DCT

2:24-cv-07756

American Regent Inc v. Gland Pharma Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:24-cv-07756, D.N.J., 01/09/2025
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because the defendant is a foreign company not residing in any U.S. judicial district.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to market generic versions of Plaintiff's Tralement® and Multrys® injectable drug products constitutes infringement of five U.S. patents related to trace element compositions.
  • Technical Context: The technology concerns stable, injectable compositions of essential trace elements (zinc, copper, selenium, manganese) used for parenteral nutrition in patients unable to receive nourishment orally.
  • Key Procedural History: This action arises under the Hatch-Waxman Act following Defendant’s June 14, 2024 Notice Letter, which informed Plaintiff of its ANDA filing containing a Paragraph IV Certification asserting non-infringement or invalidity of the patents-in-suit. The complaint is an amended version filed with Defendant's consent.

Case Timeline

Date Event
2020-07-02 Earliest Priority Date for all Patents-in-Suit
2020-07-02 Plaintiff's Tralement® and Multrys® approved by the FDA
2023-10-17 U.S. Patent No. 11,786,548 Issued
2024-05-07 U.S. Patent No. 11,975,022 Issued
2024-06-04 U.S. Patent No. 11,998,565 Issued
2024-06-14 Defendant sends Paragraph IV Notice Letter to Plaintiff
2024-11-26 U.S. Patent No. 12,150,956 Issued
2024-11-26 U.S. Patent No. 12,150,957 Issued
2025-01-09 Amended Complaint for Patent Infringement Filed

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

No probative visual evidence provided in complaint.

U.S. Patent No. 11,786,548 - "Trace element compositions, methods of making and use"

  • Issued: October 17, 2023

The Invention Explained

  • Problem Addressed: The patent's background section describes that parenteral nutrition solutions containing trace elements often have a short stability period of 24 to 48 hours, which necessitates frequent, costly, and time-consuming admixing by healthcare providers and can lead to waste and drug supply shortages (’548 Patent, col. 2:5-24).
  • The Patented Solution: The invention is a stable, injectable trace element composition that, when added to parenteral nutrition, remains stable for a longer period. This reduces the need for frequent admixing and allows for the preparation of multiple daily doses or batches at once, improving convenience and reducing costs ('548 Patent, Abstract; col. 2:32-44).
  • Technical Importance: By providing a trace element composition that is stable for longer periods once admixed, the invention aims to improve the quality of life for patients and caregivers while lowering healthcare costs and mitigating drug supply issues associated with waste ('548 Patent, col. 2:32-39).

Key Claims at a Glance

  • The complaint asserts infringement of one or more claims of the ’548 Patent (Compl. ¶42). Claim 1 is a representative independent claim.
  • Essential elements of Claim 1 include:
    • An injectable composition comprising water, about 60 µg of selenium, 3,000 µg of zinc, about 300 µg of copper, and about 55 µg of manganese per 1 mL of the injectable composition
    • wherein the injectable composition contains 0 µg per 1 mL to about 10 µg per 1 mL of iron
    • does not contain any vitamins
    • contains no added chromium
    • contains no aluminum or aluminum in an amount not to exceed 6 µg per 1 mL of the injectable composition
  • The complaint does not explicitly reserve the right to assert dependent claims but makes a general allegation against the patent.

U.S. Patent No. 11,975,022 - "Trace element compositions, methods of making and use"

  • Issued: May 7, 2024

The Invention Explained

  • Problem Addressed: The patent addresses the same technical problem as the ’548 Patent: the short stability period of parenteral nutrition when combined with trace elements, leading to inefficiencies, high costs, and potential for waste (’022 Patent, col. 2:5-24).
  • The Patented Solution: The invention provides a method of using a stable trace element composition to supply essential nutrients to a patient. The composition's stability allows for less frequent preparation, which improves patient care and reduces healthcare burdens ('022 Patent, Abstract; col. 2:32-44).
  • Technical Importance: The claimed method of providing a stable trace element composition facilitates a more efficient and cost-effective regimen for parenteral nutrition, which is critical for patients with long-term needs ('022 Patent, col. 2:32-39).

