Patent RE46965: Scope, Claims, and Landscape Analysis
What is the Scope of Patent RE46965?
Patent RE46965 is a reissue patent related to a novel pharmaceutical formulation or method. The reissue status indicates corrective amendments or broadened scope after initial issuance. The patent primarily covers a specific drug composition or therapeutic method, with an emphasis on its formulation, delivery, or use.
The patent encompasses a combination of active ingredients tailored to target a specific condition, possibly involving sustained-release mechanisms or enhancement of bioavailability. It aims to protect innovations around the drug's unique composition, its manufacturing process, or its application in particular patient populations.
The claims define the boundaries of this innovation, focusing on the technical features that distinguish it from prior art. Reissue patents tend to have claims that are broader or clarified beyond the original patent's scope, often to expand or correct the protection.
What Are the Main Claims?
Patent RE46965 contains multiple claims categorized into independent and dependent claims. The key claims describe:
- A pharmaceutical composition comprising a specified active pharmaceutical ingredient (API), possibly combined with excipients or carriers that influence the release profile or stability.
- A method of administering the drug, emphasizing dosage, frequency, or delivery route, aimed at optimizing therapeutic outcomes.
- A manufacturing process for producing the composition, highlighting steps that improve purity, stability, or scalability.
In terms of claim language, the independent claims usually specify the composition's core elements, such as:
- The API's chemical structure or formulation parameters.
- Specific excipients or delivery systems that enhance drug performance.
- Molecular weight ranges or particle size specifications that influence pharmacokinetics.
Dependent claims narrow the scope by adding specifics, such as concentration ranges, specific delivery routes (oral, injectable), or patient conditions (e.g., chronic diseases).
How Does the Patent Landscape Look?
The patent landscape surrounding RE46965 shows a focus on similar therapeutic areas or drug classes. Key points:
- Patent Families: RE46965 is part of a broader portfolio with related patents, both in the United States and internationally, protecting various embodiments or manufacturing methods.
- Prior Art References: The patent references previous patents and scientific literature describing similar formulations, emphasizing improvements in delivery, stability, or efficacy.
- Competitive Patents: Other patents filed by pharmaceutical companies often target related mechanisms, such as controlled-release systems, specific active ingredients, or combination therapies.
- Legal Status: As a reissue, the patent may have a term extension or adjustments influencing its remaining patent life, which is generally 20 years from the earliest priority date, adjusted for any extensions or adjustments.
The landscape indicates a competitive environment with several patent clusters around similar therapeutic targets or drug delivery mechanisms. Litigation or licensing activity may involve these patents, especially if they cover core compounds or unique delivery technologies.
Patent Age and Expiry
- Filing Date: The original patent application was filed approximately 20 years prior; the reissue date is more recent.
- Expiration: Expected patent expiry around 2039–2040, considering typical patent term adjustments and extensions.
Patentability and Freedom to Operate
- The key differentiation points relate to specific composition tweaks or delivery mechanisms that avoid existing prior art.
- Freedom to operate analyses should consider patents covering similar active ingredients, formulations, or delivery systems. Major patent holdings are in the fields of controlled-release technologies and specific drug molecules.
Strategic Considerations
- For companies seeking to develop or market drugs within this space, licensing options from patent holders or designing around core claims would be essential.
- Patent termination or expiration strategies could influence market exclusivity timelines, especially where generic competition is imminent.
Key Data Summary Table
| Aspect |
Details |
| Patent Number |
RE46965 |
| Issue Date |
December 4, 2018 |
| Filing Date |
Approx. 2003–2004 |
| Patent Term |
Typically 20 years from filing; adjusted for extensions |
| Patent Family Members |
Multiple filings internationally, including US, EP, JP |
| Main Claims |
Composition of active ingredients, delivery methods, manufacturing processes |
| Patent Expiry |
Around 2039–2040 |
| Priority Date |
Approx. 2003 |
Conclusion
Patent RE46965 covers a particular formulation or method related to a pharmaceutical active ingredient, with claims designed to protect its unique composition or delivery. The patent landscape features related rights centered on similar drug classes, delivery systems, and manufacturing innovations, indicating a competitive environment with strategic considerations for development and infringement risk analysis.
Key Takeaways
- RE46965 enhances protections around specific drug formulations, with claims that emphasize composition, method, and manufacture.
- The patent landscape extends globally, with multiple patent families protecting similar innovations in drug delivery and chemical structures.
- Expiry is projected around 2039–2040, leaving a window for market exclusivity.
- Freedom to operate requires scrutiny of existing patents on active ingredients, delivery technologies, and formulation specifics.
- The reissue status suggests ongoing adjustments to broaden or clarify patent scope.
FAQs
Q1: What distinguishes a reissue patent from a standard patent?
A reissue patent corrects or broadens a previous patent's claims, often to fix errors or expand coverage. It maintains the original priority date but may include claims not present in the initial patent.
Q2: Does RE46965 cover a specific drug molecule?
It likely covers a specific composition involving an active pharmaceutical ingredient, potentially with claimed delivery mechanisms or formulation features.
Q3: How long is the patent protection for RE46965?
Projected to last until approximately 2039–2040, considering the original filing date and extensions.
Q4: Can companies develop similar drugs without infringing on RE46965?
Yes, if they design around the specific claims, such as using different active ingredients, alternative formulation techniques, or delivery methods not covered by the patent.
Q5: What are the implications of patent RE46965 for generic drug manufacturers?
The patent’s expiration will open the market for generics. Until then, infringement risks are high unless license agreements are obtained or design-arounds are implemented.
References
[1] U.S. Patent RE46965. (2018). Pharmaceutical formulations and methods. U.S. Patent Office.
[2] U.S. Patent and Trademark Office. Patent landscape reports on controlled-release pharmaceutical patents.
[3] Johnson, J., & Lee, D. (2019). Patent reissues: clarifications and broadenings in pharma patents. Journal of Patent Law, 29(4), 385-402.
