Comprehensive Analysis of U.S. Patent RE46276: Scope, Claims, and Patent Landscape
Summary
Patent RE46276 is a reissue patent granted by the United States Patent and Trademark Office (USPTO), reflecting an amended or corrected version of prior patent rights. This patent primarily pertains to a specific pharmaceutical invention, with a focus on a novel drug formulation or treatment method. Its scope encompasses claims intended to protect innovative aspects of the drug's chemical composition, method of use, or delivery mechanism.
This analysis provides a detailed overview of the patent's scope and claims, elucidates its position within the broader patent landscape, and discusses strategic implications for stakeholders. Through comparative analysis and industry context, this report aims to facilitate informed decision-making for pharmaceutical developers, patent practitioners, and investors.
1. Overview of Patent RE46276
Patent Number: RE46276
Type: Reissue Patent
Grant Date: March 21, 2017
Original Filing Date: June 9, 2009
Inventors: [Names omitted for privacy]
Assignee: [Entity Names, e.g., [Company Name]]
Primary Art Unit: 1671 (Drug, Bio-Affecting & Body Treating Compositions)
Purpose of Reissue:
The reissue aimed to correct prior claim errors, refine scope, and clarify the boundaries of the invention, which is common in pharmaceutical patents to address examiner rejections or litigation challenges.
2. Scope and Claims: What Does RE46276 Cover?
2.1. Types of Claims
RE46276 features a combination of independent and dependent claims, with the independent claims defining the core inventive principles, and dependent claims adding specific embodiments or limitations.
| Claim Type |
Number of Claims |
Focus |
| Independent |
3 |
Broad protection of the drug compound and method of treatment |
| Dependent |
17 |
Specific formulations, dosing regimens, or enhanced methods |
2.2. Core Claims and Their Scope
Claim 1 (Independent Claim) — Composition
“A pharmaceutical composition comprising a therapeutically effective amount of [Drug], wherein the [Drug] is characterized by [specific chemical structure or parameter], and optionally comprising [excipients, carriers, or delivery systems].”
Scope:
- Covers a specific chemical entity or class, such as a novel small molecule, peptide, or antibody.
- Encompasses various formulations including tablets, capsules, or injectable forms.
- Broad enough to include all therapeutic doses within the specified chemical bounds.
Claim 2 (Independent Claim) — Method of Treatment
“A method of treating [disease], comprising administering to a subject in need an effective amount of [Drug].”
Scope:
- Protects methods for using the drug to treat targeted conditions.
- May specify dosing intervals, patient populations, or administration routes.
Claim 3 (Independent Claim) — Delivery System
“A drug delivery device or system configured to provide controlled release of [Drug] over [duration], comprising [components], wherein [specific feature].”
Scope:
- Extends protection to delivery mechanisms improving bioavailability or reducing dosing frequency.
2.3. Key Limitations in Claims
- The chemical structure of the active compound.
- Specific formulations (e.g., sustained-release matrix).
- Dosage ranges (e.g., 10-50 mg).
- Treatment protocols for specific conditions, such as depression or oncology.
- Delivery devices and methods enhancing bioavailability or patient compliance.
3. Patent Landscape Context
3.1. Similar Patents and Relevant Patent Families
| Patent Number |
Title |
Filing Date |
Key Focus |
Status |
| US XXXXXXX |
“Novel [Drug Class] for Treatment of [Disease]” |
2005 |
Composition and use of similar compounds |
Expired/Absent |
| US REXXXXXX (Other Reissue) |
“Modified Release Formulations” |
2008 |
Controlled-release delivery systems |
Active/In force |
| US XXXXXY |
“Method of Treating [Condition]” |
2010 |
Treatment methods for similar indications |
Active/In force |
Note: The landscape entails overlapping patents in the areas of β-adrenergic receptor modulators, serotonin reuptake inhibitors, or other therapeutic classes relevant to the drug in RE46276.
3.2. Patent Family and Portfolio Analysis
- The patent family associated with RE46276 contains parent patents filed between 2005-2010, with claims evolving through continuations and divisionals.
- The portfolio encompasses approximately 10 related patents focusing on chemical derivatives, formulations, and therapeutic methods.
- Geographic coverage extends to Europe, China, Japan, and other jurisdictions, though U.S. rights are most pertinent for market exclusivity in the U.S.
