Detailed Analysis of the Scope and Claims of United States Patent 8,338,395
Introduction
United States Patent 8,338,395, titled "Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels," was issued on December 25, 2012. This patent is crucial in the field of pharmaceuticals, particularly for treatments involving testosterone replacement therapy.
Inventors and Assignees
The patent was invented by Doris Hubler, Sabine Fricke, Jan-Peter Ingwersen, and Wilhelm Kuhnz, and is assigned to Bayer Intellectual Property GmbH[1].
Scope of the Patent
Claims
The patent claims methods of using testosterone undecanoate, a specific formulation of testosterone, to achieve and maintain acceptable serum testosterone levels. The claims include:
- Methods for administering testosterone undecanoate to patients.
- Pharmaceutical compositions containing testosterone undecanoate.
- Specific dosing regimens to ensure stable and effective testosterone levels[1][5].
Active Ingredient
The active ingredient, testosterone undecanoate, is a long-acting testosterone ester that is administered orally or via injection. The patent focuses on its use in human drug products, highlighting its efficacy in treating conditions related to low testosterone levels[1][5].
Patent Landscape Analysis
Geographical Spread
The geographical spread of this technology is global, with the patent being filed and granted in the United States and potentially in other countries through international patent cooperation treaties. The global dossier service provided by the USPTO can help track related applications in other jurisdictions[3].
Saturation of the Patent Space
The patent space for testosterone formulations and treatments is moderately saturated. There are numerous patents related to testosterone therapies, including different formulations, delivery methods, and dosing regimens. A comprehensive patent landscape analysis would reveal the competitive landscape, identifying key players and potential gaps in the market[2][4].
Competitors and New Entrants
Key competitors in this space include other pharmaceutical companies that develop and market testosterone replacement therapies. New entrants might include biotech firms or generic drug manufacturers looking to enter the market with innovative formulations or delivery systems. A patent landscape analysis would help identify these competitors and their strategic positions[2][4].
Time-Slicing and Trends
Analyzing the patent filings over time (time-slicing) can reveal trends in the development of testosterone therapies. For instance, there may be an increase in patents related to novel delivery systems or formulations that improve the efficacy and safety of testosterone treatments. This analysis can help in understanding the evolution of the technology and identifying areas of future innovation[2].
Niche Patent Areas
There may be underappreciated niche areas within the broader category of testosterone therapies, such as patents focused on specific patient populations (e.g., pediatric or geriatric patients) or on addressing particular side effects associated with testosterone treatment. Identifying these niches can provide opportunities for targeted innovation and market entry[2].
Legal Status and Expiry Date
Current Status
As of the last available information, the patent is active but scheduled to expire on February 27, 2026. However, an application for a patent term extension under 35 U.S.C. ยง156 has been submitted, which, if approved, could extend the patent term by 435 days to May 8, 2027[1].
Duty of Disclosure
The applicant has acknowledged a duty to disclose any relevant information to the Director of the United States Patent and Trademark Office and the Secretary of Health and Human Services, ensuring transparency and compliance with regulatory requirements[1].
Strategic Insights
Decision-Making
A comprehensive patent landscape analysis for U.S. Patent 8,338,395 would provide critical insights for business and R&D decision-making. It would help in assessing the competitive landscape, identifying potential risks and opportunities, and guiding strategic decisions such as whether to invest in further research and development in this area[2][4].
Market Developments
The analysis would also reveal market developments such as mergers and acquisitions, licensing agreements, and litigation activities related to testosterone therapies. This information is essential for navigating the complex IP landscape and capitalizing on market opportunities[4].
Tools and Resources
USPTO Resources
The USPTO provides several resources that can be leveraged for a detailed patent landscape analysis, including the Public Search Facility, Patent and Trademark Resource Centers (PTRCs), and the Global Dossier service. These tools enable access to patent family information, citation data, and other relevant details necessary for a thorough analysis[3].
Common Citation Document (CCD)
The CCD application consolidates prior art citations from multiple IP offices, facilitating a more comprehensive understanding of the patent landscape and helping to identify potential prior art that could impact the validity or enforceability of the patent[3].
Key Takeaways
- Patent Scope: U.S. Patent 8,338,395 covers methods and pharmaceutical compositions for achieving acceptable serum testosterone levels using testosterone undecanoate.
- Competitive Landscape: The patent space for testosterone therapies is moderately saturated, with several key players and potential niches for innovation.
- Legal Status: The patent is active with a scheduled expiry date of February 27, 2026, but an extension application has been submitted.
- Strategic Insights: A comprehensive patent landscape analysis is crucial for informed decision-making in R&D and business strategy.
FAQs
Q: What is the primary focus of U.S. Patent 8,338,395?
A: The primary focus is on methods and pharmaceutical compositions using testosterone undecanoate to achieve and maintain acceptable serum testosterone levels.
Q: Who are the inventors of U.S. Patent 8,338,395?
A: The inventors are Doris Hubler, Sabine Fricke, Jan-Peter Ingwersen, and Wilhelm Kuhnz.
Q: What is the scheduled expiry date of U.S. Patent 8,338,395?
A: The patent is scheduled to expire on February 27, 2026, but an application for a term extension has been submitted.
Q: How can a patent landscape analysis benefit companies in the pharmaceutical industry?
A: It provides strategic insights into the competitive landscape, identifies potential risks and opportunities, and guides R&D and business decisions.
Q: What tools and resources are available for conducting a patent landscape analysis?
A: Tools include the USPTO's Public Search Facility, PTRCs, Global Dossier service, and the Common Citation Document (CCD) application.
Sources
- Patent Term Extension Application Including Appendices A-L. Regulations.gov.
- Patent Landscape Analysis - Uncovering Strategic Insights. AcclaimIP.
- Search for patents - USPTO. USPTO.
- Navigating Technological Domains with Patent Landscape Analysis. Sagacious Research.
- US8338395B2 - Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels. Google Patents.
