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Last Updated: December 22, 2024

Details for Patent: 8,221,784


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Summary for Patent: 8,221,784
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:12/543,859
Patent Claim Types:
see list of patent claims
Compound; Delivery;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 8,221,784: A Detailed Analysis

Introduction to Patent 8,221,784

United States Patent 8,221,784, issued on July 17, 2012, is one of the key patents held by Agile Therapeutics, a company specializing in women’s healthcare products. This patent is part of the company's extensive portfolio related to its proprietary transdermal technology, particularly for the contraceptive patch known as Twirla.

Overview of Agile Therapeutics and Twirla

Agile Therapeutics is focused on developing innovative women’s healthcare products. Their flagship product, Twirla, is a transdermal contraceptive patch designed to provide a convenient and effective method of birth control. The patent landscape surrounding Twirla is crucial for understanding the company's intellectual property strategy and competitive advantage[2][5].

Patent Details: 8,221,784

Issuance and Expiration

  • The patent was issued on July 17, 2012, and is set to expire in 2021[2][5].

Claims and Scope

  • The patent claims are related to the company's proprietary transdermal technology. Specifically, it covers aspects of the design, formulation, and application of the contraceptive patch.
  • The claims include details on the patch's composition, the method of administration, and the delivery system, which are critical components of the transdermal technology[2][5].

Independent Claims

  • Independent claims in a patent are those that stand alone and do not depend on other claims. For Patent 8,221,784, these claims would typically outline the core inventions and innovations that distinguish Agile Therapeutics' technology from existing solutions.
  • Research suggests that the length and count of independent claims can be indicative of the patent's scope and complexity. Narrower claims, as seen in this patent, often indicate a more focused and specific invention, which can be beneficial for enforcement and litigation purposes[3].

Patent Portfolio and Protection

Existing Portfolio

  • Agile Therapeutics holds a robust portfolio of patents related to Twirla, including several U.S. patents that extend protection through at least 2028.
  • The patents cover various aspects of the transdermal technology, ensuring comprehensive protection against potential competitors[2][5].

Orange Book Listing

  • The company intends to list these patents in the Orange Book, which is a critical step in protecting the intellectual property. The Orange Book lists drug products approved by the FDA, along with related patent and exclusivity information.
  • Listing in the Orange Book requires potential competitors seeking approval for generic versions to provide a patent certification, which can be a significant barrier to entry[1].

Strategic Importance

Competitive Advantage

  • The issuance of these patents underscores the proprietary nature of Agile Therapeutics' transdermal technology, enhancing the value of their intellectual property estate.
  • Al Altomari, President and CEO of Agile Therapeutics, emphasized the importance of these patents in expanding their patent portfolio and protecting their technology[2][5].

Global Expansion

  • Agile Therapeutics is not only focusing on U.S. patents but also developing their patent portfolio in key markets around the world. This global strategy is crucial for maintaining a competitive edge in the international market[2][5].

Impact on Innovation and Competition

Innovation Incentives

  • The issuance of these patents can influence innovation by providing a clear incentive for companies to invest in research and development. Protected intellectual property allows companies to recoup their investment and profit from their innovations[3].

Litigation and Licensing

  • However, overly broad patents can lead to increased litigation and licensing costs, which can diminish the incentives for innovation. The specificity and clarity of the claims in Patent 8,221,784 help mitigate these risks[3].

Conclusion

United States Patent 8,221,784 is a significant component of Agile Therapeutics' intellectual property strategy, particularly in the context of their transdermal contraceptive patch, Twirla. The patent's claims and scope are designed to protect the company's proprietary technology, ensuring a competitive advantage in the market.

Key Takeaways

  • Patent Protection: The patent extends protection through 2021 and is part of a broader portfolio that protects Agile Therapeutics' transdermal technology.
  • Claims and Scope: The patent covers specific aspects of the contraceptive patch's design, formulation, and application.
  • Strategic Importance: The patent enhances the company's intellectual property estate and provides a competitive advantage.
  • Global Expansion: Agile Therapeutics is expanding its patent portfolio globally to maintain a competitive edge.
  • Innovation and Competition: The patent incentivizes innovation and helps mitigate risks associated with overly broad patents.

FAQs

Q: What is the main subject of United States Patent 8,221,784?

A: The main subject is the proprietary transdermal technology related to Agile Therapeutics' contraceptive patch, Twirla.

Q: When was Patent 8,221,784 issued and when does it expire?

A: The patent was issued on July 17, 2012, and it expires in 2021.

Q: How does the patent protect Agile Therapeutics' technology?

A: The patent protects the technology by covering specific aspects of the patch's design, formulation, and application, and by being listed in the Orange Book.

Q: What is the significance of listing patents in the Orange Book?

A: Listing in the Orange Book requires potential competitors to provide a patent certification, acting as a barrier to entry for generic versions.

Q: How does this patent impact innovation and competition?

A: The patent provides an incentive for innovation by protecting the company's investment in research and development, while its specificity helps mitigate risks associated with overly broad patents.

Sources

  1. UNITED STATES SECURITIES AND EXCHANGE COMMISSION: Form 10-K, Agile Therapeutics, Inc.
  2. Biospace: Agile Therapeutics, Inc. Announces Three New U.S. Patents on Its Technology and the Brand Name Twirla(TM) for Its First Contraceptive Patch.
  3. SSRN: Patent Claims and Patent Scope.
  4. USPTO: Search for patents.
  5. Pharmabiz: Agile Therapeutics' contraceptive patch technology receives three US new patents.

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Drugs Protected by US Patent 8,221,784

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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