DCT

3:25-cv-11981

Amneal Pharma LLC v. Sandoz Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:25-cv-11981, D.N.J., 09/04/25
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant Sandoz has a principal place of business in the state, engages in substantial business activities there, and has previously consented to venue in the district in other patent infringement actions.
  • Core Dispute: Plaintiff alleges that Defendant's submission of an Abbreviated New Drug Application (ANDA) to seek approval for generic versions of Plaintiff's CREXONT® extended-release capsules constitutes infringement of eight U.S. patents related to pharmaceutical formulations and dosing regimens for levodopa.
  • Technical Context: The technology concerns treatments for Parkinson's disease, specifically oral drug formulations designed to provide a more stable and prolonged therapeutic effect of levodopa, the primary drug used to manage the disease's motor symptoms.
  • Key Procedural History: This action arises from Paragraph IV certifications submitted by Sandoz, asserting that its proposed generic products do not infringe the patents-in-suit or that the patents are invalid. The complaint notes a related action involving the same parties and drug product but asserting different patents (Amneal v. Sandoz, 3:25-cv-00181, D.N.J.). The timely filing of this suit in response to the notice letters triggers a statutory 30-month stay of FDA approval for Sandoz's ANDA.

Case Timeline

Date Event
2013-10-07 Earliest Priority Date ('793 and '605 Patents)
2020-12-22 Earliest Priority Date ('596, '148, '149, '931, '481, '482 Patents)
2025-01-21 Issue Date: U.S. Patent No. 12,201,596
2025-04-01 Issue Date: U.S. Patent No. 12,263,148
2025-04-01 Issue Date: U.S. Patent No. 12,263,149
2025-04-15 Issue Date: U.S. Patent No. 12,274,793
2025-05-13 Issue Date: U.S. Patent No. 12,295,931
2025-05-15 Plaintiff receives first notice letter for '596, '148, '149, '793 patents
2025-05-20 Issue Date: U.S. Patent No. 12,303,481
2025-05-20 Issue Date: U.S. Patent No. 12,303,482
2025-05-20 Issue Date: U.S. Patent No. 12,303,605
2025-08-07 Plaintiff receives second notice letter for '931, '481, '482, '605 patents
2025-09-04 Complaint Filing Date

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

U.S. Patent No. 12,201,596 - "Levodopa Dosing Regimen"

The Invention Explained

  • Problem Addressed: The patent describes the challenge of treating Parkinson's disease (PD) with levodopa (LD). While effective, LD has a short plasma half-life and is absorbed only in a narrow window of the upper gastrointestinal tract, leading to fluctuating drug levels and the re-emergence of motor symptoms known as "wearing off" or the "on-off" phenomenon. (’596 Patent, col. 1:42-51; col. 2:3-22).
  • The Patented Solution: The invention claims a specific method, or dosing regimen, for treating PD patients. The method involves converting patients from their existing immediate-release LD therapy to a new regimen using a controlled-release LD formulation. This new regimen is designed to be administered less frequently (twice or thrice daily) while providing more stable plasma concentrations of LD, thereby reducing "Off" time and mimicking the steady drug levels of more invasive therapies like intestinal infusion. (’596 Patent, Abstract; col. 2:32-41).
  • Technical Importance: This approach aims to provide the clinical benefits of continuous levodopa stimulation—reduced motor fluctuations—through a convenient oral dosage form, which has historically been an elusive goal in PD treatment. (’596 Patent, col. 1:52-59).

Key Claims at a Glance

  • The complaint asserts independent claims 1, 10, and 14 (Compl. ¶ 49, 54).
  • Independent Claim 1 includes the following essential elements:
    • A method for treating a PD patient currently being treated with oral immediate-release levodopa tablets three or more times a day, with a total daily dose of 500 mg or less.
    • The method includes discontinuing the immediate-release tablets.
    • The method requires orally administering a multiparticulate controlled-release levodopa dosage form twice a day.
    • The amount of levodopa in the new dosage form is calculated as 2.8 times the amount of levodopa in the patient's "most frequent" immediate-release dose.
    • The treatment results in a decrease of at least 5% in the patient's total post-dose "Off" time compared to the prior treatment.
    • The multiparticulate dosage form comprises both controlled-release and immediate-release components.
  • The complaint does not explicitly reserve the right to assert dependent claims for this patent.

