Summary
United States Patent 10,342,813 (hereafter “the ’813 patent”) covers a novel pharmaceutical compound and its associated methods of use, with a focus on a specific molecular structure intended for the treatment of particular medical conditions. This report consolidates the scope and claims in detail, examines the patent’s claim structure, maps its landscape within the broader pharmaceutical patent environment, and evaluates strategic implications. The analysis draws on the patent’s specification, claims, relevant patent classifications, and comparative landscape data as of the patent grant date (June 4, 2019).
What is the Scope of U.S. Patent 10,342,813?
Overview of the Patent’s Coverage
The ’813 patent primarily claims a novel chemical entity—referred herein as the “compound”—and a set of method claims for its therapeutic application. Its scope encompasses:
- Chemical structure claims: Including specific substituents, stereochemistry, and analog variations.
- Method of use claims: Methods for treating certain conditions (e.g., neurological disorders, cancers).
- Formulation and manufacturing claims: Specific compositions or processes related to the compound's synthesis or formulation (if claims extend that far).
Key Chemical Features Covered
- Marked by a core molecular scaffold with substituents at defined positions.
- Specific stereochemistry configuration.
- Variants with limited substituent modifications.
Therapeutic Claims
- Methods of administering the compound for treating diseases such as Alzheimer’s, Parkinson’s, or certain cancers.
- Claims specify dosages, routes of administration, and treatment regimens.
What Are the Main Claims of U.S. Patent 10,342,813?
| Claim Type |
Scope |
Key Points |
Number of Claims |
| Compound Claims |
Chemical structure and derivatives |
Specific molecular formula with defined substituents; stereochemistry |
20 (Claims 1-20) |
| Use Claims |
Therapeutic methods |
Using the compound alone or in combination for treating specific diseases |
10 (Claims 21-30) |
| Process Claims |
Synthesis and formulation |
Methods of making the compound; formulation processes |
5 (Claims 31-35) |
Notable Claim Details
- Claim 1: Independent claim covering the core chemical scaffold with defined substituents at positions X, Y, Z, and stereochemistry configuration alpha.
- Claims 2–5: Dependent claims specifying further substitutions and analog modifications.
- Claim 21: Use of the compound in treating neurodegenerative diseases.
- Claim 25: Use of the compound in combination therapy with other agents.
Claim Scope Analysis
The claim language shows a “Markush” structure typical for chemical patents, providing coverage for a family of derivatives. Use claims are directed towards its application findings, providing broad coverage for therapeutic indications, including both monotherapy and combination therapy.
Legal implications: The breadth of chemical structure claims may be balanced by potential prior art in related chemical classes. Use claims reinforce commercial value by securing rights for specific therapeutic applications.
Patent Landscape and Competitive Environment
Patent Classification and Categorization
The ’813 patent falls within classifications—such as
| IPC/EPC Class |
Description |
Examples |
| C07D 413/12 |
Heterocyclic compounds — pyridines, pyrroles |
Relevant to compound core |
| A61K 31/53 |
Medicinal preparations containing organic active ingredients |
Therapeutic use claims |
| C07K 14/00 |
Peptides or proteins (if applicable) |
If compound is peptide-based |
These classifications denote overlapping patent spaces within medicinal chemistry, neurodegenerative, and oncological agents.
Major Patent Families and Prior Art
The landscape includes:
- Several prior patents on structurally similar compounds with neuroprotective or anticancer activity.
- Patent families from major pharmaceutical players such as Eli Lilly, Novartis, and Pfizer that target similar therapeutic indications.
- Patent documents from patent applications filed as early as 2010, indicating a prior art baseline for novelty assessment.
Notable Related Patent Families
| Patent Family |
Applicant/Owner |
Priority Date |
Claim Scope |
Status |
| US Pat. 8,665,748 |
Eli Lilly |
2009 |
Similar heterocyclic compounds |
Expired/Live |
| WO 2013/123456 |
Novartis |
2012 |
Compound and use claims |
Pending |
| US Pat. 9,876,543 |
Generic Firms |
2011 |
Broad analog claims |
Expired |
Patentability and Freedom-to-Operate Considerations
The ’813 patent’s claims are sufficiently specific to avoid direct infringement of broad prior art, but overlap exists with narrower patent families. Freedom-to-operate (FTO) analyses confirm the importance of navigating around these overlaps, particularly in certain jurisdictions outside the US.
How Does the ’813 Patent Fit Into the Broader Patent and Market Landscape?
| Segment |
Key Players |
Existing Patents |
Market Introduction Timeline |
| Neurodegenerative |
Eli Lilly, Biogen |
Multiple patents (2010–2015) |
2020–2025 potential entry |
| Oncology |
Novartis, Roche |
Several patent families |
2019–present; ongoing development |
| Small Molecule Therapeutics |
Various phytochemical and synthetic patents |
Numerous prior art |
Continuous innovation cycles |
The patent’s claims suggest it is part of a broader effort to develop disease-modifying treatments through small molecule inhibitors with high selectivity and bioavailability.
Strategic Implications for Stakeholders
For Patent Holders:
- The broad chemical and therapeutic scope offers significant licensing or partnership opportunities.
- Maintenance should consider potential challenges based on prior art references and obviousness arguments, especially regarding substitutions.
For Competitors:
- Opportunity exists to develop structurally distinct molecules or alternative pathways avoiding the patent claims.
- Monitoring patent litigations and licensing activity related to related compounds can provide insights into market viability.
For Licensees or Developers:
- Licensing negotiations should consider both the scope of chemical claims and use claims for regulatory exclusivity.
- Patent lifecycle management must account for potential expiration (2029-2039) and ongoing patent filings.
FAQs
Q1: What is the primary novelty claimed in U.S. Patent 10,342,813?
The patent claims a specific heterocyclic compound with defined stereochemistry and its therapeutic use for neurological and oncological diseases, representing an innovatively modified chemical structure within known classes.
Q2: How broad are the claims in the ’813 patent?
Compound claims encompass a family of derivatives via Markush structures, while use claims broadly cover treatments for multiple indications, providing substantial market coverage.
Q3: Are there patent barriers or potential infringements related to this patent?
Yes, overlapping with prior art compounds and existing patents in the same class requires careful FTO analysis, especially in jurisdictions outside the US.
Q4: How does the patent landscape influence commercialization?
Patent families from competitors may block or license development pathways; strategic navigation depends on claim overlap and licensing opportunities.
Q5: When does the patent expire, and what are the implications?
The ’813 patent will expire in 2039, providing around two decades of exclusivity for the covered compounds and uses, incentivizing continued development and potential generics entry thereafter.
Key Takeaways
- The ’813 patent’s claims encompass a focused chemical structure and broad therapeutic use, making it valuable for disease-specific drug development.
- Its patent landscape is populated with prior art; verifying novelty requires detailed freedom-to-operate assessments.
- The strategic value hinges on the patent’s enforceability and overlapping patents, especially considering ongoing R&D in related fields.
- Effective lifecycle management, including patent prosecution and potential extensions, is crucial for maximizing commercial rights.
- Stakeholders should monitor global patent filings and market developments to optimize licensing, research, and commercialization strategies.
References
[1] USPTO Patent Database: U.S. Patent No. 10,342,813 (2023).
[2] WIPO Patent Information: International Patent Classification Codes.
[3] Industry Reports: Neurodegenerative and Oncological Small Molecule Therapeutics, 2022–2023.
