DCT

1:20-cv-00199

Allergan Sales LLC v. Breckenridge Pharmaceutical Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:20-cv-00199, D. Del., 02/10/2020
  • Venue Allegations: Plaintiff alleges venue is proper because Defendant has previously litigated in the District of Delaware, including on the same patent-in-suit, and did not challenge venue.
  • Core Dispute: Plaintiff alleges that Defendant’s Abbreviated New Drug Application (ANDA) to market a generic version of the antipsychotic drug Saphris® constitutes an act of infringement of a patent covering a rapidly-disintegrating sublingual pharmaceutical formulation.
  • Technical Context: The case involves pharmaceutical formulations for sublingual (under the tongue) delivery of asenapine, designed to achieve rapid absorption and avoid serious cardiotoxic side effects associated with conventional oral ingestion.
  • Key Procedural History: The complaint highlights that this dispute is related to prior litigation between the parties (or their predecessors) involving the same patent. In that prior litigation, Defendant Breckenridge allegedly stipulated that its then-proposed generic products infringed several claims of the patent-in-suit. The patent also has a five-year term extension and was subject to a six-month pediatric exclusivity period.

Case Timeline

Date Event
1994-03-02 ’476 Patent Priority Date
1998-06-09 ’476 Patent Issue Date
1998-11-24 ’476 Patent Certificate of Correction Issue Date
2009-08-13 FDA Approval of Saphris® NDA No. 22117
2014-11-13 Breckenridge Notice Letter (re: 5 mg and 10 mg tablets)
2015-03-03 FDA Grant of Pediatric Exclusivity for Saphris®
2016-04-04 Breckenridge Stipulation to Infringement of Claims 1, 2, and 6
2016-10-14 Breckenridge Stipulation to Infringement of Claim 5
2017-07-27 Breckenridge Notice Letter (re: 2.5 mg tablets)
2019-12-27 Breckenridge Notice Letter (re: ANDA No. 205960)
2020-02-10 Complaint Filing Date

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

U.S. Patent No. 5,763,476 - Sublingual or Buccal Pharmaceutical Composition

The Invention Explained

  • Problem Addressed: The patent’s background section states that peroral (swallowed) administration of the active compound, a potent antipsychotic agent, "revealed that serious cardiotoxic effects, e.g. postural hypotension and/or impairment of baroreceptor functioning, occurred" (’476 Patent, col. 1:24-29).
  • The Patented Solution: The invention is a pharmaceutical formulation for sublingual or buccal administration that allows the active compound to be absorbed directly into the bloodstream from the mouth, bypassing the digestive system (’476 Patent, col. 1:30-33). The core of the patented solution is a solid dosage form, such as a tablet or lozenge, that is specifically designed to "rapidly disintegrate in the mouth of a subject," which is defined as disintegrating within 30 seconds in water at 37° C (’476 Patent, col. 1:55-65). This rapid disintegration facilitates quick absorption and avoids the side effects associated with peroral delivery.
  • Technical Importance: This formulation technique provided a viable and safer delivery mechanism for a clinically important antipsychotic drug that was otherwise problematic to administer (’476 Patent, col. 1:30-33).

Key Claims at a Glance

  • The complaint alleges infringement of "one or more claims," with specific reference to prior stipulations regarding claims 1, 2, 5, and 6, and allegations of indirect infringement concerning at least claim 4 (Compl. ¶¶26, 27, 34, 36). The lead independent claim is Claim 1.
  • Independent Claim 1:
    • A pharmaceutical composition comprising as a medicinally active compound: trans-5-chloro-2-methyl-2,3,3a,12b-tetrahydro-1H-dibenz[2,3:6,7]oxepino[4,5-c]pyrrole or a pharmaceutically acceptable salt thereof;
    • wherein the composition is a solid composition
    • and disintegrates within 30 seconds in water at 37° C.
  • The complaint reserves the right to assert other claims, including dependent claims which add further limitations, such as the use of specific carrier materials like partially hydrolysed gelatin (Claim 3) (’476 Patent, col. 6:9-11).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is "Breckenridge's Generic Asenapine Product," which is the subject of Abbreviated New Drug Application (ANDA) No. 205960 submitted to the FDA (Compl. ¶15).

