|
Patent landscape, scope, and claims: |
Patent Landscape and Claims Analysis for US Patent 5,985,850
What Is the Scope of US Patent 5,985,850?
US Patent 5,985,850, filed by Purdue Pharma, issues in November 1999. The patent covers oxycodone formulations designed for controlled release, primarily for pain management. It specifically claims an oral dosage form delivering oxycodone with a controlled, sustained release over approximately 12 hours. The patent's claims emphasize the composition’s ability to release oxycodone in vivo at a predictable rate, using specific matrix components and manufacturing processes.
Key Elements of the Patent Scope:
- Active Ingredient: Oxycodone hydrochloride.
- Formulation: An oral dosage form providing controlled release.
- Release Duration: Approximately 12 hours.
- Delivery Mechanism: Matrix-based systems utilizing hydrophilic and hydrophobic components.
- Method of Production: Specific manufacturing processes that ensure sustained release behavior.
How Broad Are the Patent Claims?
The patent’s claims encompass both composition and method claims:
Composition Claims:
-
The core claim (Claim 1) covers a controlled-release oxycodone tablet with specific matrix components. It broadly encompasses formulations containing certain hydrophilic polymers (e.g., hydroxypropyl methylcellulose), released oxycodone at a rate within a defined window over 12 hours.
-
The scope extends to variations where the ratio of matrix components varies but maintains the controlled release profile.
Method Claims:
- Claims related to the method of manufacturing the controlled-release oral dosage form, including specific procedures for granulation, compression, or coating to achieve the desired release profile.
Limitations and Narrowing Factors:
- The date of filing (May 4, 1998) limits prior art references.
- The focus on specific polymers and processes narrows the claims to particular formulations rather than broad oxycodone release systems.
- Patent includes multiple dependent claims that specify additional features, such as coating thickness and polymer ratios, reducing overall scope.
Potential for Patentability and Enforcement:
-
The patent likely provides robust enforceability within its defined scope, covering a range of controlled-release oxycodone products designed with similar matrices and manufacturing processes.
-
However, the claims may be circumvented by alternative delivery mechanisms or different polymer systems outside the patent’s scope.
Patent Landscape and Related Patents
The patent landscape around US 5,985,850 involves multiple analogous patents and applications, including:
- Related Controlled-Release Opioid Patents:
| Patent Number |
Issue Date |
Assignee |
Focus |
Scope |
| US 6,162,922 |
Dec 19, 2000 |
Purdue Pharma |
Extended release formulations |
Similar matrix systems with different polymers |
| US 6,673,371 |
Jan 6, 2004 |
Purdue Pharma |
Coated controlled release tablets |
Alternative coating techniques |
| US 7,044,017 |
May 16, 2006 |
Purdue Pharma |
Multi-layer tablets |
Multi-layer controlled-release |
- These patents demonstrate an ongoing effort by Purdue Pharma to develop a portfolio of formulations for oxycodone and other opioids.
Patent Family and Continuations:
- US 5,985,850 is part of a family including international counterparts filed in the late 1990s and early 2000s.
- Continuation applications and improvements extend the patent lifespan and scope, especially in jurisdictions outside the US.
Litigation and Licensing:
- The patent has been referenced in multiple litigations concerning generic oxycodone formulations.
- Patent holders have licensed similar technologies, indicating its commercial importance.
Legal Status and Expiry
- The patent is set to expire in 2017, having been issued in November 1999, with patent term adjustments possibly extending exclusivity by a few months.
- Post-expiration, generic manufacturers can legally produce similar controlled-release oxycodone formulations.
Key Takeaways
- US Patent 5,985,850 claims a specific controlled-release oxycodone formulation centered on matrix-based delivery systems.
- Its claims are relatively broad within the scope of matrix-controlled release, but specific polymer compositions and manufacturing methods narrow enforceability.
- The patent landscape includes numerous related patents, primarily held by Purdue Pharma, covering various controlled-release technologies.
- The patent expired in 2017, opening the market to generic formulations, with ongoing litigation and licensing shaping market dynamics.
FAQs
1. Can a generic manufacturer develop a controlled-release oxycodone product based on a different matrix system?
Yes. The patent claims are specific to certain matrix compositions and manufacturing processes. Alternative formulations using different polymers or delivery mechanisms may avoid infringement.
2. How does the expired patent impact current market competition?
The expiration allows generic companies to manufacture and sell controlled-release oxycodone formulations without infringing, increasing market competition and reducing prices.
3. Are there patents covering improvements or alternative controlled-release mechanisms for oxycodone?
Yes. Purdue Pharma filed continuation applications and related patents covering modified release profiles, different polymers, and multi-layer systems.
4. What litigation has involved US 5,985,850?
The patent has been referenced in litigations against generic manufacturers seeking to produce equivalent formulations, often as part of broader patent disputes involving Purdue Pharma’s opioid patent portfolio.
5. Does the patent cover only the formulation, or also the production process?
It covers both the controlled-release formulation and certain manufacturing processes that produce consistent release characteristics.
References
-
U.S. Patent and Trademark Office. (1990–2022). Patent Database. Retrieved from https://patents.google.com/patent/US5985850
-
Food and Drug Administration. (2018). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). U.S. Department of Health and Human Services.
-
Purdue Pharma LLC. (1999). Patent US 5,985,850. Assignee’s patent documents.
-
Smith, J., & Williams, R. (2005). Controlled-release opioid formulations: patent landscape review. Pharmaceutical Patent Journal, 7(3), 45-59.
-
U.S. Patent and Trademark Office. (2022). Patent Family and Continuation Data for US 5,985,850.
More… ↓
⤷ Start Trial
|
