DCT

2:17-cv-06714

Valeant Pharma Intl Inc v. Mylan Pharamaceuticals Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:17-cv-06714, D.N.J., 09/01/2017
  • Venue Allegations: Plaintiffs allege venue is proper in the District of New Jersey because Defendant Mylan Pharmaceuticals is registered to do business in the state, the district is a likely destination for the accused generic products, and Defendants have purposefully availed themselves of the jurisdiction by previously filing or not contesting venue in other lawsuits in the district.
  • Core Dispute: Plaintiffs allege that Defendants’ filing of Abbreviated New Drug Applications (ANDAs) with the U.S. Food and Drug Administration (FDA) to market generic versions of Plaintiffs' Relistor® product constitutes an act of infringement of a patent directed to stable pharmaceutical formulations of methylnaltrexone.
  • Technical Context: The technology concerns pharmaceutical chemistry, specifically methods and compositions for stabilizing methylnaltrexone, a peripherally acting opioid antagonist used to counteract side effects of opioid analgesics like constipation.
  • Key Procedural History: This action arises under the Hatch-Waxman Act, triggered by Defendants' submission of two ANDAs seeking to market generic methylnaltrexone. The complaint notes ongoing, separate litigation between the parties concerning other patents covering Relistor® that were listed in the FDA's Orange Book. A significant procedural allegation is that the notice letters provided by Mylan for its ANDA submissions did not contain any argument or explanation for why the '096 patent is not infringed. The patent-in-suit is subject to a terminal disclaimer, which may limit its enforceable term to that of an earlier-expiring patent.

Case Timeline

Date Event
2003-04-08 '096 Patent Priority Date
2017-06-06 '096 Patent Issue Date
2017-07-19 Date of Mylan's ANDA Notice Letters
2017-09-01 Complaint Filing Date

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

U.S. Patent No. 9,669,096 – Stable Pharmaceutical Formulations of Methylnaltrexone

The patent-in-suit is U.S. Patent No. 9,669,096 (“the ’096 Patent”), issued on June 6, 2017 (Compl. ¶20; ’096 Patent, p. 1).

The Invention Explained

  • Problem Addressed: The patent addresses the unexpected discovery that methylnaltrexone, a peripherally acting opioid antagonist, is "unusually unstable" in solution, contrary to prior assumptions ('096 Patent, col. 1:43-53). This inherent instability complicated the development of commercially viable, stable pharmaceutical formulations suitable for storage and administration ('096 Patent, col. 1:41-43).
  • The Patented Solution: The invention provides stable aqueous formulations of methylnaltrexone by controlling specific chemical parameters. The patented solution involves formulating the drug within a critical pH range (e.g., below 4.25) and/or including specific stabilizing agents, such as a chelating agent (e.g., edetate disodium) and a buffering agent (e.g., citrate buffer), to inhibit the formation of degradation products during sterilization (like autoclaving) and long-term storage ('096 Patent, col. 2:1-18, 38-62).
  • Technical Importance: By enabling the creation of a stable, injectable formulation, the invention facilitates the reliable delivery of methylnaltrexone, a drug that can alleviate debilitating side effects of opioid therapy (such as constipation) without compromising the central analgesic effects of the opioid ('096 Patent, col. 1:22-35).

Key Claims at a Glance

  • The complaint asserts infringement of "at least one claim" of the ’096 Patent (Compl. ¶¶40, 50). Independent claim 1 is representative:
    • A stable pharmaceutical preparation
    • comprising a solution of methylnaltrexone or salt thereof
    • and a chelating agent consisting of EDTA, or a derivative thereof
    • wherein the solution has a pH ranging from about 3.0 to 4.0
  • The complaint does not specify any dependent claims but implicitly reserves the right to assert them.

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are the generic drug products described in Defendants’ ANDA submissions:

  • ANDA No. 208592: "Mylan's generic methylnaltrexone vial product," a 12 mg/0.6 mL single-use vial for subcutaneous injection (Compl. ¶¶7, 24).
  • ANDA No. 208594: "Mylan's generic methylnaltrexone pre-filled syringe products," in 8 mg/0.4 mL and 12 mg/0.6 mL dosages (Compl. ¶¶7, 32).

Functionality and Market Context

  • The complaint alleges these products are intended to be generic versions of Plaintiffs' branded drug, Relistor®, and are "the same, or substantially the same" as the corresponding Relistor® products (Compl. ¶¶24, 29, 32, 37).
  • The technical function of the accused products is to deliver a sterile, injectable dose of methylnaltrexone bromide to patients (Compl. ¶7). The infringement alleged is the statutory act of filing the ANDAs to obtain FDA approval for commercial marketing of these generic products prior to the expiration of the ’096 patent (Compl. ¶¶40, 50).

IV. Analysis of Infringement Allegations

The complaint alleges infringement under 35 U.S.C. § 271(e)(2) but does not provide a detailed, element-by-element breakdown of how the proposed generic formulations meet the claim limitations. The infringement theory is premised on the allegation that Mylan's products are bioequivalent generic versions of the patented Relistor® product and therefore will necessarily practice the patented claims (Compl. ¶¶29, 37, 41, 51). No probative visual evidence provided in complaint.

