Comprehensive Analysis of U.S. Patent 9,011,926: Scope, Claims, and Patent Landscape
Executive Summary
U.S. Patent No. 9,011,926, granted on April 21, 2015, to Johnson & Johnson (J&J), focuses on a novel class of pharmaceutical compounds designed for treating various diseases, notably related to modulating the immune response. This patent emphasizes a specific chemical scaffold, method of synthesis, and associated therapeutic indications.
This analysis delineates the scope of the patent's claims, evaluates their strength and breadth, maps the patent landscape surrounding this patent, and considers implications for competitors, research entities, and licensees. The review incorporates a detailed breakdown of Claims 1–20, categorizes patent family members, and assesses relevant prior art and subsequent patents to determine potential freedom-to-operate (FTO) concerns.
Patent Summary
| Attribute |
Details |
| Patent Number |
9,011,926 |
| Grant Date |
April 21, 2015 |
| Assignee |
Johnson & Johnson (J&J) |
| Application Filing Date |
September 28, 2012 |
| Priority Date |
September 28, 2011 ( provisional application) |
| Patent Family Members |
Multiple family members in EPC, PCT, and national filings |
| Focus Area |
Immunomodulatory compounds, synthetic methods, therapeutic uses |
Scope of the Patent: Overview of Claims
Claim 1: The Independent Claim
Claim 1, often the broadest, defines a class of heterocyclic compounds characterized by:
- A core structure based on 2,4-disubstituted pyrimidine derivatives
- Specific substitutions at key positions (e.g., R1, R2, R3)
- Additional features including specific functional groups or moieties
Claim 1 sets out the foundational chemical structure for compounds claimed safe, effective, and suitable for pharmaceutical compositions for immune modulation.
Claims 2–20: Dependent Claims
These specify particular embodiments, including:
- Variations of substituents (alkyl, aryl, heteroaryl groups)
- Specific stereochemistry
- Particular synthesis methods
- Therapeutic indications — e.g., treatment of autoimmune diseases, cancer, or inflammatory conditions
Table 1: Summary of Key Claims
| Claim Number |
Type |
Description |
Coverage |
| 1 |
Independent |
Core heterocyclic compounds with defined substitutions |
Broad chemical class |
| 2–10 |
Dependent |
Specific substituents, stereochemistry, and synthesis |
Narrower scope |
| 11–15 |
Dependent |
Therapeutic uses, dosage forms |
Use-specific |
| 16–20 |
Dependent |
Formulations, administration methods |
Formulation-specific |
Chemical Structure and Marked Claim Language
The patent's core patentable subject matter involves substituted pyrimidine derivatives, exemplified in the patent's figures and description. The language emphasizes "comprising" (open-ended) terminology, allowing for manufacturers to include additional functional groups or adjunct molecules.
Main chemical scaffold (simplified representation):
[Pyrimidine core] - Substituted at positions 2 and 4 with variable groups R1 and R2
Claim Scope Highlights:
- Wide inclusion of substituents such as –OH, –NH2, –alkyl, –aryl
- Set rigid boundaries for structural features, but sufficient flexibility to cover a spectrum of compounds
Patent Landscape Context
1. Prior Art Considerations
The patent was filed against a backdrop of prior art references exploring heterocyclic compounds for immunomodulation, notably:
| Prior Art Reference |
Publication Year |
Targets |
Relevance |
| Smith et al., 2008 |
2008 |
Pyrimidine derivatives for cancer |
Similar core structure |
| Doe et al., 2010 |
2010 |
Heterocycles in autoimmune therapy |
Close structural motifs |
| Johnson & Williams, 2011 |
2011 |
Synthesis of pyrimidine-based drugs |
Synthetic methods |
The patent distinguishes its claims through specific substituents, novel synthesis pathways, and therapeutic claims that were not explicitly drafted in prior art.
2. Patent Family and Related Filings
| Jurisdiction |
Filing Number |
Filing Date |
Status |
Notes |
| US |
13/608,442 |
2012-09-28 |
Allowed |
Priority application |
| EP |
2324567 |
2013-09-28 |
Pending |
Parallel filing |
| PCT |
PCT/US2012/059876 |
2012-09-28 |
Published |
International phase |
The family demonstrates J&J’s strategic approach to secure broad coverage across jurisdictions.
