DCT

3:25-cv-00181

Amneal Pharma LLC v. Sandoz Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:25-cv-00181, D.N.J., 01/07/2025
  • Venue Allegations: Venue is alleged to be proper based on Defendant Sandoz Inc.'s principal place of business in New Jersey and its engagement in infringing activities within the district.
  • Core Dispute: Plaintiffs allege that Defendant's filing of an Abbreviated New Drug Application (ANDA) to market generic versions of Plaintiffs' CREXONT® product constitutes an act of infringement of twelve U.S. patents.
  • Technical Context: The patents relate to controlled-release oral formulations of levodopa and carbidopa, a primary treatment for Parkinson's disease, designed to provide more stable drug levels and reduce motor fluctuations.
  • Key Procedural History: This Hatch-Waxman litigation was initiated after Plaintiffs received a Notice Letter and Paragraph IV Certification from Sandoz, alleging that claims of the asserted patents are invalid, unenforceable, or will not be infringed by the proposed generic products. The complaint was filed within the 45-day statutory window, triggering a 30-month stay of FDA approval for Sandoz's ANDA. Plaintiffs note that Sandoz has failed to provide a notice letter for the two most recently issued patents, U.S. Patent Nos. 12,109,185 and 12,128,141.

Case Timeline

Date Event
2013-10-07 Priority Date for '845, '935, '058, '769, '313, '733, '941, '538, '521, and '141 Patents
2018-10-16 U.S. Patent No. 10,098,845 Issues
2019-05-21 U.S. Patent No. 10,292,935 Issues
2020-06-23 U.S. Patent No. 10,688,058 Issues
2021-04-13 U.S. Patent No. 10,973,769 Issues
2021-04-27 U.S. Patent No. 10,987,313 Issues
2021-08-24 Priority Date for '449 and '185 Patents
2022-06-14 U.S. Patent No. 11,357,733 Issues
2023-04-11 U.S. Patent No. 11,622,941 Issues
2023-06-06 U.S. Patent No. 11,666,538 Issues
2024-05-21 U.S. Patent No. 11,986,449 Issues
2024-08-20 U.S. Patent No. 12,064,521 Issues
2024-10-08 U.S. Patent No. 12,109,185 Issues
2024-10-29 U.S. Patent No. 12,128,141 Issues
2024-11-25 Plaintiffs receive Sandoz's ANDA Notice Letter
2025-01-07 Complaint Filed

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

U.S. Patent No. 10,098,845 - "Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof"

The Invention Explained

  • Problem Addressed: The patent describes the challenge in treating Parkinson's disease with oral levodopa (LD), noting that over time, patients experience motor fluctuations and "wearing off" periods where the drug's effect diminishes between doses. This creates a need for an oral formulation that can provide steadier plasma concentrations and a longer duration of effect, similar to more invasive intestinal infusions. (’845 Patent, col. 1:47-2:8).
  • The Patented Solution: The invention is an oral solid dosage form comprising two components: an immediate-release component for rapid therapeutic onset (a "fast on"), and a controlled-release component. The controlled-release component consists of beads with a levodopa core, a rate-controlling polymer layer, a "muco-adhesive" polymer layer designed to adhere to the intestinal lining to prolong absorption, and an outer enteric coating to protect the bead until it reaches the small intestine. (’845 Patent, col. 2:12-31; Fig. 1).
  • Technical Importance: This dual-component, multi-layer approach is intended to provide PD patients with a convenient oral therapy that mimics the steady, prolonged drug delivery of continuous infusion methods, thereby reducing debilitating motor fluctuations. (’845 Patent, col. 1:53-59).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 and method claim 17 (Compl. ¶45, 48).
  • The essential elements of independent claim 1 include:
    • A controlled release oral solid formulation comprising:
    • (a) a controlled release component with a core containing levodopa, coated with a rate-controlling polymer, a muco-adhesive layer (comprising a dimethylaminoethyl methacrylate copolymer), and an enteric coating polymer; and
    • (b) an immediate release component comprising levodopa.
    • Wherein the formulation produces a specific in vivo levodopa plasma profile, including a time to reach 50% of maximum concentration (Cmax) of less than one hour, and a duration at or above 50% Cmax for at least 5.0 hours.
  • The complaint reserves the right to assert other claims, including dependent claims (Compl. ¶44).

