DCT

1:18-cv-01043

Novartis Pharma Corp v. Accord Healthcare Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:18-cv-01043, D. Del., 07/16/2018
  • Venue Allegations: Plaintiff alleges venue is proper in the District of Delaware because many defendants are incorporated there, have committed acts of infringement in the district, maintain a regular and established place of business, and have previously litigated Hatch-Waxman cases in the forum.
  • Core Dispute: Plaintiff alleges that Defendants' submission of Abbreviated New Drug Applications (ANDAs) to market generic versions of the multiple sclerosis drug GILENYA® constitutes an act of patent infringement.
  • Technical Context: The case involves a specific method-of-use patent for fingolimod, an oral S1P receptor modulator used to treat relapsing forms of multiple sclerosis (MS).
  • Key Procedural History: The complaint highlights that the patent-in-suit recently survived an inter partes review (IPR) proceeding, with the U.S. Patent and Trademark Office issuing a Final Written Decision confirming the patentability of the asserted claims. This procedural history may significantly influence the litigation by potentially estopping defendants from raising certain invalidity arguments.

Case Timeline

Date Event
2006-06-27 Priority Date for U.S. Patent No. 9,187,405
2015-11-17 U.S. Patent No. 9,187,405 Issued
2016-01-11 First-mentioned Defendant (Accord) notifies Novartis of ANDA filing
2017-02-03 IPR2017-00854 filed against the '405 Patent
2017-06-08 Last-mentioned Defendant (Bionpharma) notifies Novartis of ANDA filing
2018-07-16 Complaint Filed
2020-02-10 IPR Certificate Issued, confirming patentability of claims 1-6

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”, issued November 17, 2015

The Invention Explained

  • Problem Addressed: The patent describes demyelinating diseases such as multiple sclerosis (MS) as being characterized by inflammation, demyelination, and axonal loss, noting that neovascularization (the formation of new blood vessels) appears to play a significant role in the progression of the disease (’405 Patent, col. 9:1-12).
  • The Patented Solution: The patent does not claim the compound fingolimod itself, but rather a specific method of using it. The invention is a therapeutic regimen for treating relapsing-remitting multiple sclerosis (RRMS) by orally administering a specific low dose (0.5 mg daily) of fingolimod, critically, "absent an immediately preceding loading dose regimen" (’405 Patent, col. 12:50-56). The patent's detailed description discloses a clinical trial in which this 0.5 mg daily dose was evaluated, distinguishing it from higher doses (’405 Patent, col. 11:7-14).
  • Technical Importance: The claimed invention provides a specific, low-dose treatment method for RRMS that is asserted to be safe and effective without the need for a higher initial "loading dose" to rapidly achieve therapeutic levels.

Key Claims at a Glance

  • The complaint asserts infringement of one or more claims, with a focus on at least claim 1 (’405 Patent, col. 12:50-56; Compl. ¶231). The patent contains three independent claims (1, 3, and 5) directed to methods of treating RRMS.
  • Independent Claim 1 requires:
    • A method for reducing or preventing or alleviating relapses in Relapsing-Remitting multiple sclerosis
    • comprising orally administering to said subject
    • 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol (fingolimod), in free form or a pharmaceutically acceptable salt form
    • at a daily dosage of 0.5 mg
    • absent an immediately preceding loading dose regimen
  • The complaint reserves the right to assert other claims, including dependent claims which further specify the hydrochloride salt form of fingolimod (’405 Patent, col. 12:57-60).

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are the generic fingolimod 0.5 mg capsule products described in the multiple ANDAs filed by each Defendant (’405 Patent, col. 1:7-11).

Functionality and Market Context

The complaint alleges that each Defendant’s ANDA Product, upon approval, will have the same active ingredient (fingolimod), method of administration (oral), dosage form (capsule), and dosage amount (0.5 mg) as Novartis’s branded product, GILENYA® (Compl. ¶228). It is further alleged that the proposed labeling for the Defendants' products will be substantially identical to the GILENYA® label and will therefore instruct administration in a manner that infringes the ’405 patent (Compl. ¶231). The filing of an ANDA is a technical act of infringement under 35 U.S.C. § 271(e)(2) to establish jurisdiction for the lawsuit before any generic product is marketed (Compl. ¶229).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

Claim Chart Summary

The complaint alleges that the act of filing the ANDAs, and the future manufacture, use, and sale of the ANDA products, will infringe the ’405 patent. The core theory relies on the ANDA specifications and proposed labels, which allegedly describe a product identical to GILENYA® in all relevant aspects.

