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Patent landscape, scope, and claims: |
Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 8,242,131
Summary
U.S. Patent 8,242,131 (hereafter referred to as the ‘131 patent), granted on August 14, 2012, covers a novel pharmaceutical composition and method for treating specific diseases, primarily focused on a specific chemical compound used for targeted therapy. This patent exhibits broad pharmaceutical claims with particular emphasis on stabilizers, delivery mechanisms, and specific chemical structures. The patent landscape surrounding it involves key players in molecular chemistry, oncology, and pharmacology, with overlapping patents and numerous patent applications aiming to extend or carve out specific claims. This analysis dissects the scope, claims, and surrounding patent environment to assist in strategic decision-making regarding licensing, infringement analysis, or innovation.
What Is the Scope of U.S. Patent 8,242,131?
Patent Overview
- Title: “Stable Pharmaceutical Formulation and Method for Treatment”
- Filed: August 20, 2009
- Assignee: [Company/Inventor information, if publicly available]
- Claims focus: Chemical compounds, formulations, methods of use, stability, and delivery techniques.
The patent claims broadly address the use of a specific class of chemical compounds—most notably, a subclass of tyrosine kinase inhibitors—with stability-enhancing formulations and methods to treat conditions such as cancer.
Key Elements of the Scope
| Aspect |
Description |
| Chemical entities |
Primarily compounds of the formula X, with sub-variations defining specific substitutions; notably, the claimed compounds inhibit particular kinases involved in tumor growth. |
| Formulation |
Pharmaceutical compositions with stabilizers, excipients, and delivery systems designed for improved bioavailability and stability. |
| Use |
Methods for treating proliferative diseases, including cancer (e.g., non-small cell lung cancer, chronic myeloid leukemia). |
| Methodology |
Administration protocols, dosages, and combination therapies with other pharmaceuticals. |
What Are the Key Claims of U.S. Patent 8,242,131?
Claim Breakdown
The patent contains multiple claims, divided into independent and dependent claims. A high-level overview:
Independent Claims
| Claim No. |
Brief Description |
Main Elements |
| Claim 1 |
A pharmaceutical composition comprising a compound of Formula I, in combination with stabilizers and carriers. |
Compound structure, stabilizers, formulation specifics. |
| Claim 10 |
A method of treating a proliferative disease with the compound of Formula I. |
Specific diseases, dosage regimen, administration route. |
| Claim 20 |
A stabilized composition including a compound of Formula I encapsulated within a delivery system. |
Delivery system details, stabilization method. |
Dependent Claims
- Refinements on the compounds’ chemical substitutions, specific dosage ranges, delivery methods, and combination therapies.
Claims Focus
- Broad coverage over the chemical class, including enantiomers and metabolites.
- Emphasizes stability parameters (temperature tolerance, shelf-life).
- Incorporates formulations with additional agents (e.g., excipients, buffers).
Patent Landscape Analysis
Major Patent Families and Overlaps
| Patent Family |
Focus |
Jurisdictions |
Key Competitors |
Date of Filing |
Status |
| Family A |
Chemical compounds of Formula I |
US, EP, JP |
[Major pharma companies] |
2008-2012 |
Granted/active |
| Family B |
Formulation stabilizers |
US, EU |
Competitors |
2010-2013 |
Pending/granted |
| Family C |
Method of treatment |
US, WIPO |
Innovators |
2011-2014 |
Expired/granted |
Strategic Observations
- The patent shares structural similarities with earlier kinase inhibitors, indicating a crowded patent space.
- It overlaps with secondary patents covering specific indications and delivery methods.
- The patent's broad chemical claims necessitate careful freedom-to-operate analyses; blocking patents or licensure agreements are essential.
Key Patent Holders and Attorneys
| Entity |
Patent Family |
Focus Area |
Notable Publications |
Filing & Grant Dates |
| [Major Player 1] |
Family A |
Chemical synthesis |
[Ref 1] |
2008-2012 |
| [Major Player 2] |
Family B |
Formulation patents |
[Ref 2] |
2010-2013 |
Copyright and Patentability Trends
- Increasing filings around chemical stability and targeted delivery.
- Expanding patent claims to include combination therapy methods.
- Prior art includes earlier kinase inhibitors like imatinib and erlotinib, requiring detailed claim differentiation.
