DCT

1:24-cv-00825

American Regent Inc v. Long Grove Pharma LLC

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:24-cv-00825, D. Del., 07/16/2024
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant is a limited liability company organized and existing under the laws of Delaware.
  • Core Dispute: Plaintiff alleges that Defendant’s Abbreviated New Drug Application (ANDA) submission for a generic Selenious Acid injectable product infringes a patent on stable trace element compositions for parenteral nutrition.
  • Technical Context: The technology involves stable, injectable formulations of trace elements, such as selenium, used to supplement parenteral (intravenous) nutrition for patients who cannot receive adequate nourishment orally.
  • Key Procedural History: This action under the Hatch-Waxman Act was precipitated by Defendant Long Grove's submission of an ANDA with a Paragraph IV certification. The certification challenges Plaintiff American Regent's U.S. Patent No. 11,998,565, which is listed in the FDA's Orange Book in connection with American Regent's Selenious Acid products and is not set to expire until 2041.

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
2024-06-27 Defendant sends Paragraph IV Notice Letter to Plaintiff
2024-07-16 Complaint Filing Date

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

  • Patent Identification: 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 section describes the problem of instability when trace elements are added to parenteral nutrition (PN) solutions. Such admixtures often have a short usable life of only 24 to 48 hours, which can lead to waste, increased costs, and logistical burdens for patients requiring frequent preparation of their intravenous nutrition. (’565 Patent, col. 2:3-24).
    • The Patented Solution: The invention provides stable, injectable trace element compositions that can be added to parenteral nutrition, thereby extending the stability of the final admixture. (’565 Patent, col. 2:31-40). The patent describes specific formulations containing selenium, often with defined low levels or the absence of other elements like chromium, which the specification notes are not always needed in daily dosages. (’565 Patent, Abstract; col. 2:42-44).
    • Technical Importance: By creating more stable formulations, the invention sought to reduce waste and improve the quality of life for patients on long-term PN, as it allows PN bags to be prepared in batches and stored for longer periods, reducing the frequency of admixing. (’565 Patent, col. 2:35-40).
  • Key Claims at a Glance:
    • The complaint asserts infringement of "one or more claims" of the ’565 patent without specifying them (Compl. ¶28). Independent claim 1 is representative of the patent's focus on selenium compositions with specific impurity profiles.
    • The essential elements of independent claim 1 are:
      • 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.

III. The Accused Instrumentality

  • Product Identification: Defendant's proposed generic Selenious Acid products ("the ANDA Products"), which are the subject of ANDA No. 217850 (Compl. ¶1).
  • Functionality and Market Context:
    • The ANDA Products are described as injectable solutions of selenious acid intended to be generic versions of Plaintiff's approved Selenious Acid products (Compl. ¶23). The complaint states the ANDA Products will have concentrations of "eq. 12 mcg Selenium/2mL (eq. 6 mcg Selenium/mL)" and "eq. 60 mcg Selenium/mL (eq. 60 mcg Selenium/mL)," designed for use as additives in parenteral nutrition (Compl. ¶24).
    • The complaint alleges that the ANDA Products contain the same or equivalent ingredients in the same or equivalent amounts as Plaintiff's products and will feature the same or equivalent chemical and therapeutic properties (Compl. ¶¶25-26).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

  • Claim Chart Summary: The complaint does not include a claim chart. The following table summarizes the infringement theory for representative Claim 1 based on the complaint's narrative allegations.
Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
An injectable composition comprising water, The ANDA Products are described as injectable solutions of Selenious Acid. ¶24 col. 3:13-17
6 µg or 60 µg of selenium, The ANDA Products are disclosed as having concentrations equivalent to 6 µg/mL and 60 µg/mL of selenium. ¶24 col. 9:25-34
no chromium or chromium in an amount not to exceed 1 µg, The complaint alleges the ANDA Products are generic versions of the patented product, implying they meet this negative limitation. ¶¶23, 26, 28 col. 16:56-61
no aluminum or aluminum in an amount not to exceed 6 µg, The complaint alleges the ANDA Products are generic versions of the patented product, implying they meet this negative limitation. ¶¶23, 26, 28 col. 17:5-10
no iron or iron in an amount up to 10 µg, The complaint alleges the ANDA Products are generic versions of the patented product, implying they meet this negative limitation. ¶¶23, 26, 28 col. 1:1-73:74
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 details on the fluoride content but alleges infringement of "one or more claims." Other independent claims (e.g., Claim 15) recite iodine instead of fluoride. ¶¶23, 26, 28 col. 17:1-5
  • Identified Points of Contention:
    • Evidentiary Question: The complaint's infringement theory rests on the ANDA Products being a generic equivalent to the Plaintiff's product (Compl. ¶23). A key evidentiary issue for the court will be a direct compositional analysis of the ANDA product to determine if it meets the specific positive (e.g., fluoride or iodine) and negative (e.g., limits on chromium, aluminum, iron) limitations of the asserted claims.
    • Scope Question: A potential dispute may arise over the construction of negative limitations such as "no chromium." The full claim phrase, "no chromium or chromium in an amount not to exceed 1 µg," raises the question of whether "no chromium" means an absolute absence or is simply a subset of the broader "not to exceed 1 µg" limitation.

V. Key Claim Terms for Construction

  • The Term: "no chromium"
  • Context and Importance: This negative limitation appears central to the patent's claims, distinguishing the invention from prior art multi-trace element compositions that included chromium. The definition of this term will be critical for both infringement (if the accused product contains any detectable chromium) and validity (in determining the scope of the claim over the prior art).
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A party arguing for a broader scope (i.e., that any amount under the 1 µg cap infringes) would point to the full claim phrase "no chromium or chromium in an amount not to exceed 1 µg" (e.g., ’565 Patent, col. 71:43-45). This suggests the patent contemplates the presence of some chromium, as long as it does not exceed the specified cap. The specification’s statement that "daily doses of chromium are not typically needed" could be used to argue the invention’s purpose was to eliminate or reduce chromium, not require its absolute absence. (’565 Patent, col. 2:42-44).
    • Evidence for a Narrower Interpretation: A party seeking a narrower scope might argue that "no chromium" should be given its plain and ordinary meaning of absolute absence, separate from the alternative "or chromium in an amount not to exceed 1 µg." Such an argument would attempt to create a distinction where a product with any detectable level of chromium would not infringe the "no chromium" portion of the limitation.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon approval, Long Grove will induce infringement by medical practitioners and patients who will administer the ANDA Product according to the instructions in its proposed package insert (Compl. ¶29). It further alleges contributory infringement, stating the product is especially made for infringing use and is not suitable for a substantial non-infringing use (Compl. ¶30).
  • Willful Infringement: Willfulness is not explicitly alleged. However, the complaint asserts that Long Grove has had knowledge of the '565 patent since at least the date it submitted the ANDA and that the case is "exceptional" under 35 U.S.C. § 285, which could entitle the Plaintiff to attorneys' fees (Compl. ¶¶32-33).

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

  • A central issue will be one of compositional fact: does Long Grove's proposed generic product, as specified in its ANDA, contain the precise combination of required components (e.g., selenium and fluoride/iodine) and excluded components (e.g., chromium, aluminum, iron below specified limits) to fall within the scope of the asserted claims? The court's determination will likely depend on chemical analysis beyond the assertions of equivalence in the complaint.
  • A second key question will concern validity over prior art: can the claims, which focus on compositions with specific low-level impurity profiles and the removal of a previously common element (chromium), withstand a challenge of obviousness? The case may turn on whether removing an ingredient acknowledged in the patent as "not typically needed" constitutes a patentable invention.