Details for Patent: 10,543,179

Which drugs does patent 10,543,179 protect, and when does it expire?

Patent 10,543,179 protects GILENYA and is included in one NDA.

This patent has forty-two patent family members in seventeen countries.

Summary for Patent: 10,543,179

Title:	Dosage regimen of an S1P receptor modulator
Abstract:	The present invention relates to a dosage regimen of an S1P receptor modulator or agonist in the course of the treatment of patients suffering from an inflammatory or autoimmune disorder, for example multiple sclerosis. Specifically, the present invention relates to testing a patient for a history of infection and vaccinating the patient prior to administration of fingolimod or a pharmaceutically acceptable salt thereof at a daily dosage of 0.5 mg.
Inventor(s):	Craig Boulton, Pascale Burtin, Olivier David, Ana de Vera, Thomas Dumortier, Irene Hunt, Robert Schmouder, William C. Collins
Assignee:	Novartis Pharmaceuticals Corp
Application Number:	US15/986,992
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,543,179
Patent Claim Types: see list of patent claims	Use;

United States Patent 10,543,179 Scope, Claim Construction, and Landscape for Fingolimod + Varicella-Zoster Virus Vaccination in Relapsing-Remitting Multiple Sclerosis (RRMS)

Executive summary: U.S. Patent 10,543,179 is directed to a specific clinical sequence in RRMS: (i) identify patients at risk for varicella-zoster virus (VZV) infection by testing for prior VZV infection history, (ii) vaccinate those at risk, and (iii) administer oral fingolimod (0.5 mg daily; salt forms covered) to limit the risk of VZV infection. The core enforceable scope is method-of-treatment claims that combine patient screening, vaccination, and fingolimod dosing, with explicit embodiments for reducing relapse rate and for hydrochloride salt administration. The patent landscape around this concept splits into (1) fingolimod label-linked safety and vaccination guidance, (2) general vaccination and immunology methods, and (3) MS treatment and fingolimod-specific composition/uses. Competitively, the patent’s novelty is tied to the specific vaccination-trigger logic (risk identification based on VZV infection history) paired with fingolimod dosing, which can constrain easy design-around if an accused regimen preserves the same sequence and decision points.

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What is U.S. Patent 10,543,179 claiming: method for RRMS that includes VZV risk testing, vaccination, and fingolimod 0.5 mg?

Short answer: The patent claims a combined clinical protocol for relapsing-remitting multiple sclerosis patients: test for VZV infection history, vaccinate those at risk of VZV infection, then treat with oral fingolimod 0.5 mg daily to limit VZV infection risk.

Claim 1: the independent method claim that frames infringement

Claim 1 has three required acts and one dose limitation:

1. Patient selection by risk-testing: “identifying a patient at risk of contracting infection caused by VZV” by testing the patient for a history of infection caused by VZV.
2. Preventive intervention: vaccinating the patient identified as at risk.
3. Disease therapy with specific dosing: administering orally fingolimod (or a pharmaceutically acceptable salt) at 0.5 mg daily to limit VZV infection risk.

Enforceable scope anchor: The “thereby limiting the risk” language ties the method to a prophylactic purpose, but the claim requires an operational link among (a) VZV history testing, (b) vaccination, and (c) fingolimod administration at 0.5 mg daily. That makes the claim both procedural and decision-based.

Functional language: “thereby limiting the risk”

Courts typically treat “thereby” as functional/contextual intent, but when it is coupled with required steps, it can still influence claim interpretation because it informs what the steps are expected to accomplish. Practically, an accused protocol that retains the steps (testing, vaccinating at-risk patients, then dosing fingolimod 0.5 mg daily) is hard to separate from the claimed purpose even if the protocol is not described as prophylactic in promotional materials.

Claim 2: relapse reduction as an alternative infringement outcome

Claim 2 depends on Claim 1 and adds: “wherein treating comprises reducing the frequency of clinical exacerbations.”

This introduces an additional clinical metric. In infringement analysis, the claim does not add a new step. It instead specifies an outcome characterization of “treating.” A regimen that satisfies Claim 1 can still fall within Claim 2 if the clinical outcome is consistent with reduced exacerbations, even if the clinician focuses on infection prevention.

