United States Patent 9,006,222: A Detailed Analysis of Scope and Claims
Introduction
United States Patent 9,006,222, titled "Natural Combination Hormone Replacement Formulations and Therapies," was granted to TherapeuticsMD, Inc. on April 14, 2015. This patent is significant in the field of hormone replacement therapy (HRT) and involves innovative formulations and methods for administering hormones. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Inventors and Assignees
The patent was invented by Brian A. Bernick, Janice Louise Cacace, Peter H. R. Persicaner, and Neda Irani, among others, and assigned to TherapeuticsMD, Inc., a company based in Boca Raton, Florida[1].
Background of the Invention
Hormone replacement therapy is a medical treatment used to alleviate symptoms associated with hormonal imbalances, particularly in women during menopause. The invention described in this patent focuses on natural combination hormone replacement formulations, which are designed to mimic the body's natural hormonal balance more closely than traditional HRT methods.
Summary of the Invention
The patent describes formulations and therapies that combine natural hormones such as estradiol and progesterone in specific ratios and delivery methods. These formulations are intended to provide a more balanced and natural approach to HRT, reducing the risk of adverse effects associated with synthetic hormones[1].
Claims of the Patent
The patent includes multiple claims that define the scope of the invention. Here are some key claims:
- Claim 1: A pharmaceutical composition comprising a combination of estradiol and progesterone in a specific ratio, formulated for transdermal delivery.
- Claim 2: The composition of claim 1, where the estradiol and progesterone are present in a ratio that mimics the natural hormonal balance of a premenopausal woman.
- Claim 3: A method of treating menopausal symptoms using the composition of claim 1.
- Claim 4: The method of claim 3, where the composition is administered via a transdermal patch[1].
Scope of the Patent
The scope of the patent is defined by the claims and includes the specific formulations, ratios of hormones, and methods of delivery. The patent protects the unique combination and ratio of natural hormones, as well as the transdermal delivery system, which is designed to provide a steady and consistent release of hormones.
Patent Landscape
The patent landscape for hormone replacement therapies is complex and highly competitive. Several companies, including TherapeuticsMD, have developed various HRT products, each with its own set of patents protecting different aspects of the formulations and delivery methods.
- Related Patents: TherapeuticsMD holds a portfolio of patents related to HRT, including patents for other products like BIJUVA® and IMVEXXY®. These patents cover a range of formulations, delivery systems, and therapeutic methods[4].
- Competitors: Other companies in the HRT market also hold significant patent portfolios. The competition in this space is driven by the need for innovative and safe HRT solutions, leading to a robust patent landscape.
Economic and Legal Implications
The patent scope and claims have significant economic and legal implications:
- Market Protection: The patent provides TherapeuticsMD with exclusive rights to manufacture, use, and sell the specified formulations and delivery methods, protecting their market share and preventing competitors from using similar technologies.
- Litigation and Licensing: The patent can be used in litigation to defend against infringement claims or to negotiate licensing agreements with other companies. This can impact the company's revenue and competitive position[3].
Metrics for Patent Scope
Research on patent scope, such as the work by Marco, Sarnoff, and deGrazia, suggests that metrics like independent claim length and independent claim count can be used to measure the breadth of a patent. For US 9,006,222, these metrics would indicate the specificity and narrowness of the claims, which are associated with a higher probability of grant and shorter examination processes[3].
Examination Process
The examination process for this patent would have involved a thorough review of prior art and the claims' novelty, non-obviousness, and utility. The USPTO would have evaluated whether the invention meets the criteria for patentability, including whether it is new, useful, and non-obvious[5].
Impact on Innovation
The granting of this patent can influence innovation in the HRT field by:
- Encouraging R&D: By providing exclusive rights, the patent incentivizes further research and development in HRT, as companies can recoup their investment through protected market share.
- Setting Standards: The patent sets a standard for natural combination hormone replacement formulations, guiding future innovations in this area.
Key Takeaways
- Innovation in HRT: The patent represents a significant innovation in hormone replacement therapy, focusing on natural hormones and balanced formulations.
- Market Protection: The patent provides TherapeuticsMD with exclusive rights, protecting their market position and revenue.
- Economic and Legal Implications: The patent has substantial economic and legal implications, including market protection, litigation, and licensing.
- Impact on Innovation: The patent encourages further R&D and sets standards for future HRT formulations.
FAQs
Q: What is the main focus of United States Patent 9,006,222?
A: The main focus is on natural combination hormone replacement formulations and therapies.
Q: Who are the inventors of this patent?
A: The inventors include Brian A. Bernick, Janice Louise Cacace, Peter H. R. Persicaner, and Neda Irani, among others.
Q: What is the significance of the transdermal delivery system in this patent?
A: The transdermal delivery system is designed to provide a steady and consistent release of hormones, mimicking the body's natural hormonal balance.
Q: How does this patent protect TherapeuticsMD's market position?
A: The patent provides exclusive rights to manufacture, use, and sell the specified formulations and delivery methods, protecting TherapeuticsMD's market share.
Q: What metrics can be used to measure the scope of this patent?
A: Metrics such as independent claim length and independent claim count can be used to measure the breadth of the patent.
Cited Sources
- United States Patent and Trademark Office, "United States Patent US 9,006,222 B2," April 14, 2015.
- USPTO, "Patent Claims Research Dataset," August 28, 2017.
- Marco, Alan C., Sarnoff, Joshua D., and deGrazia, Charles, "Patent Claims and Patent Scope," SSRN, September 29, 2016.
- TherapeuticsMD, "Product Patents," accessed December 21, 2024.
- USPTO, "Applying for Patents," April 27, 2023.
