DCT

1:12-cv-07493

Medicis Pharmaceutical Corp v. Alkem Laboratories Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:12-cv-07493, D.N.J., 12/06/2012
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey as Defendants conduct business in the state, and the claims are alleged to arise from acts committed in New Jersey, including the development and marketing of pharmaceutical drugs.
  • Core Dispute: Plaintiff alleges that Defendants' filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's SOLODYN® extended-release tablets constitutes infringement of three patents related to methods and formulations for treating acne with minocycline.
  • Technical Context: The dispute centers on oral antibiotic formulations for acne, specifically focusing on extended-release technologies designed to improve safety and patient compliance compared to immediate-release versions.
  • Key Procedural History: U.S. Patent No. 5,908,838 underwent an ex parte reexamination, with the USPTO issuing a Reexamination Certificate on June 1, 2010. This proceeding confirmed the validity of several original claims and issued new claims, a fact that may be relevant to subsequent invalidity challenges.

Case Timeline

Date Event
1998-02-19 U.S. Patent No. 5,908,838 Priority Date
1999-06-01 U.S. Patent No. 5,908,838 Issue Date
2005-06-24 U.S. Patent Nos. 7,790,705 & 8,268,804 Priority Date
2006-05-08 FDA approval of SOLODYN® (45 mg, 90 mg, 135 mg)
2008-06-01 Request for reexamination filed on the ’838 Patent
2008-08-01 USPTO granted request for reexamination of the ’838 Patent
2009-07-23 FDA approval of SOLODYN® (65 mg, 115 mg)
2010-06-01 USPTO issued Ex Parte Reexamination Certificate for the ’838 Patent
2010-08-27 FDA approval of SOLODYN® (55 mg, 80 mg, 105 mg)
2010-09-07 U.S. Patent No. 7,790,705 Issue Date
2012-09-18 U.S. Patent No. 8,268,804 Issue Date
2012-10-29 Plaintiff received Defendant's notice letter regarding the ANDA filing
2012-12-06 Complaint Filing Date

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

U.S. Patent No. 5,908,838 - "Method for the Treatment of Acne"

The Invention Explained

  • Problem Addressed: The patent’s background section identifies that oral tetracycline antibiotics, particularly minocycline, are effective for treating acne but are known to cause vestibular side effects such as vertigo, dizziness, and blurred vision, which are associated with the drug's rapid dissolution and absorption in the body (’838 Patent, col. 1:10-25).
  • The Patented Solution: The invention proposes to solve this problem by administering minocycline in a "slowly dissolving dosage form." This method is designed to reduce the rate at which the drug is absorbed, thereby decreasing the peak concentration in the bloodstream and, consequently, reducing the incidence and severity of the associated vestibular side effects while maintaining therapeutic efficacy (’838 Patent, col. 1:44-53, 1:60-65).
  • Technical Importance: This approach provided a method to improve the safety profile and tolerability of a known effective acne treatment, which could enhance patient compliance and allow for continued therapy (’838 Patent, col. 1:44-53).

Key Claims at a Glance

  • The complaint asserts dependent claims 3, 4, 12, 13 and independent claims 19, 21, 23, 25, and 27-34 (Compl. ¶9). Reexamined independent claim 27 is representative.
  • The essential elements of independent claim 27 are:
    • A method for reducing the incidence or severity of vestibular side effects resulting from the treatment of acne by the use of oral minocycline,
    • comprising administering the minocycline in a slowly dissolving dosage form,
    • wherein the minocycline dissolves at a rate no faster than 15 percent in 15 minutes, 35 percent in 30 minutes, 50 percent in 45 minutes and 80 percent in 60 minutes, as measured under standard U.S. Pharmacopeia test conditions.

U.S. Patent No. 7,790,705 - "Minocycline Oral Dosage Forms for the Treatment of Acne"

The Invention Explained

  • Problem Addressed: The patent acknowledges that while slowly dissolving dosage forms can reduce side effects, there remains a need for improved acne treatments that are effective but associated with even fewer adverse effects than existing immediate-release oral dosage forms of minocycline hydrochloride (’705 Patent, col. 1:56-63).
  • The Patented Solution: The invention provides an oral dosage form of minocycline containing a "controlled-release carrier composition" that renders the dosage form "pharmacokinetically distinct" from the standard immediate-release formulation, MINOCIN®. This distinction is defined by specific pharmacokinetic (PK) parameters, such as a lower peak plasma concentration (Cmax) or a different area under the curve (AUC), which can lead to similar efficacy with a better safety profile (’705 Patent, col. 2:1-19; Embodiment 1).
  • Technical Importance: This patent shifts the inventive concept from the physical property of dissolution rate to the biological outcome of a specific pharmacokinetic profile, offering a more precise, in-vivo method for defining a formulation that balances efficacy with safety.

Key Claims at a Glance

  • The complaint asserts "one or more claims" of the patent (Compl. ¶9). Independent claim 1 is representative.
  • The essential elements of independent claim 1 are:
    • An oral dosage form, comprising: minocycline or a pharmaceutically acceptable salt thereof;
    • and an amount of a controlled-release carrier composition that is effective to render said oral dosage form pharmacokinetically distinct from MINOCIN® immediate-release minocycline hydrochloride.