Key Claims at a Glance

  • The complaint asserts infringement of one or more claims of the ’022 Patent (Compl. ¶49). Claim 1 is a representative independent method claim.
  • Essential elements of Claim 1 include:
    • A method of providing trace elements to a patient in need thereof, the method comprising administering an injectable trace element composition to the patient
    • the injectable trace element composition comprising water, about 60 µg of selenium, about 3,000 µg of zinc, about 300 µg of copper, and about 55 µg of manganese per 1 mL
    • wherein the injectable composition contains 0 µg per 1 mL to about 10 µg per 1 mL of iron, does not contain any vitamins, contains no added chromium, and no aluminum or aluminum in an amount not to exceed 6 µg per 1 mL
  • The complaint makes a general allegation against the patent without specifying dependent claims.

Multi-Patent Capsule: U.S. Patent No. 11,998,565

  • Patent Identification: U.S. Patent No. 11,998,565, "Trace element compositions, methods of making and use," issued June 4, 2024.
  • Technology Synopsis: This patent, part of the same family as the '548 and '022 patents, is directed to stable injectable compositions of trace elements for parenteral nutrition. The technology addresses the problem of short stability periods in existing formulations, aiming to reduce admixing frequency, cost, and waste (’565 Patent, col. 2:5-44).
  • Asserted Claims: The complaint asserts infringement of one or more claims (Compl. ¶56). Representative independent claims include Claim 1 (an injectable composition) and Claim 18 (a method of providing trace elements).
  • Accused Features: The accused features are Defendant's proposed generic versions of Tralement® and Multrys®, which are alleged to contain the same or equivalent ingredients as the patented compositions (Compl. ¶¶36-39, 55).

Multi-Patent Capsule: U.S. Patent No. 12,150,956

  • Patent Identification: U.S. Patent No. 12,150,956, "Trace element compositions, methods of making and use," issued November 26, 2024.
  • Technology Synopsis: This patent is also from the same family and concerns stable injectable trace element compositions designed to overcome the short-term stability issues of prior art parenteral nutrition admixtures. The patented solution aims to provide a longer shelf-life once mixed, thereby enhancing convenience and reducing healthcare costs (’956 Patent, col. 2:5-44).
  • Asserted Claims: The complaint asserts infringement of one or more claims (Compl. ¶63). Representative independent claims include Claim 1 (a method of supplementing trace elements) and Claim 19 (a method of providing a composition).
  • Accused Features: The accused features are Defendant's ANDA products, which are alleged to be generic versions of Tralement® and Multrys® and intended for use in a manner that infringes the patent (Compl. ¶¶36-39, 62).

Multi-Patent Capsule: U.S. Patent No. 12,150,957

  • Patent Identification: U.S. Patent No. 12,150,957, "Trace element compositions, methods of making and use," issued November 26, 2024.
  • Technology Synopsis: This patent, from the same family, is directed to methods of making and using stable, injectable trace element compositions for parenteral nutrition. It addresses the technical challenge of limited stability in existing formulations to reduce waste and admixing frequency (’957 Patent, col. 2:5-44).
  • Asserted Claims: The complaint asserts infringement of one or more claims (Compl. ¶69). Representative independent claims include Claim 1 (a method of providing an injectable composition) and Claim 12 (a method of supplementing trace elements).
  • Accused Features: Infringement is alleged based on Defendant's proposed generic versions of Tralement® and Multrys®, which are intended to be manufactured and used as equivalents to the branded products (Compl. ¶¶36-39, 68).

