Details for Patent: 6,933,310

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Summary for Patent: 6,933,310

Title:	Therapeutic agent for amyotrophic lateral sclerosis (ALS)
Abstract:	An object of the present invention is to provide a novel medicament with which motor neuron diseases can be treated. According to the present invention, there is provided a therapeutic agent for motor neuron diseases which comprises 3-methyl-1-phenyl-2-pirazoline-5-on or physiologically acceptable salts thereof as an active ingredient.
Inventor(s):	Ken Ikeda
Assignee:	Tanabe Pharma Corp
Application Number:	US10/399,961
Patent Claim Types: see list of patent claims	Use;

US Patent 6,933,310 Scope of Claims and US Patent Landscape for 3-methyl-1-phenyl-2-pyrazoline-5-one (Motor Neuron Disease)

US 6,933,310 (method-of-use) claims a core therapeutic dosing concept: administering effective amounts of 3-methyl-1-phenyl-2-pyrazoline-5-one (and physiologically acceptable salts) to treat motor neuron diseases and to delay disease progression. Claim coverage is driven by (i) the specific chemical identity of the active ingredient (including salt forms), (ii) the patient population (motor neuron disease), and (iii) the claimed therapeutic outcomes (treatment and delay of progression; ALS and other specified motor neuron indications).

Key consequence for enforcement and freedom-to-operate (FTO): any US infringement risk is concentrated on method-of-treatment activity (administering the compound for these indications), not on manufacturing, formulation, or dosage-form specifics, unless separately covered by other patents.

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What is US Patent 6,933,310 and what does it claim?

US 6,933,310 is a US method-of-use patent. The claim set you provided is narrow and composition-linked: the invention is the use of a specific small molecule, 3-methyl-1-phenyl-2-pyrazoline-5-one (and physiologically acceptable salts), to treat motor neuron diseases.

Core claimed active and scope mechanics

Across claims 1-5, the claimed act is:

• “Administering an effective amount” of:
  • 3-methyl-1-phenyl-2-pyrazoline-5-one, or
  • a physiologically acceptable salt of that compound,
• to a patient with a specified disease context.

The phrase “consisting essentially of” (in claims 1, 2, 3, 4, and 5 as you listed) materially narrows the open-endedness. It permits additional elements only if they do not materially change the claimed method’s basic and novel characteristics. In practice, that supports arguments that adding other therapeutic agents does not necessarily avoid infringement if the method still involves administering the claimed compound to achieve the claimed therapeutic effect.

Claim-by-claim coverage (what is inside the fence)

Below is the operative scope based strictly on your claim language.

Claim 1 (anchor claim: treatment)

• Invention type: method of treatment.
• Claimed condition: motor neuron diseases (broad category).
• Relief/functional element: “method for treating motor neuron diseases.”
• Active: 3-methyl-1-phenyl-2-pyrazoline-5-one or physiologically acceptable salt.
• No dose schedule limitation is stated in the claim text you provided.
• No formulation route limitation is stated in the claim text you provided.

Impact: Claim 1 is the broadest. If any downstream patent or competitor’s protocol still boils down to administering the active compound to patients with motor neuron diseases with a therapeutic purpose, Claim 1 is the primary infringement target.

Claim 2 (functional outcome: delay of progression)

• Depends from claim 1.
• Adds that the method delays progress of the motor neuron disease.

Impact: This claim strengthens enforcement when clinical endpoints or trial designs emphasize disease progression delay. Even if a defendant argues “treatment” but not delay, Claim 2 may still be asserted when delay is shown.

Claim 3 (indication listing: multiple motor neuron diseases)

• Depends from claim 1.
• Specifies motor neuron diseases: ALS, SMA, progressive bulbar palsy, or PLS.

Impact: Claim 3 locks in the principal market-facing indications used in clinical development and labeling strategies. If a competitor targets any of these, Claim 3 narrows the fact pattern but increases clarity for infringement positions.

Claim 4 (ALS-focused independent subset)

• Depends from claim 1.
• Limits to ALS.

Impact: For litigation and Paragraph IV-style challenges, ALS use cases often drive the highest probability of infringement and the most commercially material damages models. Claim 4 is the cleanest ALS-specific hook.

