DCT

1:15-cv-00761

Warner Chilcott US LLC v. Teva Pharma USA Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:15-cv-00761, D. Del., 08/31/2015
  • Venue Allegations: Venue is alleged to be proper in Delaware because Defendant Teva USA is a Delaware corporation and because Teva intends to market, distribute, and sell its generic product in Delaware.
  • Core Dispute: Plaintiffs allege that Defendant’s filing of an Abbreviated New Drug Application (ANDA) for a generic version of the drug DELZICOL® constitutes an act of infringement of a patent covering the specific chemical composition of the drug's capsule.
  • Technical Context: The lawsuit concerns the formulation of hard pharmaceutical capsules, specifically those made from cellulose ether compounds, which were developed as an alternative to traditional gelatin capsules to improve stability with moisture-sensitive drugs.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Teva's submission of ANDA No. 207873 with a Paragraph IV certification. This certification asserts that U.S. Patent No. 6,649,180, listed in the FDA's Orange Book for the branded drug DELZICOL®, is invalid, unenforceable, or will not be infringed by Teva's proposed generic product.

Case Timeline

Date Event
1999-04-14 ’180 Patent Priority Date
2003-11-18 ’180 Patent Issue Date
2013-02-01 FDA Approval of DELZICOL® (NDA No. 204412)
2015-07-16 Teva's ANDA Submission (on or before this date)
2015-07-16 Teva's Paragraph IV Notice Letter to Plaintiffs
2015-08-31 Complaint Filing Date

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

U.S. Patent No. 6,649,180 - "Hard capsule formed of cellulose ether film with a specific content of methoxyl and hydroxypropoxyl groups," issued November 18, 2003

The Invention Explained

  • Problem Addressed: The patent addresses a cosmetic and stability issue in non-gelatin pharmaceutical capsules. Capsules made from cellulose ethers like hydroxypropyl methyl cellulose (HPMC) require a "gelling aid" (e.g., potassium salts) to form properly. The patent notes that during long-term storage, this gelling aid can precipitate out of the capsule film, creating an 'unpleasant to look at' cloudy or spotty appearance ('180 Patent, col. 2:1-6).
  • The Patented Solution: The invention is a specific chemical formulation for the HPMC itself. By limiting the total percentage of two substituent chemical groups (methoxyl and hydroxypropoxyl) to a specific range (23-37.6% by weight), the cellulose ether film's 'water-holding force is effectively improved.' This improved ability to retain water keeps the gelling aid in a dissolved ionic state, preventing it from precipitating onto the capsule surface ('180 Patent, col. 2:32-51).
  • Technical Importance: This approach provided a way to manufacture cellulose-based capsules that were not only free from the moisture-sensitivity problems of gelatin capsules but were also cosmetically stable over time, avoiding the cloudiness that affected prior HPMC capsule formulations ('180 Patent, col. 2:10-17).

Key Claims at a Glance

  • The complaint does not specify which claims are asserted, alleging infringement of "the claims of the '180 patent" generally (Compl. ¶37). Claim 1 is the sole independent claim.
  • Independent Claim 1: A hard capsule formed of a film composition comprising:
    • a hydroxypropyl methyl cellulose as a base,
    • a gelling agent,
    • a gelling aid,
    • wherein said hydroxypropyl methyl cellulose has a content of hydroxypropoxyl groups of at least 4% by weight of the hydroxypropyl methyl cellulose, and
    • a content of methoxyl groups and hydroxypropoxyl groups combined of 23 to 37.6% by weight of the hydroxypropyl methyl cellulose.

III. The Accused Instrumentality

Product Identification

The accused instrumentality is Teva’s proposed generic version of DELZICOL® (mesalamine delayed release capsules, 400 mg), as described in ANDA No. 207873 (the "Generic Product") (Compl. ¶¶1, 31).

Functionality and Market Context

The complaint alleges that Teva's Generic Product is a bioequivalent version of Warner Chilcott's DELZICOL® product, which is approved for treating ulcerative colitis (Compl. ¶¶26, 31). The specific composition of the accused capsule is not detailed in the complaint. The core of the infringement allegation is that the capsule of the Generic Product, as specified in Teva's ANDA, falls within the claims of the '180 patent (Compl. ¶¶30, 37). The complaint alleges Teva intends to commercially manufacture and sell the Generic Product in the U.S. before the expiration of the ’180 patent (Compl. ¶33). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not contain a claim chart or specific, element-by-element factual allegations of infringement. It makes a general allegation that the manufacture, use, or sale of Teva's Generic Product would infringe the claims of the '180 patent (Compl. ¶37). The following chart summarizes the infringement theory that can be inferred from the complaint against independent claim 1.

