Detailed Analysis of the Scope and Claims of United States Patent 11,439,610
Introduction
United States Patent 11,439,610, issued to Evofem Biosciences, is a significant development in the field of women's sexual and reproductive health. This patent covers the composition of matter of Phexxi®, a hormone-free, woman-controlled contraceptive vaginal gel.
Patent Overview
The patent, titled "Compositions and Methods for Enhancing the Efficacy of Contraceptive Microbicides," was issued on September 13, 2022, by the United States Patent and Trademark Office (USPTO)[1][5].
Composition of Matter
The patent specifically covers the composition of Phexxi, which includes lactic acid, citric acid, and potassium bitartrate. This formulation is designed to maintain vaginal pH in the optimal range of 3.5 to 4.5, creating an environment inhospitable to sperm as well as certain bacterial and viral pathogens, including chlamydia and gonorrhea[1][5].
Claims and Scope
The claims of this patent are broad and encompass various aspects of the composition and its application:
- Composition Claims: The patent protects the specific combination of lactic acid, citric acid, and potassium bitartrate, which is the core formulation of Phexxi.
- Method Claims: It includes methods for enhancing the efficacy of contraceptive microbicides by maintaining the vaginal pH within a range that is hostile to sperm and certain pathogens[4][5].
- Synergistic Effects: The patent highlights the synergistic effects of the acidic carrier, which enhances the efficacy of both the contraceptive microbicide and antiviral agents[2][5].
Patent Expiration and Protection
The patent is expected to provide protection for Phexxi until at least March 15, 2033. This extended protection period is crucial for Evofem Biosciences, as it ensures exclusive rights to make, have made, market, and sell Phexxi for commercial purposes in the United States[1][2][5].
Intellectual Property Portfolio
This patent is part of a larger intellectual property portfolio for Evofem Biosciences, which comprises more than 40 patents. The portfolio includes Orange Book-listed method of use patents and additional protection afforded by the QIDP (Qualified Infectious Disease Product) designation granted by the FDA for the prevention of chlamydia and gonorrhea in women[1][5].
Market and Public Health Impact
Phexxi is the first and only FDA-approved hormone-free, woman-controlled contraceptive gel. Since its launch in 2020, over 100,000 women have been prescribed Phexxi by nearly 21,000 healthcare providers. The patent's protection is particularly significant given the rising rates of chlamydia and gonorrhea, with over 1.6 million cases of chlamydia and 700,000 cases of gonorrhea reported in 2021. The CDC has emphasized the need for innovative STD prevention methods, and Phexxi addresses this need by providing a dual-purpose product that prevents pregnancy and reduces the risk of STDs[1][5].
Clinical Trials and Future Directions
Evofem Biosciences is conducting registrational Phase 3 clinical trials (EVOGUARD) to evaluate Phexxi for the prevention of chlamydia and gonorrhea. Positive outcomes from these trials could lead to regulatory submissions and potential approval for these new indications in 2023, further expanding the product's utility in public health[1][5].
Patent Analytics and Landscape
The issuance of this patent strengthens Evofem's position in the market by providing comprehensive protection for their product. Patent analytics tools can help the company track and manage their patent portfolio, identifying gaps and opportunities in their intellectual property landscape. This includes using claim coverage matrices and scope concepts to categorize and analyze large numbers of patent claims, ensuring that all aspects of the technology are adequately protected[3].
Conclusion
United States Patent 11,439,610 is a pivotal development for Evofem Biosciences, enhancing their intellectual property portfolio and securing exclusive rights for Phexxi. The patent's broad claims and extended protection period ensure that Phexxi remains a unique and protected product in the market, addressing critical needs in women's sexual and reproductive health.
Key Takeaways
- Composition of Matter: The patent covers the specific formulation of Phexxi, including lactic acid, citric acid, and potassium bitartrate.
- Claims and Scope: The patent includes claims for the composition and methods for enhancing the efficacy of contraceptive microbicides.
- Patent Expiration: Protection is expected until at least March 15, 2033.
- Intellectual Property Portfolio: Part of a larger portfolio of over 40 patents.
- Market Impact: Addresses rising rates of chlamydia and gonorrhea with a dual-purpose product.
- Future Directions: Ongoing clinical trials for new indications.
FAQs
Q: What is the composition of Phexxi covered by the patent?
A: The patent covers the composition of Phexxi, which includes lactic acid, citric acid, and potassium bitartrate.
Q: What is the expected expiration date of the patent?
A: The patent is expected to provide protection until at least March 15, 2033.
Q: How does Phexxi work?
A: Phexxi works by maintaining vaginal pH in the optimal range of 3.5 to 4.5, creating an environment inhospitable to sperm and certain pathogens.
Q: What are the potential new indications for Phexxi being evaluated in clinical trials?
A: The trials are evaluating Phexxi for the prevention of chlamydia and gonorrhea.
Q: How many patents are in Evofem Biosciences' intellectual property portfolio for Phexxi?
A: The portfolio comprises more than 40 patents.
Cited Sources
- PR Newswire: Evofem Announces Issuance of U.S. Patent Covering Phexxi Composition of Matter.
- Drugs.com: Generic Phexxi Availability.
- SLWIP: Patent Analytics.
- Google Patents: US11439610B2 - Compositions and methods for enhancing the efficacy of contraceptive microbicides.
- BioSpace: Evofem Announces Issuance of U.S. Patent Covering Phexxi Composition of Matter.
