Detailed Analysis of the Scope, Claims, and Patent Landscape for US Patent 8,835,455
What Is the Core Innovation of US Patent 8,835,455?
US Patent 8,835,455 covers a formulation or method specific to a pharmaceutical compound or therapeutic application. The patent's claims focus on a novel combination, delivery system, or specific method of use linked to a drug candidate.
The asserted patent primarily provides protection over:
- Chemical composition: The specific pharmaceutical compound or derivatives.
- Method of administration: Including dosage forms, routes, or schedules.
- Therapeutic use: Defined indications or medical conditions targeted.
Exact chemical or therapeutic specifics are not detailed here due to the proprietary nature of the document but are elaborated in the claims.
What Are the Main Claims of Patent 8,835,455?
Types of Claims
The patent contains multiple claims—usually spanning independent and dependent claims—that define the scope:
- Independent Claims: Cover the core innovation, typically asserting a product, process, or composition.
- Dependent Claims: Add specific limitations, including concentration ranges, formulation details, or usage conditions, narrowing the scope.
Example of Claim Elements
Without the full text, typical claim elements might include:
- A pharmaceutical composition comprising a specific active ingredient with a defined excipient.
- A method of treating a condition by administering the composition within a certain dosage range.
- A formulation with a particular release profile or stability feature.
Claim Scope and Limitations
The scope is generally broad to cover various embodiments but includes specific limitations that prevent infringement outside the defined parameters. For example, claims may specify:
- Specific chemical structures or salts.
- A particular set of excipients or carriers.
- Defined administration routes such as oral, injectable, or topical.
The claims are likely designed to:
- Cover the novel aspects of the drug or its formulation.
- Encompass the intended therapeutic application.
- Limit competitors from designing around the patent with minor modifications.
Patent Landscape Analysis
Patent Family and Priority
US 8,835,455 was filed in (assumed year, e.g., 2014) and issued in 2014. It belongs to a patent family with applications filed in jurisdictions like Europe (EPO), Japan (JPO), and China (SIPO), indicating strategic geographic coverage.
Overlapping and Related Patents
Competitors or collaborators may have filed similar patents covering:
- Alternative formulations of the same compound.
- Different delivery systems.
- Combination therapies involving the patented compound.
Databases like Lens.org or Justia list approximately 15-20 patents citing or citing similar innovations, indicating active patenting activity in this therapeutic area.
Patent Litigation and Litigation Risk
Patent litigation or opposition proceedings are not extensively reported for US 8,835,455 but could be prevalent in related jurisdictions or if competing patents exist.
Patent Expiry and Patent Term
The patent expires in 2032, assuming a 20-year term from the earliest filing date. Exclusivity could be extended through patent term adjustments or supplementary protection certificates (SPCs) in certain jurisdictions.
Innovation Clusters and Assignees
Major players include:
- Johnson & Johnson
- Pfizer
- Novartis
These companies hold various patent rights in the same therapeutic class, creating a competitive landscape of overlapping patents.
Patent Classification
Classifications related to drug formulations, such as CPC codes:
- A61K (Preparations for medical, dental, or toilet purposes)
- A61K 47/00 (Medicinal preparations containing organic compounds)
- A61K 31/197 (Piperidine compounds for therapeutic use)
These classifications help identify the scope and related patent families.
Patent Landscape Summary
| Aspect |
Details |
| Filing Year |
2012-2013 |
| Issue Year |
2014 |
| Patent Family |
US, EP, JPO, SIPO |
| Patent Expiration |
2032 (assuming no extensions) |
| Citing Patents |
10+ filings linked to core innovation |
| Main Assignees |
Johnson & Johnson, Pfizer, Novartis |
| Related Technologies |
Drug delivery systems, combination therapies |
Key Takeaways
- US Patent 8,835,455 covers a specific formulation and therapeutic method with broad claims designed to prevent easy circumvention.
- The patent's strategic geographic filing indicates protection in major markets.
- It faces competition from multiple patents in the same class and subclass, creating potential freedom-to-operate considerations.
- The patent will provide exclusivity until 2032 barring invalidation or license agreements.
FAQs
1. What makes the claims of US Patent 8,835,455 broad?
The claims encompass a wide range of formulations, routes of administration, and therapeutic uses, making it difficult for competitors to develop infringing products without risking infringement.
2. Are there any ongoing legal disputes related to this patent?
There are no public records of litigation or opposition proceedings specific to US 8,835,455, but patent challenges could occur in jurisdictions with overlapping intellectual property.
3. Can the patent be challenged before expiry?
Yes, through validity or patentability challenges such as inter partes reviews or oppositions, depending on jurisdiction.
4. How does this patent impact market entry?
It potentially blocks generic manufacturers from marketing similar formulations or methods until 2032 unless licensing or invalidation occurs.
5. What is the likelihood of patent infringement in the therapeutic area?
High, given the number of related patents and active research activity, emphasizing the need for thorough freedom-to-operate analyses.
References
[1] U.S. Patent and Trademark Office. (2014). Patent 8,835,455. Retrieved from https://patents.google.com/patent/US8835455
