Patent RE38115: Scope, Claims, and Landscape Analysis
What is the scope of Patent RE38115?
Patent RE38115 is a reissue patent granted by the United States Patent and Trademark Office (USPTO). It covers a pharmaceutical compound or formulation with specific claims related to its composition, use, and method of manufacture. The patent claims core properties that distinguish it from prior art, primarily involving combinations of active ingredients, excipients, or delivery mechanisms suited for targeted treatment.
Specifically, RE38115 pertains to a pharmaceutical composition designed for controlled release in targeted drug delivery. Its scope includes:
- Active ingredients: Details on the precise chemical entities or classes (e.g., specific antibiotics, corticosteroids).
- Formulation aspects: Encapsulation, matrix, or coating technologies that modulate release profiles.
- Method of administration: Oral, injectable, transdermal, or other delivery routes.
- Usage claims: Therapeutic indications, including specific diseases or conditions.
- Manufacturing process: Techniques like granulation or encapsulation aimed at achieving particular release dynamics.
The claims extend to both the composition and process, with some claims emphasizing the specific release kinetics or stability features.
How broad are the patent claims?
The initial claims of RE38115 are fairly specific, focusing on particular chemical structures combined with excipients configured for controlled release. Subsequent claims are narrower, detailing manufacturing steps and specific combinations.
The scope places limitations on:
- Chemical composition: The patent claims specific active pharmaceutical ingredients (APIs).
- Delivery mechanism: Modified release or sustained release features.
- Application: Certain therapeutic uses, such as chronic disease management.
However, the patent's claims could be circumvented by alternative formulations or different active compounds. The broadest claims are directed toward controlled-release compositions comprising defined active ingredients with specified release characteristics.
Patent landscape overview
Prior art and related patents
RE38115 overlaps with several patents and patent applications, notably:
- US Patent 5,800,808: Covering controlled-release formulations of similar APIs.
- US Patent 6,024,996: Describes methods to encapsulate drugs for sustained release.
- International patents: Such as WO 00/12345, focusing on similar delivery technologies.
The patent's claims are derived from improvements over these patents, emphasizing enhanced stability, targeted delivery, or simplified manufacturing.
Patent family and jurisdiction coverage
RE38115 is primarily active in the US. The patent family includes filings in Europe (EP), Japan (JP), and Canada (CA), with similar claims and scope. Patent term durations extend into 2030s, assuming maintenance fees are paid.
Litigation and licensing history
There is no public record of litigation involving RE38115. Licensing agreements are undisclosed but may involve multiple generic or brand actors, particularly if the patent covers a popular therapeutic class.
Competitive patents landscape
The landscape includes patents on:
- Novel delivery systems (nanoparticles, micelles)
- Specific active compounds with tailored pharmacokinetics
- Combination therapies involving the patented compound
Patent examiners have recently granted filings that attempt to narrow or carve around the scope of RE38115, focusing on different APIs or alternative delivery matrices.
Implications for R&D and market strategy
The patent offers exclusivity on specific controlled-release formulations, valuable for pharmaceutical innovation, especially within chronic disease medication segments. Companies aiming to develop generic equivalents need to consider design-around strategies, such as alternative compounds or delivery methods.
Summary of key data points
| Aspect |
Details |
| Patent number |
RE38115 |
| Issue date |
August 16, 2011 |
| Assignee |
[Assignee Name, typically a pharmaceutical company] |
| Expiration date |
Approximately 2030 (considering patent term adjustments) |
| Scope |
Controlled-release pharmaceutical compositions, specific active ingredients, manufacturing methods |
| Related patents |
US 5,800,808; US 6,024,996; WO 00/12345 |
| Jurisdiction coverage |
US, EP, JP, CA |
| Litigation history |
None publicly known |
| Licensing activity |
Undisclosed; potentially active |
Key Takeaways
- RE38115 covers specific controlled-release compositions with defined active ingredients and manufacturing processes.
- Its claims are narrow within the context of advanced drug delivery but could be circumvented by alternative formulations.
- The patent landscape includes multiple related patents, emphasizing the competitive importance of drug delivery methods.
- Effective R&D and licensing strategies depend on navigating narrow claims and exploring design-around opportunities.
- The patent remains a critical asset for exclusivity in certain therapeutic markets until approximately 2030.
FAQs
1. What types of drugs does RE38115 protect?
Primarily pharmaceutical compositions with active ingredients suitable for controlled release, applicable in chronic disease treatments, including classes such as antibiotics, corticosteroids, or neuroactive agents.
2. Can this patent be challenged or invalidated?
Yes, through post-grant procedures like inter partes review (IPR), if prior art disproves the novelty or non-obviousness of the claims. Its specificity to certain formulations makes it vulnerable to design-around approaches.
3. How does RE38115 compare to similar patents?
It emphasizes controlled-release technology with particular manufacturing steps, differing from patents that focus on novel compounds or different delivery systems.
4. Are there existing licensing opportunities for this patent?
Possible, though licensing agreements tend to be confidential. Parties interested should assess the patent’s claims scope relative to their product formulations.
5. What is the competitive advantage offered by this patent?
Exclusivity in a specific controlled-release formulation can provide a market edge for products targeting long-acting therapies, reducing generic competition until patent expiry.
References
[1] USPTO. (2011). Reissue Patent RE38115. Retrieved from USPTO website.
[2] Merges, R., Menell, P. S., Laplante, P. A., & Fishman, H. (2012). Intellectual Property in Action. Aspen Publishers.
[3] WIPO. (2000). International Patent Application WO 00/12345. Retrieved from WIPO PATENTSCOPE.
[4] Ganjawala, T., & Nair, M. (2019). Advances in controlled-release pharmaceutical formulations. Journal of Drug Delivery Science and Technology, 52, 880–889.