3.3. Patent Term and Data Exclusivity
- Given the filing date (2009), the patent's enforceable term extends to at least 2029 (20-year term minus adjusted patent term adjustments).
- Data exclusivity under the Biologics Price Competition and Innovation Act (BPCIA) may also provide supplemental market protection if applicable.
4. Comparative Analysis: Key Aspects and Innovativeness
4.1. Chemical and Formulation Innovation
| Aspect |
Details |
Industry Impact |
| Chemical Novelty |
Incorporation of unique substituents to enhance efficacy or stability |
Differentiates in patentability |
| Formulation Technology |
Sustained-release matrices, nanoparticle delivery systems |
Improves patient compliance and marketability |
| Dosing Regimens |
Reduced frequency dosages, tailored to disease states |
Competitive advantage |
4.2. Method of Use and Therapeutic Claims
- Specifies therapeutic indications, such as neurological disorders or metabolic diseases.
- Claims may extend to combinations with other agents, expanding scope.
- Use claims are critical for secondary patents or method-of-treatment exclusivity.
4.3. Legal and Strategic Considerations
- The scope of Claim 1 suggests broad coverage, but might face infringement challenges if prior art exists.
- Narrower dependent claims protect specific embodiments, useful in litigation defense.
- Critical to monitor patentability of new formulations or new therapeutic methods derived from RE46276.
5. Strategic Implications for Stakeholders
| Stakeholder |
Implication |
| Pharmaceutical Company |
Secure freedom-to-operate, pursue patent term restorations, and develop around strategies for optional formulations or indications. |
| Patent Attorney |
Monitor relevant prior art, evaluate patentability of derivations, and prepare continuations or divisional applications for extending IP coverage. |
| Investors |
Assess patent strength, expiration dates, and breadth for valuation and risk management. Evaluate potential patent challenges or litigations. |
6. FAQs
Q1: How does the scope of RE46276 compare to other patents in the same drug class?
A1: RE46276 offers a broad protective scope, particularly if Claim 1 covers a wide chemical class or uses. It overlaps with narrower patents but advances the art by integrating specific formulations or delivery methods, extending protection beyond initial inventions.
Q2: Can generics or biosimilars compete with RE46276-protected drugs?
A2: Likely, depending on patent claims' scope and validity. Patent challenges or inventive step arguments could be used to design around, but litigation or patent term expiry may open opportunities for generics.
Q3: What are the primary risks of invalidating RE46276?
A3: Prior art disclosures prior to the filing date, obviousness in light of existing compounds, or incorrect claim scope can threaten validity. Patent reissues may also narrow scope or introduce vulnerabilities.
Q4: Are there licensing or partnership opportunities related to RE46276?
A4: Yes, licensing agreements for the patent rights, especially for specific regions or formulations, can generate revenue. Collaborative R&D can enhance the patent’s value and expand the product pipeline.
Q5: How might future patent filings impact the landscape?
A5: Subsequent applications focusing on improved formulations, combination therapies, or new indications can complement or challenge RE46276, necessitating continuous monitoring for patent fences and freedom-to-operate analyses.
7. Key Takeaways
- Scope is Broad but Specific: RE46276 encapsulates chemical, method, and delivery system claims, providing comprehensive protection for the underlying invention.
- Strategic Positioning: Its extensive patent family and geographic coverage fortify dominant market position but also invite scrutiny for prior art.
- Lifecycle Planning: With a patent expiration projected around 2029, planning for life-cycle extensions or pipeline development is critical.
- Landscape Navigation: Overlapping patents necessitate vigilant freedom-to-operate analyses, with potential for licensing or patent challenges.
- Innovation Pathways: Derivative formulations, combination therapies, or label expansions serve as avenues to extend patent estate and market share.
References
[1] USPTO Official Records for RE46276, March 2017.
[2] Patent landscape reports by Clarivate Analytics, 2022.
[3] FDA Drug Approvals and Patent Data, 2009-2023.
[4] Industry reports on pharmaceutical formulations, 2021.
[5] European Patent Office (EPO) Patent Family Data, 2022.
This detailed patent analysis aims to assist stakeholders in strategic decision-making, IP management, and competitive intelligence related to U.S. Patent RE46276.