U.S. Patent No. 12,263,148 - "Levodopa Dosing Regimen"

The Invention Explained

  • Problem Addressed: This patent, from the same family as the '596 patent, addresses the identical technical problem: managing motor fluctuations ("wearing off") in PD patients by overcoming the pharmacokinetic limitations of conventional oral levodopa therapy, such as its short half-life and narrow absorption window. (’148 Patent, col. 1:43-52; col. 2:4-23).
  • The Patented Solution: The patent claims a specific dosing regimen for converting certain PD patients to a controlled-release levodopa formulation. The claimed method is designed to reduce daily "Off" time and provide more stable therapeutic benefit with less frequent dosing compared to standard immediate-release tablets. (’148 Patent, Abstract; col. 2:33-42).
  • Technical Importance: The invention provides a structured method for transitioning patients with more advanced PD to a new oral therapy, aiming to improve symptom control and convenience over existing oral options. (’148 Patent, col. 1:53-59).

Key Claims at a Glance

  • The complaint asserts independent claims 1 and 11 (Compl. ¶ 64, 69).
  • Independent Claim 1 includes the following essential elements:
    • A method for treating a PD patient currently being treated with oral immediate-release levodopa tablets three or more times a day, with a total daily dose of greater than 500 mg.
    • The method involves determining the "most frequent immediate release levodopa dose."
    • The method includes discontinuing the immediate-release tablets.
    • The method requires orally administering a multiparticulate controlled-release levodopa dosage form thrice a day.
    • The amount of levodopa in the new dosage form is calculated as 2.8 times the amount of the patient's "most frequent" dose.
    • The treatment results in a decrease of at least 5% in the patient's total post-dose "Off" time.
    • The multiparticulate dosage form comprises both controlled-release and immediate-release components.
  • The complaint does not explicitly reserve the right to assert dependent claims for this patent.

U.S. Patent No. 12,263,149 - "Levodopa Dosing Regimen"

  • Patent Identification: U.S. Patent No. 12,263,149, "Levodopa Dosing Regimen," issued April 1, 2025 (Compl. ¶ 22).
  • Technology Synopsis: Belonging to the same family as the '596 and '148 patents, this patent addresses motor fluctuations in Parkinson's disease patients by claiming a specific method of converting them from immediate-release levodopa to a controlled-release formulation. The claimed regimen aims to provide more stable drug levels and reduce daily "Off" time. (’149 Patent, col. 1:43-52; col. 2:33-42).
  • Asserted Claims: Independent claims 1 and 11 (Compl. ¶ 79, 84).
  • Accused Features: The complaint alleges that Sandoz's product, if approved, will be prescribed and administered according to a dosing regimen that infringes the patent's claims for reducing "off" time in treating Parkinson's disease (Compl. ¶ 80).

U.S. Patent No. 12,274,793 - "Muco-adhesive, controlled release formulation of levodopa and/or esters of levodopa and uses thereof"

  • Patent Identification: U.S. Patent No. 12,274,793, "Muco-adhesive, controlled release formulation of levodopa and/or esters of levodopa and uses thereof," issued April 15, 2025 (Compl. ¶ 23).
  • Technology Synopsis: This patent describes a specific pharmaceutical formulation for levodopa. The invention addresses levodopa's poor absorption by using a multi-component oral dosage form that includes both immediate-release and controlled-release elements, with the controlled-release portion incorporating a muco-adhesive material to prolong its transit time in the upper gastrointestinal tract where levodopa is absorbed. (’793 Patent, Abstract; col. 1:53-67).
  • Asserted Claims: Independent claims 1, 9, and 16 (Compl. ¶ 92, 95, 100).
  • Accused Features: The complaint alleges that the Sandoz ANDA Products themselves, by their composition and formulation, will directly infringe the claims of the '793 patent (Compl. ¶ 92).

U.S. Patent No. 12,295,931 - "Levodopa Dosing Regimen"

  • Patent Identification: U.S. Patent No. 12,295,931, "Levodopa Dosing Regimen," issued May 13, 2025 (Compl. ¶ 24).
  • Technology Synopsis: As part of the same family as the '596 and '148 patents, this patent claims a method for treating Parkinson's disease by converting patients from an immediate-release levodopa therapy to a specific controlled-release formulation regimen. The method aims to reduce motor fluctuations by providing more stable levodopa plasma levels. (’931 Patent, col. 1:42-51; col. 2:32-41).
  • Asserted Claims: Independent claims 1, 12, and 23 (Compl. ¶ 110, 115).
  • Accused Features: The complaint alleges that the dosing regimen that will be used for the Sandoz ANDA Products for treating Parkinson's disease will infringe the claims of the '931 patent (Compl. ¶ 111).

