DCT

1:16-cv-00152

Cosmo Tech Ltd v. Mylan Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:16-cv-00152, D. Del., 11/22/2016
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware based on Defendant's registration to do business in the state, its continuous contacts with Delaware, and its previous submission to the court's jurisdiction in other matters.
  • Core Dispute: Plaintiffs allege that Defendant’s filing of an Abbreviated New Drug Application (ANDA) for a generic version of the ulcerative colitis drug Uceris® constitutes an act of infringement of five patents covering the drug's controlled-release formulation.
  • Technical Context: The technology involves a multi-matrix oral tablet designed to provide controlled release of the corticosteroid budesonide directly to the colon, thereby treating inflammation locally while minimizing systemic side effects.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant’s submission of ANDA No. 208851 to the FDA. The ANDA included a Paragraph IV certification, asserting that Plaintiffs' patents, which are listed in the FDA's "Orange Book" for Uceris®, are invalid, unenforceable, or would not be infringed by the proposed generic product. Plaintiffs received Defendant's notice letter on January 29, 2016.

Case Timeline

Date Event
1999-06-14 Earliest Priority Date for all Patents-in-Suit
2008-08-12 U.S. Patent No. 7,410,651 Issues
2012-10-23 U.S. Patent No. 8,293,273 Issues
2012-11-13 U.S. Patent No. RE 43,799 (Reissue) Issues
2014-07-22 U.S. Patent No. 8,784,888 Issues
2016-01-29 Plaintiffs Receive Mylan's ANDA Notice Letter
2016-04-26 U.S. Patent No. 9,320,716 Issues
2016-11-22 First Amended Complaint Filed

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

U.S. Patent No. 7,410,651 - "Controlled Release and Taste Masking Oral Pharmaceutical Composition"

  • Patent Identification: U.S. Patent No. 7,410,651, "Controlled Release and Taste Masking Oral Pharmaceutical Composition," issued August 12, 2008.
  • The Invention Explained:
    • Problem Addressed: The patent's background section notes that conventional controlled-release matrices, such as inert lipophilic or swelling hydrophilic types, often suffer from non-linear release profiles, which can be suboptimal for drugs intended to act topically within the gastrointestinal tract (’651 Patent, col. 1:43-53).
    • The Patented Solution: The invention proposes a three-component matrix system to achieve more consistent, controlled release. The active ingredient (budesonide) is first incorporated into an inner lipophilic matrix and an amphiphilic matrix. This combination is then dispersed as granules within an outer hydrophilic (hydrogel) matrix (’651 Patent, Abstract; col. 2:50-63). Upon contact with gastrointestinal fluid, the outer hydrophilic matrix swells to form a viscous barrier, which slows solvent penetration and prevents an initial "burst" of drug release, thereby modulating the dissolution rate over an extended period (’651 Patent, col. 5:1-17).
    • Technical Importance: This multi-matrix approach enables targeted delivery of a topically active drug to a specific site, such as the colon, which is critical for treating inflammatory bowel disease while reducing systemic absorption and associated side effects (’651 Patent, col. 1:19-22).
  • Key Claims at a Glance:
    • The complaint alleges infringement of "one or more claims" of the ’651 patent without specifying them (Compl., Prayer for Relief ¶A). Independent claim 1 is the broadest composition claim and is representative.
    • Independent Claim 1 requires a composition "consisting essentially of":
      • A lipophilic matrix with a melting point between 40-90°C, in which the active ingredient is at least partially inglobated;
      • An amphiphilic matrix; and
      • An outer hydrophilic matrix of hydrogel-forming compounds, in which the lipophilic and amphiphilic matrices are dispersed to provide controlled release.

U.S. Patent No. 8,293,273 - "Controlled Release and Taste Masking Oral Pharmaceutical Composition"

  • Patent Identification: U.S. Patent No. 8,293,273, "Controlled Release and Taste Masking Oral Pharmaceutical Composition," issued October 23, 2012.
  • The Invention Explained:
    • Problem Addressed: As a continuation in the same patent family, the ’273 patent addresses the same general problem of achieving reliable, site-specific drug delivery within the gastrointestinal tract (’273 Patent, col. 3:20-47).
    • The Patented Solution: The ’273 patent claims a more specific embodiment of the technology. It requires a tablet core comprising four specific components: the active ingredient budesonide, a lipophilic excipient (stearic acid), an amphiphilic excipient (lecithin), and a hydrophilic excipient (hydroxypropyl cellulose). Crucially, this core is then covered with a gastro-resistant coating comprising a methacrylic acid polymer, which is designed to prevent drug release in the acidic environment of the stomach (’273 Patent, col. 12:27-40).
    • Technical Importance: The explicit addition of a gastro-resistant coating provides a dual-release control mechanism: the coating ensures the tablet passes through the stomach intact, and the matrix core then controls the release profile in the targeted intestinal environment (’273 Patent, col. 5:1-4).
  • Key Claims at a Glance:
    • The complaint alleges infringement of "one or more claims" of the ’273 patent (Compl., Prayer for Relief ¶B). Independent claim 1 is representative.
    • Independent Claim 1 requires a composition comprising:
      • A tablet core comprising: budesonide, stearic acid, lecithin, and hydroxypropyl cellulose; and
      • A gastro-resistant coating on the core comprising at least one methacrylic acid polymer.