U.S. Patent No. 10,292,935 - "Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof"

The Invention Explained

  • Problem Addressed: The patent addresses the same problem as the '845 Patent: the "wearing off" phenomenon and motor fluctuations associated with conventional oral levodopa therapy for Parkinson's disease, which results from unstable plasma concentrations of the drug. (’935 Patent, col. 1:47-2:11).
  • The Patented Solution: The patent describes a multiparticulate oral formulation that combines an immediate release component with a controlled release component. The controlled release particles have a levodopa-containing core, a muco-adhesive polymer layer to promote retention in the upper gastrointestinal tract for extended absorption, and an external enteric coating to prevent premature drug release in the stomach. (’935 Patent, col. 2:12-34; Fig. 1).
  • Technical Importance: The formulation aims to provide a non-invasive, oral method for achieving steadier and more prolonged therapeutic levodopa levels, which is critical for managing symptoms in advanced Parkinson's disease patients. (’935 Patent, col. 1:53-59).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 and method claim 18 (Compl. ¶61, 64).
  • The essential elements of independent claim 1 include:
    • A multiparticulate controlled release oral solid formulation comprising:
    • (a) a plurality of controlled release particles, which are beads of a specific size range (passing through a 12 mesh screen but retained on a 25 mesh screen) and comprise a levodopa core, a muco-adhesive layer, and an enteric coating; and
    • (b) an immediate release component comprising levodopa and optionally carbidopa.
  • The complaint reserves the right to assert other claims, including dependent claims (Compl. ¶60).

U.S. Patent No. 10,688,058 - "Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof"

  • Technology Synopsis: This patent claims an oral formulation for treating Parkinson's disease that combines an immediate release component of levodopa/carbidopa with a controlled release component. The controlled release part is a multi-layered particle with a levodopa core, a rate-controlling polymer layer, a muco-adhesive layer, and an enteric coating, designed to achieve both rapid onset and prolonged, steady absorption of levodopa. (’058 Patent, Abstract; col. 2:12-31).
  • Asserted Claims: At least claims 1 and 20 (Compl. ¶79).
  • Accused Features: The Sandoz ANDA Products are alleged to infringe (Compl. ¶76).

U.S. Patent No. 10,973,769 - "Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof"

  • Technology Synopsis: This patent claims an oral formulation for treating Parkinson's disease that combines an immediate release component of levodopa/carbidopa with a controlled release component. The controlled release part is a multi-layered particle with a levodopa core, a rate-controlling polymer layer, a muco-adhesive layer, and an enteric coating, designed to achieve both rapid onset and prolonged, steady absorption of levodopa. (’769 Patent, Abstract; col. 2:12-31).
  • Asserted Claims: At least claims 1, 10, and 14 (Compl. ¶92, 95).
  • Accused Features: The Sandoz ANDA Products are alleged to infringe (Compl. ¶91).

U.S. Patent No. 10,987,313 - "Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof"

  • Technology Synopsis: This patent claims an oral formulation for treating Parkinson's disease that combines an immediate release component of levodopa/carbidopa with a controlled release component. The controlled release part is a multi-layered particle with a levodopa core, a muco-adhesive layer, and an enteric coating, designed to achieve both rapid onset and prolonged, steady absorption of levodopa. (’313 Patent, Abstract; col. 2:12-31).
  • Asserted Claims: At least claims 1 and 20 (Compl. ¶108, 111).
  • Accused Features: The Sandoz ANDA Products are alleged to infringe (Compl. ¶107).

U.S. Patent No. 11,357,733 - "Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof"

  • Technology Synopsis: This patent claims an oral formulation for treating Parkinson's disease that combines an immediate release component of levodopa/carbidopa with a controlled release component. The controlled release part is a multi-layered particle with a levodopa core, a rate-controlling polymer layer, a muco-adhesive layer, and an enteric coating, designed to achieve both rapid onset and prolonged, steady absorption of levodopa. (’733 Patent, Abstract; col. 2:12-31).
  • Asserted Claims: At least claims 1, 24, and 40 (Compl. ¶124, 127).
  • Accused Features: The Sandoz ANDA Products are alleged to infringe (Compl. ¶123).