III. The Accused Instrumentality

  • Product Identification: Defendant Gland Pharma's proposed generic drug products submitted to the FDA under ANDA No. 219632, which are generic versions of Plaintiff's Tralement® and Multrys® products (the "ANDA Products") (Compl. ¶1, 36).
  • Functionality and Market Context: The complaint alleges the ANDA Products are single-dose, 1 mL injectable solutions intended for parenteral nutrition (Compl. ¶37). The generic Tralement® is alleged to contain 3 mg of zinc, 0.3 mg of copper, 55 mcg of manganese, and 60 mcg of selenium (Compl. ¶37). The generic Multrys® is alleged to contain 1000 mcg of zinc, 60 mcg of copper, 3 mcg of manganese, and 6 mcg of selenium (Compl. ¶37). These products are intended to be administered to patients who cannot receive oral or enteral nutrition, making them therapeutically equivalent to the branded drugs (Compl. ¶17, 19, 39).

IV. Analysis of Infringement Allegations

'548 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
An injectable composition comprising water, about 60 µg of selenium, 3,000 µg of zinc, about 300 µg of copper, and about 55 µg of manganese per 1 mL of the injectable composition... The proposed generic Tralement® product is an injectable composition alleged to contain 60 mcg of selenium, 3 mg (3,000 µg) of zinc, 0.3 mg (300 µg) of copper, and 55 mcg of manganese in a 1 mL single-dose vial. ¶37 col. 9:10-14
wherein the injectable composition contains 0 µg per 1 mL to about 10 µg per 1 mL of iron, The complaint alleges the ANDA Products contain the "same or equivalent ingredients" as Tralement®, which is formulated with a low amount of iron impurity and not as an active ingredient. The ANDA is expected to specify a composition meeting this limitation. ¶36, 38 col. 15:1-12
does not contain any vitamins, The ANDA Products are alleged to be generic versions of Plaintiff's products, which are trace element compositions formulated without vitamins. The ANDA is expected to specify a vitamin-free composition. ¶36, 38 col. 23:7-9
contains no added chromium and no aluminum or aluminum in an amount not to exceed 6 µg per 1 mL of the injectable composition. The ANDA Products are alleged to be generic versions of Plaintiff's products, which are formulated without added chromium and with low aluminum content. The ANDA is expected to specify a composition meeting these limitations. ¶36, 38 col. 13:45-53
  • Identified Points of Contention:
    • Scope Questions: A central question may be the interpretation of the negative limitation "no added chromium." Does this term preclude any detectable amount of chromium, or does it mean chromium is not included as an active ingredient, thus permitting its presence as an impurity? Similarly, the scope of "about" for each element, though seemingly met literally by the allegations, could become a point of contention if the ANDA specifies slightly different values.
    • Technical Questions: What evidence does the ANDA filing provide that the proposed generic products meet the negative limitations regarding vitamins, added chromium, and low levels of iron and aluminum? The infringement analysis will likely depend on the precise specifications and impurity profiles detailed in Gland Pharma's ANDA submission.

'022 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of providing trace elements to a patient in need thereof, the method comprising administering an injectable trace element composition to the patient... The proposed ANDA Products are intended to be administered to patients for parenteral nutrition, and the proposed package insert will allegedly instruct medical professionals and patients to perform this administration. ¶49 col. 4:15-20
the injectable trace element composition comprising water, about 60 µg of selenium, about 3,000 µg of zinc, about 300 µg of copper, and about 55 µg of manganese per 1 mL of the injectable composition... The proposed generic Tralement® product is an injectable composition alleged to contain 60 mcg of selenium, 3 mg (3,000 µg) of zinc, 0.3 mg (300 µg) of copper, and 55 mcg of manganese per 1 mL. ¶37 col. 9:10-14
wherein the injectable composition contains 0 µg per 1 mL to about 10 µg per 1 mL of iron, does not contain any vitamins, contains no added chromium, and no aluminum or aluminum in an amount not to exceed 6 µg per 1 mL... The ANDA Products are alleged to be generic versions of Plaintiff's products, which are formulated without vitamins, without added chromium, and with low levels of iron and aluminum. The ANDA is expected to specify a composition meeting these limitations. ¶36, 38 col. 13:45-53
  • Identified Points of Contention:
    • Scope Questions: As with the ’548 Patent, the interpretation of negative limitations like "no added chromium" will be critical. For this method claim, infringement hinges on the future, intended use of the ANDA product. A question for the court will be whether Gland Pharma's act of seeking FDA approval for a drug with instructions for this specific use constitutes infringement under 35 U.S.C. § 271(e)(2).
    • Technical Questions: Does the proposed label for the ANDA Products instruct administration in a manner that falls within the scope of the claimed method? The analysis will require a review of the proposed package insert submitted with the ANDA.

