DCT

1:18-cv-01039

Novartis Pharma Corp v. Teva Pharma USA Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:18-cv-01039, D. Del., 07/13/2018
  • Venue Allegations: Venue is asserted on the basis that Defendants are Delaware corporations and are therefore deemed to "reside" in the judicial district.
  • Core Dispute: Plaintiff alleges that Defendants' filing of an Abbreviated New Drug Application (ANDA) for a generic version of the multiple sclerosis drug GILENYA® constitutes an act of infringement of a patent covering a specific method of administering the drug.
  • Technical Context: The technology relates to S1P receptor modulators, specifically the compound fingolimod, used as an oral treatment for relapsing-remitting multiple sclerosis, a chronic autoimmune disease of the central nervous system.
  • Key Procedural History: The complaint notes that Defendant Teva had previously challenged the patent-in-suit in an inter partes review (IPR) proceeding before the U.S. Patent and Trademark Office. According to the complaint, the PTO issued a Final Written Decision in that proceeding upholding the patent's claims as valid and enforceable, a finding that may influence the current litigation.

Case Timeline

Date Event
2006-06-27 '405 Patent Priority Date
2015-11-17 '405 Patent Issue Date
2016-11-28 Defendants' ANDA Notice Letter Sent to Plaintiff
2017-02-03 IPR Petition Filed by Teva Against '405 Patent
2018-07-13 Complaint Filing Date

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

U.S. Patent No. 9,187,405 - "S1P Receptor Modulators for Treating Relasping[sic]-Remitting Multiple Sclerosis"

The Invention Explained

  • Problem Addressed: The patent's background section identifies multiple sclerosis (MS) as an immune-mediated disease where existing therapies are only "partially effective" ('405 Patent, col. 8:65-66). The specification further notes a "firm link" between the chronic inflammation characteristic of MS and angiogenesis (the formation of new blood vessels), suggesting that "neovascularization seems to have a significant role in the progression of disease" ('405 Patent, col. 9:9-12).
  • The Patented Solution: The patent claims that S1P receptor modulators, specifically the compound fingolimod, have an "inhibitory effect on neo-angiogenesis associated with demyelinating diseases" ('405 Patent, col. 9:13-15). The invention is not for the compound itself, but for a specific method of treatment: orally administering a daily 0.5 mg dose of fingolimod to treat Relapsing-Remitting Multiple Sclerosis (RRMS) "absent an immediately preceding loading dose regimen" ('405 Patent, col. 12:49-55). This provides a specific, low-dose therapeutic protocol.
  • Technical Importance: The invention claims a specific, convenient oral dosing regimen for a common form of MS, offering a therapeutic method distinct from other potential administration protocols.

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1 (Compl. ¶27).
  • Independent Claim 1:
    • A method for reducing, preventing, or alleviating relapses in Relapsing-Remitting multiple sclerosis (RRMS).
    • The method comprises orally administering the compound 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol (fingolimod), or its salt form.
    • The administration is at a "daily dosage of 0.5 mg."
    • The administration is performed "absent an immediately preceding loading dose regimen."
  • The complaint does not specify any dependent claims but alleges infringement of "one or more claims" (Compl. ¶28).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is Defendants' Abbreviated New Drug Application (ANDA) No. 208008, filed with the FDA to obtain approval for "Fingolimod 0.5 mg capsules" ("Teva's ANDA Product") (Compl. ¶1, ¶22).

Functionality and Market Context

  • The legal act of infringement alleged is the submission of the ANDA itself under 35 U.S.C. § 271(e)(2)(A), which seeks approval to market a generic drug prior to the expiration of the patent-in-suit (Compl. ¶25). The complaint alleges that upon approval, Teva's ANDA Product will have the "same active ingredient, method of administration, dosage form, and dosage amount as GILENYA®" and will be bioequivalent to it (Compl. ¶24). The infringement theory is centered on the allegation that Teva's proposed product labeling will be "substantially identical to the GILENYA® label" and will therefore instruct physicians and patients to use the product in a manner that directly infringes the method claimed in the '405 patent (Compl. ¶27).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

Claim Chart Summary:

