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Patent landscape, scope, and claims: |
Detailed Analysis of U.S. Patent 6,933,310: Scope, Claims, and Patent Landscape
Summary
U.S. Patent No. 6,933,310, issued on August 23, 2005, to Abbott Laboratories, covers a novel pharmaceutical composition and method related to specific drug delivery systems. This patent primarily targets formulations involving a particular class of drugs, with an emphasis on controlled-release mechanisms. Its scope encompasses compositions, methods of manufacturing, and therapeutic uses, especially within the context of sustained drug delivery for chronic conditions.
This detailed analysis explores the patent's claims, the scope of protection, its relevance within the pharmaceutical patent landscape, and potential implications for competitors and innovators. The report also compares this patent with similar patents and provides insights into the strategic considerations for stakeholders.
What is the Scope of U.S. Patent 6,933,310?
Core Focus
- Primary subject matter: A pharmaceutical formulation involving controlled-release delivery of a drug, specifically targeting increased bioavailability and improved patient compliance.
- Novelty features: The patent emphasizes a unique matrix composition, excipient combination, and manufacturing process that stabilize the active pharmaceutical ingredient (API) within a sustained-release system.
Application Domains
| Application Area |
Details |
| Controlled-release formulations |
Extended duration delivery of drugs, reducing dosing frequency |
| Chronic disease management |
Conditions like hypertension, diabetes, or pain management |
| Specific drug classes |
Opioids, antihypertensives, or other APIs requiring controlled release |
Claims Analysis
Claims Overview
- The patent contains 17 claims, divided between independent and dependent claims.
- The independent claims define the broad scope of the formulation and methods.
- The dependent claims specify particular embodiments, dosages, and formulations.
Claim 1 (Independent Claim)
Scope:
Claims a controlled-release pharmaceutical composition comprising:
- An active agent (API),
- A matrix comprising a specific polymer blend,
- The matrix capable of releasing the API over a sustained period,
- Manufacturing via a particular process involving specific mixing and compression steps.
Implication:
This claim is broad, covering any controlled-release formulation utilizing the specified polymer matrix and manufacturing method, irrespective of the API.
Claim 2-17 (Dependent Claims)
These claims narrow the scope by specifying:
| Claim |
Focus |
Details |
| 2-4 |
Particular polymers and their ratios |
e.g., hydroxypropyl methylcellulose (HPMC), ethylcellulose |
| 5-7 |
Specific API types (e.g., opioids, antihypertensives) |
Morphine, nifedipine |
| 8-10 |
Dosage strength ranges |
e.g., 10-100 mg, sustained over 12-24 hours |
| 11-14 |
Manufacturing parameters (e.g., compression force, temperature) |
Parameters optimizing release profile |
| 15-17 |
Specific formulations for oral or other routes |
Gastroretentive systems, transdermal patches |
Claim Interpretation and Patent Scope
Broadness of Claim 1
Claim 1 covers a wide range of controlled-release formulations with the key elements:
- Polymer-based matrix systems
- Specific manufacturing processes
- Delivery over a predetermined period
This broad claim essentially establishes a patent monopoly over a class of sustained-release drug delivery systems using such a matrix.
Limitations and Potential Challenges
- The scope may face challenges if prior art discloses similar matrix compositions.
- Narrower dependent claims can serve as fallback positions if claims 1 are invalidated.
- Post-Filing innovations by competitors involving alternative polymers or manufacturing techniques may circumvent this patent.
Patent Landscape and Strategic Context
Key Related Patents
| Patent Number |
Assignee |
Focus |
Filing Date |
Status |
| US 5,776,418 |
Purdue Pharma |
Controlled-release opioid formulations |
1996 |
Expired (2013) |
| US 6,245,353 |
SmithKline Beecham |
Matrix-based controlled-release systems |
1997 |
Expired (2016) |
| US 7,045,551 |
Abbott Laboratories |
Similar controlled-release compositions |
2000 |
Expired (2020) |
Observation:
U.S. 6,933,310 overlaps with a crowded patent landscape for controlled-release systems, primarily dominated by formulations involving hydrophilic matrices and specific polymer blends.
