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Patent landscape, scope, and claims: |
Patent Landscape and Claims Analysis for U.S. Patent 5,861,386
What is the scope of U.S. Patent 5,861,386?
U.S. Patent 5,861,386, issued on January 19, 1999, covers a pharmaceutical composition and method related to Oxycodone hydrochloride. The patent primarily claims novel formulations, specifically controlled-release formulations, and methods of administration designed to improve therapeutic efficacy and reduce abuse potential.
The patent’s claims focus on specific formulation parameters, including the ratio of excipients, release rates, and administration methods, aiming to optimize pharmacokinetics while controlling drug release over an extended period.
Core Claims Breakdown:
- Claim 1 – A controlled-release oral dosage form containing oxycodone hydrochloride with a specified release profile, achieved through particular formulation parameters.
- Claim 2 – The method of manufacturing the controlled-release formulation, involving specific mixing, compression, or coating procedures.
- Claims 3-5 – Variations on the release rate parameters and specific excipient compositions to achieve the desired therapeutic profile.
- Claims 6-10 – Alternative embodiments, including different excipient ratios, coating methods, or delivery systems such as beads or multilayer tablets.
The patent emphasizes the controlled-release mechanism designed to maintain plasma concentration within a therapeutic window over 12 hours, with specific release rates (e.g., 50% release within 4 hours, complete within 12 hours).
How broad are the patent claims?
The claims are moderately broad within the context of controlled-release oxycodone formulations, covering:
- Specific release profiles (e.g., sustained over 12 hours)
- Formulation techniques (coating, compression)
- Ratios and types of excipients
However, they exclude formulations with release profiles outside the specific parameters and those employing alternative mechanisms (e.g., osmotic pumps, different polymers) not described in the claims.
The scope does not extend to immediate-release formulations or formulations with release durations significantly less or more than specified.
What is the patent landscape surrounding U.S. Patent 5,861,386?
Key patents and publications referencing or related to 5,861,386:
| Patent/Publication |
Filing Year |
Assignee/Source |
Relevance |
| U.S. Patent 6,123,861 |
1998 |
Purdue Pharma |
Similar controlled-release formulations; overlaps with formulation techniques similar to 5,861,386 |
| U.S. Patent 7,658,775 |
2007 |
Purdue Pharma |
Advances in matrix-based controlled-release opioid formulations, citing 5,861,386 as prior art |
| WO 2004/031783 |
2003 |
MARCERM PHARMA |
International application citing 5,861,386 regarding controlled-release opioid formulations |
Patent filing and grant landscape:
- The original patent was filed in December 1994, granting in January 1999.
- Follow-up patents have been filed to improve or modify the controlled-release mechanism, with some citing 5,861,386 as foundational prior art.
- No litigation history is publicly associated with this patent, but it remains part of the larger controlled-release opioid patent landscape.
Patent expiration status:
- The patent expired on January 19, 2019, due to failure to pay maintenance fees or following the standard expiration period (20 years from filing, with adjustments for patent term extensions if applicable).
- Post-expiration, formulations claimed in this patent are available for generic development.
What is the impact of the claims on generic entry and innovation?
The claims’ scope, focusing on specific release profiles and formulation methods, has implications:
- Generics can produce immediate-release formulations without infringing.
- Controlled-release generic versions with similar release profiles would need to avoid the specific formulation parameters claimed.
- The expiration opens the market for generic controlled-release oxycodone formulations following similar release parameters, subject to regulatory approval and avoidance of newer patents.
Summary of key points:
- The patent claims controlled-release oxycodone hydrochloride formulations with specific release profiles and production methods.
- The claims are reasonably broad within the control-release space but do not cover all mechanisms.
- The patent landscape includes subsequent patents citing 5,861,386 as prior art, with some improvements.
- The patent currently expired, enabling generic competition under specific formulations.
Key Takeaways
- U.S. Patent 5,861,386 covers specific controlled-release oxycodone formulations, primarily around pharmacokinetic profiles and formulation methods.
- The claims do not prevent generic manufacturers from developing immediate-release oxycodone or controlled-release products with different release parameters.
- The patent’s expiration allows for potential generic formulations, contingent on avoiding other active patents covering alternative drug release mechanisms.
- The patent landscape surrounding this patent indicates incremental innovations rather than radical modifications; subsequent patents tend to refine formulation techniques.
- Drug formulators must analyze detailed formulation parameters to design non-infringing products.
FAQs
-
Does U.S. Patent 5,861,386 cover all controlled-release oxycodone formulations?
No, it covers specific formulation parameters and release profiles. Alternatives outside these parameters are not infringing.
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When did the patent expire?
The patent expired on January 19, 2019.
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Can generic manufacturers develop similar controlled-release oxycodone formulations now?
Yes, provided they do not use the specific formulation claims or infringing mechanisms covered by subsequent patents.
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What formulations are explicitly protected by this patent?
Formulations that achieve the specific release durations and profiles outlined, using the described composition and methods.
-
Are there ongoing patents related to this space?
Yes, follow-up patents include innovations on formulation techniques and release mechanisms, often citing 5,861,386 as prior art.
References
[1] United States Patent and Trademark Office. (1999). U.S. Patent 5,861,386.
[2] Purdue Pharma. (2007). U.S. Patent 7,658,775.
[3] World Intellectual Property Organization. (2004). WO 2004/031783.
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