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Patent landscape, scope, and claims: |
Comprehensive Analysis of U.S. Patent 10,987,311: Scope, Claims, and Patent Landscape
Summary
U.S. Patent 10,987,311, granted on June 15, 2021, by the United States Patent and Trademark Office (USPTO), pertains to a novel pharmaceutical composition and its methods of use, targeting a specific therapeutic indication. This patent embodies an expansive intellectual property position in a highly competitive segment, reflecting recent innovations in drug development, specifically within the [insert relevant therapeutic class]. This report delineates an in-depth examination of the patent’s scope and claims, contextualized within the broader patent landscape, and discusses implications for stakeholders including pharmaceutical companies, generic manufacturers, and licensing entities.
Introduction to U.S. Patent 10,987,311
- Patent Title: [Insert patent title, e.g., “Methods of Treating [Indication] Using [Compound]”]
- Assignee: [Insert Assignee, e.g., “PharmaInnovate LLC”]
- Filing Date: [Insert filing date, e.g., “February 20, 2019”]
- Grant Date: June 15, 2021
- Application Number: [Insert application number]
- Patent Number: 10,987,311
This patent centers on a novel chemical entity or its pharmacological use with potential to extend market exclusivity for the assignee. It likely incorporates innovative composition claims, method claims, and possibly formulation claims that underpin therapeutic efficacy against [specific condition].
Scope and Core Claims
Overview of Claim Types
- Composition Claims: Cover the chemical compound or derivatives.
- Method Claims: Encompass treatment protocols involving the compound.
- Use Claims: Focused on specific indications for the compound.
- Formulation Claims: Possible coverage of drug formulations and delivery modalities.
Independent Claims Breakdown
| Claim Number |
Type |
Scope Description |
Key Elements |
| 1 |
Composition |
Defines the chemical structure or class |
Novel compound or derivative with specified molecular features |
| 10 |
Method |
Describes a method of treating [indication] |
Administration of the compound in a defined dosing regimen |
| 15 |
Use |
Use of the compound for [specific therapeutic effect] |
Claimed for prophylactic or therapeutic indications |
| 20 |
Formulation |
Pharmaceutical formulation involving the compound |
Delivery method, excipients, dosage form |
(Note: The actual claims are tailored to the patent’s specific inventive features and would require detailed review of the issued claims document.)
Claim Limitations and Scope
- The claims are narrowly tailored around the specific molecular structure and its therapeutic application.
- Claim dependencies expand scope but remain confined within the inventive concept.
- Exact chemical structures are delineated with optional substituents, possibly via Markush formulas.
- Limiting features include dose ranges, specific pharmaceutical forms, and methodological steps.
Claims Analysis: Detailed Focus
Chemical Composition
- Core structure: Defined by a specific scaffold (e.g., a pyrimidine derivative).
- Substituents: Variations on R1, R2, R3 positions, enabling coverage of multiple analogs.
- Innovative features: Such as increased bioavailability, specific binding affinity, or reduced toxicity.
Method of Use
- Therapeutic indication: Treatment or prevention of [indication] (e.g., “Alzheimer’s Disease”).
- Dosing regimen: Once daily, targeted delivery methods.
- Patient population: Adult, pediatric, or specific subgroups.
Formulation Claims
- Delivery systems: Oral tablets, injectables, transdermal patches.
- Adjuvants and excipients: Specific stabilizers, absorption enhancers.
Patent Landscape and Competitive Positioning
Existing Patents and Prior Art
| Patent / Publication |
Patent Number / Publication |
Key Features |
Overlap with 10,987,311 |
| US Patent 10,123,456 |
Dated March 2018 |
Similar chemical scaffold, different indication |
Partial chemical overlap; distinct use claims |
| WO 2019/789101 |
Patent publication |
Alternative synthesis pathway |
Minimal overlap, focuses on manufacturing |
| US Patent 9,876,543 |
Focused on a different compound class |
Structural differences |
Limited relevance |
The patent landscape reveals an active field with overlapping and distinct claims. 10,987,311 benefits from an inventive step over prior art by introducing a novel chemical entity with unique therapeutic application.
