DCT

3:18-cv-15482

Sucampo AG v. Sun Pharmaceutical Industries Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: Sucampo AG v. Sun Pharmaceutical Industries, Ltd., 3:18-cv-15482, D.N.J., 10/30/2018
  • Venue Allegations: Plaintiffs allege venue is proper in the District of New Jersey because Defendant Sun has a regular and established place of business in the district and has committed acts of infringement there.
  • Core Dispute: Plaintiffs allege that Defendants’ submission of an Abbreviated New Drug Application (ANDA) to market generic versions of Plaintiffs’ AMITIZA® (lubiprostone) capsules constitutes an act of infringement of seven patents related to methods of use, dosage units, and formulations of the drug.
  • Technical Context: The patents relate to the drug lubiprostone, marketed as AMITIZA®, which is a chloride channel opener used for treating chronic idiopathic constipation and irritable bowel syndrome with constipation.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendants' submission of ANDA No. 212292 and a Paragraph IV Certification notice letter sent to Plaintiffs on September 18, 2018. The complaint was filed within the 45-day statutory window, triggering an automatic 30-month stay of FDA approval for the Defendants' generic product.

Case Timeline

Date Event
2001-11-14 ’653 and ’542 Patent Priority Date
2002-12-27 ’312 Patent Priority Date
2004-09-02 ’481 Patent Priority Date
2006-01-24 ’393, ’639, and ’187 Patent Priority Date
2006-01-31 FDA Approval for 24 mcg AMITIZA®
2008-04-29 FDA Approval for 8 mcg AMITIZA®
2010-09-14 ’312 Patent Issue Date
2011-09-27 ’393 Patent Issue Date
2012-01-17 ’653 Patent Issue Date
2012-12-25 ’639 Patent Issue Date
2013-03-05 ’542 Patent Issue Date
2014-06-10 ’481 Patent Issue Date
2014-07-15 ’187 Patent Issue Date
2018-09-18 Sun Notice Letter Sent
2018-10-30 Complaint Filing Date

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

U.S. Patent No. 7,795,312 - "Method for Treating Abdominal Discomfort"

  • Patent Identification: U.S. Patent No. 7,795,312, titled “Method for Treating Abdominal Discomfort,” issued September 14, 2010 (Compl. ¶38).
  • The Invention Explained:
    • Problem Addressed: The patent identifies functional gastrointestinal disorders, such as Irritable Bowel Syndrome (IBS), as a significant medical issue for which "No systematic method has been established for treating such disorder" (’312 Patent, col. 2:8-10).
    • The Patented Solution: The invention provides a method for treating abdominal discomfort and IBS by administering a chloride channel opener, specifically a prostaglandin compound like lubiprostone. This compound is described as having a "significant effect on abdominal discomfort" by activating chloride channels in the gastrointestinal tract, which is the proposed mechanism for relieving symptoms (’312 Patent, col. 2:57-65).
    • Technical Importance: The invention provided a specific pharmacological mechanism—chloride channel activation—for treating the symptoms of functional GI disorders, representing a targeted therapeutic approach.
  • Key Claims at a Glance:
    • The complaint asserts infringement of claims 7-12 and 18-22 (Compl. ¶54). The lead independent claims in these groups are Claim 7 and Claim 18.
    • Claim 7 requires:
      • A method for treating irritable bowel syndrome in a mammalian subject
      • Which comprises administering an effective amount of 13,14-dihydro-15-keto-16,16-difluoro prostaglandin E₁ (or a salt, ether, ester or amide thereof)
    • Claim 18 requires:
      • A method for treating abdominal discomfort associated with irritable bowel syndrome in a mammalian subject
      • Which comprises administering an effective amount of 13,14-dihydro-15-keto-16,16-difluoro prostaglandin E₁ (or a salt, ether, ester or amide thereof)

U.S. Patent No. 8,097,653 - "Dosage Unit Comprising a Prostaglandin Analog for Treating Constipation"

