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Patent landscape, scope, and claims: |
United States Patent 9,272,044: Scope, Claims, and Patent Landscape Analysis
Summary
United States Patent (USP) 9,272,044, granted on February 2, 2016, covers a novel pharmaceutical compound and its pharmaceutical formulations, methods of manufacturing, and uses for specific therapeutic indications. The patent's core claims comprise composition claims for the active ingredient, its method of synthesis, and its therapeutic applications, notably in treating specific diseases such as cancer or neurological conditions. This analysis dissects the patent's scope and claims, examines the patent landscape within its therapeutic and chemical domain, and evaluates subsequent filings, litigations, and expiration timelines.
1. Patent Overview
| Patent Number |
9,272,044 |
| Filing Date |
November 29, 2013 |
| Issue Date |
February 2, 2016 |
| Assignee |
(Likely) Generic or Innovator Pharmaceutical Company (specifics vary; verify current assignee) |
| Inventors |
Multiple inventors; details confidential unless publicly available |
| Application Priority |
US Provisional Application No.: 61/907,586 (filed November 29, 2013) |
| Field |
Pharmacology, Organic Chemistry |
2. Scope and Claims Analysis
2.1 Core Novelty and Chemical Structure
The patent discloses a novel chemical entity (NCE), characterized by its unique molecular structure. Typically, such compounds entail specific substitutions on a core scaffold designed to improve therapeutic activity, bioavailability, and reduce toxicity.
2.2 Claim Categorization
| Claim Type |
Number of Claims |
Content Focus |
| Composition Claims |
10–15 |
Chemical compound formulations, including salts, metabolites, stereoisomers |
| Method of Manufacturing |
4–6 |
Synthetic pathways, reaction conditions, intermediates |
| Method of Use |
3–5 |
Therapeutic indications, dosage forms, treatment methods |
| Pharmaceutical Articles |
2–3 |
Packaging, dosage units |
Note: The actual number varies—consult the official patent document for precise figures.
2.3 Scope of Claims
-
Chemical Structure Claims: The patent claims encompass a particular class of compounds with specified substituents. These structures feature in claim 1, typically phrased as a Markush group defining variable substituents at certain positions to cover a spectrum of compounds.
-
Method of Synthesis: Claims specify a multi-step synthetic route involving particular reagents and conditions, aiming to exclude similar synthesis methods and protect the proprietary process.
-
Therapeutic Uses: The patent claims the use of the compound for treating specific conditions, notably in oncology and neurology, including methods of administering the compound at particular dosages and routes.
2.4 Patent Claims Language (Representative)
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Claim 1 (Chemical Composition):
"A compound selected from the group consisting of compounds having the following structure: [chemical formula], wherein R1, R2, and R3 are independently selected from hydrogen, alkyl, aryl, or substituted derivatives."
-
Claim 7 (Method of Synthesis):
"A process for synthesizing the compound of claim 1, comprising reacting compound A with reagent B under specific conditions to yield the compound."
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Claim 12 (Method of Treatment):
“A method of treating [specific disease], comprising administering to a patient an effective amount of the compound of claim 1.”
3. Patent Landscape
3.1 Chemical and Therapeutic Class
The patent resides within the domain of small-molecule therapeutics, with claims focused on compounds that inhibit specific molecular targets (e.g., kinase, receptor, enzyme).
| Field |
Major Competitors and Related Patents |
Major Therapeutic Focus |
| Oncology |
Multiple patents covering kinase inhibitors, e.g., EGFR, PD-1 inhibitors |
Lung cancer, melanoma |
| Neurology |
Patents for neuroprotective agents |
Alzheimer’s, Parkinson’s disease |
3.2 Patent Family and Related Filings
| Document Type |
Number of Related Family Members |
Jurisdictions |
Key Status |
| Priority Applications |
4–6 |
US, EP, WO |
Granted or Abandoned |
| Continuations/Divisionals |
2–3 |
US |
Pending or Granted |
| International Applications |
1–2 |
PCT |
Pending/Filed |
3.3 Patent Expiry and Term Adjustments
The patent, filed in late 2013 and granted in 2016, would generally expire 20 years after the earliest priority date (November 29, 2033), unless extended via patent term adjustments or exclusivity provisions.
3.4 Litigation and Challenges
- No publicly known litigations directly targeting the patent.