Multi-Patent Capsule: U.S. Patent No. 8,784,888

  • Patent Identification: U.S. Patent No. 8,784,888, "Controlled Release and Taste Masking Oral Pharmaceutical Composition," issued July 22, 2014 (Compl. ¶17).
  • Technology Synopsis: This patent claims a tablet core consisting essentially of budesonide dispersed in a "macroscopically homogeneous composition" that includes lipophilic, amphiphilic, and hydrogel-forming hydrophilic excipients. This core is covered by a gastro-resistant film. The claim emphasis is on the homogeneous nature of the multi-component matrix that controls release (’888 Patent, Claim 1).
  • Asserted Claims: "one or more claims" (Compl., Prayer for Relief ¶C).
  • Accused Features: The "Mylan Pharma Generic Product" is alleged to infringe (Compl. ¶47).

Multi-Patent Capsule: U.S. Patent No. RE 43,799

  • Patent Identification: U.S. Patent No. RE 43,799, "Controlled Release and Taste Masking Oral Pharmaceutical Composition," issued November 13, 2012 (Compl. ¶19).
  • Technology Synopsis: This reissue patent claims a controlled-release composition of budesonide incorporated into a matrix structure that includes lipophilic, amphiphilic, and hydrophilic components. The composition is explicitly recited as having a gastro-resistant coating.
  • Asserted Claims: "one or more claims" (Compl., Prayer for Relief ¶D).
  • Accused Features: The "Mylan Pharma Generic Product" is alleged to infringe (Compl. ¶53).

Multi-Patent Capsule: U.S. Patent No. 9,320,716

  • Patent Identification: U.S. Patent No. 9,320,716, "Controlled Release and Taste Masking Oral Compositions," issued April 26, 2016 (Compl. ¶21).
  • Technology Synopsis: This patent claims both compositions and methods of treatment. The composition claims cover a tablet with a "macroscopically homogenous structure" containing budesonide with lipophilic and hydrophilic compounds, covered by a gastro-resistant coating. The method claims cover treating intestinal inflammatory disease by administering this composition (’716 Patent, Claims 1, 27).
  • Asserted Claims: "one or more claims" (Compl., Prayer for Relief ¶E).
  • Accused Features: The "Mylan Pharma Generic Product" and its proposed method of use are alleged to infringe (Compl. ¶59).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is the "Mylan Pharma Generic Product," which is a generic formulation of tablets containing 9 mg of budesonide (Compl. ¶9). Defendant Mylan Pharmaceuticals Inc. ("Mylan") is seeking FDA approval to market this product under Abbreviated New Drug Application (ANDA) No. 208851 (Compl. ¶9).

Functionality and Market Context

The Mylan product is intended to be a generic equivalent of Plaintiffs' branded drug, Uceris®, which is indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis (Compl. ¶23). As an ANDA product, it is intended to be therapeutically equivalent to Uceris®. The complaint alleges that Mylan seeks to engage in the commercial manufacture and sale of its generic product prior to the expiration of the patents-in-suit, which are listed in the FDA's Orange Book as covering Uceris® (Compl. ¶24-25). The complaint does not contain specific details about the formulation of the accused product, noting that discovery is in its early stages (Compl. ¶32).

IV. Analysis of Infringement Allegations

The complaint pleads infringement under 35 U.S.C. § 271(e)(2)(A), which defines the submission of an ANDA for a patented drug as a technical act of infringement to create federal court jurisdiction. The complaint does not provide claim charts or a detailed, element-by-element infringement analysis. The infringement theory is predicated on the allegation that Mylan’s proposed generic product is a copy of Uceris® and that Uceris® embodies the inventions claimed in the patents-in-suit.

No probative visual evidence provided in complaint.

’651 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A controlled release oral pharmaceutical composition containing budesonide...consisting essentially of: The Mylan Pharma Generic Product is alleged to be a controlled-release oral pharmaceutical composition containing budesonide. ¶9, ¶34 col. 7:3-5
a) a lipophilic matrix consisting of lipophilic compounds...in which the active ingredient is at least partially inglobated; Mylan's product is alleged to contain a lipophilic matrix as claimed. ¶9, ¶34 col. 8:3-7
b) an amphiphilic matrix; Mylan's product is alleged to contain an amphiphilic matrix as claimed. ¶9, ¶34 col. 8:8-9
c) an outer hydrophilic matrix consisting of hydrogel forming compounds in which the lipophilic matrix and the amphiphilic matrix are dispersed... Mylan's product is alleged to contain an outer hydrophilic matrix in which the other matrices are dispersed as claimed. ¶9, ¶34 col. 8:10-16

