet all limitations of a formulation patent. (Compl. ¶31). While the selenium concentration appears to match, the infringement case will turn on the presence and quantity of other, non-active ingredients and potential impurities (chromium, aluminum, iron, fluoride) in the ANDA product, which are not addressed by bioequivalence alone.

V. Key Claim Terms for Construction

  • The Term: "no chromium or chromium in an amount not to exceed 1 µg"
  • Context and Importance: This is a negative limitation that defines the boundary of the claimed invention by what it is not. The construction of this term is critical because if the ANDA Product contains any amount of chromium, the infringement analysis will depend on whether that amount is above or below the threshold and how the "no chromium" language is interpreted. Practitioners may focus on this term because the interplay between "no chromium" and the specific upper limit ("not to exceed 1 µg") creates ambiguity that is central to defining the claim's scope.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A party could argue that the entire phrase should be read as a single limitation setting an upper bound. The explicit recitation "not to exceed 1 µg" could be interpreted as defining what "no chromium" means in the context of the claim, thereby permitting any amount of chromium from zero up to 1 µg/mL. The patent’s specification discusses chromium as a potential impurity to be minimized. (’565 Patent, col. 13:55-61).
    • Evidence for a Narrower Interpretation: A party could argue that "no chromium" and "chromium in an amount not to exceed 1 µg" are alternatives. The disjunctive "or" could mean the claim covers compositions with either an absolute absence of chromium or, alternatively, a measurable amount that is no more than 1 µg/mL. The patent repeatedly highlights the development of compositions "without chromium" as a departure from prior art, which could support construing "no chromium" as a distinct and preferred embodiment requiring absolute absence or a level below standard detection. (’565 Patent, col. 31, table title).

VI. Other Allegations

Indirect Infringement

  • The complaint alleges induced infringement on the basis that Defendants' proposed product labeling and instructions will encourage and direct medical practitioners to administer the ANDA Product in a manner that directly infringes the ’565 Patent. (Compl. ¶37). It further alleges contributory infringement, stating that the ANDA Product is especially made for an infringing use and is not suitable for a substantial non-infringing use. (Compl. ¶38).

Willful Infringement

  • The complaint asserts willfulness based on Defendants' knowledge of the ’565 Patent, which it claims existed "since at least the date Sun submitted the ANDA with a Paragraph IV Certification." (Compl. ¶40). This allegation forms the basis for a request for enhanced damages and a finding that the case is "exceptional" for the purpose of awarding attorneys' fees. (Compl. ¶41).

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

  • A central evidentiary question will be one of compositional identity: What are the precise amounts of chromium, aluminum, iron, and fluoride in the Defendants' ANDA Product? The case will likely depend on discovery related to the ANDA filing to determine if the proposed generic formulation falls within the specific positive and negative limitations of the asserted claims.
  • The key legal question will be one of claim construction: 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—whether it sets a simple upper limit or defines distinct alternatives—will be determinative of the scope of the patent and, consequently, the infringement analysis.