Claim 3: hydrochloride salt specification

Claim 3 depends on Claim 1 and narrows fingolimod to “administered as a hydrochloride salt.”

This matters for scope because Claim 1 covers “pharmaceutically acceptable salt(s),” while Claim 3 captures at least one specific salt form. If a product uses a different salt form (if any), Claim 3 may be avoided while Claim 1 remains available. Conversely, a hydrochloride product can support both Claim 1 and Claim 3 exposure.

Claim 4: chickenpox as a specific VZV infection embodiment

Claim 4 depends on Claim 1 and specifies the infection as “chickenpox.”

Chickenpox is a clinical manifestation of primary VZV infection; “VZV infection” in Claim 1 includes chickenpox and other VZV-related conditions. Claim 4 narrows the infection type, which can affect how broadly a protocol needs to target risk of chickenpox versus broader VZV outcomes to land within the dependent claim.

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How do courts likely construe the key claim elements: “testing for VZV infection history,” “at risk,” “vaccinating,” and “limiting risk”?

“Identifying a patient at risk … by testing … for a history of infection”

The claim requires a testing modality tied to whether the patient has had VZV infection in the past. Claim language does not specify assay type (serology vs other), so scope likely covers tests used to establish prior VZV infection history or immunity status.

Operationally, an “at risk” finding must be traceable to the patient having a history (or lack of history) of VZV infection. A regimen that vaccinates broadly without risk stratification could be outside if it omits the “identifying … at risk … by testing … history” step.

Design-around pressure point: The step is both a decision and a predicate. Eliminating the test-for-history step or using a different risk proxy can reduce Claim 1 risk exposure, depending on whether the replacement step can still be construed as “testing … for a history of infection caused by VZV.”

“Vaccinating the patient at risk”

The claim is not limited by vaccine brand, schedule details, route, or timing within the method. Still, the vaccination is a required act in the method sequence.

A protocol that delays vaccination until after fingolimod initiation could face infringement arguments because the claim requires vaccinating the at-risk patient and then administering fingolimod “to limit the risk.” A post-initiation vaccination might be argued as not meeting the required sequence or “thereby limiting risk” nexus, depending on exact timing and clinician implementation.

“Administering orally fingolimod … daily dosage of 0.5 mg”

This is a hard numerical limitation. If an accused protocol uses a different daily dose (for example, titration or reduced dose), a literal infringement argument weakens. However, nonliteral infringement and doctrine-of-equivalents analysis may still apply depending on claim construction and jurisdiction.

Design-around pressure point: deviating from 0.5 mg daily dosing is the cleanest literal noninfringement lever, but clinical practice for fingolimod is typically 0.5 mg maintenance in established labeling, so commercial protocols often match the claim.

“Thereby limiting the risk of infection caused by VZV”

This ties the method’s purpose to prophylaxis. If clinical documentation shows the vaccination is used to mitigate VZV infection risk in the context of fingolimod-induced immune risk, the “thereby” limitation is easier to map.

A sponsor that uses the same steps without stating it is to limit VZV risk can still be assessed based on the steps and clinical rationale.

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How broad is the claim set: what is actually protected beyond “fingolimod + vaccine”?

Short answer: The protection is narrower than a generic “fingolimod patient vaccination” idea. It is anchored to (1) VZV infection-history testing to identify at-risk patients, (2) vaccinating identified at-risk patients, and (3) administering oral fingolimod at 0.5 mg daily to limit VZV infection risk.

Scope boundaries that matter for freedom-to-operate

1. Required method steps: testing, identification, vaccination, then oral fingolimod.
2. Required drug and dose: fingolimod at 0.5 mg daily (salt variants covered in Claim 1).
3. Required patient population: “patient in need thereof” with RRMS and “relapsing remitting multiple sclerosis.”
4. VZV infection risk domain: VZV infection (with chickenpox as dependent embodiment).
5. Outcome tie-in: limiting risk (and dependent claim on reducing exacerbations).

What it does not explicitly cover

Based solely on the claim text provided, the patent does not expressly cover:

• other dosing strengths or titration regimens,
• other immunomodulators besides fingolimod,
• other viral prophylaxis targets,
• vaccination schedules defined with temporal specifics (not present in the excerpt),
• non-oral administration forms (the claim is “orally”).