Claim 5 (enhancing motor neurons)

• Method for enhancing motor neurons.
• Same active ingredient and salt coverage.
• Uses “consisting essentially of,” which may still tolerate concomitant elements only if they do not materially alter the method’s core characteristics.

Impact: Claim 5 can be used to capture alternative trial rationales that do not frame themselves as “treating” but as “enhancing” motor neuron function or survival. Practically, plaintiffs often align this to biomarkers, functional scales, or neurophysiologic measures consistent with “enhancement.”

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How broad is claim coverage: treatment method vs. composition, formulation, and dosing?

What is not in the claims you provided

Based on your claim text, US 6,933,310 does not expressly limit:

• dosage regimen (mg range, frequency, titration),
• route of administration (oral, parenteral),
• specific dosage form (tablet, capsule, solution, etc.),
• specific salt identity (e.g., HCl vs. sulfate),
• mechanism-of-action,
• specific biomarkers or clinical endpoints beyond “delay of progress.”

What is in the claims that matters most

The enforceable boundary is anchored on:

• the identity of the compound (and salts as a category),
• the patient condition (motor neuron diseases, and listed subsets),
• the therapeutic purpose (“treating” and “enhancing”), and
• the claimed progression effect for claim 2.

Practical breadth implications for competitors

• If a competitor uses a different compound, it avoids these claims.
• If a competitor uses the same compound but targets a different disease area, it avoids the motor neuron-disease limitation.
• If a competitor uses the same compound but for motor neuron indications without a “treatment/enhancement” purpose, infringement depends on inducement and “intended use” evidence. In Hatch-Waxman contexts, intended-use arguments often turn on labeling and marketing materials.
• Salt coverage means substitution among “physiologically acceptable salts” is not a safe harbor by itself.

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What patents likely exist around US 6,933,310: composition, salts, intermediates, and other methods?

US method-of-use patents for small molecules are commonly accompanied by companion estates that cover:

1. Composition of matter for the active ingredient and/or key intermediates.
2. Salt patents (individual salt forms, crystallinity, polymorphs).
3. Formulation and dosage patents (delivery system, stability, bioavailability).
4. Additional therapeutic indications (beyond the motor neuron diseases listed).
5. Combination therapy patents (e.g., with standard-of-care ALS agents).
6. Manufacturing method patents (process and purification).

However, without the complete bibliographic data for US 6,933,310 (application/priority data, assignee, related family members), a complete, accurate mapping of the landscape cannot be produced from the claim text alone. Under the constraints here, only the claim-governed scope analysis is deliverable.

Actionable enforcement posture based on claim structure alone:

• Method-of-use enforcement for US 6,933,310 is strongest where a competitor’s product is marketed and used for ALS/SMA/PLS/progressive bulbar palsy and where physicians administer the compound.
• Inventory and process are not the claim focus, unless other patents in the family cover those steps.

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When does US 6,933,310 lose exclusivity and how does that drive generic or biosimilar risk?

A precision exclusivity and expiration timeline requires the patent’s filing date, priority date, and any adjustments/extensions, none of which is present in your prompt. Without those inputs, an exact “loss of exclusivity” date cannot be stated while maintaining correctness.

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What does US 6,933,310 mean for Paragraph IV challenges and FDA Orange Book status?

A determination of Orange Book listing, listed patents, and any Paragraph IV certifications requires the FDA NDC/Orange Book record for the relevant marketed drug using 3-methyl-1-phenyl-2-pyrazoline-5-one, including:

• listed patent numbers tied to each NDC,
• expiry date(s),
• patent claim categories.

Your prompt does not include the Orange Book record or the associated product/NDC. Under the constraints, a complete Orange Book and Paragraph IV analysis cannot be produced.

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Which indication strategies create the highest infringement exposure under US 6,933,310?

Even without timeline and Orange Book, the infringement exposure is indication-driven because the claims specify motor neuron diseases and subsets.

Highest exposure: ALS

• Claim 4 targets ALS.
• Claim 3 also targets ALS through its listed group.
• ALS is also the most common commercial and clinical focus in motor neuron disease programs, increasing odds of the “intended use” or “therapeutic purpose” evidence needed in method-of-use disputes.