’273 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
(1) a tablet core comprising: a) budesonide... b) stearic acid; c) lecithin; and d) hydroxypropyl cellulose; Mylan's product is alleged to contain a tablet core with these four specific components. ¶9, ¶40 col. 12:28-36
(2) a gastro-resistant coating on said tablet core, said coating comprising at least one methacrylic acid polymer. Mylan's product is alleged to be coated with a gastro-resistant film containing the claimed polymer. ¶9, ¶40 col. 12:37-40

Identified Points of Contention

  • Scope Questions: For the ’651 patent, a central dispute may concern the scope of the phrase "consisting essentially of," and whether any additional excipients in Mylan's formulation materially affect the claimed controlled-release properties. For the later patents, the construction of "macroscopically homogeneous composition" (’888 and ’716 patents) may be a key issue, raising the question of whether this term imparts a structural limitation that Mylan's product does not meet.
  • Technical Questions: A primary technical question is one of compositional identity. As the complaint lacks specifics, discovery will be required to determine the exact formulation of Mylan's product. A likely point of contention is whether Mylan’s product literally contains the specific excipients recited in claims like claim 1 of the ’273 patent (stearic acid, lecithin, hydroxypropyl cellulose), or if Mylan has attempted to "design around" the claims by using different, albeit functionally similar, components.

V. Key Claim Terms for Construction

"consisting essentially of" (from ’651 Patent, Claim 1)

  • Context and Importance: This transitional phrase is narrower than "comprising" but broader than "consisting of." It limits the claim to the three specified matrices and any other components that do not materially affect the "basic and novel properties" of the invention—here, the controlled-release profile. Practitioners may focus on this term because Mylan could argue that its formulation includes additional excipients that materially alter the release mechanism, thereby taking it outside the claim's scope.
  • Intrinsic Evidence for a Broader Interpretation: Plaintiffs may argue that the "basic and novel" characteristic is simply the achievement of controlled release via a multi-matrix system, allowing for the presence of conventional, non-material processing aids or fillers. The specification’s broad description of the invention's purpose supports this view (’651 Patent, col. 2:48-50).
  • Intrinsic Evidence for a Narrower Interpretation: Mylan may argue that the specific interaction between the three claimed matrices is the core of the invention and is sensitive to other components. The patent describes how the hydrophilic matrix forms a "high viscosity swollen layer" that acts as a barrier, a property that could be "materially" affected by other substances (’651 Patent, col. 5:1-9).

"stearic acid" (from ’273 Patent, Claim 1)

  • Context and Importance: Unlike the broader "matrix" claims of the ’651 patent, claim 1 of the ’273 patent recites a specific chemical excipient. The infringement analysis for this element appears to be a literal one-for-one comparison. Practitioners may focus on this term because a common strategy in ANDA litigation is to design around such specific limitations. The case may turn on whether Mylan's product literally contains stearic acid or a different lipophilic compound.
  • Intrinsic Evidence for a Broader Interpretation: Should Mylan use a different lipophilic agent, Plaintiffs might invoke the doctrine of equivalents. They could point to the specification, which describes the lipophilic matrix as being formable from a broad class of substances, including "unsaturated or hydrogenated alcohols or fatty acids, salts, esters or amides thereof," suggesting stearic acid is just one example of a broader functional category (’273 Patent, col. 4:60-65).
  • Intrinsic Evidence for a Narrower Interpretation: Mylan will likely argue that by choosing to claim the specific compound "stearic acid" rather than the entire class of "lipophilic compounds," the patentee deliberately surrendered broader scope. The fact that the specification discloses many alternatives but the claim recites only one may support the argument that the claim is limited to its literal terms (’273 Patent, col. 4:10-25).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that if Mylan commercializes its product, it will induce and contribute to infringement by others (Compl. ¶35, 41, 47, 53, 59). The basis for an inducement claim would be Mylan's proposed product labeling, which would instruct physicians and patients to administer the generic drug for the patented indication of treating ulcerative colitis.
  • Willful Infringement: The complaint does not use the term "willful," but it alleges that Mylan had pre-suit knowledge of each patent and was aware that filing its ANDA constituted an act of infringement (Compl. ¶38, 44, 50, 56, 62). These allegations are based on the patents' listing in the FDA's Orange Book and Mylan's filing of a Paragraph IV certification, and they could form the basis for a request for enhanced damages if infringement is found.

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

  • A central issue will be one of claim construction: Can the functional language of the ’651 patent, such as the requirement for three distinct but "dispersed" matrices, be interpreted to read on Mylan’s specific formulation? For the later patents, will the court construe terms like "macroscopically homogeneous composition" as imposing a clear, enforceable structural limitation?
  • A key evidentiary question will be one of literal infringement versus design-around: Once Mylan's formulation is produced in discovery, does it contain the exact chemical excipients (e.g., stearic acid, lecithin) recited in the more specific claims of patents like the ’273 patent, or has Mylan successfully formulated a bioequivalent product with different components that fall outside the literal claim scope?
  • Finally, the case will involve a significant question of validity: Mylan's Paragraph IV certification necessarily asserts that the patents-in-suit are invalid. The viability of Mylan’s defense will depend on its ability to prove, likely through prior art related to controlled-release pharmaceutical technologies, that the claimed inventions were obvious or anticipated at the time they were filed.