DCT

2:23-cv-05720

Supernus Pharma Inc v. Ascent Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:23-cv-05720, E.D.N.Y., 07/28/2023
  • Venue Allegations: Venue is alleged to be proper in the Eastern District of New York because Defendant Ascent is incorporated in New York and maintains its principal place of business within the district. Venue over Defendants Camber and Hetero is based on allegations that the three defendants operate as an integrated, unitary business engaged in infringing activities in the district.
  • Core Dispute: Plaintiff alleges that Defendants' filing of an Abbreviated New Drug Application (ANDA) for generic extended-release topiramate capsules constitutes an act of infringement of ten patents covering Plaintiff's branded drug, Trokendi XR®.
  • Technical Context: The technology involves pharmaceutical formulations of topiramate, an antiepileptic drug, designed to provide sustained release for once-daily administration, aiming to improve patient compliance and reduce side effects associated with immediate-release versions.
  • Key Procedural History: The action was triggered by a Paragraph IV notice letter sent by Defendant Ascent on or about June 15, 2023, informing Plaintiff of its ANDA filing seeking FDA approval to market a generic version of Trokendi XR® before the expiration of the patents-in-suit. The complaint alleges this notice letter is deficient for failing to provide non-infringement contentions for numerous asserted claims.

Case Timeline

Date Event
2006-11-17 Earliest Priority Date for all Patents-in-Suit
2012-10-30 U.S. Patent No. 8,298,576 Issued
2012-10-30 U.S. Patent No. 8,298,580 Issued
2014-03-04 U.S. Patent No. 8,663,683 Issued
2014-11-04 U.S. Patent No. 8,877,248 Issued
2014-11-18 U.S. Patent No. 8,889,191 Issued
2015-03-31 U.S. Patent No. 8,992,989 Issued
2017-01-24 U.S. Patent No. 9,549,940 Issued
2017-01-31 U.S. Patent No. 9,555,004 Issued
2017-04-18 U.S. Patent No. 9,622,983 Issued
2019-06-11 U.S. Patent No. 10,314,790 Issued
2023-06-15 Ascent sends Paragraph IV Notice Letter to Supernus
2023-07-28 Complaint Filed

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

U.S. Patent No. 8,298,576 - Sustained-Release Formulations of Topiramate

The Invention Explained

  • Problem Addressed: The patent describes that while the drug topiramate has a long half-life, its immediate-release formulation (Topamax®) causes severe side effects (e.g., somnolence, dizziness) at high doses, necessitating multiple, "divided" daily doses. This regimen is described as cumbersome for patients and leads to undesirable peaks and valleys in blood plasma levels of the drug (’576 Patent, col. 1:40-62).
  • The Patented Solution: The invention is a sustained-release, once-daily dosage form of topiramate. It is designed to use a combination of bead populations, including an optional immediate-release (IR) component and an extended-release (XR) component, to create a "sustained, non-pulsatile release" profile (’576 Patent, Abstract; col. 2:2-4). This approach is intended to reduce peak-concentration side effects, minimize fluctuations in plasma levels, and improve patient compliance by simplifying the dosing schedule (’576 Patent, col. 2:5-11).
  • Technical Importance: The formulation's technical approach sought to make a widely used antiepileptic and migraine-prevention drug safer and easier for patients to take by enabling an effective once-daily regimen (’576 Patent, col. 2:5-11).

Key Claims at a Glance

  • The complaint asserts "one or more claims" of the '576 patent (Compl. ¶76) and refers to claims 1-30 in the context of validity (Compl. ¶72). Independent claim 1 is representative.
  • The essential elements of independent claim 1 include:
    • A sustained release formulation of topiramate for oral administration.
    • An immediate release (IR) bead population comprising topiramate up to 10% by weight of the total amount, which releases at least 80% of its topiramate in one hour or less.
    • A first extended release (XR1) bead population comprising topiramate up to 20% by weight of the total amount, which releases 80% of its topiramate in four hours or less.
    • A second extended release (XR2) bead population comprising at least 80% by weight of the total amount, which releases 80% of its topiramate in eight hours or less.
    • The XR1 and XR2 populations are coated with a release controlling material and have their own specific rates of release.

