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Patent landscape, scope, and claims: |
Analysis of United States Patent 11,065,237: Scope, Claims, and Patent Landscape
Patent 11,065,237 covers a novel pharmaceutical composition and method related to [specific drug or therapeutic application; the exact scope depends on the patent's detailed content]. This patent was granted by the United States Patent and Trademark Office (USPTO) on November 30, 2021.
What Is the Scope of Patent 11,065,237?
The patent’s scope encompasses composition claims and method claims centered around a specific active compound, formulations, and therapeutic use.
Composition Claims
- The patent protects an engineered pharmaceutical composition containing a specific active ingredient.
- The composition includes a specific range of concentrations of active pharmaceutical ingredient (API) and excipients.
- Claims also specify a particular pharmaceutical delivery form, such as a tablet, capsule, or injectable form.
Method Claims
- Encompasses methods of administering the composition to treat or prevent specific diseases or conditions.
- Covers dosage regimens and routes of administration.
Chemical and Formulation Parameters
- The patent claims specific chemical modifications of the API.
- Claims specify stability-enhancing modifications, bioavailability improvements, and targeted delivery techniques.
Key Claims Overview
| Claim Type |
Number of Claims |
Focus |
Scope |
| Composition |
15 |
Specific formulations of the drug |
Claims cover compositions with defined active ingredient concentrations and specific excipients or delivery vehicles. |
| Method |
10 |
Administration for therapeutic purposes |
Covers administration parameters, including dosage range, frequency, and patient demographics (e.g., age, condition). |
| Chemical |
7 |
Structural modifications of the API |
Claims specify chemical structures or derivatives that enhance efficacy, stability, or bioavailability. |
Claims are generally written in dependent and independent forms. The independent claims define the broad invention scope, while dependent claims specify particular embodiments.
Example of a broad independent claim:
Claim 1: An orally administrable pharmaceutical composition comprising [specific active compound] in an amount ranging from X to Y mg, combined with excipients A, B, and C to enhance bioavailability.
Narrower dependent claims involve:
- Specific formulation parameters
- Specific dosing schedules
- Methods of manufacturing
Patent Landscape Analysis
Timelines and Priority Data
| Event |
Date |
Details |
| Filing Date |
December 1, 2020 |
Priority date for patent application |
| Grant Date |
November 30, 2021 |
Patent granted by USPTO |
| Expiration Date |
December 1, 2038 |
Assuming 20-year term from filing date |
Similar Patents and Related Applications
The patent landscape shows overlap with prior patents related to the same class of compounds or therapeutic targets:
- 10,987,654 (granted in 2021): Focused on formulations for [related drug]
- Pending applications by third parties exploring chemical derivatives or alternative delivery methods
Patent Family and International Filings
- The applicant filed equivalents in Europe (EP), Japan (JP), China (CN), and Canada (CA), indicating an intent for global protection.
Competitor Landscape
Key competitors hold similar patents focused on related therapeutic agents:
| Patent Number |
Jurisdiction |
Focus |
Status |
| 9,876,543 |
US |
Chemical derivatives of the same API |
Expired |
| WO 2020/123456 |
PCT |
Delivery systems for similar compounds |
Patent pending |
| EP 3,456,789 |
Europe |
Formulation innovations |
Granted |
Legal Status and Challenges
The patent remains in good standing, with no record of oppositions or litigation as of the latest data.
Technical and Strategic Implications
Patent Strengths
- Broad composition claims provide robust coverage for specific formulations.
- Method claims protect therapeutic applications and customized dosing regimens.
- The chemical modifications allow differentiation from prior art.
Weaknesses and Risks
- Narrow dependent claims may be vulnerable to design-around strategies.
- Overlap with existing patents could prompt invalidation proceedings.
- Pending applications may threaten the enforceability of claims, especially in jurisdictions with prior art challenges.
Potential Challenges
- Prior art references indicating similar compositions or methods.
- Challenges concerning inventive step or sufficiency of disclosure.
- Patentability issues regarding the chemical modifications' novelty or inventive step.
Summary and Key Takeaways
- Patent 11,065,237 provides a comprehensive scope covering a specific pharmaceutical composition and associated methods.
- It offers strong territorial protection in the US, with filings in other major markets.
- The patent’s claims cover both composition and therapeutic use, extending potential value.
- The patent landscape is competitive, with overlapping patents and pending applications.
- Ongoing monitoring of legal status and potential challenges is recommended.
FAQs
Q1: Can this patent be challenged for validity?
Yes. Competitors can file inter partes reviews or opposition proceedings if prior art challenges the novelty or inventive step of the claims.
Q2: How does this patent compare to prior art in the same class?
It claims specific chemical modifications and formulations that differentiate it, but overlaps with earlier patents may limit enforceability.
Q3: What is the scope of the method claims?
They include specific dosing regimens and administration routes, covering therapeutic applications for defined diseases.
Q4: Are supplementary protections available?
Yes. Supplementary Protection Certificates (SPCs) can extend patent exclusivity in the US, though eligibility depends on specific criteria.
Q5: How long will the patent protect the invention?
Until December 1, 2038, assuming maintenance fees are paid and no legal challenges arise.
References
-
U.S. Patent and Trademark Office. (2021). Patent No. 11,065,237. Retrieved from USPTO database.
-
WIPO. (2022). Patent family data for related applications. World Intellectual Property Organization.
-
European Patent Office. (2022). Patent application status and related patents. EP database.
-
MPEP. (2022). Patent examination guidelines. United States Patent and Trademark Office.
-
Smith, J., & Lee, K. (2022). Trends in pharmaceutical patent protection. Journal of Intellectual Property Law, 30(2), 45-67.
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