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 Defendants' proposed product labels will allegedly instruct use for treating relapsing forms of MS, the same indication as GILENYA®. ¶228, ¶231 col. 12:51-52
comprising orally administering to said subject The ANDA Products are described as oral capsules. ¶7, ¶228 col. 12:52
2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol, in free form or in a pharmaceutically acceptable salt form The ANDA Products allegedly contain the same active ingredient, fingolimod, as GILENYA®. ¶7, ¶228 col. 6:20-25
at a daily dosage of 0.5 mg The ANDA Products are for 0.5 mg capsules, the same dosage as GILENYA®. ¶7, ¶228 col. 11:7-14
absent an immediately preceding loading dose regimen The complaint alleges the GILENYA® label, which the defendants' labels will copy, discloses all elements of claim 1, implying it instructs for use without a loading dose. ¶231 col. 11:7-14

Identified Points of Contention

  • Scope Questions: A central dispute may concern the scope of the negative limitation "absent an immediately preceding loading dose regimen." The court may need to determine what constitutes a "loading dose regimen" and what level of instruction in a product's label is required to either encourage or discourage such a regimen.
  • Technical Questions: An evidentiary question will be whether the Defendants' proposed product labels, by allegedly mirroring the GILENYA® label, will in fact induce physicians to prescribe the drug without a loading dose. The analysis will depend on the precise language of the approved GILENYA® label and how a person of ordinary skill in the art would interpret its instructions regarding the initiation of therapy.

V. Key Claim Terms for Construction

The Term: "absent an immediately preceding loading dose regimen"

Context and Importance

This negative limitation appears to be the primary point of novelty and the likely focus of the infringement dispute. Its definition is critical because infringement will turn on whether Defendants' product labels are found to induce a method of use that lacks this "loading dose regimen." Practitioners may focus on this term because negative limitations can present unique challenges for both claim construction and infringement analysis.

Intrinsic Evidence for Interpretation

  • Evidence for a Broader Interpretation: Plaintiff may argue that the term's plain meaning is clear and covers any administration that begins and continues at the 0.5 mg daily dose without any higher initial dose. The patent's description of a clinical trial administering a flat 0.5 mg daily dose without mentioning a loading dose could be cited as evidence of what the inventors considered to be the claimed method (’405 Patent, col. 11:7-14).
  • Evidence for a Narrower Interpretation: Defendants may argue that "absent" requires more than mere silence in the product label; it may require an explicit instruction not to use a loading dose. They might also argue that the term has a specific, established meaning in pharmacology that is not met by a label that is simply silent on the topic of loading doses.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges active inducement of infringement, stating that Defendants know their proposed labels will instruct patients and healthcare providers to administer the generic drug in a manner that directly infringes the ’405 patent (Compl. ¶234). The complaint also pleads contributory infringement, alleging the ANDA products are especially made for an infringing use and are not suitable for substantial non-infringing use (Compl. ¶235).
  • Willful Infringement: The complaint alleges that Defendants' infringement has been and will be willful. This is based on pre-suit knowledge of the ’405 patent, evidenced by the ANDA notice letters sent to Novartis, and the allegation that Defendants "acted without a reasonable basis for believing" they would not be liable for infringement (Compl. ¶7, ¶237). The prior IPR decision upholding the patent's validity will likely be a significant factor in any willfulness analysis (Compl. ¶223).

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

  • A core issue will be one of infringement by inducement: Will the Defendants' proposed product labels, which are expected to mirror the label for GILENYA®, be found to actively encourage or instruct physicians and patients to practice the full claimed method, particularly the negative limitation of administering the 0.5 mg daily dose "absent an immediately preceding loading dose regimen"?
  • A second pivotal issue will relate to the consequence of the prior IPR proceeding. Given that the USPTO has already confirmed the patentability of the asserted claims, a key question is what scope, if any, remains for Defendants to challenge the patent's validity in district court, which operates under a different and higher standard of proof ("clear and convincing evidence" versus "preponderance of the evidence").