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What is the most relevant prior-art and adjacent-IP theme: fingolimod safety risk and vaccination guidance in RRMS?

Short answer: The closest technical adjacency is fingolimod’s immunomodulatory profile and known VZV risk management, especially pre-treatment vaccination and screening. The patent’s key differentiation is its method structure: test VZV infection history, vaccinate at-risk patients, then give fingolimod 0.5 mg daily to limit VZV infection risk.

Likely categories of prior art

1. Fingolimod therapeutic use and RRMS treatment documents: broad MS use claims without the VZV testing-vaccination sequence.
2. Immunosuppression-associated VZV risk management: general guidance to assess VZV immunity and vaccinate prior to immunosuppressive therapy, but not necessarily in combination with fingolimod at 0.5 mg daily with a VZV-history testing trigger.
3. Vaccine method claims: vaccine use/administration methods not tied to fingolimod dosing or RRMS.
4. Salt form chemistry: if fingolimod hydrochloride appears elsewhere, Claim 3 may be a narrower extension of a known salt rather than a core novelty driver.

How the claim structure changes validity risk

If prior art exists that teaches:

• testing VZV immunity/history,
• vaccinating non-immune individuals,
• and then starting an immunomodulatory agent, then the question becomes whether it specifically teaches fingolimod at 0.5 mg daily and whether the prior art discloses the method in a way that anticipates all elements of Claim 1.

Where prior art is “general vaccination before immunosuppression,” novelty may survive if fingolimod-specific pairing or the exact protocol sequence is missing. Where prior art is fingolimod-specific with the same steps, the validity risk increases.

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What patent estate could block or enable licensing around U.S. 10,543,179?

Short answer: Enforcement leverage typically sits at the method protocol level. Licensing and design-around strategies will focus on whether a generic or competitor can practice an RRMS regimen that avoids the claim’s required steps (VZV-history testing and at-risk vaccination) or avoids the exact fingolimod 0.5 mg daily administration.

Practical licensing implications

• If a company’s clinical protocol for fingolimod includes VZV screening and vaccination before initiating therapy, that protocol is vulnerable to method claim coverage if it tracks Claim 1’s required steps.
• If the protocol follows a different workflow (for example, no VZV history testing, or vaccination only after fingolimod start), legal exposure shifts to whether those differences are sufficient to move outside “testing … for history” and the sequence implied by “vaccinating … and administering.”

Likely “bundles” in patent portfolios

Because the claim is a method sequence, related portfolios often include:

• fingolimod composition/salt patents,
• manufacturing process patents,
• use patents for MS,
• immunogenicity or risk-management patents,
• and device/biomarker screening patents.

Even if U.S. 10,543,179 is the key VZV-risk method claim, it is usually not the only blocker if the defendant’s product and manufacturing are also covered by other fingolimod IP.

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How does U.S. 10,543,179 affect generic fingolimod entry risk scenarios?

Short answer: If generics are granted approval for fingolimod 0.5 mg and then follow labeled or guideline VZV risk mitigation with VZV-history testing and vaccination, they may not be able to rely on the “generic label” argument to avoid method infringement. Method claims can be infringed by practicing clinicians and companies using the patented regimen, even when the generic product itself is approved.

Key infringement pathway for generics

• Generics can sell fingolimod as an active pharmaceutical ingredient and dosing product, but method infringement can occur if the licensed use practices all steps of the claimed method.
• If U.S. 10,543,179 is asserted, the relevant evidence is clinical protocol, prescriber practice patterns, and documentation showing VZV-history testing and at-risk vaccination before (or as required by the claim) fingolimod initiation.

“Designing around” generic method risk

Most realistic levers:

• modify patient selection logic such that it no longer matches “testing … for history of infection caused by VZV,”
• vaccinate without the risk-testing predicate (if the claim construction requires the test step),
• change dosing away from “daily dosage of 0.5 mg” (often difficult clinically),
• or adjust sequence/timing.

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What does the claim say about VZV infection scope: chickenpox vs broader VZV outcomes?

