United States Patent 8,729,057: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 8,729,057, titled "Testosterone Gel and Method of Use," is a significant patent in the pharmaceutical industry, particularly in the treatment of hypogonadism. This patent, issued to Unimed Pharmaceuticals, LLC, and Besins Healthcare Luxembourg SARL, is part of a broader portfolio of patents related to testosterone gel formulations.
Patent Overview
Publication and Issuance
The patent was issued on May 20, 2014, to inventors Ramana Malladi and Jodi Stahlman. It is part of the "New Malladi Patents" group, which includes several related patents such as U.S. Patent Nos. 8,741,881, 8,754,070, and 8,759,329[5].
Patent Claims
The '057 patent includes multiple claims that define the scope of the invention. These claims cover various aspects of the testosterone gel formulation, including:
- Pharmaceutical Composition: The patent describes a transdermal hydroalcoholic testosterone gel formulation that includes specific ingredients such as glycerine, propylene glycol, and other excipients[1].
- Method of Use: The claims also encompass the method of applying the testosterone gel to the skin, ensuring effective absorption and therapeutic efficacy[1].
Scope of the Invention
Formulation Details
The patent specifies an improved formulation that enhances the stability and bioavailability of testosterone. Key components include:
- Glycerine and Propylene Glycol: These ingredients are crucial for the hydroalcoholic base, which facilitates skin penetration and maintains the stability of the testosterone[1].
- Other Excipients: The formulation may include additional excipients to enhance skin permeability and patient comfort.
Therapeutic Use
The testosterone gel is designed to treat hypogonadism in adult males. The method of use involves applying a specific dose of the gel to the skin, typically on the shoulders, upper arms, or abdomen, to achieve therapeutic testosterone levels[1].
Claim Construction and Legal Implications
Claim Construction
The claims of the '057 patent have been subject to legal scrutiny, particularly in the context of Abbreviated New Drug Applications (ANDAs) and patent infringement disputes. The court has considered the construction of disputed terms to determine the scope of the invention and potential infringement by generic manufacturers[2][5].
Patent Infringement
The patent holders have asserted that generic versions of the testosterone gel, such as those proposed by TWi Pharmaceuticals, infringe on the claims of the '057 patent. These disputes often involve detailed claim construction and analysis to determine whether the generic formulations fall within the scope of the patented invention[5].
Patent Landscape
Related Patents
The '057 patent is part of a larger family of patents related to testosterone gel formulations. Other patents in this group include:
- U.S. Patent Nos. 8,741,881, 8,754,070, and 8,759,329: These patents also cover various aspects of testosterone gel formulations and methods of use[5].
- U.S. Patent Nos. 8,466,136, 8,466,137, and 8,486,925: These are part of the "Malladi Patents" and cover earlier developments in testosterone gel technology[2].
Expiration Dates
The '057 patent, along with other related patents, has specific expiration dates that impact the market availability of generic versions. For example, the '057 patent and the '329 patent are listed to expire on October 12, 2026, with pediatric exclusivity extending the exclusivity period[5].
Economic and Market Impact
Market Dominance
The '057 patent, along with other related patents, has allowed the patent holders to maintain market dominance in the testosterone replacement therapy market. This has significant economic implications, as it affects the pricing and availability of generic alternatives.
Generic Competition
The expiration of these patents will open the market to generic competition, potentially reducing costs for patients and increasing market competition. However, until then, the patent holders continue to enjoy exclusive rights to manufacture and market the patented formulations.
Conclusion
The United States Patent 8,729,057 is a critical component of the intellectual property portfolio related to testosterone gel formulations. Its claims and scope define a specific and improved method for treating hypogonadism, and its legal implications have been central to several patent infringement disputes.
Key Takeaways
- Improved Formulation: The patent describes an enhanced transdermal hydroalcoholic testosterone gel formulation.
- Therapeutic Use: The method of use is designed for treating hypogonadism in adult males.
- Legal Implications: The patent has been involved in several legal disputes regarding claim construction and infringement.
- Related Patents: It is part of a larger family of patents covering testosterone gel formulations.
- Market Impact: The patent affects market competition and the availability of generic alternatives.
FAQs
What is the main subject of the United States Patent 8,729,057?
The main subject of the patent is an improved transdermal hydroalcoholic testosterone gel formulation and its method of use for treating hypogonadism.
Who are the inventors of the '057 patent?
The inventors of the '057 patent are Ramana Malladi and Jodi Stahlman.
What are the key ingredients in the patented testosterone gel formulation?
The key ingredients include glycerine, propylene glycol, and other excipients that enhance skin penetration and stability.
What is the therapeutic use of the patented testosterone gel?
The gel is used to treat hypogonadism in adult males by applying it to the skin to achieve therapeutic testosterone levels.
When does the '057 patent expire?
The '057 patent is listed to expire on October 12, 2026, with additional pediatric exclusivity extending the exclusivity period.
Sources
- US8729057B2 - Testosterone gel and method of use - Google Patents
- 13-236.pdf - District of Delaware
- Patent Claims Research Dataset - USPTO
- Research and Course Guides: Patent Searching, Advanced: Overview - Clemson University
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT ... - Insight.RPXcorp.com