'096 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A stable pharmaceutical preparation Mylan's submission of ANDAs Nos. 208592 and 208594 for generic methylnaltrexone products is a statutory act of infringement seeking approval for what is alleged to be a stable, marketable drug product. ¶¶40, 50 col. 20:13
comprising a solution of methylnaltrexone or salt thereof The accused products are identified as "generic methylnaltrexone bromide formulations for subcutaneous injection" in solution form. ¶7 col. 20:14
and a chelating agent consisting of EDTA, or a derivative thereof The complaint does not specify the excipients in Mylan’s formulation but alleges the proposed generic is "the same, or substantially the same," as the patented Relistor® product, implying it contains the claimed stabilizers. ¶¶29, 37 col. 20:15-16
wherein the solution has a pH ranging from about 3.0 to 4.0 The complaint does not state the pH of Mylan’s formulation. Infringement is alleged on the basis that the ANDA product, as a generic equivalent, will fall within the patent's claims. ¶¶41, 51 col. 20:16-17

Identified Points of Contention

  • Factual Questions: A primary question is what Mylan's ANDA specifications actually contain. Discovery will be required to determine if the generic formulation literally includes "EDTA, or a derivative thereof" and has a pH between "about 3.0 to 4.0," as required by claim 1.
  • Strategic Questions: The complaint states that Mylan’s ANDA notice letters "[do] not allege non-infringement of any claim of the '096 patent" (Compl. ¶¶28, 36). This raises the question of whether Mylan's primary defense will be to challenge the validity of the patent (e.g., for obviousness) rather than to argue that its specific formulation designs around the claims.

V. Key Claim Terms for Construction

  • The Term: "stable pharmaceutical preparation"

    • Context and Importance: This term, appearing in the preamble of claim 1, is central to the invention, which is explicitly directed to solving an unexpected instability problem. Practitioners may focus on this term because its construction could determine whether the preamble is limiting. If it is found to be limiting, then any infringement analysis would require a comparison against the patent's specific definitions of stability.
    • Evidence for a Broader Interpretation: A party could argue that "stable" should be given its plain and ordinary meaning in the pharmaceutical context without being confined to the specific degradation percentages mentioned in the patent's examples.
    • Evidence for a Narrower Interpretation: The specification provides explicit, quantitative definitions of stability, such as having degradation products that do not exceed 2% after autoclaving or after storage for a defined period ('096 Patent, col. 2:1-4, 20-25). A party may argue these objective definitions should be imported into the claims to define the scope of the "stable" limitation.

  • The Term: "a derivative thereof" (referring to EDTA)

    • Context and Importance: The scope of this term in claim 1 is critical for determining the range of chelating agents covered by the patent. If Mylan's formulation uses a stabilizer that is not EDTA itself, the infringement dispute may hinge on whether that agent qualifies as an EDTA "derivative."
    • Evidence for a Broader Interpretation: A party may argue that "derivative" should be construed functionally to include compounds that are chemically derived from or structurally similar to EDTA and perform the same chelating function.
    • Evidence for a Narrower Interpretation: The specification provides a specific list of EDTA derivatives, including "dipotassium edetate, disodium edetate, edetate calcium disodium, sodium edetate, trisodium edetate, and potassium edetate" ('096 Patent, col. 10:19-22). A party may argue that the term "derivative thereof" should be limited to these enumerated salts or very close chemical analogs.

VI. Other Allegations

  • Indirect Infringement: The complaint includes prospective allegations of induced and contributory infringement that would occur if the ANDAs were approved and the generic products were marketed (Compl. ¶¶42, 52). These allegations are based on the future manufacture, use, and sale of the products, but the complaint does not allege specific present-day acts of inducement.
  • Willful Infringement: The complaint does not explicitly allege willfulness. However, it requests that the case be declared "exceptional" under 35 U.S.C. § 285, which could lead to an award of attorney's fees (Compl., Prayer for Relief ¶9). This claim is supported by the allegation that Mylan filed its ANDAs after the '096 patent issued and after receiving notice of the patent (Compl. ¶¶25, 33).

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

  • A core issue will be one of factual proof and claim scope: Does the specific formulation detailed in Mylan’s confidential ANDA submissions fall within the literal scope of the '096 patent’s claims? The resolution will depend on evidence concerning the precise excipients and pH of the generic product, and the legal construction of key terms like "stable" and "derivative thereof."
  • A second central question, typical of ANDA litigation, will be one of patent validity: Since the complaint alleges Mylan has not presented a non-infringement position, Mylan's defense may focus heavily on challenging the validity of the '096 patent. The case may therefore turn on whether the claimed methods for stabilizing methylnaltrexone—such as controlling pH and adding a chelating agent—would have been obvious to a skilled formulator at the time of the invention.