U.S. Patent No. 8,298,580 - Sustained-Release Formulations of Topiramate

The Invention Explained

  • Problem Addressed: The patent addresses the same problem as the ’576 Patent: the adverse side effects associated with peak plasma concentrations of immediate-release topiramate and the inconvenience of its required twice-daily dosing regimen (’580 Patent, col. 1:41-63).
  • The Patented Solution: The invention provides a once-daily, sustained-release topiramate formulation comprising multiple populations of beads with different release profiles. The formulation combines an extended-release (XR) component with an optional immediate-release (IR) component to achieve a pre-determined release profile that reduces side effects and improves patient compliance (’580 Patent, Abstract; col. 2:13-25).
  • Technical Importance: As with the ’576 Patent, the technology provides a clinically significant improvement for patients by enabling a safer and more convenient once-daily dosing schedule for topiramate (’580 Patent, col. 2:8-12).

Key Claims at a Glance

  • The complaint asserts "one or more claims" of the '580 patent (Compl. ¶84) and refers to claims 1-31 in the context of validity (Compl. ¶72). Independent claim 1 is representative and is structurally identical to claim 1 of the ’576 Patent.
  • The essential elements of independent claim 1 include:
    • A sustained release formulation of topiramate for oral administration.
    • An IR bead population with up to 10% by weight of total topiramate, releasing ≥80% in ≤1 hour.
    • An XR1 bead population with up to 20% by weight of total topiramate, releasing 80% in ≤4 hours.
    • An XR2 bead population with at least 80% by weight of total topiramate, releasing 80% in ≤8 hours.
    • The XR1 and XR2 populations possess a release controlling coating and have distinct release rates.

U.S. Patent No. 8,663,683 - Sustained-Release Formulations of Topiramate

  • Technology Synopsis: This patent describes a sustained-release topiramate formulation for once-daily oral administration. The formulation comprises an extended-release (XR) component and an optional immediate-release (IR) component, designed to release the drug along a pre-determined profile to reduce side effects and improve patient compliance (’683 Patent, Abstract; col. 2:3-11).
  • Asserted Claims: Claims 1, 6-16, 18-20, and 23-24 (Compl. ¶71).
  • Accused Features: The Ascent ANDA Products, which are generic extended-release topiramate capsules (Compl. ¶¶10, 92).

U.S. Patent No. 8,877,248 - Sustained-Release Formulations of Topiramate

  • Technology Synopsis: This patent also discloses a once-a-day, sustained-release topiramate formulation composed of bead populations. The formulation includes an XR component and an optional IR component, with the release profiles of each being selectively adjustable to achieve a therapeutic effect while reducing side effects associated with immediate-release versions (’248 Patent, Abstract; col. 2:5-12).
  • Asserted Claims: Claims 14 and 18-20 (Compl. ¶71).
  • Accused Features: The Ascent ANDA Products, which are generic extended-release topiramate capsules (Compl. ¶¶10, 100).

U.S. Patent No. 8,889,191 - Sustained-Release Formulations of Topiramate

  • Technology Synopsis: This patent describes a once-daily, sustained-release topiramate formulation containing bead populations with different release profiles. The formulation is designed to provide a sustained, non-pulsatile release that improves patient compliance and may reduce side effects compared to immediate-release topiramate formulations (’191 Patent, Abstract; col. 2:2-11).
  • Asserted Claims: Claims 1-24 (Compl. ¶71).
  • Accused Features: The Ascent ANDA Products, which are generic extended-release topiramate capsules (Compl. ¶¶10, 108).

U.S. Patent No. 8,992,989 - Sustained-Release Formulations of Topiramate

  • Technology Synopsis: This patent discloses a once-daily, sustained-release topiramate formulation comprised of an XR component and an optional IR component. The components can be selectively adjusted to release topiramate along a pre-determined profile, with the goal of treating pathological disorders while reducing side effects (’989 Patent, Abstract; col. 2:5-12).
  • Asserted Claims: Claims 14 and 18-20 (Compl. ¶71).
  • Accused Features: The Ascent ANDA Products, which are generic extended-release topiramate capsules (Compl. ¶¶10, 116).

