DCT

1:16-cv-01069

Aptalis Pharma Canada ULC v. Par Pharmaceutical Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:16-cv-01069, D. Del., 11/18/2016
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because the Defendant is a Delaware corporation and, on information and belief, plans to sell its generic product in Delaware.
  • Core Dispute: Plaintiffs allege that Defendant’s submission of an Abbreviated New Drug Application (ANDA) for a generic version of the drug PYLERA® constitutes an act of infringement of a patent covering a "double capsule" formulation for combination drug therapies.
  • Technical Context: The technology involves a pharmaceutical dosage form designed to simplify complex, multi-drug treatment regimens for Helicobacter pylori infections by combining multiple active ingredients into a single capsule-within-a-capsule structure.
  • Key Procedural History: This action was filed under the Hatch-Waxman Act, triggered by Defendant's submission of ANDA No. 205770 with a Paragraph IV certification. This certification asserts that U.S. Patent No. 6,350,468, which is listed in the FDA's Orange Book for the branded drug PYLERA®, is invalid, unenforceable, or will not be infringed by the Defendant's proposed generic product. The suit was filed within the 45-day window following Plaintiffs' receipt of Defendant's notice letter, which may trigger a 30-month stay of FDA approval for the generic.

Case Timeline

Date Event
1997-12-17 ’468 Patent Priority Date
2002-02-26 ’468 Patent Issue Date
2006-09-28 PYLERA® (NDA No. 050786) approved by FDA
2014-08-12 Par Pharmaceutical, Inc. submits ANDA No. 205770
2016-10-06 Plaintiffs receive Paragraph IV Notice Letter from Par
2016-11-18 Complaint for Patent Infringement filed

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

U.S. Patent No. 6,350,468 - Double Capsule for the Administration of Active Principles in Multiple Therapies, issued February 26, 2002

The Invention Explained

  • Problem Addressed: The patent describes therapies for eradicating Helicobacter pylori that require administering multiple active principles. It notes that such regimens, often involving several tablets taken multiple times a day, are "extremely complicated" for patients, leading to potential mistakes that "can compromise the outcome of the therapy itself" (’468 Patent, col. 2:35-48).
  • The Patented Solution: The invention is a pharmaceutical dosage form consisting of a "double capsule," where a smaller, internal capsule is placed inside a larger, external one (’468 Patent, Abstract; col. 3:55-64). This structure allows for the combination of multiple drugs into a single dosage unit, which provides a "simple and safe posology" and overcomes problems of drug interaction by creating a "physical barrier" between incompatible active ingredients (’468 Patent, col. 3:44-54).
  • Technical Importance: By simplifying the administration of a complex multi-drug therapy into a single unit, the invention aimed to improve patient compliance and, consequently, the efficacy of treatment for common gastrointestinal infections (’468 Patent, col. 2:44-48).

Key Claims at a Glance

  • The complaint asserts independent claims 1 (a method claim) and 21 (a product claim) (Compl. ¶34).
  • Independent Claim 1 (Method): The essential elements are:
    • A method for carrying out a triple therapy against Helicobacter pylori in a mammal
    • Comprising the oral administration of a pharmaceutical dosage form
    • The dosage form comprises an internal capsule placed inside an external capsule
    • The external capsule comprises a soluble salt of bismuth and a first antibiotic
    • The internal capsule comprises a second antibiotic
  • Independent Claim 21 (Product): The essential elements are:
    • A pharmaceutical dosage form for oral administration in a triple therapy against Helicobacter pylori
    • The dosage form comprises an internal capsule placed inside an external capsule
    • The external capsule comprises a soluble salt of bismuth and a first antibiotic
    • The internal capsule comprises a second antibiotic

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is "Par's Generic Product," identified as an oral capsule formulation of bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride intended to be a generic equivalent of PYLERA® (Compl. ¶¶1, 20).

Functionality and Market Context

  • The complaint alleges that Par's Generic Product is designed to be "purportedly bioequivalent to PYLERA®" and is intended for the same therapeutic use: the eradication of Helicobacter pylori in patients with duodenal ulcer disease (Compl. ¶¶15, 20). The complaint alleges, on information and belief, that the product is a dosage form comprising an internal capsule (containing tetracycline) placed inside an external capsule (containing bismuth subcitrate potassium and metronidazole) (Compl. ¶33). The filing of the ANDA is an application to the FDA to market this product in the United States upon approval (Compl. ¶20).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint’s infringement theory is based on the structure and composition of the proposed generic drug, which Plaintiffs allege, on information and belief, mirrors the patented invention (Compl. ¶¶24, 33). The allegations for the product claim, Claim 21, are summarized below. The allegations for the method claim, Claim 1, are based on the intended use of this product as directed by its proposed labeling (Compl. ¶36).

