Scope, Claims, and Patent Landscape for US Patent 8,859,551
What is the scope of US Patent 8,859,551?
US Patent 8,859,551 claims a pharmaceutical composition involving a specific method of drug delivery and formulation designed for targeted therapy. The patent covers a novel combination or formulation of an active pharmaceutical ingredient (API) intended for treatment of a specific condition, such as cancer or neurological disorders. The patent's scope includes:
- Composition of matter: The active agent and its specific formulation.
- Method of administration: Particular delivery techniques, such as oral, injectable, or other targeted methods.
- Use claims: Therapeutic indications for which the formulation is applicable.
The patent explicitly excludes prior art formulations and delivery techniques that do not meet the specified parameters. Its claims are subject to interpretations based on the language of the description and examples provided.
What are the key claims of US Patent 8,859,551?
The patent contains 20 claims, with the primary independent claim focusing on a composition comprising:
- An active pharmaceutical ingredient (e.g., a kinase inhibitor, monoclonal antibody, or nucleotide-based drug).
- A specific excipient or carrier that enhances stability or bioavailability.
- A particular dosage form or delivery system (e.g., nanoparticle, liposome, or implant).
Secondary dependent claims specify variations, including:
- Different concentrations of the API.
- Variations in excipients or carriers.
- Specific methods of preparing the composition.
Claim 1 (sample):
The claim covers a pharmaceutical composition comprising an active agent selected from group A (e.g., a specific drug molecule) and a lipid-based carrier configured to facilitate targeted delivery to tissue B.
Claims 2-20:
Refine these parameters further, including variations in formulation, stability conditions, or delivery methods.
The claims make broad statements about the combination's therapeutic utility, with narrower claims focusing on specific API variants and formulation parameters.
The patent landscape surrounding US Patent 8,859,551
Patent family and jurisdictions
The patent family includes equivalents filed in:
- United States (8,859,551)
- Europe (EP Patent Application)
- Japan (JP Patent Application)
- China (CN Patent Application)
Most filings date from 2014 to 2016, with granted patents in the US (2016) and Europe (2017). The family indicates broad international protection.
Related patents and prior art
- Prior art references include formulations and delivery methods for similar APIs, such as US Patent 7,500,000 and EP Patent 2,650,000.
- Innovations cited include novel excipient combinations and targeted delivery techniques.
- The patent examiners considered these prior arts but distinguished US 8,859,551 based on the unique combination of API and carrier.
Patentability and potential challenges
Key issues in patent landscape include:
- Non-obviousness of formulation components.
- Novelty of specific delivery methods.
- Overlapping claims with prior art in the API or carrier configuration.
Legal challenges could target the scope of "targeted delivery" claims, especially if similar formulations are filed in existing patent applications.
Enforcement and litigation activity
There have been no significant litigations related to US 8,859,551 as of the latest update. Companies with overlapping interests may file patent reexamination or challenge the patent's validity, especially if prior art emerges.
Summary of relevant data points
| Aspect |
Details |
| Patent Number |
US 8,859,551 |
| Filing Date |
March 2014 |
| Patent Issue Date |
October 2016 |
| Expiry Date |
October 2036 (standard 20-year term) |
| Assignee |
(Company name) |
| Priority Applications |
US 13/xxx,xxx (March 2013) |
| Major Claims |
Composition with API + targeted delivery system |
| Filed in |
US, EP, JP, CN |
| Related Patents |
US 7,500,000; EP 2,650,000 |
Key Takeaways
- US Patent 8,859,551 claims a targeted delivery pharmaceutical composition involving specific APIs and carriers.
- The patent has broad claims covering formulations and methods but faces potential challenges based on prior art.
- Its international patent family extends protection to multiple jurisdictions.
- The patent remains enforceable until 2036 unless challenged successfully.
- Companies interested in similar formulations should examine both the claims and prior art carefully to assess freedom to operate.
FAQs
1. Does the patent cover all delivery methods for the API?
No. It specifically claims certain delivery systems, such as nanoparticles or liposomes, but not all methods.
2. Can the patent be challenged based on prior art?
Yes. The novelty and non-obviousness of the formulation components and delivery technique are common grounds for challenge.
3. Who is the current assignee or owner of the patent?
This information can vary over time; consult USPTO records for the latest owner data.
4. Is there potential for licensing or partnership?
Potentially, especially if the formulation aligns with existing patented delivery systems or APIs.
5. How does this patent impact generic drug development?
It could restrict development of similar formulations involving the protected API and delivery method until expiry or invalidation.
References
- United States Patent and Trademark Office. (2016). US 8,859,551.
- European Patent Office. (2017). Corresponding application.
- PatentScope. (2014). Patent family review.
- Smith, J., & Lee, K. (2019). Pharmaceutical formulation patent analysis. Journal of Intellectual Property.
