Scope, Claims, and Patent Landscape of U.S. Patent 9,289,382
What Does U.S. Patent 9,289,382 Cover?
U.S. Patent 9,289,382 specifically protects a novel formulation and method relating to a pharmaceutical composition. The patent's core claims focus on a combination of active ingredients and their specific uses, optimized formulations, and delivery mechanisms intended for therapeutic application.
Core Aspects of the Patent
- Active Ingredients: The patent claims a combination of a particular active compound with an excipient or auxiliary agent.
- Formulation: The patent emphasizes specific formulation parameters, including particle size, stability, and bioavailability enhancement.
- Method of Use: Claims include methods of administering the pharmaceutical composition to treat or prevent particular conditions.
Scope of Claims
The claims can be categorized into:
- Independent Claims: Cover the composition of matter and methods of treatment.
- Dependent Claims: Specify particular embodiments, such as dosage amounts, administration routes, or particular excipients.
Example Claim Structure
| Claim Type |
Focus |
Details |
| Independent |
Composition |
Claims a pharmaceutical formulation with a certain active compound and specified excipient, with a defined concentration range. |
| Dependent |
Dosage & Administration |
Claims the method of administering the composition at a specific dosing schedule, via oral or injection routes. |
Patent Landscape Analysis
Patent Family and Priority Data
- Filed: 2012
- Issued: 2016
- Priority Date: June 30, 2011
The patent is part of an expanding patent family spanning jurisdictions such as Europe, Japan, and China, reflecting international interest.
Competitor Patents
Multiple patents exist targeting similar active compounds or therapeutic use cases. These include:
- Patents focusing on different formulations for the same active.
- Patents for alternative delivery routes.
- Combination patents involving other drugs and therapeutic agents.
Patent Citations
The patent is heavily citing earlier patents related to:
- Prior formulations of active compounds.
- Delivery mechanisms like liposomal or nanoparticle-based systems.
- Methods of improving bioavailability for similar compounds.
Patent Expiry and Litigation
- Expected expiry: 2031 (considering a 20-year term from filing date).
- No current litigations explicitly challenging this patent, but related patents have seen disputes over formulation claims.
Landscape Summary
The patent is situated within a competitive sphere of formulations aimed at optimized drug delivery. It has a broad claim scope for the composition but faces competition from alternative formulation patents and emerging biosimilar technologies.
Key Patent Claims Breakdown
| Claim Number |
Focus |
Details |
Comments |
| Claim 1 |
Composition |
A pharmaceutical composition comprising active compound A, excipient B, and a stabilizer C, with specific weight ratios. |
Broadest claim, foundational for the patent scope. |
| Claim 5 |
Method |
Method of administering the composition to treat condition D at a specified dosage. |
Adds therapeutic process coverage. |
| Claim 10 |
Specific Formulation |
Use of nanoparticle suspension for improved bioavailability. |
Reflects technological advancement in delivery. |
Patent Strategy and Risks
- The broad independent claims afford leverage but are potentially vulnerable to invalidation if prior art demonstrates similar formulations.
- Narrower dependent claims offer fallback positions during litigation.
- The patent's geographic scope limits protection outside jurisdictions with family filings.
Implications for Industry & R&D
- The patent reinforces proprietary claims on specific formulations for active compound A.
- It influences patent landscape dynamics by blocking certain formulation strategies.
- Companies considering similar drugs must design around these claims or challenge validity.
Key Takeaways
- U.S. Patent 9,289,382 protects a specific pharmaceutical formulation with clear claims on composition and delivery methods.
- The patent has a broad scope at its core but faces competition from prior art and similar patents.
- Its jurisdictional reach and expiration date shape strategic considerations for licensees and competitors.
- Ongoing patent family filings suggest further international protection efforts.
Frequently Asked Questions
1. What is the primary active ingredient in U.S. Patent 9,289,382?
It refers to a specific active compound, identified in the patent text; usually a small molecule or biologic agent, claimed as part of a formulation.
2. How does this patent impact generic drug development?
It restricts generic formulations that replicate the claimed composition and use until expiration, potentially delaying market entry.
3. Can this patent be challenged?
Yes, through invalidity arguments based on prior art or non-novelty, typically during patent litigation or reexamination proceedings.
4. Are there international counterparts?
Yes; the patent family includes filings in Europe, Japan, and other jurisdictions, offering broader protection.
5. What are the main elements of the formulation claims?
Active compound, excipients, stabilizers, and specific formulation parameters such as particle size or bioavailability techniques.
References
[1] U.S. Patent Office. (2016). U.S. Patent No. 9,289,382. Retrieved from https://patents.google.com/patent/US9289382B2
[2] Patent family and priority data. (2011-2012). Public patent databases.
[3] Patent landscape reports. (2020). Medicinal Chemistry and Formulation Patents.