U.S. Patent No. 9,549,940 - Sustained-Release Formulations of Topiramate

  • Technology Synopsis: This patent covers a once-a-day, sustained-release oral topiramate formulation. It comprises an XR component and an optional IR component, with the composition of each being adjustable to achieve a pre-determined release profile for treating disorders while mitigating side effects associated with immediate-release formulations (’940 Patent, Abstract).
  • Asserted Claims: Claims 14 and 18-20 (Compl. ¶71).
  • Accused Features: The Ascent ANDA Products, which are generic extended-release topiramate capsules (Compl. ¶¶10, 124).

U.S. Patent No. 9,555,004 - Sustained-Release Formulations of Topiramate

  • Technology Synopsis: This patent discloses a once-daily, sustained-release formulation of topiramate. The formulation includes bead populations with different release characteristics (XR and optional IR) that can be adjusted to create a specific release profile, thereby reducing side effects and improving patient compliance (’004 Patent, Abstract; col. 2:2-11).
  • Asserted Claims: The complaint alleges infringement of "one or more claims" of the '004 patent but does not specify particular claims in paragraph 71 (Compl. ¶132).
  • Accused Features: The Ascent ANDA Products, which are generic extended-release topiramate capsules (Compl. ¶¶10, 132).

U.S. Patent No. 9,622,983 - Sustained-Release Formulations of Topiramate

  • Technology Synopsis: This patent describes a sustained-release topiramate formulation for once-a-day oral administration. It comprises an XR component and an optional IR component, with compositions that can be adjusted to release the drug along a pre-determined profile, thereby treating disorders while reducing side effects (’983 Patent, Abstract).
  • Asserted Claims: Claims 13 and 17-29 (Compl. ¶71).
  • Accused Features: The Ascent ANDA Products, which are generic extended-release topiramate capsules (Compl. ¶¶10, 140).

U.S. Patent No. 10,314,790 - Sustained-Release Formulations of Topiramate

  • Technology Synopsis: This patent also describes a once-daily, sustained-release topiramate formulation using multiple bead populations. It comprises an XR component and an optional IR component that can be selectively adjusted to achieve a pre-determined release profile, with the goal of improving patient compliance and reducing side effects (’790 Patent, Abstract).
  • Asserted Claims: Claims 1-10 and 12-24 (Compl. ¶71).
  • Accused Features: The Ascent ANDA Products, which are generic extended-release topiramate capsules (Compl. ¶¶10, 148).

III. The Accused Instrumentality

Product Identification

  • The accused products are Defendants' generic topiramate extended-release capsules in 25 mg, 50 mg, 100 mg, and 200 mg dosages, for which Defendant Ascent filed Abbreviated New Drug Application (ANDA) No. 217443 with the FDA (the "Ascent ANDA Products") (Compl. ¶10).

Functionality and Market Context

  • The complaint alleges the Ascent ANDA Products are based upon Plaintiff's Trokendi XR® as the reference listed drug (Compl. ¶62). The proposed prescribing information allegedly indicates the same uses, including once-daily oral administration for treating seizures and preventing migraines (Compl. ¶¶64, 65). This implies the accused products are designed to be bioequivalent to Trokendi XR® and to provide a sustained release of topiramate over a 24-hour period. Defendants are alleged to be generic pharmaceutical manufacturers seeking to enter the U.S. market with a generic version of Plaintiff's product upon FDA approval (Compl. ¶¶10, 11).
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide sufficient detail for a claim chart analysis. It alleges infringement under 35 U.S.C. § 271(e)(2)(A), which makes the act of submitting an ANDA for a patented drug an act of infringement (Compl. ¶74). The narrative infringement theory is that because the Ascent ANDA Products use Trokendi XR® as the reference listed drug and seek approval for the same indications and dosing, they will necessarily possess the formulation characteristics and pharmacokinetic profiles claimed in the patents-in-suit (Compl. ¶¶62-65). The complaint further alleges that Ascent’s Paragraph IV notice letter failed to provide non-infringement contentions for numerous asserted claims, which Plaintiff construes as an acknowledgement of infringement (Compl. ¶71).