High exposure: SMA, progressive bulbar palsy, PLS

• Each appears in claim 3, creating clear alignment between trial indication and infringement theory.

Broad exposure: “motor neuron diseases” generally

• Claim 1 covers the category broadly.
• Even if a competitor targets a less common motor neuron syndrome that falls within the category, claim 1 remains a potential hook, subject to proof that the treated condition is a “motor neuron disease” as construed.

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How strong is the patent estate for compound-based motor neuron method-of-use claims?

Strength here is assessed by the claim architecture you supplied:

Strength factors

• Single-agent specificity: the active ingredient is uniquely defined as 3-methyl-1-phenyl-2-pyrazoline-5-one (or physiologically acceptable salts).
• Multiple layered claims: broad treatment (claim 1), progression delay (claim 2), specific indications (claims 3 and 4), and functional neuroenhancement framing (claim 5).
• No formulation constraints: avoids common design-around routes that swap routes/dosage forms while retaining the active ingredient.

Potential vulnerability factors (relative, not asserting invalidity)

• “consisting essentially of” can invite arguments about whether additional steps materially change the basic and novel characteristics of the method. These disputes are highly fact-dependent.
• “effective amount” and “enhancing motor neurons” rely on functional interpretation. Claim construction may scrutinize how “enhancing” is proven and what constitutes “effective.”

These are standard litigation variables. A definitive strength rating requires the patent’s prosecution history, specification support, and claim construction outcomes, none of which are included in your prompt.

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What generic entry risks exist if a product uses the same active ingredient for ALS or other motor neuron indications?

A generic entry risk assessment depends on whether the generic:

• uses the same compound (including physiologically acceptable salts),
• is marketed and prescribed for motor neuron diseases and/or the listed indications, and
• is used in a manner that satisfies “treating,” “enhancing,” and “delaying progression” elements.

Without Orange Book status and without the product labeling, the risk cannot be quantified to a defensible launch scenario.

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Key Takeaways

• US 6,933,310 claims a method-of-treatment centered on administering 3-methyl-1-phenyl-2-pyrazoline-5-one or physiologically acceptable salts for motor neuron diseases.
• Claim 1 is the broadest: motor neuron disease treatment by administration of the compound at an “effective amount.”
• Claim 2 adds a progression-delay outcome, strengthening enforcement when disease-course endpoints are used.
• Claims 3 and 4 specify major clinical indications, with ALS singled out in claim 4.
• Claim 5 captures alternative framing as “enhancing motor neurons,” which can map to functional or neurobiologic benefit endpoints.
• The claims focus on use/administration, not on dose, route, or formulation, creating design-around difficulty for competitors who keep the same active and indication.

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FAQs

1) Do these claims cover combination therapy with standard ALS drugs?
The “consisting essentially of” language can still permit additional elements if they do not materially change the method’s basic and novel characteristics, but the exact result depends on claim construction and the accused method’s particulars.

2) If a competitor uses a different salt form, does it avoid infringement?
Not necessarily. The claims expressly include “physiologically acceptable salts,” so salt substitution is not automatically a workaround.

3) Are endpoints required for infringement under claims 1 and 4?
Claim 1 requires “treating” and claim 4 targets ALS treatment, while claim 2 specifically requires “delaying progress.” Proof often turns on how “treating” is established and how the accused method is intended/used in practice.

4) Do these claims protect manufacturing processes?
Based on your provided claim text, the protection is method-of-use. Manufacturing is not recited in the claims you listed.

5) Can a company avoid infringement by not labeling for ALS?
Avoiding “intended use” evidence can help, but method-of-use exposure can still arise from actual prescribing and use patterns. Liability theories depend on the record of how the product is used.

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References

1. United States Patent 6,933,310.

Drugs Protected by US Patent 6,933,310

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

Foreign Priority and PCT Information for Patent: 6,933,310

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Japan	2000-324476	Oct 24, 2000

PCT Information
PCT Filed	November 13, 2000	PCT Application Number:	PCT/JP00/07994
PCT Publication Date:	May 02, 2002	PCT Publication Number:	WO02/34264

International Family Members for US Patent 6,933,310

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	303808
Germany	60022560
European Patent Office	1405637
Spain	2248144
Japan	3758164