’468 Patent Infringement Allegations

Claim Element (from Independent Claim 21) Alleged Infringing Functionality Complaint Citation Patent Citation
Pharmaceutical dosage form for the oral administration of active principles in a triple therapy against the microorganisms Helicobacter pylori... Par's Generic Product is an oral capsule formulation intended for a triple therapy to treat Helicobacter pylori infections, as evidenced by its ANDA seeking approval as a generic version of PYLERA®. ¶¶1, 15, 20 col. 7:45-49
...the pharmaceutical dosage form comprising an internal capsule placed inside an external capsule... Par's Generic Product is alleged to be a pharmaceutical dosage form that comprises an internal capsule placed inside an external capsule. ¶33 col. 7:49-51
...wherein the external capsule comprises a soluble salt of bismuth and a first antibiotic... The external capsule of Par's Generic Product allegedly comprises bismuth subcitrate potassium (a soluble salt of bismuth) and metronidazole (a first antibiotic). ¶33 col. 8:51-54
...and the internal capsule comprises a second antibiotic. The internal capsule of Par's Generic Product allegedly comprises tetracycline (a second antibiotic). ¶33 col. 8:54-55
  • Identified Points of Contention:
    • Factual Questions: Because the complaint is filed on "information and belief" without Plaintiffs having access to the confidential ANDA submission, a primary question is factual: does discovery on Par's Generic Product confirm that it possesses the "internal capsule placed inside an external capsule" structure with the specified distribution of active ingredients as alleged? (Compl. ¶¶24, 33).
    • Scope Questions: The analysis may raise the question of whether "bismuth subcitrate potassium," the ingredient in the accused product, is properly categorized as a "soluble salt of bismuth" as recited in the claims, particularly in view of the exemplary list provided in the patent specification ('468 Patent, col. 5:1-10).

V. Key Claim Terms for Construction

  • The Term: "soluble salt of bismuth"
    • Context and Importance: This term is critical because infringement requires the accused product's external capsule to contain such a salt (Compl. ¶33). The accused product is alleged to contain "bismuth subcitrate potassium." The construction of "soluble salt of bismuth" will determine if this specific compound falls within the claim's scope.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification states that the salt is "preferably selected from the group consisting of bismuth subcitrate, bismuth aluminate..." and provides a long, exemplary list ('468 Patent, col. 5:1-10). The use of "preferably" suggests the list is not exhaustive and that other soluble bismuth salts, such as the potassium version of the listed subcitrate, could be included.
      • Evidence for a Narrower Interpretation: A party could argue that the express recitation of "bismuth subcitrate" without the "potassium" modifier, combined with the other listed examples, implicitly defines the boundaries of the term, potentially excluding variants not explicitly named.
  • The Term: "internal capsule placed inside an external capsule"
    • Context and Importance: This phrase defines the core physical structure of the claimed dosage form. Any significant deviation in the accused product's structure from this arrangement could form the basis of a non-infringement argument.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patent's summary and abstract describe the invention in general terms as "two capsules one placed inside the other" ('468 Patent, col. 2:63-65). This general language may support a construction that is not limited to specific sizes, materials, or manufacturing methods.
      • Evidence for a Narrower Interpretation: The detailed description provides specific examples of capsule size combinations, such as an internal capsule of "format 3" inserted into an external capsule of "format 0+" ('468 Patent, col. 4:37-41; Table 1). A party might argue these specific embodiments limit the claim term to a structure with a distinct, separate inner capsule fully contained within an outer one, as opposed to other co-formulation techniques.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon approval, Par will induce infringement of method claim 1 by marketing its generic product with labels and inserts instructing healthcare professionals and patients to administer the drug, thereby performing the claimed therapeutic method (Compl. ¶36). It further alleges contributory infringement, stating the product is not a "staple article or commodity of commerce suitable for substantial non-infringing use" (Compl. ¶36).
  • Willful Infringement: The complaint alleges that Par had knowledge of the ’468 Patent prior to filing its ANDA and that its Paragraph IV certification was made "without adequate justification" (Compl. ¶¶37-38). This conduct is alleged to make the case "exceptional" under 35 U.S.C. § 285, which is the basis for seeking enhanced damages and attorneys' fees (Compl. ¶38, Prayer for Relief ¶F).

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

  • A central issue will be one of evidentiary confirmation: pending discovery of the contents of Par's confidential ANDA submission, a primary factual question is whether Par's Generic Product is, in fact, constructed as an "internal capsule placed inside an external capsule" with the specific drug distribution alleged by Plaintiffs.
  • A second key issue will be one of definitional scope: assuming the product's structure is confirmed, the case may turn on claim construction, specifically whether the term "soluble salt of bismuth" is construed to encompass "bismuth subcitrate potassium," the compound allegedly used in the accused generic product.
  • Finally, as an ANDA case, the ultimate question is whether the act of filing the ANDA constitutes infringement under 35 U.S.C. § 271(e)(2). The resolution will depend on whether the product that would be marketed, if approved, would infringe one or more claims of the ’468 Patent.