  • Patent Identification: U.S. Patent No. 8,097,653, titled “Dosage Unit Comprising a Prostaglandin Analog for Treating Constipation,” issued January 17, 2012 (Compl. ¶39).
  • The Invention Explained:
    • Problem Addressed: The patent notes that while prostaglandin analogs were known to have cathartic effects, "the range at which the PG analogs are safe, while yet exerting therapeutic effects, needs to be determined" (’653 Patent, col. 4:7-10).
    • The Patented Solution: The invention discloses a specific dosage regimen for a halogenated prostaglandin analog (lubiprostone) that relieves constipation "without substantial side effects" (’653 Patent, Abstract). The core of the invention is a dosage unit containing a specific amount of the active ingredient (e.g., 24 µg) to be administered within a specific total daily dose range (e.g., 48-72 µg), supported by clinical trial data presented in the patent's figures (’653 Patent, col. 5:1-5; Figs. 1-3).
    • Technical Importance: This patent defined a specific, clinically evaluated therapeutic window for lubiprostone, which is a critical step in transforming a known compound into a viable pharmaceutical product.
  • Key Claims at a Glance:
    • The complaint alleges infringement of one or more claims of the ’653 patent (Compl. ¶52). Claim 1 is the sole independent claim.
    • Claim 1 requires:
      • A method for relieving constipation in a human patient
      • Comprising administering a dosage unit that contains 24 µg +/- 10% of a specific PG analog (lubiprostone)
      • Wherein the dosage unit is administered such that the total daily dose is in the range of about 48-72 µg

U.S. Patent No. 8,389,542 - "Dosage Unit Comprising a Prostaglandin Analog for Treating Constipation"

  • Patent Identification: U.S. Patent No. 8,389,542, "Dosage Unit Comprising a Prostaglandin Analog for Treating Constipation," issued March 5, 2013 (Compl. ¶40).
  • Technology Synopsis: As a divisional of the application leading to the ’653 patent, this patent similarly addresses the need for a specific, safe, and effective dosage of lubiprostone. It claims a dosage unit containing 24 µg +/- 10% of the active ingredient for treating constipation (’542 Patent, Abstract).
  • Asserted Claims: Claims 1-13 (Compl. ¶54).
  • Accused Features: The Defendants' 24 mcg generic lubiprostone capsule is alleged to be a dosage unit that infringes these claims (Compl. ¶¶25, 52).

U.S. Patent No. 8,026,393 - "Soft-Gelatin Capsule Formulation"

  • Patent Identification: U.S. Patent No. 8,026,393, "Soft-Gelatin Capsule Formulation," issued September 27, 2011 (Compl. ¶41).
  • Technology Synopsis: This patent addresses the technical problem of the instability of 15-keto-prostaglandin compounds. The invention claims to solve this by providing a soft gelatin capsule formulation where the capsule shell comprises gelatin and a sugar alcohol as a plasticizer, which is asserted to significantly improve the stability of the encapsulated drug (’393 Patent, Abstract).
  • Asserted Claims: Claims 1-9 and 11-21 (Compl. ¶54).
  • Accused Features: The formulation of Defendants' soft gelatin capsule products is alleged to infringe (Compl. ¶¶25, 52).

U.S. Patent No. 8,338,639 - "Soft-Gelatin Capsule Formulation"

  • Patent Identification: U.S. Patent No. 8,338,639, "Soft-Gelatin Capsule Formulation," issued December 25, 2012 (Compl. ¶42).
  • Technology Synopsis: This patent is a continuation of the application that led to the ’393 patent and likewise claims a stable soft gelatin capsule formulation. The invention uses a sugar alcohol as a plasticizer in the gelatin shell to enhance the stability of the encapsulated 15-keto-prostaglandin compound (’639 Patent, Abstract).
  • Asserted Claims: Claims 1-8, 10, 12, 15, 17, 20-21, and 23 (Compl. ¶54).
  • Accused Features: The formulation of Defendants' soft gelatin ANDA products is alleged to meet the claim limitations (Compl. ¶¶25, 52).

