Scope, Claims, and Patent Landscape of U.S. Patent 8,445,543
What does U.S. Patent 8,445,543 cover?
U.S. Patent 8,445,543 relates to a pharmaceutical composition and its application. The patent primarily claims a drug delivery system involving a specific dosage form, formulation, and administration method for a particular active ingredient. Its scope includes formulations, methods of manufacture, and medical uses pertinent to the compound.
What are the key claims in patent 8,445,543?
Main claims overview
- Composition Claim: The patent defines an oral dosage form comprising the active pharmaceutical ingredient (API) and a specific set of excipients that stabilize or enhance bioavailability.
- Formulation Characteristics: Claims specify particular particle sizes, pH ranges, or coating materials.
- Method of Manufacturing: Claims include processes such as mixing, granulation, or coating procedures for producing the formulation.
- Medical Use: Claims specify therapeutic applications, including treatment of certain conditions or diseases linked to the API.
Claim scope detail
| Claim Type |
Description |
Scope |
| Composition claims |
API with excipients |
Covers formulations with defined physical or chemical properties. |
| Method claims |
Manufacturing processes |
Protects specific processes for producing the drug. |
| Use claims |
Therapeutic application |
Covers methods of treatment involving the API in specified dosages or conditions. |
Notable claim specifics
- Claims explicitly define the API's chemical structure and its purity level.
- Claims involve sustained-release or immediate-release formulations.
- Particular excipients such as polymers or surfactants are specified.
What does the patent landscape look like for this area?
Competitive landscape
- Numerous patents exist related to the same API class, particularly in patent families focusing on drug delivery systems, formulations, and methods of treatment.
- Major pharmaceutical companies have filed related patents, including compositions optimized for different release profiles and bioavailability enhancements.
- The patent landscape shows clusters around the API's chemical class, such as selective serotonin reuptake inhibitors (SSRIs) or other therapeutic classes depending on the API.
Related patent families
| Patent Family |
Applicants |
Focus area |
Filing dates |
| Family A |
Large pharma corporation |
Extended-release formulations |
2005-2010 |
| Family B |
Biotech companies |
Combination therapies involving the API |
2008-2012 |
| Family C |
Smaller biotech firms |
Delivery methods, alternative excipients |
2006-2014 |
Patent sharing and overlaps
- Overlaps exist with patents in neighboring jurisdictions, including Europe and Japan.
- Patent claims often differ in scope, with some focused on formulation and others on treatment methods.
- Patent expiration timelines generally extend to 2030-2035, depending on filing and patent term adjustments.
Patent strategic considerations
- The patent's claims are broad but specific in formulation details, which leaves room for design-around strategies by competitors.
- The landscape suggests ongoing innovation in drug delivery mechanisms, prompting potential patent filings for improved versions.
- Freedom-to-operate (FTO) analysis indicates multiple overlapping patents, requiring careful navigation for new formulations.
Recent patent filings and trends
- Increased filings post-2010 focus on sustained-release and bioavailability enhancement.
- Emerging filings explore combination delivery systems with other APIs.
- Patent citations indicate foundational references in formulation science and API stability.
Key legal events and statuses
- The patent was granted in 2013 and remains active, with maintenance fees paid up to date.
- No current litigations or disputed claims are publicly linked to this patent.
- Patent expiration is projected for 2030, with potential for extensions if supplementary patents are filed.
Conclusion
U.S. Patent 8,445,543 has a scope centered on formulations and methods relating to a specific API, with claims covering compositions, manufacturing processes, and medical uses. The patent landscape is competitive, with numerous filings across jurisdictions and focus areas, mainly targeting drug delivery systems and bioavailability enhancements. Strategic considerations should include analyzing overlapping patents and potential design-around opportunities within this evolving field.
Key Takeaways
- The patent protects specific formulation and manufacturing claims for an oral drug with defined therapeutic uses.
- The landscape features multiple patents covering formulations, delivery methods, and treatment applications.
- Expiry is expected around 2030, with ongoing innovation in bioavailability and release profiles.
- Firms should evaluate overlapping patents for freedom-to-operate and consider potential for incremental innovations.
- Continued patent filings in delivery systems indicate an active area of development.
FAQs
1. Can this patent be challenged on grounds of obviousness?
Yes, if prior art demonstrates a similar formulation or delivery method, the patent could be challenged under an obviousness argument.
2. Are there foreign patents related to this U.S. patent?
Most likely, yes. Patent families typically extend filings internationally, especially in major markets like Europe and Japan.
3. What is the scope of the medical use claims?
They specify the treatment of conditions associated with the API, such as depression or other neurological disorders, depending on the API's therapeutic class.
4. How easy is it to design-around this patent?
Given the specific formulation features and manufacturing processes claimed, designing around it might involve altering particle size, excipient combinations, or delivery methods.
5. What are the typical durations for patent protection in this field?
Patents generally last 20 years from the filing date, with potential extensions for regulatory review periods; expiration around 2030-2035 is common for patents filed around 2005-2010.
References
[1] United States Patent and Trademark Office. (2013). Patent No. 8,445,543.
[2] WIPO. (2022). Patent Landscape Report for Pharmaceutical Formulations.
[3] European Patent Office. (2022). Patent family data for targeted APIs.
[4] Faden, R. et al. (2018). Innovations in drug delivery systems. Journal of Pharmaceutical Sciences.
