DCT

8:12-cv-01190

Shire Development LLC v. Mylan Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: Shire Development LLC et al v. Mylan Pharmaceuticals Inc. et al, 8:12-cv-01190, M.D. Fla., 05/25/2012
  • Venue Allegations: Venue is based on allegations that Defendant Mylan Pharmaceuticals resides and transacts business within the judicial district, and that both Defendants derive substantial revenue from sales within the district.
  • Core Dispute: This is a Hatch-Waxman Act lawsuit in which Plaintiffs allege that Defendants' submission of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiffs' Lialda® product constitutes infringement of a patent covering a controlled-release pharmaceutical formulation.
  • Technical Context: The technology concerns oral drug delivery systems designed to control the release of an active pharmaceutical ingredient, specifically for treating inflammatory bowel diseases like ulcerative colitis by ensuring targeted delivery within the gastrointestinal tract.
  • Key Procedural History: The patent-in-suit is listed in the U.S. Food and Drug Administration's "Orange Book" as covering the branded drug Lialda®. The dispute was triggered by Defendants' filing of an ANDA with a Paragraph IV certification, asserting non-infringement or invalidity of the patent. Subsequent to the filing of this complaint, the patent-in-suit (U.S. Patent No. 6,773,720) survived an Inter Partes Review (IPR) proceeding (IPR2015-00988), with a certificate issued in 2018 confirming the patentability of all claims.

Case Timeline

Date Event
1999-06-14 '720 Patent Priority Date
2004-08-10 '720 Patent Issue Date
2012-04-12 Date of Mylan's Paragraph IV Notice Letter
2012-05-25 Complaint Filing Date
2018-03-19 IPR Certificate Issued for '720 Patent

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

U.S. Patent No. 6,773,720 - "Mesalazine Controlled Release Oral Pharmaceutical Compositions"

The Invention Explained

  • Problem Addressed: The patent describes a need to improve upon existing controlled-release drug formulations, which can suffer from non-linear release rates or an initial "burst effect" where too much drug is released too quickly after administration ('720 Patent, col. 1:33-36). This is particularly problematic for drugs like mesalazine (5-amino-salicylic acid) that are intended to act topically on the lining of the colon ('720 Patent, col. 1:9-12).
  • The Patented Solution: The invention proposes a "matrix-in-matrix" structure. First, the active ingredient is incorporated into an "inner lipophilic matrix," composed of fatty or waxy substances, to form granules ('720 Patent, col. 2:50-57). These granules are then dispersed within an "outer hydrophilic matrix" made of substances that swell in water to form a gel. When the tablet is ingested, the outer matrix swells to form a viscous barrier that slows the penetration of water, thereby controlling the release of the drug from the inner lipophilic granules in a more gradual and linear fashion ('720 Patent, col. 2:57-67).
  • Technical Importance: This dual-matrix approach is designed to provide a more homogeneous and predictable release profile, avoiding the initial burst and ensuring the medication is delivered more consistently over time as it passes through the gastrointestinal tract ('720 Patent, col. 3:57-65).

Key Claims at a Glance

  • The complaint alleges infringement of "one or more claims," which would include the sole independent claim, Claim 1 ('720 Patent, col. 6:7-38).
  • The essential elements of independent Claim 1 are:
    • A controlled-release oral pharmaceutical composition containing 5-amino-salicylic acid as the active ingredient.
    • An "inner lipophilic matrix" made of substances with melting points below 90° C. (e.g., waxes, fatty acids).
    • An "outer hydrophilic matrix" (e.g., celluloses, gums) in which the inner lipophilic matrix is dispersed.
    • The active ingredient comprises 80% to 95% of the total composition weight.
    • A key limitation requires that the active ingredient is "dispersed both in said the lipophilic matrix and in the hydrophilic matrix."

III. The Accused Instrumentality

Product Identification

The accused instrumentality is "the Mylan Product," identified as a generic mesalamine delayed-release tablet containing 1.2g of mesalamine, which is the subject of Mylan's Abbreviated New Drug Application (ANDA) No. 20-3574 (Compl. ¶17).

