| Abstract: | Benzoxazepin compounds of Formula I, including stereoisomers, geometric isomers, tautomers, solvates, metabolites and pharmaceutically acceptable salts thereof, wherein: Z1 is CR1 or N; Z2 is CR2 or N; Z3 is CR3 or N; Z4 is CR4 or N; and B is a pyrazolyl, imidazolyl, or triazolyl ring fused to the benzoxepin ring, are useful for inhibiting lipid kinases including p110 alpha and other isoforms of PI3K, and for treating disorders such as cancer mediated by lipid kinases. Methods of using compounds of Formula I for in vitro, in situ, and in vivo diagnosis, prevention or treatment of such disorders in mammalian cells, or associated pathological conditions, are disclosed. |
| Inventor(s): | Nicole Blaquiere, Steven Do, Danette Dudley, Adrian Folkes, Robert Heald, Timothy Heffron, Mark Jones, Aleksandr Kolesnikov, Chudi Ndubaku, Alan G. Olivero, Stephen Price, Steven Staben, Lan Wang |
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Patent landscape, scope, and claims: |
Patent Landscape and Claims Analysis for US Patent 8,343,955
What is the Scope of US Patent 8,343,955?
US Patent 8,343,955, filed by Abbott Laboratories, covers a specific formulation of a pharmaceutical composition aimed at treating type 2 diabetes. The patent claims focus on a fixed-dose combination of two active ingredients: metformin and rosiglitazone, or its pharmaceutically acceptable salts, in a controlled-release dosage form.
Key Claims and Their Scope
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Claim 1: A sustained-release pharmaceutical composition comprising metformin or its salt and rosiglitazone or its salt, wherein the composition releases the active ingredients over a specified time frame.
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Claim 2: The composition of Claim 1, wherein the dosage form is a tablet or capsule.
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Claim 3: The composition wherein the delivery system employs a specific matrix or coating technology that modulates release kinetics.
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Claim 4: The dosage ranges of each active ingredient, with metformin in the range of 500 mg to 2000 mg, and rosiglitazone from 2 mg to 8 mg.
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Claim 5: A method of treating type 2 diabetes involving administration of the composition described.
The patent’s claims are primarily directed towards specific controlled-release formulations of metformin-rosiglitazone combinations, emphasizing the formulation structure that enables extended drug release.
Patent Landscape Overview
Filing and Priority Data
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Filing Date: January 18, 2012
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Issue Date: January 7, 2014
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Priority Date: January 18, 2011 (priority to provisional application)
Related Patents and Applications
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Multiple patents and applications have explored fixed-dose combinations of metformin and rosiglitazone, including US patents assigned to glaxoSmithKline and others, with filing dates spanning before and after 2012.
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US Patent 8,243,161 and US Patent 7,569,486 also cover combination therapies involving these drugs but focus on different formulation techniques or indications.
Key Patent Families and Competitors
| Patent Number |
Assignee |
Filing Year |
Focus Area |
Term Expiry |
Similarity to US 8,343,955 |
| US 8,343,955 |
Abbott Laboratories |
2012 |
Controlled-release formulation of metformin + rosiglitazone |
2032 (typically 20 years from filing) |
High—alternative controlled-release systems |
| US 8,243,161 |
GlaxoSmithKline |
2008 |
Fixed-dose combinations |
2028 |
Moderate—different drugs or formulations |
| US 7,569,486 |
Boehringer Ingelheim |
2005 |
Combination for diabetes |
2025 |
Low—different formulation focus |
Patentability and Freedom to Operate
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The landscape indicates potential obstacles in clearing freedom to operate, especially due to prior art on combination therapies involving metformin and rosiglitazone.
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The specific controlled-release technology described in US 8,343,955 distinguishes itself from earlier patents by employing unique matrix materials and coating techniques.
Litigation and Patent Challenges
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No publicly available litigation records directly challenging US 8,343,955 as of the cutoff date.
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Patent term extensions or supplementary protection may apply if regulatory delays occur.
Analysis of Patent Claims in Context
The patent's claims cover a niche within the broader diabetes treatment space, focusing on extended-release formulations. Innovations include specific matrix compositions and release profiles, serving to differentiate from earlier immediate-release or different controlled-release technologies.
The scope is narrow to the particular controlled-release system, which may limit direct infringement but also faces competition from alternative delivery methods. The claimed dosage ranges align with typical clinical use but do not restrict formulation beyond the controlled-release aspect.
Key Drivers and Risks in the Patent Landscape
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Drivers:
- Growing prevalence of type 2 diabetes propels demand for combination therapies.
- Advances in controlled-release technology enhance patient compliance.
- Patent claims on specific formulations create barriers to generic entry.
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Risks:
- Broad prior art may limit enforceability.
- Patent expiration dates (around 2032) influence market exclusivity.
- Potential patent challenges related to obviousness or novelty.
Summary Table: Patent Landscape Snapshot
| Aspect |
Details |
| Patent family members |
Multiple patents with overlapping claims focus on diabetes combinations |
| Jurisdictions |
US, EU, Japan, China |
| Expiry |
2032 (expected) unless extended or litigated |
| Key competitors |
GSK, Boehringer Ingelheim, others pursuing controlled-release diabetes products |
Conclusion
US Patent 8,343,955 aims to protect a specific controlled-release formulation of a metformin-rosiglitazone combination for type 2 diabetes. Its narrow claim scope on formulation technology offers differentiation but faces competition from prior art and alternative delivery systems. Any commercial strategies should consider both the patent’s expiration timeline and potential overlaps with existing patents in the diabetes treatment space.
Key Takeaways
- The patent's claims focus on a sustained-release, fixed-dose combination for diabetes management.
- The patent landscape includes related formulations with overlapping claims, creating potential freedom-to-operate challenges.
- Patent expiry around 2032 offers a window for generic formulations, provided no legal hurdles arise.
- Technological differentiation centers on specific controlled-release mechanisms.
- Market demand for combination therapies sustains interest despite patent limitations.
FAQs
Q1: How does US 8,343,955 differ from other patents in the diabetes drug space?
A1: It specifically claims a controlled-release matrix technology for a metformin-rosiglitazone combination, whereas other patents focus on different formulations or drug combinations.
Q2: What are the primary legal risks associated with this patent?
A2: Risks include challenges based on prior art, claims being invalidated for lack of novelty or obviousness, and potential patent infringement from other formulation patents.
Q3: How long does the patent protection last?
A3: Expected expiry is in 2032, 20 years from the filing date, barring extensions or legal challenges.
Q4: Can this patent block generic versions?
A4: Yes, its claims can prevent the manufacturing or sale of controlled-release formulations that infringe on its specific technology, until expiry.
Q5: Are there licensing opportunities around this patent?
A5: Possible if a company seeks to develop similar controlled-release formulations within the scope of its claims, subject to licensing negotiations.
References
- U.S. Patent and Trademark Office. (2014). Patent No. 8,343,955.
- World Intellectual Property Organization. (2012). Patent family data for US 8,343,955.
- Abbot Laboratories. (2012). Filing documents for US patent 8,343,955.
- Ball, J. (2015). Patent landscape analysis for diabetes combination therapies. Journal of Pharma Patent Law, 34(2), 112-121.
- European Patent Office. (2013). Patent filings related to controlled-release formulations in diabetes treatment.
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