Short answer: Claim 1 covers “infection caused by VZV” generally, while Claim 4 narrows to chickenpox. That broad base increases exposure if the accused protocol aims to prevent both primary VZV infection (chickenpox) and other VZV manifestations.

Litigation mapping

In practice, defendants may argue their prophylaxis aims at herpes zoster risk rather than chickenpox, or vice versa. Claim 4’s presence indicates the patentee considered at least chickenpox expressly. Claim 1’s broad wording can still capture other VZV infection manifestations.

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What is the likely Orange Book and regulatory positioning relevance for enforcement?

Short answer: Method claims like U.S. 10,543,179 do not depend on composition registration in the Orange Book as such, but Orange Book listings and FDA labeling can strongly influence evidence of standard-of-care practices, which can map to the claimed method.

Regulatory evidence sources typically used in method cases

• FDA-approved labeling for fingolimod (including sections addressing infection risk and vaccination before treatment),
• insurer guidelines and MS center protocols,
• clinical trial protocols,
• prescriber educational materials.

If labeling includes VZV screening and vaccination language that matches Claim 1, the evidentiary burden for plaintiffs in method infringement typically improves.

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How strong is the patent estate for this exact protocol concept, based on claim structure alone?

Short answer: The estate strength is concentrated around a specific sequence and a specific dose. That can make it easier to argue practical infringement, but it also limits the claim’s generality against broader “vaccinate before immunosuppression” or “immunization guidance” defenses.

Strength drivers

• Clear step structure: test, vaccinate, administer.
• Defined dose: 0.5 mg daily.
• Drug identity: fingolimod.
• Defined disease context: RRMS.

Vulnerability drivers

• Prior-art overlap risk: if fingolimod labeling or earlier documents already describe essentially the same protocol, validity risk rises.
• Construction risk around functional intent: “thereby limiting the risk” could be treated as non-limiting or as a statement of intended result depending on how courts construe “thereby.”

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What are the most plausible litigation and settlement triggers for U.S. 10,543,179?

Short answer: The claim’s reliance on clinically standard safety practices means disputes likely center on whether the accused parties actually perform VZV-history testing and vaccinate at-risk patients before fingolimod initiation, and whether the dose matches the 0.5 mg limitation.

Potential settlement patterns (typical for method-of-use disputes)

• covenant not to assert against certain screening and vaccination workflows,
• agreements tied to timing and required documentation of VZV serostatus testing,
• limitations to hydrochloride salt use if Claim 3 becomes a secondary focus.

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Key Takeaways

• U.S. Patent 10,543,179 is a protocol claim for RRMS that requires VZV infection-history testing, vaccination of at-risk patients, and oral fingolimod at 0.5 mg daily to limit VZV infection risk.
• Claim 2 adds a clinical outcome characterization (reduced exacerbations) without adding new steps.
• Claim 3 narrows fingolimod to hydrochloride salt; it is secondary to Claim 1’s broader salt coverage.
• Claim 4 specifies chickenpox as an embodiment of the VZV infection target.
• Fingolimod competitors and generics face method infringement risk if their real-world patient management matches the claim’s step sequence and dosing.

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FAQs

1. Does U.S. Patent 10,543,179 cover vaccinating all RRMS patients before fingolimod, even without VZV-history testing?
2. If a protocol vaccinates after starting fingolimod, does it still practice the claimed sequence?
3. How critical is the “0.5 mg daily” limitation for infringement analysis?
4. Does Claim 1 cover herpes zoster (reactivation) or is it limited to primary VZV infection like chickenpox?
5. Can a generic avoid infringement by using a different fingolimod salt form than hydrochloride?

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References

1. U.S. Patent 10,543,179 (claims excerpt provided by user).

Drugs Protected by US Patent 10,543,179

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Novartis	GILENYA	fingolimod hydrochloride	CAPSULE;ORAL	022527-001	Sep 21, 2010	AB	RX	Yes	Yes						TREATMENT OF RELAPSING REMITTING MULTIPLE SCLEROSIS BY DETERMINING VARICELLA ZOSTER VIRUS (VZV) STATUS AND VACCINATING PRIOR TO COMMENCING TREATMENT

International Family Members for US Patent 10,543,179

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2010101513
Australia	2010300918
Australia	2010300919