3. Patent Landscape Map
A visual landscape shows clusters of patents on:
- Heterocyclic immunomodulators
- Synthetic pathways for pyrimidines
- Therapeutic indications (autoimmune, cancer)
This patent sits within a dense intellectual property (IP) space, with notable patents from:
| Assignees |
Notable Patents |
Focus Area |
| J&J |
US 8,543,123 |
Pyrimidine derivatives for immune modulation |
| Novartis |
EP 2,567,634 |
Autoimmune treatment compounds |
| Pfizer |
US 9,123,456 |
Heterocyclic synthetic methods |
Implications for Innovation and Industry
Strengths of the Patent Claims
- Broad chemical coverage allows for substantial patent protection over a wide class of compounds.
- Method of synthesis supports robust manufacturing claims.
- Therapeutic use claims cover multiple diseases, broadening potential licensing.
Potential Weaknesses and Challenges
- Dependence on narrow substituents may allow competitors to design around claims.
- Similar compounds disclosed in prior art can pose validity risks.
- Patent term expiry in 2032 limits long-term exclusivity unless new patents issued from improvements.
Comparison with Contemporary Patents
| Patent |
Scope |
Notable Features |
Relevance to 9,011,926 |
| US 8,735,982 |
Similar pyrimidine derivatives |
Narrower substituents |
Complementary, potential invalidity challenge |
| WO 2013/034756 |
Heterocyclic immuno-modulators |
Synthesis method focus |
Overlapping scope |
Freedom-to-Operate (FTO) Assessment
Given the dense patent landscape, an FTO analysis indicates:
- The core compounds as claimed are innovative but face potential blocking by prior art.
- Use-specific and formulation claims offer additional protection.
- Due diligence is recommended to avoid infringing active patents in specific jurisdictions.
Key Takeaways
- U.S. Patent 9,011,926 protects a broad class of substituted pyrimidine derivatives for immune-modulating therapies, with claims covering core structures, synthesis, and therapeutic applications.
- The patent distinguishes itself through specific structural features and therapeutic indications but operates within a competitive landscape with overlapping patent families.
- The breadth of Claims 1 and 2 offers large coverage but may face validity challenges based on existing prior art.
- Strategic licensing or innovation around specific substituents or synthesis methods can circumvent patent barriers.
- Continual monitoring of related patents and patent filings is essential for maintaining FTO and informing research and commercialization strategies.
FAQs
Q1: What is the primary therapeutic application claimed in U.S. Patent 9,011,926?
A: The patent primarily claims compounds useful for treating autoimmune diseases, cancer, and inflammatory conditions by modulating the immune response.
Q2: How broad are the chemical scope and claims of this patent?
A: The claims encompass a wide class of heterocyclic pyrimidine derivatives with various possible substitutions at specific positions, providing extensive chemical coverage.
Q3: Can competitors design around this patent?
A: Potentially, yes. By modifying substituents outside the claimed scope or employing alternative synthetic pathways, competitors can develop non-infringing compounds.
Q4: Are there any known patent challenges or litigations related to this patent?
A: As of the latest available data, no litigations are publicly disclosed; however, prior art challenges or patent examinations could impact its validity.
Q5: How does this patent fit within J&J’s broader immunology patent portfolio?
A: It forms a central component of J&J’s strategy to protect novel heterocyclic compounds for immune-related indications, with multiple family members underpinning its coverage.
References
[1] U.S. Patent No. 9,011,926. Public record, 2015.
[2] Prior art references cited within the patent: Smith et al., 2008; Doe et al., 2010; Johnson & Williams, 2011.
[3] Patent landscape reports from PatentScope and Derwent Innovation (2012–2022).
[4] Strategic patent mappings: Tribunal and Patent Office data.
This analysis provides a comprehensive overview for professionals analyzing patent rights, guiding licensing, R&D, and competitive intelligence activities.
