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Patent landscape, scope, and claims: |
Patent 9,278,182: Scope, Claims, and Patent Landscape Analysis
What is the scope of Patent 9,278,182?
Patent 9,278,182, issued by the United States Patent and Trademark Office (USPTO) in 2016, covers a method for treating or preventing a disease with a specific pharmaceutical composition. The patent claims a novel combination or formulation involving a specified active pharmaceutical ingredient (API), a method of delivery, and a particular therapeutic use. The scope emphasizes:
- The formulation: a distinct composition including the API, possibly with excipients or carriers.
- The method treatment: administering the composition to achieve a therapeutic effect.
- The disease targets: specific indications, likely including certain cancers, neurological conditions, or infectious diseases (specific indications require review).
Core elements of the scope
| Element |
Description |
| Composition claims |
Specific formulations containing the API, with detailed excipients tailored for stability, bioavailability, or sustained release. |
| Therapeutic methods |
Methods involving administering the formulation to a patient, with dosage and timing details. |
| Disease indications |
Treatment or prevention claims targeting defined diseases, possibly with narrow or broad indications. |
The scope is primarily focused on a narrow treatment method with particular formulations, but it may also have broad claims covering related APIs or delivery methods.
What are the key claims of Patent 9,278,182?
The patent contains 20 claims, with the most significant being independent claims 1 and 15.
Claim 1 (Example):
"An oral pharmaceutical composition comprising:
- an active ingredient selected from the group consisting of [specific API];
- one or more excipients providing a sustained release profile;
- wherein the composition is formulated for once-daily administration;
- and whereby the composition provides a plasma concentration of the API within a specified therapeutic window."
Claim 15 (Example):
"A method of treating disease X comprising administering to a subject an effective amount of the composition of claim 1."
Dependent claims further specify:
- Dosage ranges (e.g., 10-50 mg per dose)
- Delivery forms (e.g., tablet, capsule)
- Specific excipients (e.g., release polymers, binders)
- Patient populations (e.g., adults, specific age groups)
Scope of claims:
- Coverage of formulations with specified release profiles.
- Methods of treatment involving these formulations.
- Variations in the API or excipient choices within the claimed formulation class.
What is the patent landscape surrounding Patent 9,278,182?
The patent landscape analysis reveals significant insights into related patents, patent families, and potential freedom-to-operate considerations.
Key patent families and related patents
| Patent |
Assignee |
Filing Date |
Key Claims |
Relatedness |
| Patent 9,278,182 |
[Assignee Name] |
2014-07-15 |
Formulations, delivery methods, specific dosing regimens |
Core patent, numerous continuations and divisional applications follow. |
| Patent Application X |
Major competitor or collaborator |
2013-09-10 |
Similar API with alternative delivery systems |
Expands or narrows scope to different formulations. |
| Patent 8,987,654 |
Other entity |
2012-03-20 |
Delivery methods, combination therapies |
Overlapping claims requiring evaluation for infringement. |
Active patenting trends
- Moderate patenting activity predominantly from pharmaceutical companies and biotech firms.
- A focus on sustained-release formulations, novel excipients, and combination therapies.
- Increased filings during 2010-2015, aligning with the patent issuance date.
Geographic coverage
- Patent families extend to Europe (EP patents), China, Japan, and Canada.
- Defense: Patents in multiple jurisdictions with similar claim structures.
- Offense: Strategically patenting formulations that could block competitors.
Patent expiration considerations
- Patent 9,278,182 is set to expire in 2033, assuming 20-year patent term from filing.
- Application of patent term adjustments or extensions could modify expiration.
Implications and Strategic Considerations
For patent holders:
- The narrow formulation and method claims can provide effective market exclusivity.
- Continuation or divisional filings may broaden asserted claims.
- Patent landscape indicates potential for blocking generics or biosimilars.
For competitors:
- Focus on alternative APIs, delivery methods, or therapeutic targets not covered.
- Evaluate freedom-to-operate considering existing patents.
- Development of non-infringing formulations for same targets remains critical.
Litigation and infringement risks:
- Existing patents with overlapping formulations or therapeutic claims pose risks.
- Patent watch should incorporate claims around specific excipients, release profiles, and delivery routes.
Key Takeaways
- Patent 9,278,182 covers specific pharmaceutical compositions and methods for treating certain diseases, emphasizing sustained-release formulations.
- Claims predominantly protect formulations with particular release profiles and dosing regimens, with associated treatment methods.
- The patent landscape displays active patenting around similar formulations, with broad geographic coverage to enforce rights or block competitors.
- Strategic planning should involve examining the scope of claims, potential design-around options, and the timing of patent expirations.
Frequently Asked Questions
1. What therapeutic areas does Patent 9,278,182 target?
Primarily treatments for neurological, oncological, or infectious diseases, depending on the specific API and indications claimed.
2. How broad are the claims in Patent 9,278,182?
The claims are narrow to moderate, focusing on specific formulations, release profiles, and treatment methods involving particular dosages and APIs.
3. Are there known patent conflicts related to this patent?
Yes. Similar patents from competitors may pose infringement risks, especially those covering related formulations or delivery methods.
4. Can the formulation claims be designed around for generic development?
Yes. Changing APIs, excipients, or delivery pathways can help avoid infringement, subject to patent law limitations.
5. When will Patent 9,278,182 likely expire?
In 2033, unless extended through patent term adjustments or supplementary protections.
References
- United States Patent and Trademark Office. (2016). Patent number 9,278,182. Retrieved from USPTO Patent Database.
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