DCT

1:20-cv-00133

Novartis Pharma Corp v. HEC Pharm Co Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:20-cv-00133, D. Del., 07/23/2025
  • Venue Allegations: Venue is alleged based on Defendants’ acts of infringement in Delaware, extensive business contacts in the state, and sales of the accused product within the district. Additionally, Defendant Rising Pharma Holdings, Inc. is a Delaware corporation, making it "at home" in the district.
  • Core Dispute: Plaintiff alleges that Defendants’ generic fingolimod product, through its accompanying label, induces infringement of a patent covering a method of treating multiple sclerosis.
  • Technical Context: The technology concerns a specific therapeutic regimen for fingolimod (Gilenya®), an oral drug for treating relapsing forms of multiple sclerosis, a significant autoimmune disease of the central nervous system.
  • Key Procedural History: The complaint notes extensive prior litigation between the parties concerning generic versions of Gilenya®. This specific action is a First Amended Complaint filed within a consolidated case, following Defendants' launch of their generic product. The patent-in-suit expires on December 25, 2027, a date confirmed by a terminal disclaimer filed during prosecution.

Case Timeline

Date Event
2009-09-29 ’179 Patent Priority Date
2016-01-28 HEC Notifies Plaintiff of ANDA Submission
2020-01-28 U.S. Patent No. 10,543,179 Issues
2020-01-28 Novartis Initiates First Suit Against HEC on ’179 Patent
2021-09-14 HEC Sends Second Notice Letter Regarding ’179 Patent
2021-11-10 HEC Obtains Final FDA Approval for ANDA Product
2022-10-17 Defendants Allegedly Begin Commercial Sale of ANDA Product
2022-11-04 Court Enters Scheduling Order for Related Cases
2025-07-23 First Amended Complaint Filed

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

U.S. Patent No. 10,543,179 - "Dosage Regimen of an S1P Receptor Modulator"

  • Patent Identification: U.S. Patent No. 10,543,179, titled "Dosage Regimen of an S1P Receptor Modulator", issued on January 28, 2020. (Compl. ¶30; ’179 Patent, p. 1).

The Invention Explained

  • Problem Addressed: The patent describes that while S1P receptor modulators like fingolimod are effective oral treatments for multiple sclerosis (MS), their administration can be associated with adverse events, including an increased risk of certain infections. ('179 Patent, col. 1:5-18; col. 2:51-59). Specifically, treatment can pose a risk of infection from the varicella zoster virus (VZV), the virus that causes chickenpox and shingles. ('179 Patent, col. 10:48-51).
  • The Patented Solution: The patent claims to solve this problem by teaching a specific, multi-step method of treatment. The method involves first identifying patients at risk for VZV infection by testing them for a history of the infection, then vaccinating those at-risk patients, and only then administering the 0.5 mg daily oral dosage of fingolimod. ('179 Patent, Abstract; col. 24:6-21). This sequence of testing, vaccinating, and administering is purported to limit the risk of VZV infection during treatment. ('179 Patent, col. 10:59-64).
  • Technical Importance: This prophylactic approach allows for the administration of a potent oral MS therapy while proactively managing a known infection risk, which may improve the drug’s overall safety profile and patient compliance. ('179 Patent, col. 2:35-49).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1. (Compl. ¶50).
  • The essential elements of independent claim 1 are:
    • A method for treating relapsing remitting multiple sclerosis in a patient.
    • The method comprises the following steps:
      • (a) identifying a patient at risk of contracting infection caused by varicella zoster virus (VZV) by testing for a history of VZV infection;
      • (b) vaccinating the at-risk patient against VZV; and
      • (c) administering a 0.5 mg daily oral dosage of fingolimod.
    • The method thereby limits the risk of VZV infection. (Compl. ¶41; ’179 Patent, col. 24:6-21).

III. The Accused Instrumentality

Product Identification

  • Defendants' generic fingolimod 0.5 mg capsules, manufactured and sold under Abbreviated New Drug Application (ANDA) No. 207939 ("HEC's ANDA Product"). (Compl. ¶1, ¶9). An image of the product carton for "Rising Fingolimod Capsules 0.5 mg" is provided as part of the product labeling. (Compl., Ex. B, p. 65).