'405 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for reducing or preventing or alleviating relapses in Relapsing-Remitting multiple sclerosis in a subject in need thereof... The filing of ANDA No. 208008 seeks approval to market a generic version of GILENYA®, a drug indicated for treating relapsing forms of MS. The proposed label is alleged to instruct this use. ¶1, ¶18, ¶27 col. 10:1-10
...comprising orally administering to said subject 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol, in free form or in a pharmaceutically acceptable salt form... Teva's ANDA is for Fingolimod 0.5 mg capsules for oral administration. Fingolimod is the common name for the claimed compound. ¶22, ¶24 col. 12:51-53
...at a daily dosage of 0.5 mg... Teva's ANDA seeks approval for a 0.5 mg dosage form, and the proposed label allegedly will instruct a 0.5 mg daily dose. ¶22, ¶24, ¶27 col. 12:54
...absent an immediately preceding loading dose regimen. The complaint alleges that the proposed Teva label will be substantially identical to the GILENYA® label, which "discloses all elements of at least claim 1," implying the label instructs a method without a loading dose. ¶27 col. 12:54-55
  • Identified Points of Contention:
    • Evidentiary Question: A primary question will be whether Teva's proposed product label, as submitted in its ANDA, actually instructs a method that meets every limitation of the asserted claims. The complaint's allegation that the label will be "substantially identical" to the GILENYA® label will require factual proof (Compl. ¶27).
    • Scope Question: The interpretation of the negative limitation "absent an immediately preceding loading dose regimen" will be critical. The case may turn on what constitutes a "loading dose regimen" and whether Teva's proposed instructions for use fall outside of that definition.

V. Key Claim Terms for Construction

  • The Term: "absent an immediately preceding loading dose regimen"
  • Context and Importance: This negative limitation is central to defining the scope of the claimed invention. The infringement analysis depends entirely on whether the administration method described on Teva’s proposed label is one that is "absent" a loading dose. Practitioners may focus on this term because its construction will determine whether a standard, continuous 0.5 mg/day dosage from the outset of therapy infringes, and its potential for indefiniteness could be a focus of a validity challenge.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation (favoring infringement): The claim language itself, given its plain and ordinary meaning, suggests that any therapeutic regimen that begins and continues with a 0.5 mg daily dose, without any higher initial dose, would be covered. The patent's description of a clinical trial where patients receive a 0.5 mg daily dosage could be argued to exemplify the claimed method (see '405 Patent, col. 11:8-10).
    • Evidence for a Narrower Interpretation (disfavoring infringement): A defendant could argue that the term is ambiguous or indefinite because the specification does not provide an explicit definition of what constitutes a "loading dose regimen." One might argue that without such a definition, the boundary between what is "absent" and what is not is unclear.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges active inducement of infringement, stating that Teva "plans and intends to...actively induce infringement" by virtue of its proposed product labeling, which will allegedly direct medical professionals and patients to administer the drug according to the patented method (Compl. ¶29-30). It also alleges contributory infringement, asserting the product is "especially made or adapted for use in infringing" and is "not suitable for any substantial noninfringing use" (Compl. ¶31).
  • Willful Infringement: The complaint alleges that Teva "acted without a reasonable basis for believing that it would not be liable for infringing the '405 patent" (Compl. ¶33). This allegation is supported by Teva's pre-suit knowledge of the patent, evidenced by its November 28, 2016 notice letter (Compl. ¶22), and potentially strengthened by the fact that the patent's claims were upheld in an IPR proceeding that Teva itself initiated (Compl. ¶18).

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

  • A central question will be one of claim scope and evidence: Can Novartis prove that the instructions on Teva's proposed generic label will direct a method of use that practices every element of the asserted claims? This will turn on both the precise wording of Teva's label and the court's construction of key claim terms.
  • The case will also involve a core question of negative limitation construction: How will the court define the phrase "absent an immediately preceding loading dose regimen"? The interpretation of this limitation, which lacks an explicit definition in the patent, will be determinative for infringement.
  • A third key issue relates to the impact of prior proceedings: How will the '405 patent's survival of an inter partes review, where its claims were found patentable over challenges brought by Teva, affect Defendants' invalidity defenses and Plaintiff's allegations of willful infringement?