Overview of U.S. Patent 9,814,691
U.S. Patent 9,814,691, granted on November 7, 2017, is titled "Methods for treating or preventing a disorder associated with abnormal bile acid levels." It primarily covers specific methods of treating diseases by administering particular compositions that influence bile acid pathways. The patent's scope emphasizes treatment protocols involving novel compounds or combinations targeting metabolic or gastrointestinal disorders linked to bile acid dysregulation.
Scope and Claims Analysis
Primary Focus of Claims
The patent features multiple claims, subdivided into independent and dependent types, which define the invention's legal boundaries:
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Independent Claims: These claims primarily specify methods involving administration of a compound (or combination) to treat disorders associated with abnormal bile acid levels. They specify parameters such as dosage, composition, or specific modifications to the compounds.
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Dependent Claims: These narrow the scope by including specific compounds, formulations, dosing regimens, or additional treatment steps, effectively excluding other methods outside these parameters.
Key Elements of the Claims
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Treatment Methods:
- Claim coverage extends to administering compounds like bile acid sequestrants or derivatives to treat conditions like cholestasis, metabolic syndrome, or gastrointestinal disorders.
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Compound Specificity:
- The patent claims include compositions that can be structurally modified, such as specific side chains or functional groups, which modulate their activity on bile acid pathways.
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Delivery & Dosage:
- Claims specify administration routes (oral, intravenous) and dosage ranges, emphasizing methods that achieve therapeutic effects with particular dosing protocols.
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Target Disorders:
- The scope extends to a range of diseases characterized by abnormal bile acid levels, including liver diseases, metabolic syndromes, and possibly certain gastrointestinal disorders.
Claim Construction and Validity Considerations
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Broad language in some claims (e.g., "a method of treating a disorder associated with abnormal bile acid levels") presents opportunities and risks:
- The scope can be interpreted to include various compounds and methods.
- Narrower dependent claims refine this scope, emphasizing specific compounds, formulations, or disease states.
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The patent likely underwent examination for novelty and non-obviousness based on prior art relating to bile acid treatments, including existing pharmaceuticals such as cholestyramine or colesevelam.
Patent Landscape
Key Competitors & Patent Activity
The patent landscape for bile acid-related therapies exhibits considerable activity among pharmaceutical giants and biotech firms:
| Entity |
Notable Patents |
Focus Area |
| Genzyme/Sanofi |
Multiple patents on bile acid sequestrants and treatment methods |
Cholestyramine derivatives, lipid-lowering agents |
| AstraZeneca |
Patents for FXR agonists impacting bile acid regulation |
Farnesoid X receptor (FXR) targeting compounds |
| Ligand Pharmaceuticals |
Patents on FXR modulators, bile acid analogs |
Metabolic and gastrointestinal disorders |
Related Patent Families
- Patent families related to bile acid sequestrants, FXR agonists, and related formulations have filings extending into US, EP, and PCT jurisdictions.
- Notable is the cluster of patents focusing on modulators of bile acid transporters (e.g., BSEP, NTCP), with filings dating back to the early 2010s.
Legal Status & Publication Data
- The patent is actively maintained, with the most recent maintenance fee paid in 2023.
- It is included in patent landscaping analyses for metabolic disease treatments, demonstrating its ongoing relevance.
Trends and Gaps
- Increase in filings around FXR and TGR5 modulators from 2015 onward.
- A relative scarcity of patents on combination therapies specifically involving bile acid modulation and other metabolic pathways.
- Opportunities remain in expanding the scope to novel formulations or delivery technologies.
Implications for R&D and Business Strategy
- The broad nature of the claims suggests that competitors seeking to develop bile acid therapeutics need to design around these claims or license rights.
- Patent expiration dates, typically 20 years from filing, indicate potential availability around 2035 unless extended.
- The patent's emphasis on methods rather than compounds suggests opportunities in developing innovative compounds with similar or improved efficacy that avoid infringement.
Key Takeaways
- The patent protects specific methods of treating bile acid-related disorders, with claims that encompass a range of compounds and treatment protocols.
- Its scope is broad but can be circumvented with alternative compounds or delivery methods.
- The landscape is competitive, with existing patents on related compounds and mechanisms, especially FXR modulators and bile acid sequestrants.
- Patent protection remains enforceable until its expiration in 2037, considering U.S. patent term adjustments.
FAQs
1. What is the primary therapeutic focus of U.S. Patent 9,814,691?
It covers methods to treat disorders associated with abnormal bile acid levels, including gastrointestinal and liver diseases.
2. Which types of compounds are involved in the patent claims?
The patent encompasses compounds that influence bile acid pathways, including derivatives of existing sequestrants and novel chemical entities.
3. How broad are the patent claims?
Claims include methods of treatment, compositions, and formulations, with some claims covering broad categories of compounds and disorders, which can be selectively narrowed by dependent claims.
4. What is the current status of the patent landscape for bile acid therapies?
The landscape features active patent filings, especially around FXR agonists and transporter modulators. Major pharmaceutical companies hold numerous patents, creating a competitive environment.
5. When will the patent likely expire?
Assuming standard patent terms and no extensions, expiration is projected around 2037.
References
[1] U.S. Patent 9,814,691. "Methods for treating or preventing a disorder associated with abnormal bile acid levels."
[2] Patent landscape reports on bile acid therapeutics and FXR modulators, available from patent databases.
[3] USPTO patent status and maintenance fee data, accessed via public records.
