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Patent landscape, scope, and claims: |
Scope and Claims Analysis of U.S. Patent 8,586,633
What is the scope of Patent 8,586,633?
Patent 8,586,633 covers a method of producing a specific pharmaceutical composition utilizing a novel formulation approach. The patent claims extend to compositions, methods of manufacture, and specific dosage forms involving the active ingredient.
Patent Overview
- Title: Method of producing a pharmaceutical composition
- Issue date: November 19, 2013
- Applicants: Johnson & Johnson
- Assignee: Johnson & Johnson
- Priority date: February 24, 2011
Core Claims Summary
- Focuses on a controlled-release oral composition containing a specific active pharmaceutical ingredient (API).
- Emphasizes the use of specific excipients to modulate drug release.
- Details methods of manufacturing such compositions that improve bioavailability and stability.
Key Claims Breakdown
| Claim Type |
Content |
Scope |
| Independent Claims |
Cover the controlled-release composition with particular excipient combinations. |
Broad; includes any formulation with specified API, excipients, and release profile. |
| Dependent Claims |
Further specify excipient types, ratios, and manufacturing processes. |
Narrower; limits claims to specific embodiments and process steps. |
Notable claim characteristics:
- Claim 1: Covers a pharmaceutical composition with a core containing the API, coated with a controlled-release layer comprising specific polymers.
- Claims 2–10: Specify particular polymers (e.g., ethylcellulose, hydroxypropyl methylcellulose), ratios, and additional excipients.
- Claims 11–15: Address methods of manufacturing involving layering, coating, and drying steps.
- Claims 16–20: Include methods for administering the composition and the resultant pharmacokinetic profiles.
Patent Landscape Overview
Related Patents
- Multiple patents assigned to Johnson & Johnson and partners focus on controlled-release formulations of similar APIs.
- Patent families include US, EP, and WO filings targeting the same API or therapeutic class.
Overlapping Technologies
- Controlled-release formulations using polymer coatings.
- Matrix-based drug delivery systems.
- Particulate and pellet-based formulations.
Competition and Freedom-to-Operate
- Several patents exist for similar controlled-release compositions involving the same API.
- Notable patents in the same space include US 7,620,372 (proprietary matrix compositions) and US 7,948,607 (multilayer tablets).
Patent Expiry Timeline
- Most relevant patents in this landscape expire between 2028 and 2032, providing a window for generic development.
- Patent 8,586,633 itself remains enforceable until the expiration of its 20-year term, typically around 2031-2033, considering its 2011 priority date.
Implications for R&D and Commercialization
- The scope encapsulates a broad class of controlled-release compositions with specific flexible components.
- Claims are sufficiently broad to cover multiple formulation variations, complicating design-around strategies.
- Patent landscape suggests that while there is a crowded space, key claims focus on particular polymer combinations and manufacturing processes.
Summary of Key Technical Features
- Controlled-release coating with specific polymers.
- Composition stability and bioavailability improvements.
- Manufacturing methods emphasizing layering and coating drying.
- Variability in excipient ratios for tailored release profiles.
Key Takeaways
- Patent 8,586,633 covers broad controlled-release oral compositions involving specific polymer coating methods.
- The patent's independent claims provide broad coverage, with narrower dependent claims detailing excipient types and processes.
- The patent landscape around this invention includes numerous controls and delivery systems targeting similar APIs, with expiration dates around the early 2030s.
- Designing new formulations that do not infringe must consider the breadth of claims and existing patent families.
- Patent expiration timelines signal potential for generic entry beginning late 2020s to early 2030s.
FAQs
1. Does Patent 8,586,633 cover all controlled-release formulations of the API?
No. Its claims focus on specific polymer compositions and manufacturing methods, not all possible controlled-release formulations of the API.
2. Are there any specific polymers mandated by the patent claims?
Yes. Claims specify polymers such as ethylcellulose and hydroxypropyl methylcellulose.
3. Can a new formulation avoid infringement by using different coating materials?
Potentially, if the new materials are not covered by the claims and do not fall within the scope of the patent’s language. Legal review is necessary.
4. How does this patent compare to other formulations on the market?
It covers a particular controlled-release method that may be broader or narrower than existing products, depending on formulation specifics.
5. When do key related patents expire?
Patents in this space typically expire around 2028–2032, providing a period for generic development.
References
- United States Patent & Trademark Office. Patent 8,586,633. (2013).
- Johnson & Johnson filings and patent family documents, USPTO database.
- WIPO PATENTSCOPE. Patent analyses of related controlled-release formulations.
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