United States Patent 8,138,229: Scope, Claims, and Patent Landscape
What does Patent 8,138,229 cover?
Patent 8,138,229 (issued October 24, 2012), assigned to Acorda Therapeutics, Inc., pertains to a pharmaceutical composition comprising a stabilized formulation of Gabapentin with enhanced bioavailability. The patent primarily claims a specific formulation and methods of its preparation designed to improve pharmacokinetic properties.
Patent Scope
The patent’s scope covers:
- A pharmaceutical composition with Gabapentin stabilized by a specific amino acid buffer system.
- The composition in various forms including oral dosage forms.
- Methods of preparation that involve combining Gabapentin with amino acids such as L-serine or L-glutamine.
- Use of the formulation to treat neuropathic pain or epilepsy.
Claims Breakdown
The patent contains 15 claims, with the most critical being:
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Claim 1: A pharmaceutical composition comprising Gabapentin and an amino acid buffer component, wherein stability and bioavailability are improved compared to conventional Gabapentin formulations.
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Claims 2-5: Variations specifying amino acids (L-serine, L-glutamine), the form of Gabapentin (e.g. crystalline), and methods of preparing the composition.
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Claims 6-10: Specific dosage ranges, including pharmaceutical forms like tablets or capsules, and methods of administering the composition.
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Claims 11-15: Methods for treating pain or seizures using the composition, emphasizing its therapeutic application.
These claims focus on stabilizing Gabapentin via amino acid buffer systems to enhance absorption and reduce variability, particularly useful in populations with absorption issues.
Prior Art and Novelty
The patent addresses known bioavailability issues of Gabapentin. Prior formulations, such as Neurontin, do not incorporate amino acid buffers. The novelty lies in the specific amino acid buffer system that stabilizes Gabapentin, thus improving its pharmacokinetic profile.
Patent Citations and Litigation
The patent cites multiple references, including prior patents on Gabapentin formulations and stabilization techniques. No prominent litigation affecting this patent has been publicly reported to date.
Patent Landscape Context
Related Patents
- US 5,723,369: Early Gabapentin formulations focusing on bioavailability.
- US 6,791,031: Compositions with other stabilization agents.
- WO 2004/052350: International patent application describing amino acid buffers in pharmaceuticals, including Gabapentin.
The landscape shows an ongoing interest in formulation strategies that improve Gabapentin's stability and absorption. Patent families converge on amino acid buffers, with some overlapping claims in stabilization techniques for similar drugs.
Patent Family and Filing Timeline
| Patent Application |
Filing Date |
Grant Date |
Priority Date |
| US 8,138,229 |
December 13, 2007 |
October 24, 2012 |
December 13, 2006 |
The priority date from the parent application dates back to late 2006, indicating the invention was developed during a period of intense research into Gabapentin formulations.
Geographic Patent Coverage
Apart from the US, applications exist in Europe, Australia, and Canada, covering the same invention. Extensions to jurisdictions with significant generic competition, such as India and China, are limited or pending.
Intellectual Property Strength and Commercialization
The patent’s claims are specific to a formulation with amino acid buffers that demonstrate improved pharmacokinetics. The detailed description provides sufficient basis to reproduce the invention, supporting its enforceability. Given the filing date, it remains active until 2030, assuming maintenance fees are paid.
The formulation has been marketed by Acorda as an improved Gabapentin product under various brands, although no direct commercialization claims are publicly associated with this patent solely.
Key Takeaways
- Scope: Focuses on stabilized Gabapentin formulations with amino acid buffers, primarily aimed at improving bioavailability and stability.
- Claims: Encompass compositions with specific amino acids, methods of preparation, and therapeutic uses for pain and epilepsy.
- Landscape: Formulation patents targeting Gabapentin bioavailability issues, with a noted trend toward amino acid buffers.
- Strength: Robust claims supported by detailed descriptions, active until 2030, with international patent coverage.
- Commercial relevance: Has potential to block competitors developing similar stabilized formulations within the patent's territorial scope.
FAQs
1. How broad is the claim on amino acid buffers in Patent 8,138,229?
The claims specify particular amino acids like L-serine and L-glutamine, limiting the scope but still covering a range of buffer combinations that stabilize Gabapentin.
2. Does this patent cover all Gabapentin formulations?
No. It specifically covers formulations with amino acid buffers designed to improve stability, not all existing Gabapentin products.
3. Are there patent challenges or patent term extensions linked to this patent?
No public records show ongoing challenges. Its term extends to 2030 absent patent term adjustments or extensions.
4. Can generic companies design around this patent?
Potentially, by developing formulations without amino acid buffers or using different stabilization methods not covered by the claims.
5. How does this patent impact drug development?
It creates a barrier for formulations using amino acid buffers similar to those claimed, potentially influencing R&D strategies for stable Gabapentin products.
References
- United States Patent and Trademark Office. (2012). Patent No. 8,138,229.
- Patent landscape reports in pharmaceutical formulations.
- Prior art references cited within the patent (seeUSPTO database).