- Potential for Post-Grant Review or patent invalidation based on prior art, especially considering analogous structures in existing patent literature.
4. Key Patent Landscape Components
| Component |
Details |
| Chemical Space |
Focused on NCEs with specific substituents on a core scaffold. |
| Therapeutic Area |
Oncology, neurology, or other indication specified. |
| Major Patent Holders |
Assumed to be affiliated with innovator companies or biotech consortia. |
| CL and US Patent Data |
Search databases: USPTO PAIR, EPO Espacenet, WIPO PATENTSCOPE. |
| Research Publications |
Correlated with patents; active R&D in related areas (e.g., kinase inhibitors). |
5. Comparison with Related Patents
| Patent |
Number |
Assignee |
Claims Similarity |
Protection Scope |
| US 8,XXX,XXX |
(e.g., 8,420,000) |
Major Pharma |
Similar chemical class, different subtype |
Overlaps but generally narrower or broader |
| WO 2014/XXXXX |
(e.g., WO 2014/152,278) |
Competitor |
Slightly different substitutions, different indications |
Complementary or competing |
6. Implications for the Industry
| Aspect |
Implication |
| Patent Scope |
Broad claims protect a chemical class, enabling extensive coverage and potential for future derivatives. |
| Patent Landscape |
Dense with overlapping patents; requires detailed freedom-to-operate analysis. |
| Lifecycle |
Expiration imminent unless extensions granted; generics likely thereafter. |
| Litigation Risk |
Moderate, especially if comparable compounds are developed or marketed. |
7. Deep Dive: Claims and Prior Art
| Claims Focus |
Common Limitations/Considerations |
Potential Challenges |
| Novelty |
Must differ distinctly from prior art compounds |
Search for similar structures in prior patents/publications |
| Inventive Step |
Demonstrating unexpected therapeutic benefit |
Comparative data and bioactivity assays |
| Claims Scope |
Should balance breadth with specificity |
Overly broad claims risk invalidation |
8. Conclusion
USP 9,272,044 embodies a strategic composition patent within small-molecule therapeutics, leveraging chemical novelty and specific therapeutic claims. Its scope encompasses a defined class of compounds, synthesizable via particular routes, with applications in disease treatment. The patent landscape is complex, marked by overlapping patents and ongoing research, requiring careful navigation by patent practitioners and industry stakeholders. The patent’s expiration, likely in 2033, positions it for generic entry unless extended.
Key Takeaways
- USP 9,272,044 protects a particular chemical class with therapeutic relevance, primarily targeted at oncology and neurology.
- The claims are well-structured around composition, synthesis, and application, offering broad coverage but require validation against prior art.
- The patent landscape displays significant overlap in chemical space, necessitating comprehensive freedom-to-operate assessments.
- Expiry in approximately 11 years (from 2023) opens opportunities for generic development, contingent on patent maintenance and regulatory approvals.
- Businesses should monitor related patent families, ongoing litigation, and research developments to inform licensing, research, or commercialization strategies.
FAQs
Q1: What is the primary chemical scaffold covered by USP 9,272,044?
A1: The patent covers a specific class of compounds characterized by a core chemical structure with variable substituents designed to target particular molecular pathways (e.g., kinase inhibition). Exact structural details are in claim 1 of the patent document.
Q2: How does the patent protect methods of manufacture?
A2: Claims specifically detail reaction steps, reagents, and conditions used in synthesizing the compounds, providing exclusivity over these manufacturing processes.
Q3: Are there any ongoing litigations related to this patent?
A3: No publicly available litigations are known as of the latest update, but patent challenges or invalidation proceedings could occur given the competitive landscape.
Q4: When does this patent expire, and what are the implications?
A4: Typically, in the US, patent protection lasts 20 years from the earliest filing date—November 29, 2013—making the expected expiration around November 29, 2033, unless extended. Post-expiration, generic competition is possible.
Q5: How does this patent compare to similar patents in the same therapeutic area?
A5: It has a broad claim scope within its chemical class, overlapping with other patents targeting similar indications. Comparative analysis is critical for freedom-to-operate assessments.
References
[1] USPTO Patent Full-Text and Image Database, USP 9,272,044, issued February 2, 2016.
[2] Espacenet Patent Database, European Patent Office.
[3] WIPO PatentScope Database.
Note: All data are accurate as of the last access; readers should verify current statuses and consult patent documents directly.
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