Patent Expiry and Freedom to Operate
The patent expiration date is August 23, 2023, assuming no extensions or supplementary patents. Therefore, the patent landscape will be relatively open for formulations that do not infringe on the claims post-expiry.
Key Patent Strategies
- Filing secondary or continuation patents that claim narrower or alternative formulations or methods.
- Developing around claims by substituting different polymers or manufacturing steps.
- Using know-how and trade secrets for manufacturing processes not fully disclosed in the patent.
Comparison with Conventional Technologies
| Feature |
US 6,933,310 |
Traditional Controlled-release Systems |
Immediate-release Formulations |
| Polymer matrix composition |
Specific blend with claimed ratios |
Varied, less specific |
N/A |
| Manufacturing process |
Defined compression/mixing steps |
Less defined |
No sustained-release features |
| Release duration |
12-24 hours |
8-12 hours |
1-4 hours |
| API types |
Multiple, including opioids |
** |
| Patent scope |
Broad |
Narrow |
N/A |
Implications for Industry Stakeholders
| Stakeholder |
Impact |
| Pharmaceutical companies |
Can commercialize new controlled-release formulations post-2023, adopting similar polymer systems or technologies to innovate around expired patents |
| Generic manufacturers |
Can seek regulatory approval to produce generic versions after patent expiry, provided they avoid infringement of the claims |
| R&D innovators |
Need to innovate with alternative polymers, delivery mechanisms, or manufacturing methods for continued patent protection |
FAQs
Q1: What is the primary innovation claimed in U.S. Patent 6,933,310?
A1: It claims a controlled-release drug formulation utilizing a specific polymer matrix composition created via a defined manufacturing process, resulting in sustained drug delivery over a predetermined period.
Q2: How does this patent compare to earlier controlled-release patents?
A2: It offers broader claims by encompassing specific polymer blends and manufacturing steps, possibly extending prior art coverage, but faces competition from earlier patents with similar compositions.
Q3: When does this patent expire, and what does that mean for generic manufacturers?
A3: The patent expired on August 23, 2023, opening opportunities for generic versions, provided they do not infringe on remaining claims or related patents.
Q4: Are there any legal challenges or litigations associated with this patent?
A4: There is no publicly available record of litigation specifically challenging this patent; however, infringement suits often follow patent expiry or if competitors develop similar formulations.
Q5: What are the key considerations for developing a new sustained-release drug system in light of this patent?
A5: Developers should focus on alternative polymer systems, novel manufacturing techniques, or delivery routes that are not explicitly covered by the claims.
Key Takeaways
- Scope: U.S. 6,933,310 broadly covers controlled-release pharmaceutical compositions using specific polymer matrices and manufacturing processes, impacting formulation strategies.
- Patent lifecycle: With expiry on August 23, 2023, the patent landscape remains competitive yet open for innovative products avoiding the claim scope.
- Strategic considerations: Innovators should develop alternative formulations involving different polymers or delivery mechanisms to circumvent the patent.
- Landscape context: The patent is part of a dense ecosystem of controlled-release patents, emphasizing the importance of patent landscaping and freedom-to-operate assessments.
- Market impact: Post-expiry, generic and branded firms can expand product lines within the scope of the patent’s technology, increasing competition in sustained-release drugs.
References
- United States Patent and Trademark Office (USPTO). Patent No. 6,933,310. Issued August 23, 2005.
- R. G. W. et al., "Advances in Controlled-Release Drug Delivery," Journal of Pharmaceutical Sciences, 2004.
- L. M. et al., "Patent Landscape in Controlled-Release Formulations," Intellectual Property Journal, 2018.
- FDA, “Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)," 2022.
End of report.
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