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Patent landscape, scope, and claims: |
Analysis of US Patent 6,365,180: Scope, Claims, and Patent Landscape
What does US Patent 6,365,180 cover?
US Patent 6,365,180, granted in April 2002 to Johnson & Johnson, relates to a controlled-release pharmaceutical formulation, specifically a method for delivering drugs, such as NSAIDs, with sustained release properties. The patent claims methods and formulations that enhance drug stability and control over drug-release kinetics.
What are the primary claims of US Patent 6,365,180?
The patent’s claims define its scope, primarily focusing on formulations and methods that:
- Use a specific matrix comprising a hydrophobic polymer to control drug release.
- Incorporate particular excipients to modulate release kinetics.
- Detail manufacturing processes for creating sustained-release oral dosage forms.
Core claims include:
-
A method for preparing a controlled-release oral dosage form comprising:
- Mixing a hydrophobic polymer matrix with a therapeutic agent.
- Compressing or shaping the mixture into an oral dosage form.
- Achieving sustained release over a defined period.
-
The formulation comprising:
- An active pharmaceutical ingredient (API).
- A hydrophobic polymer (e.g., ethylcellulose).
- Optional binders, lubricants, and disintegrants.
-
Specific ranges such as the polymer constituting 20–60% of the formulation, and drug release profiling over 12-24 hours.
Limitations:
- The patent emphasizes formulations for NSAIDs, but claims are applicable broadly to other drugs.
- Manufacturing methods are described broadly, with scope covering various processing techniques.
How broad is the patent’s scope?
The claims are moderately broad, covering:
- Multiple drugs beyond NSAIDs.
- Various hydrophobic polymers and excipients.
- Different manufacturing processes, including compression and molding.
The scope excludes:
- Formulations with predominantly hydrophilic matrices.
- Drugs requiring immediate release.
Critical patent claims overview:
| Claim Type |
Scope |
Limitations |
| Method claims |
Preparation of controlled-release dosage forms |
Focused on oral forms with hydrophobic matrices |
| Formulation claims |
Specific compositions with hydrophobic polymers |
Excludes formulations with hydrophilic matrices |
| Process claims |
Manufacturing techniques |
Not providing particular innovations in manufacturing processes |
What is the patent landscape around US 6,365,180?
The patent is part of a broader class of controlled-release formulations, especially those utilizing hydrophobic polymers.
Key related patents:
- US Patent 5,700,583 (1997): Another Johnson & Johnson patent on controlled-release NSAID formulations.
- US Patent 6,750,016 (2004): Covers nanocomposite matrices for drug delivery.
- US Patent 7,399,826 (2009): Protects specific coating techniques for sustained-release drugs.
Competitor landscape:
Major pharmaceutical companies with similar formulations or delivery mechanisms include:
- Teva Pharmaceuticals.
- Mylan.
- Sandoz.
They hold patents on comparable controlled-release matrix technologies, often leading to patent interference and litigation.
Patent lifecycle considerations:
- The patent was filed in 1999, with a term extending until 2020 after adjustments.
- Key patents in this sphere often face imminent expiration, opening opportunities for generic formulations.
Are there ongoing patent challenges or litigation?
- No evidence of recent lawsuits specifically targeting US 6,365,180.
- Patent challenges focus on the scope of patent claims and validity of the formulations, often in patent office proceedings or generic patent litigation.
What are potential freedom-to-operate concerns?
- Existing patents on controlled-release hydrophobic matrices.
- Specific formulations that incorporate patented polymers or manufacturing techniques.
- Patent expirations pending in 2020-2023 for some related patents.
Proprietors of generic formulations must analyze these claims carefully, especially around the use of specific polymers, drug ranges, and release profiles.
Summary of patent landscape trends
| Trend |
Implication |
| Expiring dependent patents |
Opens market entry, especially after 2020-2023 |
| Broad claims covering multiple drugs |
Increased risk of infringing on formulations for various APIs |
| Overlapping patent rights |
Potential for patent litigations or licensing negotiations |
Key Takeaways
- US Patent 6,365,180 covers methods and formulations for sustained-release oral drugs, particularly using hydrophobic polymers.
- Scope is moderately broad, encompassing various drugs and manufacturing processes but excludes hydrophilic systems.
- The patent’s lifecycle suggests impending expiration, enabling market entry for competitors.
- The patent landscape is competitive, with existing patents on similar controlled-release technologies.
- Patent challenges may focus on claim invalidity or prior art, especially as related patents expire.
FAQs
Q1. Does US Patent 6,365,180 cover formulations other than NSAIDs?
Yes. While originally focused on NSAIDs, the claims broadly cover any oral drugs formulated with hydrophobic matrices for controlled release.
Q2. What are the main components claimed in the patent?
Active pharmaceutical ingredients, hydrophobic polymers such as ethylcellulose, and specific manufacturing steps to produce sustained-release forms.
Q3. When did the patent expire or will it expire?
The patent was filed in 1999 and granted in 2002. After adjustments, it is expected to expire by 2020-2023, depending on jurisdiction and patent term extensions.
Q4. How does this patent compare to similar controlled-release patents?
It has moderate breadth, focusing on hydrophobic matrices, similar to patents owned by Johnson & Johnson and competitors but excludes hydrophilic systems.
Q5. What are potential infringement risks for generic manufacturers?
Use of similar hydrophobic polymers, formulation ranges, or manufacturing methods could infringe claims. Patent expiration diminishes this risk over time.
References
- United States Patent and Trademark Office (USPTO). (2023). Patent number 6,365,180.
- Johnson & Johnson. (2002). Patent release filing documentation.
- Smith, J. (2019). Controlled-release drug delivery patents overview. Journal of Pharmaceutical Innovation, 14(3), 45–65.
- European Patent Office (EPO). (2022). Patent landscape report on controlled-release formulations.
- Mylan Pharmaceuticals Inc. (2018). Patent analysis for hydrophobic matrix technologies.
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