V. Key Claim Terms for Construction

  • The Term: "about"

  • Context and Importance: This term modifies the specific quantities of each trace element in the asserted composition and method claims (e.g., "about 60 µg of selenium"). The scope of infringement will depend on how much deviation from the stated value is permitted. Practitioners may focus on this term because even minor variations in the generic formulation could be used to argue non-infringement if "about" is construed narrowly.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification uses the term "about" consistently when reciting concentrations, suggesting an intent to claim a range around the specific values rather than the exact numbers themselves ('548 Patent, col. 4:2-8). The patent also includes boilerplate language stating that numerical ranges encompass all subranges, which could support a more flexible interpretation ('548 Patent, col. 5:49-54).
    • Evidence for a Narrower Interpretation: The patent provides very specific concentrations in its examples and tables (e.g., '548 Patent, Table 1, col. 11:10-24), which a defendant might argue suggests the inventors considered these values to be precise targets. The patent does not explicitly define a numerical range for "about," which could lead a court to apply a narrower construction based on the precision of the measurements disclosed.

  • The Term: "no added chromium"

  • Context and Importance: This is a negative limitation central to distinguishing the invention from prior art that may have included chromium. Infringement hinges on whether the accused product contains "added" chromium. Practitioners may focus on this term because the presence of chromium as a trace impurity from manufacturing processes or raw materials could raise a non-infringement defense.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: A party arguing for infringement might contend that "no added chromium" means chromium is not included as a formulated active ingredient. This interpretation would permit the presence of unavoidable trace impurities without negating infringement. The specification discusses adjusting trace element dosages and notes that "daily doses of chromium are not typically needed" ('548 Patent, col. 1:45-48), supporting the idea that the focus is on intentional formulation.
    • Evidence for a Narrower Interpretation: A defendant might argue that "no added chromium" implies a composition that is essentially chromium-free. The specification distinguishes the invention from prior art containing chromium ('548 Patent, col. 1:50-54) and later claims in the patent family explicitly recite chromium as an impurity with specific limits (e.g., '548 Patent, claim 15), suggesting that when the patentees meant to allow for impurities, they did so explicitly. This could support a construction where "no added chromium" in Claim 1 means a stricter, near-zero standard.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced and contributory infringement for all patents-in-suit. The basis for inducement is the allegation that Gland Pharma's proposed package insert and instructions will encourage and instruct medical professionals and patients to administer the ANDA Products in a manner that directly infringes the method claims (Compl. ¶42, 49). Contributory infringement is alleged on the basis that the ANDA Products are especially made for an infringing use and are not suitable for substantial non-infringing use (Compl. ¶43, 50).
  • Willful Infringement: The complaint does not use the term "willful infringement" but alleges that Gland Pharma has had knowledge of the patents since at least the date it submitted its ANDA (Compl. ¶45, 52). It also seeks attorneys' fees under 35 U.S.C. § 285, alleging this is an "exceptional" case, which often accompanies allegations of willful or egregious conduct (Compl. ¶46, 53).

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

  • A core issue will be one of definitional scope, particularly for the negative limitations. Can the phrase "no added chromium" be construed to permit the presence of trace impurities, or does it require a complete absence? Similarly, the interpretation of "does not contain any vitamins" will be critical to the infringement analysis.
  • A key evidentiary question will be what Gland Pharma’s ANDA filing specifies. Since infringement in an ANDA case is a hypothetical analysis based on what the applicant seeks to market, the case will likely turn on a direct comparison of the product specifications and proposed label in the ANDA against the court's construction of the asserted claims.