United States Patent 8,241,664: A Comprehensive Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,241,664, titled "Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same," is a significant patent in the pharmaceutical industry, particularly in the realm of drug delivery systems. This patent, issued to Clarus Therapeutics, Inc., protects innovative formulations and methods for the oral administration of hydrophobic drugs, including testosterone and its esters.
Patent Overview
Issuance and Assignee
The patent was issued on August 14, 2012, to Clarus Therapeutics, Inc., with inventors Dudley Robert E. and Constantinides Panayiotis P.[5].
Patent Title and Description
The patent describes a drug delivery system designed for the oral administration of hydrophobic drugs. It focuses on formulations that enhance and extend the absorption of these drugs, improving their pharmacokinetics. Specifically, it includes formulations comprising testosterone and testosterone esters, such as testosterone palmitate, and methods for treating hormone deficiencies or effecting male contraception with these formulations[5].
Claims and Scope
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims are crucial as they outline what is protected under the patent.
- Claim 1: This claim typically defines the broadest scope of the invention, often describing the overall system or method.
- Subsequent Claims: These claims narrow down the scope, providing more specific details about the components, methods, and applications of the drug delivery system[4].
Dependent Claims
Dependent claims build upon the independent claims, adding additional limitations and specifics. These claims help to further define the invention and provide a clearer understanding of what is protected.
- Claim 2-10: These claims might specify particular formulations, methods of preparation, or specific uses of the drug delivery system, such as the treatment of testosterone deficiency[4].
Patent Scope Metrics
Independent Claim Length and Count
Research suggests that the scope of a patent can be measured using metrics such as independent claim length and count. Patents with narrower claims, as indicated by shorter independent claim lengths and fewer independent claims, tend to have a higher probability of grant and a shorter examination process[3].
Examination Process Impact
The examination process often narrows the scope of patent claims. For US Patent 8,241,664, the claims were likely refined during the examination process to ensure clarity and specificity, which is a common practice to avoid overly broad claims that could lead to litigation and licensing issues[3].
Patent Landscape
Related Patents
The patent landscape surrounding US Patent 8,241,664 includes several related patents that protect various aspects of the drug Jatenzo, which is based on the formulations described in this patent.
- US10617696: Protects oral testosterone ester formulations and methods of treating testosterone deficiency, expiring in April 2030[2][5].
- US11179402: Covers pharmaceutical delivery systems for hydrophobic drugs, similar to the current patent, expiring in April 2026[2][5].
- US11564933: Focuses on methods of treating testosterone deficiency, expiring in April 2039[2][5].
Exclusivities and Generic Availability
In addition to the patent protection, Jatenzo benefits from FDA-granted exclusivities that delay the launch of generic or bioequivalent versions. These exclusivities are crucial in maintaining market exclusivity beyond the patent expiration dates[2].
Patent Infringement Assessment
Automated Systems
Advanced systems like PatentFinder are being developed to automate the process of patent infringement assessment. These systems can analyze molecular structures and Markush images to determine infringement, providing detailed reports that are both informative and interpretable. This is particularly relevant for patents like US 8,241,664, which involve complex chemical structures and formulations[1].
Challenges in Chemical Structure Comparison
LLMs (Large Language Models) often struggle with fine-grained comparisons of chemical structures, leading to errors in reasoning steps. This highlights the need for specialized tools and models, like those used in PatentFinder, to accurately assess patent infringement in the pharmaceutical domain[1].
Economic and Legal Implications
Patent Maintenance and Expiration
The patent is currently active but will expire on March 29, 2029. After expiration, the protected formulations and methods will enter the public domain, allowing other companies to develop and market similar products. However, any generic versions must still comply with FDA regulations and may be delayed due to existing exclusivities[5].
Licensing and Litigation
The clarity and specificity of the patent claims are crucial in avoiding licensing and litigation issues. Overly broad claims can lead to increased costs and diminished innovation incentives. The metrics of independent claim length and count can help in assessing the patent's scope and potential for disputes[3].
Key Takeaways
- Patent Scope: Defined by independent and dependent claims, with narrower claims generally associated with a higher grant probability and shorter examination process.
- Related Patents: Part of a broader landscape protecting various aspects of Jatenzo, including formulations, delivery systems, and treatment methods.
- Exclusivities: FDA-granted exclusivities play a significant role in delaying generic launches beyond patent expiration dates.
- Infringement Assessment: Advanced systems like PatentFinder are essential for accurate infringement analysis, especially in complex chemical structures.
- Economic Implications: Patent expiration and maintenance fees are critical factors influencing the economic viability of the protected inventions.
FAQs
What is the primary focus of US Patent 8,241,664?
The primary focus of US Patent 8,241,664 is on pharmaceutical delivery systems for the oral administration of hydrophobic drugs, including formulations of testosterone and its esters.
Who are the inventors and assignee of this patent?
The inventors are Dudley Robert E. and Constantinides Panayiotis P., and the assignee is Clarus Therapeutics, Inc.
What are the key metrics for measuring patent scope?
Key metrics include independent claim length and independent claim count, which help in assessing the patent's scope and potential for disputes.
How do FDA exclusivities impact the generic availability of Jatenzo?
FDA exclusivities delay the launch of generic or bioequivalent versions of Jatenzo, even after the patent expiration dates.
What challenges do LLMs face in patent infringement assessment for chemical structures?
LLMs often struggle with fine-grained comparisons of chemical structures, leading to errors in reasoning steps, which highlights the need for specialized tools like PatentFinder.
Sources
- Intelligent System for Automated Molecular Patent Infringement ... - arxiv.org
- Jatenzo patent expiration - Pharsight - pharsight.greyb.com
- Patent Claims and Patent Scope - hoover.org
- US8241664B2 - Pharmaceutical delivery systems for hydrophobic ... - patents.google.com
- Generic Jatenzo Availability - Drugs.com - drugs.com