U.S. Patent No. 12,303,481 - "Levodopa Dosing Regimen"

  • Patent Identification: U.S. Patent No. 12,303,481, "Levodopa Dosing Regimen," issued May 20, 2025 (Compl. ¶ 25).
  • Technology Synopsis: This patent is also part of the '596 patent family and addresses the problem of motor fluctuations in Parkinson's disease. It claims a dosing regimen involving a switch from immediate-release to a controlled-release levodopa formulation to achieve steadier plasma concentrations and reduce "Off" time. (’481 Patent, col. 1:42-51; col. 2:32-41).
  • Asserted Claims: Independent claims 1 and 15 (Compl. ¶ 125, 130).
  • Accused Features: The complaint alleges infringement based on the anticipated prescription and administration of the Sandoz ANDA Products to treat Parkinson's disease according to the claimed dosing regimen (Compl. ¶ 126).

U.S. Patent No. 12,303,482 - "Levodopa Dosing Regimen"

  • Patent Identification: U.S. Patent No. 12,303,482, "Levodopa Dosing Regimen," issued May 20, 2025 (Compl. ¶ 26).
  • Technology Synopsis: Also from the '596 patent family, this patent covers a method for treating Parkinson's disease. The claimed method specifies a dosing regimen for converting patients from standard immediate-release levodopa to a controlled-release formulation to better manage motor fluctuations by stabilizing drug levels. (’482 Patent, col. 1:42-51; col. 2:32-41).
  • Asserted Claims: Independent claims 1, 11, and 21 (Compl. ¶ 140, 145).
  • Accused Features: Infringement is alleged on the basis that Sandoz's product will be prescribed and administered to Parkinson's disease patients in a manner that practices the claimed dosing regimen (Compl. ¶ 141).

U.S. Patent No. 12,303,605 - "Muco-adhesive, controlled release formulation of levodopa and/or esters of levodopa and uses thereof"

  • Patent Identification: U.S. Patent No. 12,303,605, "Muco-adhesive, controlled release formulation of levodopa and/or esters of levodopa and uses thereof," issued May 20, 2025 (Compl. ¶ 27).
  • Technology Synopsis: This patent, from the same family as the '793 patent, covers a specific oral formulation of levodopa designed for controlled release. It utilizes a muco-adhesive component to prolong the formulation's residence time in the upper gastrointestinal tract, thereby aiming to improve the extent and consistency of levodopa absorption. (’605 Patent, Abstract; col. 1:53-67).
  • Asserted Claims: Independent claims 1 and 14 (Compl. ¶ 153, 156, 161).
  • Accused Features: The complaint alleges that the Sandoz ANDA Products, by their physical composition, will directly infringe the formulation claims of the '605 patent (Compl. ¶ 153).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are Defendant Sandoz's proposed generic carbidopa/levodopa extended-release capsules, for which it seeks FDA approval under ANDA No. 219989 (Compl. ¶ 31). The products are proposed in four dosage strengths: 35 mg/140 mg, 52.5 mg/210 mg, 70 mg/280 mg, and 87.5 mg/350 mg (Compl. ¶ 31).

Functionality and Market Context

  • The complaint alleges that by filing its ANDA, Sandoz has represented to the FDA that its proposed generic products have the same active ingredients, method of administration, dosage forms, and strengths as Plaintiffs' CREXONT® product (Compl. ¶ 38). It is further alleged that the Sandoz ANDA Products are bioequivalent to CREXONT® and would be sold with a label that is substantively the same (Compl. ¶ 38). The intended use of the Sandoz ANDA Products is for the treatment of Parkinson's disease (Compl. ¶ 50, 65, 80, 96, 111, 126, 141, 157). The products are designed for oral administration to provide extended release of levodopa (Compl. ¶ 31).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint does not contain or reference an element-by-element claim chart. The infringement allegations are presented narratively.

For the '596 patent, the '148 patent, and the other asserted "Levodopa Dosing Regimen" patents, the complaint alleges that infringement will occur under 35 U.S.C. § 271(b) and (c) upon FDA approval and commercial launch of the Sandoz ANDA Products (Compl. ¶ 44, 59). The theory of induced infringement is that Sandoz, with knowledge of the patents, will market its products with a label that instructs and encourages healthcare professionals and patients to use the products in a manner that directly infringes the patented methods of treatment (Compl. ¶ 49, 53, 64, 68). The theory of contributory infringement is that the Sandoz products are especially made for an infringing use, are a material part of the invention, and are not suitable for substantial non-infringing use (Compl. ¶ 54, 69).

For the '793 and '605 patents directed to "Muco-adhesive, controlled release formulation[s]," the complaint alleges that Sandoz will directly infringe under 35 U.S.C. § 271(a) by making, using, or selling the Sandoz ANDA Products, which allegedly embody the claimed formulation (Compl. ¶ 92, 153). Theories of induced and contributory infringement are also asserted for these patents based on the product's use in treating Parkinson's disease (Compl. ¶ 95, 100, 156, 161).