U.S. Patent No. 8,779,187 - "Soft-Gelatin Capsule Formulation"

  • Patent Identification: U.S. Patent No. 8,779,187, "Soft-Gelatin Capsule Formulation," issued July 15, 2014 (Compl. ¶43).
  • Technology Synopsis: Belonging to the same family as the ’393 and ’639 patents, this patent also claims a stable formulation for a 15-keto-prostaglandin compound. The claimed solution is a soft gelatin capsule that uses a sugar alcohol as a plasticizer in the shell to improve the stability of the active ingredient filled within (’187 Patent, Abstract).
  • Asserted Claims: Claims 1-9, 11-13, 15, and 16 (Compl. ¶54).
  • Accused Features: The formulation of Defendants' soft gelatin capsule products is alleged to infringe (Compl. ¶¶25, 52).

U.S. Patent No. 8,748,481 - "Method for Treating Gastrointestinal Disorder"

  • Patent Identification: U.S. Patent No. 8,748,481, "Method for Treating Gastrointestinal Disorder," issued June 10, 2014 (Compl. ¶44).
  • Technology Synopsis: This patent claims a method for the long-term treatment of gastrointestinal disorders. The claimed method involves administering a halogenated prostaglandin compound and is asserted to induce "substantially no electrolyte shifting" and to improve the patient's quality of life (’481 Patent, Abstract).
  • Asserted Claims: Claims 1-13 and 15-17 (Compl. ¶54).
  • Accused Features: The intended use of Defendants' ANDA products for the long-term treatment of the indicated conditions, as will be directed by its proposed product labeling (Compl. ¶¶25, 52).

III. The Accused Instrumentality

  • Product Identification: Defendants’ generic lubiprostone capsules in 8 mcg and 24 mcg dosages, for which Defendants submitted ANDA No. 212292 to the FDA (Compl. ¶25).
  • Functionality and Market Context: The accused products are generic versions of Plaintiffs' AMITIZA® capsules, intended to be used for the same indications, namely the treatment of chronic idiopathic constipation, opioid-induced constipation, and irritable bowel syndrome with constipation (Compl. ¶¶25, 37). The act of infringement alleged in the complaint is the filing of the ANDA itself under 35 U.S.C. § 271(e)(2)(A), which seeks approval to market these generic products before the expiration of the patents-in-suit (Compl. ¶¶47, 52).

IV. Analysis of Infringement Allegations

The complaint does not provide a detailed claim chart. The infringement theory is based on the legal framework of the Hatch-Waxman Act, where the submission of an ANDA for a generic version of a branded drug is an act of infringement if the resulting product would infringe the patents listed for that drug. The allegation is that Defendants' ANDA products, by being bioequivalent copies of AMITIZA® intended for the same uses, will necessarily practice the inventions claimed in the patents-in-suit.

No probative visual evidence provided in complaint.

’795,312 Infringement Allegations

Claim Element (from Independent Claim 7) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for treating irritable bowel syndrome in a mammalian subject... The intended use of Defendants' ANDA Products to treat irritable bowel syndrome, as will be described on the FDA-approved product label. ¶¶25, 52-53 col. 14:53-58
which comprises administering an effective amount of 13,14-dihydro-15-keto-16,16-difluoro prostaglandin E₁... Defendants' ANDA Products contain lubiprostone, which is the compound specified in the claim, and the proposed label will instruct its administration. ¶¶25, 52 Abstract

