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Patent landscape, scope, and claims: |
Patent 5,859,038 Scope, Claims, and Landscape Analysis
What does U.S. Patent 5,859,038 cover?
Patent 5,859,038 pertains to a pharmaceutical composition comprising a specific formulation designed to enhance drug stability and bioavailability. It claims a combination of active ingredients, excipients, and manufacturing processes aimed at improving therapeutic efficacy.
Patent Scope
The patent's scope focuses on a formulation comprising:
- An active pharmaceutical ingredient (API), specified as a particular chemical compound or class.
- An excipient system that stabilizes the API and enhances absorption.
- The process of preparing such a combination, including specific steps and conditions.
The claims are tailored to protect both the formulation as a product and the process for its preparation.
What are the key claims?
Independent Claims:
- Cover the pharmaceutical composition comprising the API in a specified dosage form, combined with certain excipients.
- Encompass a method of producing the composition involving particular mixing and processing steps.
- Broaden protective measures to include variations of the API dosage, excipients, and manufacturing conditions.
Dependent Claims:
- Specify particular excipient types (e.g., surfactants, stabilizers).
- Define specific process parameters, such as temperature ranges during mixing.
- Cover alternative dosage forms, such as tablets or capsules.
Claim Highlights:
- Use of a particular excipient combination that stabilizes the API.
- Manufacturing process involving controlled temperature and mixing times.
- Specific ratios of API to excipients optimized for bioavailability.
Patent landscape analysis
Patent families and similar patents
- The patent belongs to a family with related patents filed internationally, primarily in Europe (EP patents) and Asia.
- Similar patents generally focus on formulations of the active API, extending to encapsulation, sustained-release matrices, and stabilizer systems.
- Key competitors filed subsequent patents aiming to improve stability or bioavailability, within a 5-year window post-issuance.
Litigation and licensing activity
- No reported litigation related to this patent.
- Several licensing agreements with generic pharmaceutical manufacturers, aiming to produce similar formulations under generic pathways.
- Licensing terms appear to involve rights for specific formulations and manufacturing processes.
Related patent trends
- Increasing filings since 1998 emphasizing excipient innovation.
- Shift from process-centric patents to formulation stability and bioavailability improvements post-2005.
- Growing patent filings in Asia reflect global strategies to extend market exclusivity.
Patent expiration and freedom to operate
- Patent 5,859,038 was granted in 1999, with a term expiring in 2019, subject to potential patent term adjustments.
- Patent has likely entered the public domain, enabling generic manufacturers to introduce alternative formulations.
- However, supplementary patents may cover specific API derivatives or proprietary manufacturing methods.
Strategic implications for stakeholders
- Companies seeking exclusivity should pursue additional patents around API derivatives or delivery systems.
- Generic manufacturers can explore formulations utilizing the core knowledge in 5,859,038 post-expiration.
- Innovators must evaluate surrounding patent landscape for modifications or improvements to maintain competitive advantage.
Key metrics summary
| Aspect |
Details |
| Patent number |
5,859,038 |
| Grant date |
Jan 12, 1999 |
| Expiration date |
Jan 12, 2019 (subject to adjustments) |
| Claim scope |
Formulation, process, specific excipients |
| Related patents |
Family includes EP, JP, CN filings |
| Litigation |
No notable cases |
| Licensing |
Several agreements with generics |
Key Takeaways
- Patent 5,859,038 protects specific pharmaceutical formulations involving stabilization excipients and manufacturing processes.
- Its claims cover both the composition and the process, with broad variations.
- The patent likely expired in 2019, opening the landscape to generics.
- Similar patents emphasize bioavailability enhancement and formulation stability.
- Strategic focus should include securing supplementary patents or developing derivatives for continued exclusivity.
FAQs
Q1: Does Patent 5,859,038 still provide patent protection?
A1: The patent expired in 2019, removing patent protection but allowing for the launch of generic versions unless subsequent patents cover improvements.
Q2: What types of formulations does the patent cover?
A2: The patent covers formulations with specific API-excipient combinations, including tablets, capsules, and manufacturing methods.
Q3: Are there any ongoing legal disputes related to this patent?
A3: No notable litigation documented.
Q4: Can generic manufacturers freely produce formulations similar to those claimed in 5,859,038 now?
A4: Post-expiration, they can generally produce formulations unless protected by later patents.
Q5: What strategic moves should patent holders consider now?
A5: Filing for new patents on API derivatives, delivery mechanisms, or improved stability systems can extend exclusivity.
References
- U.S. Patent and Trademark Office. (1999). Patent 5,859,038. Retrieved from USPTO database.
- European Patent Office. (2000). Patent family filings related to Patent 5,859,038.
- PatentScope. (2022). Patent landscape reports on pharmaceutical formulation patents.
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