Functionality and Market Context

  • The accused product is a generic equivalent to Novartis’s GILENYA®, containing the same active ingredient, fingolimod hydrochloride, at the same 0.5 mg dosage. (Compl. ¶46). It is indicated for treating relapsing forms of multiple sclerosis. (Compl. ¶47).
  • The infringement allegations center on the instructions provided in the product’s FDA-approved labeling. (Compl. ¶45, Ex. B). The label allegedly instructs healthcare providers to administer a 0.5 mg daily dose of fingolimod. (Compl. ¶48).
  • Crucially, the label also directs physicians that patients "without a healthcare professional confirmed history of chickenpox or without documentation of a full course of vaccination against VZV should be tested for antibodies to VZV before initiating fingolimod." (Compl. ¶49).
  • Furthermore, the label states that "VZV vaccination of antibody-negative patients is recommended prior to commencing treatment with fingolimod." (Compl. ¶49).
  • The complaint alleges these sales cause direct competitive harm to Novartis and that over 1,000 prescriptions have already been sold to U.S. customers. (Compl. ¶43, ¶44).

IV. Analysis of Infringement Allegations

  • ’179 Patent Infringement Allegations
Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
(a) identifying a patient at risk of contracting infection caused by varicella zoster virus by testing said patient for a history of infection caused by varicella zoster virus, Defendants' product label instructs that patients without a confirmed history of chickenpox or VZV vaccination "should be tested for antibodies to VZV before initiating fingolimod." ¶49 col. 10:59-62
(b) vaccinating the patient at risk of contracting infection caused by varicella zoster virus, and Defendants' product label states that "VZV vaccination of antibody-negative patients is recommended prior to commencing treatment with fingolimod." ¶49 col. 10:62-64
(c) administering orally fingolimod or a pharmaceutically acceptable salt thereof to said patient at a daily dosage of 0.5 mg, Defendants' product label instructs healthcare providers to administer a 0.5 mg dose of fingolimod orally once-daily. ¶48 col. 18:3-6
  • Identified Points of Contention:
    • Scope Questions: The case is one of induced infringement, where Novartis must prove the product label encourages or promotes physicians to perform the patented method. A central dispute may arise over the claim term "vaccinating." The defense may argue that the label's language that vaccination "is recommended" is merely a suggestion, not a directive sufficient to meet the legal standard for inducement, which requires intent to cause the infringing acts.
    • Technical Questions: The asserted claim requires the performance of all three steps by a single actor (the physician). A key factual question for the court will be whether the complaint provides sufficient evidence that physicians, in response to the label, actually perform the full sequence of testing, vaccinating, and then administering the drug. The complaint alleges this on "information and belief," which will need to be substantiated during discovery. (Compl. ¶53).

V. Key Claim Terms for Construction

  • The Term: "vaccinating"
  • Context and Importance: This term is the lynchpin of the inducement allegation for the second step of the claimed method. Practitioners may focus on this term because its construction will determine whether the label's statement that vaccination "is recommended" is sufficient to constitute active encouragement of an infringing act.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A plaintiff may point to the specification's permissive language, such as "the patient may be vaccinated," to argue that the invention contemplates a non-mandatory step, consistent with a "recommendation." ('179 Patent, col. 10:62-63). The argument would be that recommending the step is a way of teaching the patented method of safe use.
    • Evidence for a Narrower Interpretation: A defendant may argue that the claim's use of the active gerund "vaccinating" requires an affirmative act that is not captured by a mere "recommendation" on a label. They may argue the specification's use of "may be" indicates the step is optional and not essential to the invention, and thus a label that only recommends it cannot be said to induce infringement of the complete claimed method.

VI. Other Allegations

  • Indirect Infringement: The complaint's primary theory is induced infringement under 35 U.S.C. § 271(b). It alleges that Defendants, with knowledge of the ’179 patent, intentionally encourage infringement by physicians through the express instructions and recommendations on their product label. (Compl. ¶¶ 40, 49, 51, 55).
  • Willful Infringement: The complaint alleges that Defendants acted "without a reasonable basis for believing that they would not be liable for inducing infringement," tracking the legal standard for willfulness. (Compl. ¶57). The claim is supported by allegations that Defendants have had knowledge of the ’179 Patent since at least its issue date on January 28, 2020, well before the accused product was launched in October 2022. (Compl. ¶40, ¶42).

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

  • A central issue will be one of inducement standard: does the product label's language that vaccination "is recommended" constitute sufficient affirmative intent to encourage infringement, or is it merely informational, falling short of the legal requirement to find that Defendants induced the complete patented method?
  • A key evidentiary question will be one of direct infringement by a third party: what evidence will be presented to establish that prescribing physicians actually perform the full, three-part sequence of testing, vaccinating, and administering the drug as a direct result of the instructions and recommendations on the accused product's label?