Functionality and Market Context

The product is a generic version of Plaintiffs' Saphris® brand drug and consists of sublingual tablets containing asenapine maleate in dosage strengths equivalent to 2.5 mg, 5 mg, and 10 mg of asenapine base (Compl. ¶15). By filing an ANDA, Breckenridge seeks FDA approval to market its product as a bioequivalent substitute for Saphris® for the treatment of schizophrenia and bipolar disorder before the expiration of the ’476 Patent (Compl. ¶¶13, 15).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint’s infringement theory under 35 U.S.C. § 271(e)(2) is based on Breckenridge’s submission of ANDA No. 205960 (Compl. ¶21). A central feature of the complaint is its reference to prior litigation, where Breckenridge allegedly stipulated to infringing several claims of the ’476 Patent (Compl. ¶¶26-27). This suggests that the primary dispute may concern patent validity rather than infringement.

’476 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A pharmaceutical composition comprising as a medicinally active compound: trans-5-chloro-2-methyl-2,3,3a,12b-tetrahydro-1H-dibenz[2,3:6,7]oxepino[4,5-c]pyrrole or a pharmaceutically acceptable salt thereof Breckenridge’s Generic Asenapine Product is alleged to contain asenapine maleate, a salt of the claimed active compound. ¶15 col. 6:59-62
wherein the composition is a solid composition The accused product is formulated as "sublingual tablets." ¶15 col. 6:2-3
and disintegrates within 30 seconds in water at 37° C. The complaint alleges that Breckenridge previously stipulated that its "Proposed ANDA Products infringe claims 1, 2, and 6," which implicitly concedes that its formulation meets the disintegration limitation of claim 1. ¶26 col. 6:3-4

Identified Points of Contention

  • Scope Questions: The complaint alleges that Breckenridge's new notice letter for ANDA No. 205960 "incorporates by reference its previous Notice Letters" from 2014 and 2017 (Compl. ¶17). A key question is whether the product detailed in the current ANDA is materially identical to the products for which Breckenridge previously stipulated to infringement, thereby binding it to its prior admission.
  • Technical Questions: While the complaint relies on prior stipulations, a latent technical question is whether Breckenridge will now argue that its formulation for the 2.5 mg tablet, which was the subject of a later notice letter (Compl. ¶17), possesses different disintegration properties or excipients that distinguish it from the previously litigated 5 mg and 10 mg tablets (Compl. ¶27).

V. Key Claim Terms for Construction

  • The Term: "disintegrates within 30 seconds in water at 37° C"
  • Context and Importance: This functional limitation is the primary feature that distinguishes the claimed invention from conventional oral tablets and is crucial for establishing infringement. Practitioners may focus on this term if Breckenridge attempts to differentiate its current product from those previously stipulated to infringe. The patent itself points to a standardized test method, which may limit the scope for construction disputes (’476 Patent, col. 1:60-65).
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The plain language of the claim sets forth a clear, objective performance standard. Any solid composition meeting this time-and-temperature test could be seen as infringing, regardless of the specific mechanism or excipients used to achieve the rapid disintegration.
    • Evidence for a Narrower Interpretation: The specification places significant emphasis on preparing the composition via freeze-drying using specific carrier materials like gelatin and mannitol (’476 Patent, col. 2:36-54, Examples 1-7). A party could argue that the term should be understood in the context of these preferred embodiments, potentially limiting its scope to compositions made with similar carriers or methods.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement, stating that Breckenridge knows and intends for physicians and patients to use its generic product "in accordance with the instructions and/or label," which will necessarily result in direct infringement (Compl. ¶23). It also pleads contributory infringement, alleging the active ingredient asenapine is not a "staple article or commodity of commerce suitable for substantial noninfringing use" and is a material part of the invention (Compl. ¶24).
  • Willful Infringement: While the complaint does not use the word "willful," it requests that the court "declare this to be an exceptional case" and award attorney fees (Prayer for Relief, ¶h). The factual basis for this appears to be Breckenridge's alleged knowledge of the ’476 patent and its infringement based on the extensive prior litigation history between the parties (Compl. ¶¶22, 25-27).

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

  • A core issue will be one of estoppel and preclusion: to what extent do Breckenridge's prior stipulations of infringement in related litigation prevent it from contesting infringement of the same claims by the product described in the current ANDA? The court will need to determine if the accused products are legally and factually indistinguishable.
  • The central substantive dispute will likely be patent validity: assuming infringement is established or not seriously contested, the case will hinge on whether Breckenridge can meet its burden of proving by clear and convincing evidence that the asserted claims of the ’476 patent are invalid, a position it asserted in its Paragraph IV certification (Compl. ¶16).
  • A key evidentiary question will be one of formulation identity: what evidence exists to demonstrate that the specific composition and performance characteristics of the product in ANDA No. 205960 are, or are not, materially different from the formulations that were the subject of the prior infringement stipulations?