Functionality and Market Context

The complaint alleges the Mylan Product is a generic version of Plaintiffs' Lialda® product, which is indicated for the treatment of ulcerative colitis (Compl. ¶¶ 15, 17). The complaint does not provide any technical details about the formulation or structure of the Mylan Product, noting that Plaintiffs have not been granted full access to the confidential ANDA that would contain this information (Compl. ¶¶ 21-22).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint does not provide specific, element-by-element infringement allegations or a claim chart. Instead, it asserts infringement based on the statutory act of Mylan filing an ANDA with a Paragraph IV certification, which seeks FDA approval to market a generic drug before the expiration of a listed patent (Compl. ¶29). Plaintiffs state that they must "resort to the judicial process to fully assess" infringement because they have not been provided with sufficient detail regarding the Mylan Product's formulation (Compl. ¶22). Therefore, a detailed claim chart analysis is not possible based on the complaint alone.

Identified Points of Contention

  • Technical Question: As the complaint lacks technical specifics, the central issue for the infringement analysis will depend on facts established during discovery. The key question will be whether the Mylan Product is formulated using a "matrix-in-matrix" structure where an inner lipophilic matrix containing the drug is dispersed within a separate, outer hydrophilic matrix, as required by the claims.
  • Scope Question: A likely point of dispute will be the claim limitation requiring the active ingredient to be "dispersed both in said the lipophilic matrix and in the hydrophilic matrix" ('720 Patent, col. 6:15-17, 6:36-38). The case may turn on evidence of whether a portion of the mesalazine in the Mylan Product exists outside of any inner lipophilic granules and is instead mixed directly with the excipients forming the outer hydrophilic phase.

V. Key Claim Terms for Construction

The Term: "an inner lipophilic matrix... dispersed" in "an outer hydrophilic matrix"

  • Context and Importance: This phrase defines the core "matrix-in-matrix" architecture of the invention. The entire infringement case hinges on whether the Mylan Product embodies this specific two-phase physical structure.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A party could argue the term encompasses any formulation that simply contains a mixture of lipophilic and hydrophilic components, regardless of the specific manufacturing process or final physical arrangement.
    • Evidence for a Narrower Interpretation: The specification describes a method where the active ingredient is first "inglobated" in a molten lipophilic excipient to form an inert matrix, which is then mixed with hydrophilic excipients ('720 Patent, col. 2:50-64). This suggests the claims may require a distinct, pre-formed granular lipophilic phase distributed within a continuous hydrophilic phase, rather than a simple blend of all components.

The Term: "the active ingredient is dispersed both in said the lipophilic matrix and in the hydrophilic matrix"

  • Context and Importance: This limitation is critical because it requires the drug to be present in two specific locations within the tablet. Proving infringement necessitates demonstrating that the active ingredient is not confined solely to the inner matrix.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: An infringing party might argue this is met if any trace amount of the active ingredient is detectable in the hydrophilic portion, perhaps as an unavoidable result of manufacturing.
    • Evidence for a Narrower Interpretation: The patent specification states that "Part of mesalazine can optionally be mixed with hydrophilic substances to provide compositions in which the active ingredient is dispersed both in the lipophilic and the hydrophilic matrix" ('720 Patent, col. 3:35-39). This language suggests a deliberate formulation choice to place a distinct and measurable quantity of the active ingredient in the outer matrix, not merely an incidental or trace presence.

VI. Other Allegations

Indirect Infringement

The complaint alleges that Mylan Inc. induced infringement by Mylan Pharmaceuticals by "actively induc[ing], encourag[ing], aid[ing], or abett[ing]" the preparation and filing of the ANDA with the Paragraph IV certification (Compl. ¶37). It is also alleged that future commercial activity would induce infringement by third parties (Compl. ¶31).

Willful Infringement

Willfulness is alleged on the basis that Defendants were aware of the ’720 patent "as of the date of the Mylan Notice Letter" and proceeded to act "without a reasonable basis for believing that they would not be liable for infringement" (Compl. ¶32).

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

  • A primary issue will be one of factual discovery: What is the precise formulation of the Mylan Product as detailed in its ANDA? The infringement analysis is entirely dependent on whether that formulation employs a two-phase structure corresponding to the "matrix-in-matrix" system claimed in the '720 patent.
  • A key question of claim scope and proof will be: Does the Mylan Product meet the limitation that the active ingredient is "dispersed both in... the lipophilic matrix and in the hydrophilic matrix"? This will require evidence not only of the product's components but also of the specific physical location of the mesalazine within the proposed generic tablet, a determination that may require sophisticated analytical techniques.