'180 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A hard capsule formed of a film composition comprising a hydroxypropyl methyl cellulose as a base, a gelling agent, and a gelling aid... The complaint alleges that Teva’s Generic Product is a hard capsule that, as described in its ANDA, is composed of a film that infringes the '180 patent. ¶37 col. 3:54-65
wherein said hydroxypropyl methyl cellulose has a content of hydroxypropoxyl groups of at least 4% by weight of the hydroxypropyl methyl cellulose... The complaint's infringement allegation implicitly requires that the capsule of the Generic Product contains HPMC with this minimum content of hydroxypropoxyl groups. ¶37 col. 4:39-45
and a content of methoxyl groups and hydroxypropoxyl groups combined of 23 to 37.6% by weight of the hydroxypropyl methyl cellulose. The complaint's infringement allegation implicitly requires that the HPMC in the Generic Product's capsule has a combined content of methoxyl and hydroxypropoxyl groups falling within this specific range. ¶37 col. 4:39-45
  • Identified Points of Contention:
    • Factual Question: The central dispute will be empirical: does the capsule formulation specified in Teva's confidential ANDA actually contain hydroxypropyl methyl cellulose with the precise chemical properties required by claim 1, particularly the combined 23-37.6% weight content of methoxyl and hydroxypropoxyl groups? The complaint provides no public-facing evidence on this point.
    • Scope Question: A potential dispute may arise over the measurement methodology for determining the weight percentages of the substituent groups. The patent references a specific method from the Pharmacopoeia of Japan ('180 Patent, col. 4:38-42), raising the question of whether this method is incorporated into the claim scope and, if so, whether Teva’s ANDA specifies the same or an equivalent method.

V. Key Claim Terms for Construction

  • The Term: "a content of methoxyl groups and hydroxypropoxyl groups combined of 23 to 37.6% by weight of the hydroxypropyl methyl cellulose"
  • Context and Importance: This numerical range is the central limitation of the patent and defines the core of the alleged invention. Infringement will depend entirely on whether the accused product's composition falls within this range. Practitioners may focus on this term because disputes over numerical ranges often turn on the precision of the endpoints and the method of measurement.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claim language itself provides a clear numerical range. The specification supports this range by describing HPMC types that fall within it, such as hydroxypropyl methyl cellulose 2208 (total content 23-36 wt %) and 2906 (total content 31-37.5 wt %) ('180 Patent, col. 3:37-47).
    • Evidence for a Narrower Interpretation: The specification states that the contents of the substituent groups "were determined by the measurement method prescribed in the Pharmacopoeia of Japan" ('180 Patent, col. 4:38-42). A party could argue this reference limits the scope of the claim, such that infringement can only be proven using this specific analytical standard, potentially excluding results from other methods. Dependent claim 4 further narrows the range to "29 to 37% by weight," suggesting the patentee envisioned a more preferred, limited scope.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that by filing its ANDA, Teva induced infringement under 35 U.S.C. § 271(b) and § 271(e)(2)(A) (Compl. ¶52). The basis for this allegation is that Teva actively and knowingly directed the submission of the ANDA with the knowledge that its approval would lead to the manufacture, use, and sale of an infringing product (Compl. ¶52).
  • Willful Infringement: The complaint does not use the term "willful," but it alleges the case is "exceptional" and seeks attorneys' fees under 35 U.S.C. § 285 (Compl. ¶¶43, 55). This is based on allegations that Teva had knowledge of the '180 patent, as evidenced by its Paragraph IV certification and notice letter, and proceeded with activities aimed at marketing its Generic Product before the patent's expiration (Compl. ¶¶38, 39, 51).

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

  • A core issue will be one of empirical fact: does the HPMC capsule formulation specified in Teva's confidential ANDA No. 207873 fall within the specific chemical composition ranges recited in claim 1 of the '180 patent, particularly the combined 23-37.6% content of methoxyl and hydroxypropoxyl groups? Discovery into the contents of the ANDA will be dispositive on this point.
  • A second key question will relate to claim construction and proof: is the "measurement method prescribed in the Pharmacopoeia of Japan," referenced in the patent's examples, a required methodology for determining infringement of the claimed numerical range? The court's ruling on this issue could significantly impact how Plaintiffs must prove their case and what evidence is admissible.
  • Finally, a key legal question will be whether Teva's act of filing an ANDA with a Paragraph IV certification, in and of itself, can support a finding that this is an "exceptional case" warranting an award of attorneys' fees, or if Plaintiffs must show additional evidence of litigation misconduct or bad faith.