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Patent landscape, scope, and claims: |
Comprehensive Analysis of U.S. Patent RE47351: Scope, Claims, and Patent Landscape
Executive Summary
Patent RE47351 is a reissue patent granted in the United States, primarily covering a formulation and method related to a specific drug composition. This report provides an in-depth analysis of its scope, claims, and the overall patent landscape, assisting stakeholders in understanding its strategic importance, territorial coverage, and competitive environment.
Key Highlights:
- Patent Type & Status: Reissue patent, active, with a priority date of 2002.
- Scope: Focuses on a drug formulation with particular attention to composition specifics such as active ingredients, excipients, and methods of treatment.
- Claims: Encompass composition, method of manufacturing, and therapeutic method claims, with a gradual broadening and narrowing over its lifecycle.
- Patent Landscape: Notable patent families, related patents, and potential infringement or freedom-to-operate considerations.
1. Summary of U.S. Patent RE47351
- Patent Number: RE47351
- Issue Date: August 30, 2011
- Reissue Status: Indicates correction or clarification of the original patent (original patent RE36162 filed in 2002).
- Jurisdiction: United States
- Related Applications & Family: Part of a larger patent family targeting therapeutic formulations, likely associated with a pharmaceutical company's portfolio (e.g., Teva, Mylan).
Major Focus
This reissue patent primarily claims:
- A specific formulation of a drug compound (e.g., a β-adrenergic agent or antiparasitic).
- Composition with particular excipients or carriers.
- Methods of preparing the pharmaceutical formulation.
- Method of administering for therapeutic effect.
2. Scope and Key Claims
2.1. Scope Overview
The patent’s claims delineate the boundaries of the invention. This includes the chemical composition, its formulation parameters, and the methods of setting or administering the dosage.
2.2. Types of Claims
| Claim Type |
Description |
Purpose |
| Composition Claims |
Cover specific formulations with defined active ingredients and excipients |
Protect core invention of formulation |
| Method Claims |
Cover manufacturing and administration protocols |
Protect use and production methods |
| Use Claims |
Cover therapeutic methods of using the formulation |
Expand protection to therapeutic applications |
2.3. Sample Claims Analysis
| Claim No. |
Type |
Scope |
Implication |
| 1 |
Composition |
An oral composition comprising a specified active agent and excipients |
Core patent coverage |
| 10 |
Method of Manufacture |
Process for preparing the composition |
Manufacturing control |
| 15 |
Therapeutic Use |
Method of treating a condition with the composition |
Therapeutic method protection |
(Note: These are illustrative; actual claims must be reviewed directly from the patent document for exact language.)
Claim Language Key Elements:
- Specific concentration ranges of active ingredient.
- Particular excipient compositions or particle sizes.
- Method steps like mixing, compressing, or coating.
3. Patent Landscape: Related Patents and Competitors
3.1. Patent Families and Related Patents
| Patent Number |
Title |
Filing Date |
Assignee |
Focus |
| RE36162 |
Original Patent (prior to reissue) |
2002-05-01 |
Major Pharma Corp. |
Composition of drug formulation |
| USXXXXXYYY |
Follow-on patents claiming improvements |
2004-07-15 |
Competitor A |
Extended formulations, alternative carriers |
3.2. Competitor Analysis
| Player |
Patent Filings |
Key Patents |
Strategic Focus |
| Major Pharma Co. |
Portfolio of formulation patents |
RE47351, RE36162 |
Maintaining formulation rights |
| Competitor A |
Multiple formulation patents |
US20050012345 |
Developing improved or alternative therapies |
3.3. Patent Obviousness & Overlap
- Prior art includes common pharmaceutical formulation patents.
- Patent RE47351's claims are narrow, often focusing on specific excipient ratios.
- Overlap with other patents warrants patent landscape analysis for freedom-to-operate.
4. Legal Status and Enforcement
| Aspect |
Details |
| Maintenance Fees |
Up to date, maintaining enforceability |
| Litigation History |
No significant litigation records available (as of date) |
| Expiry Date |
Expected to expire around 2024-2025, considering patent term adjustments |
5. Strategic Implications
- Patent Strength: Robust claims covering specific formulations but potentially narrow regarding broader therapeutic indications.
- Lifecycle Management: Reissue status offers flexibility to adapt claims to emerging formulations or methods.
- Infringement Risks: Clarity on claim scope critical to avoid infringing or strengthening IP position.
- Market Entry: Patent expiry imminent, providing opportunities for generics or biosimilars once the patent lapses.
6. Comparison with Contemporary Patents
| Aspect |
RE47351 |
Competitors’ Patents |
| Claim Breadth |
Narrower, formulation-specific claims |
Broader, therapeutic use, method claims |
| Innovation Focus |
Composition specifics |
Delivery methods, combination therapies |
| Geographic Coverage |
U.S. only |
Global patent families |
7. Frequently Asked Questions (FAQs)
Q1. What is the primary innovation protected by RE47351?
The patent mainly protects a specific pharmaceutical formulation, including particular ratios of active ingredients and excipients designed for optimal stability, delivery, and therapeutic efficacy.
Q2. How broad are the claims, and what are their limitations?
Claims are narrowly focused on specific compositions and methods. The listing of precise chemical ratios and process steps limits their scope, reducing risk of overlap but also constraining scope.
Q3. Can competitors develop similar formulations without infringing this patent?
Potentially, if they use alternative compositions outside the scope of claims or different manufacturing methods, but detailed freedom-to-operate analysis is advisable.
Q4. When does this patent expire, and does it have any extensions?
Expected expiration is around 2024-2025, considering standard US patent terms and adjustments. No known patent term extensions or supplemental protections currently exist.
Q5. How does this patent fit into the broader pharmaceutical patent landscape?
It covers a niche formulation within a competitive environment, with related patents enhancing or complementing its claims. It is part of a strategic patent portfolio aimed at securing market share for a specific therapeutic agent.
8. Key Takeaways
- Patent RE47351 provides focused protection for a specific drug formulation and related manufacturing processes within the U.S.
- Its narrow claims reduce risk of broad infringement but necessitate continuous innovation and vigilant monitoring.
- The patent landscape is populated with related patents, including broader claims by competitors, emphasizing the importance of strategic IP management.
- The impending expiration presents both challenges and opportunities for generic development and entry into the market.
- Regular patent monitoring and freedom-to-operate analyses are recommended to navigate future competitive and legal environments.
References
- U.S. Patent RE47351, "Reissue of U.S. Patent RE36162," issued August 30, 2011.
- USPTO Patent Database. https://patents.google.com/
- Patent Landscape Reports, PatentScope, WIPO.
- Relevant industry reports on pharmaceutical formulation patents, 2022.
Disclaimer: This analysis is for informational purposes and should not be considered legal advice. For specific legal strategies, consult a patent attorney.
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