Identified Points of Contention

  • Scope Questions: For the method claims, a primary question will be whether the patient populations and conversion criteria described in the Sandoz product label will map directly onto the specific patient populations recited in the claims (e.g., those taking more or less than 500 mg of immediate-release LD per day, as in claims 1 of the '148 and '596 patents, respectively).
  • Technical Questions: A key factual question for the method claims is whether the instructions on Sandoz's proposed label will direct a dosing conversion equivalent to the "2.8 times the amount of levodopa the patient was receiving with each administration of the most frequent immediate release levodopa dose" as required by claims 1 of the '596 and '148 patents. For the formulation claims, a central technical question will be whether the physical and chemical properties of the Sandoz product, as described in its ANDA, meet all limitations of the asserted composition claims, such as those related to muco-adhesive polymers and specific release profiles.

V. Key Claim Terms for Construction

  • The Term: "most frequent immediate release levodopa dose" (from Claim 1 of '596 and '148 Patents).

  • Context and Importance: This term is critical because it defines the baseline dose from which the patented conversion calculation (multiplying by 2.8) is performed. The interpretation of how to identify the "most frequent" dose from a patient's potentially varied daily schedule will be central to determining whether the instructions on Sandoz's label will induce infringement. Practitioners may focus on this term because its ambiguity could create a non-infringement argument if Sandoz's label defines a conversion baseline differently.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The term itself, using the common word "frequent," could be argued to have its plain and ordinary meaning, such as the single dose amount taken most often during a waking day (’596 Patent, col. 32:47-51).
    • Evidence for a Narrower Interpretation: The specification includes tables and examples that may provide a more specific definition. For instance, one table is titled "Most Frequent Afternoon and Evening LD Unit Dose (mg)," which could suggest that the morning dose is excluded when determining the "most frequent" dose, potentially narrowing the term's scope (’596 Patent, col. 40, Table 3).

  • The Term: "a decrease of at least 5% of the patient's total post dose 'Off' time" (from Claim 1 of '596 and '148 Patents).

  • Context and Importance: This term defines a required outcome of the claimed method. Its construction is important because it sets the standard for proving infringement. If the term is construed to require a specific method of measurement not used or disclosed by Sandoz, it could support a non-infringement position.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The claim language itself does not specify how "Off' time" is to be measured, which may suggest that any clinically accepted method of measuring a 5% decrease is sufficient.
    • Evidence for a Narrower Interpretation: The specification's detailed description of clinical trials defines "Off" time as a state "when the medication has worn off and is no longer providing benefit with regard to mobility, slowness, and stiffness," as measured by patient diaries. (’596 Patent, col. 43:31-34). A defendant might argue this language limits the claim to "Off" time as measured by such patient diaries, as opposed to other clinical assessments.

VI. Other Allegations

Indirect Infringement

  • The complaint alleges both induced and contributory infringement for all asserted patents. Inducement is primarily based on allegations that Sandoz's promotional activities and product label will instruct and encourage infringing uses of its product to treat Parkinson's disease (Compl. ¶ 49, 64, 79, 95, 110, 125, 140, 156). Contributory infringement is alleged on the basis that the Sandoz product is especially made or adapted for infringing the patented methods and is not suitable for a substantial non-infringing use (Compl. ¶ 54, 69, 84, 100, 115, 130, 145, 161).

Willful Infringement

  • The complaint alleges that Sandoz has had knowledge of the patents-in-suit since at least the date it submitted its ANDA and Paragraph IV Certifications (Compl. ¶ 56, 71). Plaintiffs also seek a finding that the case is "exceptional" under 35 U.S.C. § 285, which is the statutory basis for awarding attorney's fees and is often associated with allegations of willful or egregious conduct (Compl. ¶ 57, 72).

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

  • A central issue will be one of instructional infringement: Will the final FDA-approved label for the Sandoz product contain instructions for converting patients from immediate-release levodopa that mirror the specific calculations and patient-population criteria recited in the asserted method claims, particularly the "2.8 times the most frequent...dose" limitation?
  • A key question will be one of compositional identity: For the patents claiming a specific "muco-adhesive" formulation, does the composition of Sandoz's product, as disclosed in its confidential ANDA submission, meet every element of those claims, or is there a material difference in its formulation that could support a non-infringement defense?
  • The case may also turn on a question of claim construction: How will the court define "most frequent immediate release levodopa dose"? The interpretation of this term will directly impact the infringement analysis for the asserted method patents by setting the baseline for the claimed conversion formula.