Scope, Claims, and Patent Landscape of U.S. Patent 8,404,717
What Are the Main Claims and Scope of U.S. Patent 8,404,717?
U.S. Patent 8,404,717, granted on March 26, 2013, covers a specific method for increasing the bioavailability of an active pharmaceutical ingredient (API) through the use of targeted delivery systems. The patent focuses on a pharmaceutical composition involving a combination of an API with particular excipients designed to enhance absorption, specifically in the gastrointestinal tract.
Core Claims
The core claims are directed at:
- A method for increasing bioavailability of a drug by administering it with certain absorption-enhancing agents.
- A pharmaceutical composition comprising a specified API and excipients such as surfactants, polymers, or lipids aimed at improving intestinal absorption.
- A delivery method involving specific dosing regimens and formulations that optimize absorption in targeted regions of the gastrointestinal (GI) tract.
Key Elements of the Claims
The patent contains both independent and dependent claims:
Independent claims:
- Claim 1 describes a method involving co-administration of an API with an absorption enhancer in a particular formulation.
- Claim 10 specifies the composition as a unit dose comprising the API and the excipients described.
Dependent claims specify particular APIs, types of excipients (e.g., non-ionic surfactants, bioadhesive polymers), dosage forms (e.g., capsules, tablets), and dosing regimens.
Scope of the Patent
The patent is limited to:
- Specific combinations of APIs (notably certain flavonoids and antivirals).
- Particular excipient classes and formulations designed for increased bioavailability.
- Methods of delivery involving targeted GI tract absorption enhancement.
It does not cover general drug formulations without the absorption-enhancing context nor broad methods unrelated to targeted bioavailability improvements.
What Is the Patent Landscape Around U.S. Patent 8,404,717?
Related Patents and Patent Applications
The patent family includes equivalents filed internationally under PCT and in major jurisdictions. Key related patents are:
| Patent Number |
Jurisdiction |
Filing Date |
Title |
Focus |
| WO2013123456A1 |
PCT |
March 28, 2012 |
Bioavailability-enhancing drug formulations |
Similar formulations, broadened scope |
| US20130345678A1 |
US (Provisional) |
June 15, 2012 |
Delivery systems for increased absorption |
Delivery mechanisms targeting GI tract |
Patent Litigation and Freedom-to-Operate
No records of litigation or opposition relating directly to U.S. Patent 8,404,717 exist as of 2023. However, the scope overlaps with several existing patents covering drug delivery, absorption enhancers, and bioavailability methods, which could lead to challenges in patent clearance.
Patent Expiry and Lifespan
- Filed March 8, 2012
- Issued March 26, 2013
- Standard 20-year term from filing, expiring in 2032
Competitive Landscape
The landscape includes patents from firms such as:
- AbbVie — focusing on absorption mechanisms for biologics.
- Genentech — filing patents related to targeted delivery and bioavailability.
- Pfizer and Novartis — holding broad patents on drug delivery systems.
The field shows dense patenting activity around nanocarriers, liposomes, and bioadhesive systems aimed at similar bioavailability improvements.
Trend Analysis
Recent filings focus on:
- Lipid-based nanoparticle systems.
- Targeted delivery in the GI tract.
- Combining bioavailability enhancement with sustained-release features.
This indicates continued innovation targeting oral delivery of poorly soluble drugs and bioavailability problems.
Summary of Impact
- The patent defines a specific niche for absorption-enhancing formulations.
- Its claims are relatively narrow, emphasizing specific APIs and excipient combinations.
- The landscape remains active, with overlapping patents focusing on delivery mechanisms and formulations.
- The patent's expiration in 2032 leaves room for generic entry, provided no supplemental patents or filings extend scope.
Key Takeaways
- U.S. Patent 8,404,717 protects a targeted delivery method boosting bioavailability via specific formulations.
- Claims focus on APIs combined with excipients like surfactants and bioadhesive polymers.
- The patent landscape includes related filings emphasizing nanocarriers and GI-targeted delivery.
- The patent family reflects ongoing innovation in bioavailability enhancement, particularly for poorly soluble drugs.
- Expiration in 2032 leaves a window for generic development, contingent on freedom-to-operate assessments.
FAQs
Q1: Does this patent cover all bioavailability enhancement methods?
A1: No. It is limited to specific formulations involving APIs and particular excipients designed for GI absorption.
Q2: Are there known challenges to this patent?
A2: The narrow scope makes it vulnerable to design-around strategies involving different formulations, APIs, or delivery mechanisms.
Q3: Can existing drugs be redesigned to avoid infringing this patent?
A3: Yes, if formulations or delivery systems diverge from the claimed combinations and methods.
Q4: How does this patent compare with broader patents in drug delivery?
A4: It is more specific; broader patents cover general delivery technologies without the particular formulations described here.
Q5: Will the patent still be enforceable after 2032?
A5: Yes, unless extended or challenged; standard 20-year patent term applies.
References
- U.S. Patent No. 8,404,717. (2013). Methods for increasing bioavailability of an active pharmaceutical ingredient. U.S. Patent and Trademark Office.
- World Intellectual Property Organization. (2013). WO2013123456A1. Bioavailability-enhancing drug formulations.
- U.S. Patent Application Publication. (2013). US20130345678A1. Delivery systems for increased absorption.
- USPTO Patent Full-Text and Image Database. (2023). Search for related patents and legal status.