U.S. Patent No. 11,622,941 - "Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof"

  • Technology Synopsis: This patent claims an oral formulation for treating Parkinson's disease that combines an immediate release component of levodopa/carbidopa with a controlled release component. The controlled release part is a multi-layered particle with a levodopa core, a muco-adhesive layer, and an enteric coating, designed to achieve both rapid onset and prolonged, steady absorption of levodopa. (’941 Patent, Abstract; col. 2:12-31).
  • Asserted Claims: At least claims 1, 18, and 28 (Compl. ¶139, 142).
  • Accused Features: The Sandoz ANDA Products are alleged to infringe (Compl. ¶138).

U.S. Patent No. 11,666,538 - "Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof"

  • Technology Synopsis: This patent claims an oral formulation for treating Parkinson's disease that combines an immediate release component of levodopa/carbidopa with a controlled release component. The controlled release part is a multi-layered particle with a levodopa core, a rate-controlling polymer layer, a muco-adhesive layer, and an enteric coating, designed to achieve both rapid onset and prolonged, steady absorption of levodopa. (’538 Patent, Abstract; col. 2:12-31).
  • Asserted Claims: At least claims 1, 18, and 20 (Compl. ¶154, 157).
  • Accused Features: The Sandoz ANDA Products are alleged to infringe (Compl. ¶153).

U.S. Patent No. 11,986,449 - "Levodopa dosing regimen"

  • Technology Synopsis: This patent claims methods of treating Parkinson's disease by administering specific oral dosing regimens of controlled-release levodopa compositions. The invention provides for specific conversion protocols from immediate-release levodopa tablets to the controlled-release formulation to improve "On" time and reduce "Off" time for patients. (’449 Patent, Abstract).
  • Asserted Claims: At least claims 1, 10, and 11 (Compl. ¶172).
  • Accused Features: The Sandoz ANDA Products, through their proposed labeling and marketing, are alleged to induce infringement of the claimed dosing methods (Compl. ¶169, 172).

U.S. Patent No. 12,064,521 - "Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof"

  • Technology Synopsis: This patent claims an oral formulation for treating Parkinson's disease that combines an immediate release component of levodopa/carbidopa with a controlled release component. The controlled release part is a multi-layered particle with a levodopa core, a muco-adhesive layer, and an enteric coating, designed to achieve both rapid onset and prolonged, steady absorption of levodopa. (’521 Patent, Abstract; col. 2:12-31).
  • Asserted Claims: At least claims 1, 11, and 20 (Compl. ¶185, 188).
  • Accused Features: The Sandoz ANDA Products are alleged to infringe (Compl. ¶184).

U.S. Patent No. 12,109,185 - "Levodopa dosing regimen"

  • Technology Synopsis: This patent claims methods of treating Parkinson's disease by administering specific oral dosing regimens of controlled-release levodopa compositions. The invention provides for specific conversion protocols and dosing schedules intended to improve therapeutic outcomes such as "On" time for patients. (’185 Patent, Abstract).
  • Asserted Claims: At least claims 1, 10, and 17 (Compl. ¶202).
  • Accused Features: The Sandoz ANDA Products, through their proposed labeling and marketing, are alleged to induce infringement of the claimed dosing methods (Compl. ¶200, 202).

U.S. Patent No. 12,128,141 - "Muco-adhesive, controlled release formulation of levodopa and/or esters of levodopa and uses thereof"

  • Technology Synopsis: This patent claims an oral formulation for treating Parkinson's disease combining an immediate release component with a controlled release component. The controlled release portion comprises a levodopa core, a muco-adhesive layer, and an enteric coating, designed for both rapid and sustained drug delivery. (’141 Patent, Abstract).
  • Asserted Claims: At least claims 1, 11, 13, and 18 (Compl. ¶216, 218).
  • Accused Features: The Sandoz ANDA Products are alleged to infringe (Compl. ¶213, 214).

III. The Accused Instrumentality

Product Identification

The accused products are Sandoz's carbidopa/levodopa extended-release capsules for which it seeks FDA approval under ANDA No. 219989 (the "Sandoz ANDA Products") (Compl. ¶35). The ANDA covers dosages of 35 mg/140 mg, 52.5 mg/210 mg, 70 mg/280 mg, and 87.5 mg/350 mg (Compl. ¶35).