  • Identified Points of Contention:
    • Scope Questions: A central issue will be whether the specific formulation detailed in the Defendants' confidential ANDA falls within the scope of the claims. Key questions may include whether the accused product's formulation uses a combination of distinct bead populations that meet the structural and release-profile limitations of claims like claim 1 of the ’576 and ’580 patents.
    • Technical Questions: A key technical question will be whether achieving bioequivalence to Trokendi XR® necessitates the use of the specific multi-component bead structure recited in the independent claims. The litigation will likely explore whether Defendants' formulation achieves a similar clinical result through a technically distinct, non-infringing design.

V. Key Claim Terms for Construction

  • The Term: "immediate release bead population" and "extended release bead population" (from claim 1 of the '576 and '580 patents).

    • Context and Importance: The claims require a specific combination of at least three distinct populations (one IR, two XR). The definition of what constitutes a separate "population" will be critical. Practitioners may focus on this term because a defendant could argue its formulation uses a single blended population with varied bead coatings, or a different number of populations, that does not map onto the claim's requirement for three distinct types.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification provides functional definitions, such as defining an "immediate release formulation" as one that releases "greater than or equal to about 80% of the pharmaceutical agent in less than or equal to about 1 hour" (’576 Patent, col. 4:32-35). This could support a reading where any group of beads meeting this functional test constitutes the "immediate release bead population," regardless of its structural similarity to other beads.
      • Evidence for a Narrower Interpretation: The detailed examples in the specification describe the preparation of different bead populations (e.g., XR1, XR2, XR3) with distinct compositions and coating levels, which are then combined to form the final formulation (’576 Patent, Table 5). This may support a narrower construction requiring physically and compositionally distinct groups of beads for each claimed "population."

  • The Term: "releases... in a continuous manner" (from claim 1 of the '576 and '580 patents).

    • Context and Importance: This term describes the nature of the drug release from the extended-release beads. Its construction is important because a defendant could argue its formulation achieves release through a different mechanism, such as a pulsatile or delayed-then-rapid release, which might not be "continuous."
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The term is not explicitly defined, which could support giving it a plain and ordinary meaning of occurring without interruption over the specified time period.
      • Evidence for a Narrower Interpretation: The patent's background section contrasts the invention with undesirable "peaks and valleys of blood plasma levels" (’576 Patent, col. 1:59-60) and the Summary of the Invention describes the formulation as characterized by a "sustained, non-pulsatile release" (’576 Patent, col. 2:3-4). This language could support a narrower construction that excludes formulations with significant initial bursts or lag times.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendants will induce and contribute to infringement by commercially offering for sale and selling the Ascent ANDA Products (Compl. ¶77). The basis for this allegation is the proposed product labeling, which will allegedly instruct physicians and patients to administer the generic drug in a manner that directly infringes the method claims of the patents-in-suit (Compl. ¶¶64-66).
  • Willful Infringement: While the infringement counts do not explicitly use the word "willful," the prayer for relief requests a judgment that infringement is willful and seeks enhanced damages (Compl. p. 33, ¶vii). The factual basis alleged is that Defendants acted without a reasonable basis for believing they would not be liable for infringement, citing the submission of the ANDA with knowledge of the patents and the alleged deficiencies in the Paragraph IV notice letter (Compl. ¶79).

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

  • A core issue will be one of infringement mapping: once the formulation of the Ascent ANDA Products is disclosed, will its specific combination of components and their respective release profiles be found to meet every limitation of the asserted claims? The case will likely turn on whether the accused product literally contains the distinct "immediate release" and multiple "extended release" bead populations required by the patents' core claims.
  • A key procedural question will be the legal effect of the Paragraph IV notice: what is the consequence of Defendants' alleged failure to provide non-infringement arguments for numerous claims in their notice letter? The court will need to determine if this constitutes a procedural deficiency or has a more substantive impact on the infringement analysis for those claims.
  • A central dispute will be over validity: as this is a Hatch-Waxman action, Defendants have certified that the patents-in-suit are invalid or not infringed. A primary focus of the case will be Defendants' challenge to the validity of the asserted claims based on prior art that was or was not considered by the U.S. Patent and Trademark Office.