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Last Updated: December 22, 2024

Details for Patent: 8,221,785


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Summary for Patent: 8,221,785
Title:Transdermal hormone delivery system: compositions and methods
Abstract: A transdermal hormone delivery system (THDS) is disclosed. The THDS is useful for control of fertility and as therapy for a variety of diseases and conditions treatable by robust delivery of progestin and estrogen hormones, particularly the progestin, levonorgestrel. The THDS comprises a backing layer, an adjoining adhesive polymer matrix comprising an effective amount of at least a progestin hormone, delivery of which is enhanced by one or more skin permeation enhancing agents present in pre-determined amounts. The THDS is capable of providing effective daily doses of progestin and estrogen hormones from a small surface area in contact with the skin, e.g., less than 20 square centimeters. Methods of fertility control and various types of hormone replacement therapy utilizing the THDS are also disclosed.
Inventor(s): Chien; Te-Yen (Neshanic Station, NJ)
Assignee: Agile Therapeutics, Inc. (Princeton, NJ)
Application Number:12/556,740
Patent Claim Types:
see list of patent claims
Compound; Delivery;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 8,221,785

Introduction

United States Patent 8,221,785, issued to Agile Therapeutics, Inc., is a significant patent in the field of transdermal drug delivery systems. This patent is part of Agile Therapeutics' portfolio, particularly related to their contraceptive patch, Twirla™. Here, we will delve into the details of the patent's scope, claims, and the broader patent landscape.

Patent Overview

Patent Number and Issue Date

  • The patent number is 8,221,785, and it was issued on July 17, 2012[2].

Patent Expiration

  • The patent is set to expire in 2021, although this date may have passed, it is crucial to understand the patent's lifespan and its impact during its validity period[2].

Patent Scope

Technology and Application

  • The patent pertains to Agile Therapeutics' proprietary transdermal technology, specifically the AG200-15 contraceptive patch. This technology involves the delivery of hormones through the skin to prevent pregnancy[2].

Claims and Innovations

  • The patent includes claims related to the composition, design, and method of use of the transdermal patch. These claims are critical in defining the scope of protection for the invention.
    • Composition Claims: These claims detail the specific formulation of the patch, including the types and amounts of hormones and other components.
    • Design Claims: These claims cover the physical structure and design of the patch, ensuring that any similar products do not infringe on these specific design elements.
    • Method of Use Claims: These claims outline how the patch is applied and used, protecting the unique method of hormone delivery[2].

Independent and Dependent Claims

  • Independent Claims: These are the primary claims that stand alone and define the invention. For example, Claim 1 might describe the overall composition and structure of the patch.
  • Dependent Claims: These claims build upon the independent claims, providing additional details or variations. For instance, Claim 2 might specify a particular concentration of a hormone that is part of the composition described in Claim 1[3].

Metrics for Measuring Patent Scope

  • Independent Claim Length and Count: Research suggests that the length and number of independent claims can be metrics for measuring patent scope. Narrower claims with fewer dependencies are often associated with a higher probability of grant and a shorter examination process[3].

Patent Landscape

Competitive Environment

  • The patent landscape in the field of transdermal drug delivery is highly competitive. Companies like TherapeuticsMD, Inc. also hold patents in similar areas, such as vaginal inserted estradiol pharmaceutical compositions[1].

Global Protection

  • Agile Therapeutics has extended its patent protection globally, not just in the U.S. This strategic move enhances the value of their intellectual property and protects their technology in key markets around the world[2].

Economic and Innovation Impact

  • Patent Quality and Innovation: The quality and scope of patents can significantly impact innovation. Patents with clear and narrow claims can reduce licensing and litigation costs, thereby encouraging further innovation[3].

Search and Analysis Tools

  • USPTO Resources: The United States Patent and Trademark Office (USPTO) provides various tools for searching and analyzing patents, including the Patent Claims Research Dataset and the Common Citation Document (CCD) application. These tools help in understanding the prior art and the scope of existing patents[4][5].

Industry Expert Insights

  • CEO's Perspective: Al Altomari, President and CEO of Agile Therapeutics, highlighted the importance of these patents in enhancing the value of their intellectual property estate and underscoring the proprietary nature of their transdermal technology[2].

Statistical Insights

  • Patent Maintenance and Forward Citations: Studies have shown that patents with narrower claims tend to have higher maintenance payments and more forward citations, indicating their significance and impact on subsequent innovations[3].

Conclusion

United States Patent 8,221,785 is a crucial asset for Agile Therapeutics, protecting their innovative transdermal contraceptive patch technology. Understanding the scope and claims of this patent provides insights into the competitive landscape and the strategic importance of intellectual property in the pharmaceutical industry.

Key Takeaways

  • Patent Scope and Claims: The patent's scope is defined by its claims, which include composition, design, and method of use.
  • Metrics for Patent Scope: Independent claim length and count are useful metrics for measuring patent scope.
  • Global Protection: Agile Therapeutics has extended its patent protection globally to protect its technology.
  • Economic Impact: Clear and narrow claims can reduce costs and encourage innovation.
  • Industry Tools: USPTO resources like the Patent Claims Research Dataset and CCD application are essential for patent analysis.

FAQs

What is the main subject of United States Patent 8,221,785?

The main subject of United States Patent 8,221,785 is Agile Therapeutics' proprietary transdermal technology, specifically the AG200-15 contraceptive patch.

When was the patent issued and when does it expire?

The patent was issued on July 17, 2012, and it was set to expire in 2021.

What are the key claims in this patent?

The key claims include composition, design, and method of use claims related to the transdermal contraceptive patch.

How does the patent landscape affect innovation in this field?

A clear and narrow patent scope can reduce licensing and litigation costs, thereby encouraging further innovation in the field of transdermal drug delivery.

What tools are available for analyzing patent scope and claims?

The USPTO provides tools such as the Patent Claims Research Dataset and the Common Citation Document (CCD) application for analyzing patent scope and claims.

How does global patent protection impact a company's intellectual property?

Global patent protection enhances the value of a company's intellectual property and protects its technology in key markets around the world.

Sources

  1. United States Patent and Trademark Office, "VAGINAL INSERTED ESTRADIOL PHARMACEUTICAL COMPOSITIONS AND METHODS," US 10,668,082 B2.
  2. Biospace, "Agile Therapeutics, Inc. Announces Three New U.S. Patents on Its Technology and the Brand Name Twirla™ for Its First Contraceptive Patch."
  3. SSRN, "Patent Claims and Patent Scope," by Marco, Alan C., Sarnoff, Joshua D., and deGrazia, Charles.
  4. USPTO, "Search for patents."
  5. USPTO, "Patent Claims Research Dataset."

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Drugs Protected by US Patent 8,221,785

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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