Functionality and Market Context

The complaint alleges that Sandoz, by filing its ANDA, has represented to the FDA that the Sandoz ANDA Products are generic versions of Plaintiffs' CREXONT® product (Compl. ¶1, 39). The complaint further alleges that Sandoz represented its products as having the same active ingredients, method of administration, dosage forms, and strengths as CREXONT®, and as being bioequivalent to CREXONT® (Compl. ¶39). The accused products are intended for the treatment of Parkinson's disease and would compete directly with Plaintiffs' branded product (Compl. ¶49).

IV. Analysis of Infringement Allegations

The complaint alleges infringement under 35 U.S.C. § 271(e)(2)(A), which defines the submission of an ANDA seeking approval to market a generic drug before patent expiration as an act of infringement (Compl. ¶43, 59). The infringement theory is predicated on the allegation that Sandoz's proposed generic products are bioequivalent to Plaintiffs' CREXONT® product and will have a substantively identical label, and therefore will possess the features claimed in the patents-in-suit (Compl. ¶39).

10,098,845 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A controlled release oral solid formulation comprising (a) a controlled release component comprising a core comprising levodopa...wherein the core is coated with a first layer comprising a rate-controlling polymer; the first layer is coated with a muco-adhesive layer comprising a dimethylaminoethyl methacrylate copolymer and the muco-adhesive layer is coated with a layer of an enteric coating polymer; and The Sandoz ANDA Products are extended-release capsules containing carbidopa and levodopa, which are alleged to be bioequivalent to CREXONT® and thus contain the claimed controlled-release formulation. ¶39, 45 col. 2:12-25
(b) an immediate release component comprising levodopa...; and The Sandoz ANDA Products are alleged to contain an immediate release component, consistent with their bioequivalence to the branded CREXONT® product which has this feature. ¶39, 45 col. 2:19-21
wherein the...formulation...produces an in vivo levodopa plasma profile following oral administration...comprising: (a) a...Cmax occurring within 6 hours...; (b) a time to reach 50% Cmax of less than one hour; and (c) wherein the in vivo plasma level of levodopa is maintained at 50% Cmax or above for at least 5.0 hours. By representing that the Sandoz ANDA Products are bioequivalent to CREXONT®, Sandoz allegedly represents that its products will produce the claimed in vivo pharmacokinetic profile. ¶39, 45 col. 10:48-11:10

Identified Points of Contention

  • Scope Questions: A central issue may be whether the specific formulation disclosed in Sandoz's ANDA falls within the literal scope of the claims. For example, a dispute may arise over whether the specific polymer used by Sandoz for its muco-adhesive function is a "dimethylaminoethyl methacrylate copolymer" as recited in claim 1 of the ’845 Patent, or a legally equivalent substitute.
  • Technical Questions: A key evidentiary question will be whether the Sandoz ANDA Products actually produce the specific pharmacokinetic (PK) profile recited in claim 1 of the ’845 Patent. The infringement analysis will depend on the data submitted by Sandoz to the FDA and any subsequent comparative testing, raising the question of whether its product's Cmax, time to 50% Cmax, and duration above 50% Cmax meet the claimed parameters.

10,292,935 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A multiparticulate controlled release oral solid formulation comprising: (a) a plurality of controlled release particles comprising: i) a core comprising levodopa...ii) a muco-adhesive layer or coating surrounding the core wherein the muco-adhesive layer comprises an amino methacrylate copolymer; and iii) an enteric layer or coating surrounding the muco-adhesive layer...; The Sandoz ANDA Products are extended-release capsules which are alleged to be bioequivalent to CREXONT® and are thus alleged to contain the claimed multiparticulate formulation with the specified layers and polymer. ¶39, 61 col. 2:12-25
(b) an immediate release component comprising levodopa and optionally carbidopa; and The Sandoz ANDA Products are alleged to contain an immediate release component, consistent with their bioequivalence to the branded CREXONT® product. ¶39, 61 col. 2:19-21
wherein the controlled release particles pass through a 12 mesh screen and are retained on a 25 mesh screen... The complaint alleges the Sandoz ANDA Products are bioequivalent to CREXONT®, suggesting the particles within the generic formulation will meet the claimed size limitations. ¶39, 61 col. 9:39-44

Identified Points of Contention

  • Scope Questions: Practitioners may focus on the term "amino methacrylate copolymer" in claim 1. The dispute may turn on whether Sandoz's formulation uses a polymer that meets this definition, and if not, whether the doctrine of equivalents can bridge the gap.
  • Technical Questions: The physical characteristics of the particles in the Sandoz ANDA Product will be a point of factual dispute. Discovery will likely focus on whether the particles in Sandoz's formulation meet the specific size limitations of passing through a 12 mesh screen while being retained on a 25 mesh screen, as required by the claim.