U.S. Patent No. 8,268,804 - "Method for the Treatment of Acne"

  • Patent Identification: U.S. Patent No. 8,268,804, "Method for the Treatment of Acne," issued September 18, 2012.
  • Technology Synopsis: As a continuation of the same patent family as the ’705 Patent, this patent claims methods of treating acne, rather than the composition itself. It protects the act of administering a controlled-release oral dosage form of minocycline that is pharmacokinetically distinct from the immediate-release MINOCIN® brand product (’804 Patent, Abstract; col. 2:1-19).
  • Asserted Claims: The complaint asserts "one or more claims" of the patent (Compl. ¶9).
  • Accused Features: The accused act is the filing of an ANDA to obtain approval for the commercial manufacture and sale of a generic minocycline product for the treatment of acne, which would induce infringement of the patented method (Compl. ¶61-62, 65).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is Defendants' proposed generic minocycline hydrochloride extended-release tablets in 45 mg, 65 mg, 90 mg, 115 mg, and 135 mg strengths, for which Defendants filed Abbreviated New Drug Application No. 204453 with the FDA (Compl. ¶10, 40).

Functionality and Market Context

The product is an extended-release oral antibiotic intended for the treatment of acne (Compl. ¶10). The act of infringement alleged in the complaint is statutory, arising under 35 U.S.C. § 271(e)(2) from the filing of the ANDA with a Paragraph IV certification. This certification asserts that the patents-in-suit are invalid, unenforceable, or will not be infringed by the proposed generic product (Compl. ¶11, 40). This filing allows the generic manufacturer to challenge the patent holder's rights before entering the market.

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide a detailed claim chart or technical breakdown of the accused product's formulation. The infringement allegations are based on the statutory act of filing Abbreviated New Drug Application No. 204453, which seeks approval for a generic version of Plaintiff's SOLODYN® product, the use of which is allegedly covered by the patents-in-suit (Compl. ¶11-13, 39, 50, 61).

  • Identified Points of Contention:
    • Factual Questions (Dissolution and PK Profile): The central dispute will likely concern the technical characteristics of Defendants' proposed generic product as disclosed in their ANDA. A primary question for the ’838 Patent will be whether the dissolution profile of the accused product meets the specific "no faster than" rates required by the claims. For the ’705 and ’804 Patents, the key question will be whether the product's pharmacokinetic profile, as established by bioequivalence studies in the ANDA, is "pharmacokinetically distinct" from immediate-release MINOCIN®.
    • Scope Questions (Claim Construction): The interpretation of key claim terms will be critical. For the ’838 Patent, the definition of a "slowly dissolving dosage form" as defined by the specific dissolution rates will be paramount. For the ’705 and ’804 Patents, the definition of "pharmacokinetically distinct" will determine the standard against which Defendants' product is measured.

V. Key Claim Terms for Construction

  • The Term: "slowly dissolving dosage form" (from the ’838 Patent)

  • Context and Importance: This term is the central technical limitation of the asserted claims of the ’838 Patent. The infringement analysis will depend entirely on whether the dissolution data for Defendants' ANDA product falls within the scope of this term as defined by the specific rates recited in the claims.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The claims themselves provide an explicit, numerical definition: "wherein the minocycline dissolves at a rate no faster than 15 percent in 15 minutes, 35 percent in 30 minutes..." (’838 Patent, Reexamination Certificate, col. 2:2-5). A party may argue this objective definition is controlling and sufficient on its own.
    • Evidence for a Narrower Interpretation: The specification contrasts the invention with conventional dosage forms that achieve "rapid dissolution" and links the claimed slower dissolution to the functional result of reducing vestibular side effects (’838 Patent, col. 1:26-34, 1:44-53). A party could argue that the term should be construed in light of this stated purpose and the clinical data presented in the patent's examples.

  • The Term: "pharmacokinetically distinct" (from the ’705 Patent)

  • Context and Importance: This term is the core of the invention claimed in the ’705 Patent. Whether Defendants' product infringes will turn on whether its pharmacokinetic profile, as revealed in its ANDA, is "distinct" from the MINOCIN® reference standard according to the patent's definition.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent specification provides a clear and objective definition, stating the term refers to a drug that "provides a pharmacokinetic profile that is outside the range of 80% to 125% of the reference standard" for key parameters like AUC and Cmax (’705 Patent, col. 4:18-23). This creates a bright-line test based on established bioequivalence standards.
    • Evidence for a Narrower Interpretation: The patent further provides specific examples of what constitutes a distinct profile, such as "a single-dosage Cmax that is about 80% or less of the single-dosage Cmax of the MINOCIN® immediate-release minocycline hydrochloride" (’705 Patent, col. 12:20-24). A party might argue that the term should be limited to these specific disclosed profiles rather than encompassing any deviation from the 80%-125% bioequivalence window.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendants' future commercial manufacture, use, sale, or importation of the ANDA product would directly infringe or contribute to or induce the infringement of the patents-in-suit (Compl. ¶44, 55, 66). The basis for inducement is the allegation that Defendants, by seeking approval for a drug with a label instructing its use for acne, will encourage and instruct physicians and patients to perform the patented methods.
  • Willful Infringement: The complaint does not contain an explicit allegation of willful infringement.

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

  • A central issue will be one of technical fact: Does the formulation detailed in Defendants' confidential ANDA possess the specific dissolution rates required by the ’838 Patent and the particular pharmacokinetic profile (distinct from MINOCIN®) required by the ’705 and ’804 Patents? This determination will rely heavily on expert analysis of the data submitted to the FDA.
  • A key legal question will concern patent validity: Can Defendants demonstrate by clear and convincing evidence that the asserted patent claims are invalid, particularly for the ’838 Patent, given that its claims survived an ex parte reexamination proceeding where the USPTO considered prior art and reaffirmed their patentability?