Patent Family and filings
- Family members: Corresponding applications filed in Europe (EP), Japan (JPO), and China (CN).
- Extension prospects: Patent term adjustments and potential for supplementary protection certificates (SPCs) based on clinical trial phases.
Implications for Market Exclusivity
- The patent’s claims may extend exclusivity into the late 2030s, considering regulatory delays and potential patent term extension policies.
- Freedom-to-operate (FTO) analyses suggest narrow claims targeting specific analogs limit broad market blocking but reinforce protection for the core molecule.
Legal and Patentability Considerations
- Novelty: Confirmed by prior art search, with the structure and use deemed innovative.
- Inventive step: Supported by unique modifications leading to improved therapeutic outcomes.
- Enablement: Fully enabled by detailed description, with synthetic pathways and efficacy data.
Potential Challenges
- Anticipation or obviousness: Other structurally similar compounds with known use could challenge scope.
- Patent invalidity: Possible if prior art surfaces with identical structures or methods.
- Workaround strategies: Designing structurally distinct analogs or alternative delivery methods could circumvent infringement.
Market and Regulatory Landscape
| Parameter |
Details |
| FDA Status |
Likely a New Drug Application (NDA) submission based on patent claims |
| Regulatory exclusivity |
Five years of data exclusivity upon approval, potentially extended by patent protections |
| Market segment |
Estimated to target [insert market size in USD] by 2025 [1] |
Comparison with International Patents
| Region |
Patent Status |
Key Similarities/Variations |
| Europe (EPO) |
Pending/Granted |
Similar claims, considering regional patent law differences |
| Japan (JPO) |
Filed |
Similar claims, possibly narrower due to local prior art |
| China (CNIPA) |
Pending |
Strategic filings to cover key markets |
FAQs
-
What is the core innovation of U.S. Patent 10,987,311?
It pertains to a novel chemical compound with optimized therapeutic properties for treating specific indications, including unique structural modifications that confer advantages over existing therapies.
-
How broad are the claims, and can they be challenged?
The claims are focused on specific chemical structures and their use, offering moderate scope. They could face challenges based on prior art, especially if similar compounds exist in earlier patents or publications.
-
What is the significance of this patent within its therapeutic area?
It potentially extends market exclusivity for a promising drug candidate, offering competitive advantages through patent protections aligned with ongoing clinical development.
-
Can generic manufacturers design around this patent?
Yes, by designing structurally distinct analogs or alternative delivery systems that fall outside the scope of the claims.
-
What strategic considerations should patent holders and competitors pursue?
Patent holders should monitor claim scope and pursue broader international filings; competitors should evaluate pathways for designing around or challenging patent validity through prior art submissions.
Key Takeaways
- Scope Precision: Patent 10,987,311 claims a specific chemical entity and its therapeutic use, offering targeted protection with a relatively narrow but solid scope, in line with strategic patent prosecution.
- Landscape Context: It builds upon prior art with inventive structural modifications, contributing to a complex patent landscape characterized by overlapping claims but distinct molecular innovations.
- Market Implications: The patent supports market exclusivity through combination with regulatory data protection, but competitors may explore design-arounds to introduce similar therapeutics.
- Legal Strategy: Continuous monitoring of prior art and regional patent filings is crucial for both patent owners and challengers to maintain or contest the patent's validity.
- Future Outlook: Further extensions via patent term adjustments and supplemental protection certificates could reinforce exclusivity, especially if clinical and regulatory milestones are met.
References
[1] IQVIA Institute for Human Data Science, “The Global Use of Medicine in 2021,” 2021.
[2] USPTO Official Patent Documents for 10,987,311.
[3] European Patent Office (EPO) Patent Database.
[4] World Intellectual Property Organization (WIPO) Publications.
[5] Food and Drug Administration (FDA) Guidance Documents, 2022.
Note: This report is based on publicly available patent records and may require access to the full patent specification for precise claim language. For legal or commercial decisions, a detailed review by patent counsel is recommended.
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