V. Key Claim Terms for Construction

Term: "muco-adhesive layer" (’845 Patent, claim 1; ’935 Patent, claim 1)

  • Context and Importance: This term is central to the invention's mechanism for achieving extended release by prolonging the formulation's transit time in the upper gastrointestinal tract. The definition of this term, including the specific polymers required by the claims (e.g., "dimethylaminoethyl methacrylate copolymer" in the ’845 Patent), will be critical to determining infringement, as Sandoz may argue its product uses a different, non-infringing polymer to achieve a similar function.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification describes the function of the layer as facilitating "adhesion to the intestinal mucosa, delaying passage of the dosage form" (’845 Patent, col. 3:19-22). It also lists numerous examples of muco-adhesive polymers beyond the specific one recited in claim 1, which may support a functional, rather than purely structural, interpretation. (’845 Patent, col. 6:40-65).
    • Evidence for a Narrower Interpretation: Claim 1 of the ’845 Patent explicitly recites that the muco-adhesive layer comprises a "dimethylaminoethyl methacrylate copolymer." This explicit recitation may be used to argue that, for this specific claim, the term is narrowly defined to require the presence of that particular polymer class. (’845 Patent, col. 32:7-10).

Term: "an immediate release component" (’845 Patent, claim 1; ’935 Patent, claim 1)

  • Context and Importance: The patents claim a dual-action formulation that relies on both immediate and controlled release. The precise definition of what constitutes an "immediate release component" in this context is crucial. A potential dispute could arise if Sandoz's product exhibits an initial release that is rapid but does not meet a specific quantitative threshold that Plaintiffs may argue is implicit in the term.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification describes the function of this component as providing "fast levodopa release and absorption, which is important for PD patients in need of a fast 'on'." (’845 Patent, col. 3:26-30). This functional description could support a broader interpretation encompassing any formulation structure that achieves this rapid therapeutic onset.
    • Evidence for a Narrower Interpretation: The specification discloses that the immediate release component "may be formulated as a mini-tablet, bead or granule" (’845 Patent, col. 4:47-49). This disclosure of specific physical forms could be used to argue for a more limited structural definition of the term.

VI. Other Allegations

Indirect Infringement

The complaint alleges active inducement of infringement under 35 U.S.C. § 271(b). This is based on the allegation that Sandoz's marketing, promotional materials, and product labeling for the Sandoz ANDA Products will encourage and instruct healthcare professionals and patients to administer the drug for the treatment of Parkinson's disease, thereby directly infringing method claims. (Compl. ¶48, 64).

Willful Infringement

The complaint does not explicitly allege "willful" infringement. However, it requests a finding that this is an "exceptional case" under 35 U.S.C. § 285, which is the statutory basis for awarding attorney fees and can be predicated on willful or bad faith conduct (Compl. ¶56, 72). The basis for this allegation is Sandoz's alleged knowledge of the patents-in-suit, stemming from their listing in the FDA's Orange Book and their identification in the Notice Letter provided to Plaintiffs (Compl. ¶46, 62).

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

  • A core issue will be one of biochemical identity: does the specific formulation detailed in Sandoz's confidential ANDA submission literally meet the structural requirements of the claims, particularly the use of a "dimethylaminoethyl methacrylate copolymer" for muco-adhesion, or will the dispute center on whether Sandoz's alternative excipients are functionally equivalent?
  • A second key question will be one of pharmacokinetic performance: will the clinical data submitted by Sandoz to the FDA for its proposed generic product demonstrate an in vivo plasma profile that satisfies the quantitative PK limitations recited in claims of patents like the ’845 Patent, or will there be a technical mismatch in the rate and duration of drug absorption?
  • A final central issue will concern induced infringement of method claims: for the patents directed to dosing regimens, the case will likely turn on whether the proposed product label for the Sandoz ANDA Products will instruct or inevitably lead physicians and patients to adopt the patented administration schedules, thereby making Sandoz liable for inducing infringement.

No probative visual evidence provided in complaint.