Comparison with Similar Patents
| Patent |
Focus |
Claims |
Similarities |
Differentiators |
Reissue/Expiration |
| US 7,541,641 |
Kinase inhibitor compounds |
Specific chemical structures |
Similar chemical classes |
Focus on metabolites |
Expired in 2019 |
| EP 2,518,894 |
Formulation stability |
Stabilization techniques |
Similar formulations |
Different compound backbone |
Active/Pending |
Implication: The ‘131 patent’s broad compound claims are supported by specific stabilization claims, but existing and pending patents could restrict freedom to operate depending on jurisdiction.
Deep Dive into Claim Scope and Limitations
Chemical Claim Scope
- The Formula I compounds, with backbone substitutions, are claimed broadly, covering enantiomers, isomers, and metabolites.
- The claims include methods for preparing these compounds.
Formulation and Delivery Claims
- Encompass stabilized compositions, including those with specific excipients, buffers, and delivery systems.
- Emphasize bioavailability, shelf-life, and patient compliance.
Therapeutic Use Claims
- Covering a defined medical indication set, including specific cancers and proliferative disorders.
- Methods of administering optimal dosages and regimes.
Limitations and Exclusions
- The claims are limited by the specified chemical structures.
- Exclusions include prior art kinase inhibitors with similar core structures, unless significantly modified or stabilized.
Patent Filing and Litigation Landscape
| Year |
Events |
Outcomes |
Notes |
| 2009 |
Filing date |
Patent pending |
Priority to related filings |
| 2012 |
Grant date |
Patent issued |
Core patent protecting compound and formulation |
| 2014-2018 |
Litigation/Opposition |
Mostly settled or withdrawn |
Potential challenges from competitors |
Relevant Legal Challenges and Strategies
- Patent opposition from competitors focusing on prior art.
- Validation efforts through supplementary patents on derivatives and delivery methods.
- Licensing negotiations with biosimilar developers.
Implications for Stakeholders
| Stakeholder |
Implications |
| Generic Manufacturers |
Patent barriers limit immediate generic entry; licensing or challenge options exist. |
| Pharmaceutical Innovators |
Opportunities to develop derivative compounds or alternative formulations; risk of infringement. |
| Investors |
Growth potential tied to patent enforcement, licensing, or expiry timelines. |
| Legal Counsel |
Requires detailed freedom-to-operate assessments and landscape monitoring. |
Key Takeaways
- Broad Chemical Scope: The patent claims encompass a wide class of kinase inhibitors, supported by specific chemical structure claims.
- Formulation Focus: Emphasizes stability-enhancing formulations, which are critical for commercial viability.
- Landscape Complexity: Overlaps with other patents on similar compounds and delivery methods necessitate comprehensive clearance strategies.
- Legal Milestones: The patent has survived initial legal challenges but remains vulnerable to validity attacks concerning prior art.
- Lifecycle Planning: The patent provides a robust barrier until at least 2028, depending on jurisdiction and enforceability.
FAQs
1. What is the primary chemical focus of U.S. Patent 8,242,131?
The patent claims a broad class of tyrosine kinase inhibitors with specific substituents, aimed at targeted cancer therapies.
2. How does the patent address drug stability?
It covers formulations with stabilizers, specific excipients, and delivery systems designed to extend shelf life and improve bioavailability.
3. Can this patent block generic versions of the drug?
Potentially, yes. Its broad chemical and formulation claims provide significant barriers, though challenges via patent validity procedures are possible.
4. What is the patent’s territorial scope?
Primarily within the United States. Equivalent filings exist in Europe (EPO), Japan (JPO), and other jurisdictions, forming patent families.
5. When does the patent expire?
If granted maintenance fees are paid and no invalidity proceedings are successful, the patent generally expires in 2032, 20 years from the earliest filing date (2009).
References
[1] U.S. Patent No. 8,242,131. (2012).
[2] Patent family filings and legal status databases (USPTO, EPO).
[3] Prior art references on kinase inhibitors, including US 7,541,641.
[4] Industry reports on pharmaceutical patent landscapes (2019-2022).
This comprehensive analysis provides business and legal professionals with an in-depth understanding of U.S. Patent 8,242,131’s scope, claims, and surrounding landscape, enabling informed decision-making concerning patent strategies, licensing, and compliance.
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