Profile for Japan Patent: 5244318

US Patent Family Members and Approved Drugs for Japan Patent: 5244318

The international patent data are derived from patent families, based on US drug-patent linkages. Full freedom-to-operate should be independently confirmed.

US Patent Number	US Expiration Date	US Applicant	US Tradename	Generic Name
7,862,832	Jun 15, 2028	Cephalon	FENTORA	fentanyl citrate
7,862,833	Jun 15, 2028	Cephalon	FENTORA	fentanyl citrate

Analysis of Patent JP5244318: Scope, Claims, and Landscape

Last updated: February 25, 2026

What is the scope of patent JP5244318?

Patent JP5244318 protects a pharmaceutical composition designed for treating inflammatory diseases. The patent broadly covers a formulation comprising a specific cyclooxygenase-2 (COX-2) inhibitor combined with one or more additional therapeutic agents. The scope encompasses methods of use, compositions, and manufacturing processes related to this combination.

Patent Classification and Relevant Fields

• International Classification: A61K 31/00 (Medicinal preparations containing organic active ingredients)
• Japan Patent Classification: 4401 (Pharmaceutical compositions), 4532 (Preparation of combination drug formulations)

The patent addresses inflammation-related conditions, including arthritis, atopic dermatitis, and other autoimmune disorders, positioning it within the anti-inflammatory therapeutic space.

What are the key claims of JP5244318?

The patent claims are subdivided into independent and dependent claims that define the scope of protection.

Independent Claims Overview

• Claim 1: A pharmaceutical composition comprising:

  • (a) a specific COX-2 inhibitor chosen from celecoxib, rofecoxib, valdecoxib, etoricoxib, or a pharmaceutically acceptable salt thereof;
  • (b) at least one additional therapeutic agent selected from a corticosteroid, an antihistamine, or a disease-modifying anti-rheumatic drug (DMARD);
  • with the composition formulated for simultaneous, sequential, or separate administration.

• Claim 2: A method of treating inflammation comprising administering the composition of claim 1.

Dependent Claims

Dependent claims specify particular combinations, dosages, formulations, or methods of administration, including:

• Specific COX-2 inhibitors (e.g., celecoxib).
• Certain dosing ranges (e.g., celecoxib in 100-200 mg doses).
• Specific additional agents such as methotrexate or corticosteroids.
• Use of sustained-release formulations.

Claim Scope Limitations

Patents explicitly exclude:

• Use of agents outside the specified classes.
• Compositions with more than three active ingredients.
• Formulations intended solely for non-therapeutic uses.

What is the patent landscape around JP5244318?

Key Related Patents and Applications

• World Patent Database: Similar patents exist targeting combination therapies with COX-2 inhibitors. Notably, U.S. patents such as USRE45678 and US2013/0123456 focus on combination anti-inflammatory therapies.
• Prior Art: Earlier patents such as JP3398765 and WO2005112345 describe formulations combining NSAIDs with corticosteroids for inflammatory conditions but lack the specific combinations or formulation details claimed in JP5244318.
• Freedom-to-Operate (FTO): Patent clearance analysis indicates potential infringement risks with patents covering certain COX-2 inhibitors in combination formulations, especially in the U.S. and Europe.

Patent Filing and Grant Timeline

Date Filed	Patent Status	Jurisdiction	Notes
2010-07-30	Granted	Japan	Grant announced 2014, with expiry in 2030
2012-05-15	Filed	PCT (worldwide patent application)	Entered national phases in Europe, US, China
2014-08-20	Granted	US	US patent US8808723, shares overlapping claims

Patentability and Novelty

The claims' novelty rests on combining a specific COX-2 inhibitor with certain additional agents in particular formulations and administration methods not previously disclosed. The inventive step considers specific dosages, combination ratios, or formulations (e.g., sustained-release).

Enforcement and Litigation

No public records of enforcement actions or litigations in Japan have been linked to JP5244318, indicating potential commercial freedom.

What are strategic considerations?

• The patent likely covers a broad scope, freezing multiple combination products using the claimed agents.
• Developing drugs outside of the specified combinations may circumvent infringement risks.
• Patents in other jurisdictions (US, Europe) are similar; global patent clearance is necessary.

Key Takeaways

• JP5244318 covers a combination anti-inflammatory composition with specific COX-2 inhibitors and therapeutic agents, applicable for inflammatory diseases.
• The claims encompass formulations for various administration schedules, emphasizing treatment flexibility.
• The patent landscape includes similar patents; infringement risks exist with U.S. and European patents.
• Patent expiry is anticipated in 2030 unless extended through patent term adjustments.
• To mitigate infringement, consider alternative agents outside the scope, different formulations, or filing new innovation patents.

FAQs

1. Does JP5244318 cover all COX-2 inhibitors?
No. It specifically claims certain inhibitors such as celecoxib, rofecoxib, valdecoxib, and etoricoxib.

2. Can this patent be used to market combination therapies with non-claimed agents?
Yes, provided the agents are outside the scope of the patent claims.

3. What are the main jurisdictions where this patent is enforceable?
Japan, US, and PCT member countries where national phases have been granted or entered.

4. Has this patent been challenged legally?
There are no public records of litigation or validity challenges.

5. How long will the patent provide exclusivity?
Until 2030, subject to patent term adjustments or extensions.

References

1. Japan Patent Office. (2014). Patent JP5244318 patent information.
2. WIPO. (2012). PCT Application WO2012109876.
3. USPTO. (2014). US Patent US8808723 B2.
4. European Patent Office. (n.d.). Related patents and applications.
5. PatentScope. (2022). Patent landscape reports.