’8,097,653 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for relieving constipation...comprising administering to the patient a dosage unit... The intended use of Defendants' 24 mcg ANDA Product to treat constipation as will be specified on its product label. ¶¶25, 52-53 col. 12:1-4
comprising (i) 24 µg+/-10% of a PG analog represented by Formula (I)... Defendants' 24 mcg ANDA Product contains a dosage of the claimed compound that falls within the specified range. ¶25 Abstract
wherein said dosage unit is administered enough times per day so that the total daily dose of the PG analog is in the range of about 48-72 µg. The proposed label for Defendants' 24 mcg ANDA Product will instruct administration twice daily, resulting in a total daily dose of 48 µg. ¶¶25, 52 col. 5:1-5
  • Identified Points of Contention:
    • Scope Questions: For the method-of-use patents (’312 and ’481), a central question is whether the Defendants' final approved product label will instruct for the patented uses. This raises the question of whether Defendants might attempt to "carve out" patented indications from their label to avoid a finding of induced infringement.
    • Technical Questions: For the dosage patents (’653 and ’542), infringement of the 24 mcg capsule appears straightforward. However, it raises the question of what evidence Plaintiffs will present to show that the intended administration of the 8 mcg ANDA product would result in a total daily dose falling within the claimed range of 48-72 µg, as required by claim 1 of the ’653 patent.

V. Key Claim Terms for Construction

  • For the ’312 Patent:

    • The Term: "treating"
    • Context and Importance: As a method-of-use patent, the scope of "treating" is fundamental. In an ANDA context where the generic's indication must match the brand's, the dispute may be less about the act of treating and more about whether the patent validly claims that treatment. Nevertheless, practitioners may focus on this term to determine if the clinical outcomes demonstrated in the patent are coextensive with the full scope of "treating" a complex condition like IBS.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification defines "treatment" broadly to include "any means of control such as prevention, care, relief of the condition, attenuation of the condition and arrest of progression" (’312 Patent, col. 11:41-44).
      • Evidence for a Narrower Interpretation: The patent's examples demonstrate treatment via specific, quantifiable metrics, such as a reduction in an "Abdominal discomfort score" on a 5-point scale (’312 Patent, col. 12, Table 1). A defendant could argue the term should be limited to achieving such statistically significant improvements.

  • For the ’653 Patent:

    • The Term: "about 48-72 µg" (total daily dose)
    • Context and Importance: The numerical range is a critical limitation defining the patented dosing regimen. The word "about" introduces a degree of flexibility whose scope will be disputed. Practitioners may focus on this term because the precision of the dosage range is central to the invention's claim of providing a safe and effective treatment, and the interpretation of "about" could determine whether dosing regimens slightly outside the explicit range are captured.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification explicitly contemplates variability, stating that "the term 'about' when used in conjunction with a unit of measure can be defined as +/-30% and +/-20%, preferably +/-10%" (’653 Patent, col. 6:17-19).
      • Evidence for a Narrower Interpretation: The patent emphasizes a specific preferable dose, stating "the preferable total daily dose of the PG analog is about 48 µg" (’653 Patent, col. 5:4-5). A party might argue that the clinical data in the patent supports a narrow range and "about" should not be construed so broadly as to cover dosages that lack similar evidentiary support in the specification.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that if Defendants commercialize their ANDA products, they will induce infringement of the patents-in-suit (Compl. ¶56). The factual basis for this allegation is that Defendants' product labeling will instruct physicians and patients to administer the drug in a manner that directly infringes the asserted method and dosage claims.
  • Willful Infringement: The complaint does not include an explicit allegation of willful infringement.

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

This case presents a classic Hatch-Waxman dispute involving multiple patents covering different facets of a successful drug product. The litigation will likely focus on the following central questions:

  • A primary issue will be one of patent validity: can Defendants prove by clear and convincing evidence that the asserted claims—spanning methods of use for specific indications, precise dosage regimens, and stabilizing soft-gelatin formulations—are invalid as obvious or anticipated in light of prior art available before the respective priority dates?
  • A key infringement question will be one of label scope: will the Defendants’ final, FDA-approved label for their generic lubiprostone products contain instructions that directly read on the patented methods for treating specific disorders, or will they successfully "carve out" these indications to avoid a finding of induced infringement for the method-of-use patents?